{"id":"https://openalex.org/W7155197492","doi":"https://doi.org/10.1007/s10916-026-02388-z","title":"Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan","display_name":"Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan","publication_year":2026,"publication_date":"2026-04-23","ids":{"openalex":"https://openalex.org/W7155197492","doi":"https://doi.org/10.1007/s10916-026-02388-z","pmid":"https://pubmed.ncbi.nlm.nih.gov/42024289"},"language":"en","primary_location":{"id":"doi:10.1007/s10916-026-02388-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10916-026-02388-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10916-026-02388-z.pdf","source":{"id":"https://openalex.org/S37151855","display_name":"Journal of Medical Systems","issn_l":"0148-5598","issn":["0148-5598","1573-689X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Systems","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://link.springer.com/content/pdf/10.1007/s10916-026-02388-z.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5134242124","display_name":"Kohei Takahashi","orcid":"https://orcid.org/0009-0009-3528-5695"},"institutions":[{"id":"https://openalex.org/I4210099339","display_name":"Chiba University Hospital","ror":"https://ror.org/0126xah18","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210099339"]}],"countries":["JP"],"is_corresponding":true,"raw_author_name":"Kohei Takahashi","raw_affiliation_strings":["Biostatistics section, Clinical Research Center, Chiba University Hospital, Chiba, Japan. kohei.high84@chiba-u.jp"],"raw_orcid":"https://orcid.org/0009-0009-3528-5695","affiliations":[{"raw_affiliation_string":"Biostatistics section, Clinical Research Center, Chiba University Hospital, Chiba, Japan. kohei.high84@chiba-u.jp","institution_ids":["https://openalex.org/I4210099339"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049471017","display_name":"Hideto Yokoi","orcid":null},"institutions":[{"id":"https://openalex.org/I4210135297","display_name":"Kagawa University Hospital","ror":"https://ror.org/033sspj46","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I201933988","https://openalex.org/I4210135297"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Hideto Yokoi","raw_affiliation_strings":["Clinical Research Support Center, Kagawa University Hospital, Kagawa, Japan","Department of Medical Informatics, Kagawa University Hospital, Kagawa, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Research Support Center, Kagawa University Hospital, Kagawa, Japan","institution_ids":["https://openalex.org/I4210135297"]},{"raw_affiliation_string":"Department of Medical Informatics, Kagawa University Hospital, Kagawa, Japan","institution_ids":["https://openalex.org/I4210135297"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5134312378","display_name":"Fumiaki Mikami","orcid":null},"institutions":[{"id":"https://openalex.org/I4210135297","display_name":"Kagawa University Hospital","ror":"https://ror.org/033sspj46","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I201933988","https://openalex.org/I4210135297"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Fumiaki Mikami","raw_affiliation_strings":["Department of Medical Informatics, Kagawa University Hospital, Kagawa, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Informatics, Kagawa University Hospital, Kagawa, Japan","institution_ids":["https://openalex.org/I4210135297"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056185498","display_name":"Tomomi Satomi","orcid":null},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Tomomi Satomi","raw_affiliation_strings":["Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067473884","display_name":"Morikazu SEKI","orcid":null},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Morikazu Seki","raw_affiliation_strings":["Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5134271472","display_name":"Takako Takayama Niwa","orcid":null},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Takako Takayama Niwa","raw_affiliation_strings":["Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Medical Safety and Report Management Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061929521","display_name":"Hideki Hanaoka","orcid":"https://orcid.org/0000-0003-0186-9296"},"institutions":[{"id":"https://openalex.org/I4210099339","display_name":"Chiba University Hospital","ror":"https://ror.org/0126xah18","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210099339"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Hideki Hanaoka","raw_affiliation_strings":["Clinical Research Center, Chiba University Hospital, Chiba, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Research Center, Chiba University Hospital, Chiba, Japan","institution_ids":["https://openalex.org/I4210099339"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5070639273","display_name":"Yosuke Inaba","orcid":"https://orcid.org/0000-0002-8659-2873"},"institutions":[{"id":"https://openalex.org/I4210099339","display_name":"Chiba University Hospital","ror":"https://ror.org/0126xah18","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210099339"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Yosuke Inaba","raw_affiliation_strings":["Biostatistics section, Clinical Research Center, Chiba University Hospital, Chiba, Japan"],"raw_orcid":"https://orcid.org/0000-0002-8659-2873","affiliations":[{"raw_affiliation_string":"Biostatistics section, Clinical Research Center, Chiba University Hospital, Chiba, Japan","institution_ids":["https://openalex.org/I4210099339"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5085295316","display_name":"Daisuke Koide","orcid":"https://orcid.org/0000-0002-4238-0334"},"institutions":[{"id":"https://openalex.org/I74801974","display_name":"The University of Tokyo","ror":"https://ror.org/057zh3y96","country_code":"JP","type":"education","lineage":["https://openalex.org/I74801974"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Daisuke Koide","raw_affiliation_strings":["Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"],"raw_orcid":"https://orcid.org/0000-0002-4238-0334","affiliations":[{"raw_affiliation_string":"Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan","institution_ids":["https://openalex.org/I74801974"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":9,"corresponding_author_ids":["https://openalex.org/A5134242124"],"corresponding_institution_ids":["https://openalex.org/I4210099339"],"apc_list":{"value":3390,"currency":"EUR","value_usd":4390},"apc_paid":{"value":3390,"currency":"EUR","value_usd":4390},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.91611778,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":null,"biblio":{"volume":"50","issue":"1","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.14100000262260437,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.14100000262260437,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.12359999865293503,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.12120000272989273,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.5454999804496765},{"id":"https://openalex.org/keywords/stent","display_name":"Stent","score":0.5024999976158142},{"id":"https://openalex.org/keywords/adverse-effect","display_name":"Adverse effect","score":0.48510000109672546},{"id":"https://openalex.org/keywords/confidence-interval","display_name":"Confidence interval","score":0.37400001287460327},{"id":"https://openalex.org/keywords/event","display_name":"Event (particle physics)","score":0.3418000042438507},{"id":"https://openalex.org/keywords/patient-safety","display_name":"Patient safety","score":0.34139999747276306}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.796999990940094},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.5454999804496765},{"id":"https://openalex.org/C2778583881","wikidata":"https://www.wikidata.org/wiki/Q1325542","display_name":"Stent","level":2,"score":0.5024999976158142},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.48510000109672546},{"id":"https://openalex.org/C126838900","wikidata":"https://www.wikidata.org/wiki/Q77604","display_name":"Radiology","level":1,"score":0.42329999804496765},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.37400001287460327},{"id":"https://openalex.org/C2779662365","wikidata":"https://www.wikidata.org/wiki/Q5416694","display_name":"Event (particle physics)","level":2,"score":0.3418000042438507},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.34139999747276306},{"id":"https://openalex.org/C203595873","wikidata":"https://www.wikidata.org/wiki/Q25389927","display_name":"Change detection","level":2,"score":0.3409999907016754},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.33320000767707825},{"id":"https://openalex.org/C164705383","wikidata":"https://www.wikidata.org/wiki/Q10379","display_name":"Cardiology","level":1,"score":0.30880001187324524},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.29739999771118164},{"id":"https://openalex.org/C145642194","wikidata":"https://www.wikidata.org/wiki/Q870895","display_name":"Health informatics","level":3,"score":0.2957000136375427},{"id":"https://openalex.org/C2982822547","wikidata":"https://www.wikidata.org/wiki/Q179661","display_name":"Medical treatment","level":2,"score":0.28630000352859497},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.2818000018596649},{"id":"https://openalex.org/C2779843651","wikidata":"https://www.wikidata.org/wiki/Q7390335","display_name":"SIGNAL (programming language)","level":2,"score":0.2587999999523163}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007564","descriptor_name":"Japan","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007564","descriptor_name":"Japan","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D015607","descriptor_name":"Stents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D015607","descriptor_name":"Stents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D057867","descriptor_name":"Endoleak","qualifier_ui":"Q000209","qualifier_name":"etiology","is_major_topic":true},{"descriptor_ui":"D057867","descriptor_name":"Endoleak","qualifier_ui":"Q000209","qualifier_name":"etiology","is_major_topic":true},{"descriptor_ui":"D057867","descriptor_name":"Endoleak","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":true},{"descriptor_ui":"D057867","descriptor_name":"Endoleak","qualifier_ui":"Q000453","qualifier_name":"epidemiology","is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1007/s10916-026-02388-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10916-026-02388-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10916-026-02388-z.pdf","source":{"id":"https://openalex.org/S37151855","display_name":"Journal of Medical Systems","issn_l":"0148-5598","issn":["0148-5598","1573-689X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Systems","raw_type":"journal-article"},{"id":"pmid:42024289","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42024289","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of medical systems","raw_type":null},{"id":"pmh:oai:pubmedcentral.nih.gov:13106239","is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13106239/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Med Syst","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1007/s10916-026-02388-z","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10916-026-02388-z","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10916-026-02388-z.pdf","source":{"id":"https://openalex.org/S37151855","display_name":"Journal of Medical Systems","issn_l":"0148-5598","issn":["0148-5598","1573-689X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Systems","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.5847440361976624}],"awards":[{"id":"https://openalex.org/G1546689916","display_name":null,"funder_award_id":"23mk0101234h0002","funder_id":"https://openalex.org/F4320311405","funder_display_name":"Japan Agency for Medical Research and Development"},{"id":"https://openalex.org/G5463131793","display_name":null,"funder_award_id":"JP21lk0201701","funder_id":"https://openalex.org/F4320311405","funder_display_name":"Japan Agency for Medical Research and Development"}],"funders":[{"id":"https://openalex.org/F4320311405","display_name":"Japan Agency for Medical Research and Development","ror":"https://ror.org/004rtk039"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7155197492.pdf","grobid_xml":"https://content.openalex.org/works/W7155197492.grobid-xml"},"referenced_works_count":36,"referenced_works":["https://openalex.org/W121470278","https://openalex.org/W980260691","https://openalex.org/W1636470495","https://openalex.org/W1968477822","https://openalex.org/W1988100739","https://openalex.org/W1995945562","https://openalex.org/W2019952252","https://openalex.org/W2031365995","https://openalex.org/W2047305837","https://openalex.org/W2053592190","https://openalex.org/W2088642644","https://openalex.org/W2099645926","https://openalex.org/W2109852870","https://openalex.org/W2121354097","https://openalex.org/W2153972688","https://openalex.org/W2170736894","https://openalex.org/W2194417674","https://openalex.org/W2515822248","https://openalex.org/W2730626381","https://openalex.org/W2738680803","https://openalex.org/W2840731271","https://openalex.org/W3009168315","https://openalex.org/W3122207805","https://openalex.org/W3131294011","https://openalex.org/W3135647435","https://openalex.org/W3182937403","https://openalex.org/W4206821471","https://openalex.org/W4281661349","https://openalex.org/W4286252876","https://openalex.org/W4290792300","https://openalex.org/W4322489596","https://openalex.org/W4378905632","https://openalex.org/W4390796873","https://openalex.org/W4391261634","https://openalex.org/W4404358254","https://openalex.org/W4415635005"],"related_works":[],"abstract_inverted_index":{"Signal":[0],"detection":[1,223],"is":[2,230],"essential":[3],"for":[4,23,42,61,75,147],"identifying":[5],"potential":[6],"safety":[7],"issues":[8],"with":[9,30,119],"drugs":[10],"and":[11,49,55,71,86,141,188,210,240],"medical":[12,25,238],"devices.":[13,32],"Change":[14],"point":[15],"analysis":[16],"(CPA)":[17],"detects":[18],"changes":[19,115],"in":[20,67,116,155,158,171,180,190],"longitudinal":[21],"data":[22],"a":[24,152],"device":[26,139],"without":[27],"incorporating":[28],"comparisons":[29],"other":[31,237],"This":[33],"study":[34],"investigated":[35],"the":[36,50,53,81,96,102,164,186,196,214],"temporal":[37,114],"relationship":[38],"between":[39,83],"endoleak":[40,156],"reports":[41,74,92,134],"aortic":[43,76],"stent":[44,77],"grafts":[45,78],"identified":[46,151],"using":[47],"CPA":[48,109,150,202],"issuance":[51],"of":[52,64,105,132,174,207],"\"Pharmaceuticals":[54],"Medical":[56,65,97,106],"Devices":[57,107],"Agency":[58],"(PMDA)":[59],"Alert":[60],"Proper":[62],"Use":[63],"Devices\"":[66],"Japan.":[68],"Device":[69,98],"malfunction":[70],"adverse":[72,143,211],"event":[73],"submitted":[79],"to":[80,95,112,225,232,236],"PMDA":[82],"April":[84,159,191],"2008":[85,182],"September":[87],"2022":[88],"were":[89,93,135],"analyzed.":[90],"The":[91],"mapped":[94],"Problem":[99],"Terminology":[100],"from":[101],"Japan":[103],"Federation":[104],"Associations.":[108],"was":[110],"used":[111],"identify":[113],"report":[117],"counts,":[118],"change":[120],"points":[121],"having":[122],"confidence":[123],"levels":[124,168],"\u2265":[125],"90%":[126,170],"being":[127],"considered":[128],"significant.":[129],"A":[130],"total":[131],"20,678":[133],"analyzed,":[136],"including":[137],"23,541":[138],"malfunctions":[140,209],"30,500":[142],"events.":[144,149,212],"Endoleaks":[145],"accounted":[146],"10,779":[148],"significant":[153],"increase":[154],"events":[157],"2015":[160],"(2":[161],"years":[162,184],"before":[163,185,195],"regulatory":[165,226],"alert).":[166,197],"Confidence":[167],"exceeded":[169],"76":[172],"out":[173],"174":[175],"evaluated":[176],"time":[177],"points,":[178],"first":[179],"July":[181],"(9":[183],"alert)":[187],"next":[189],"2016":[192],"(1":[193],"year":[194],"Based":[198],"on":[199],"these":[200],"findings,":[201],"may":[203],"help":[204],"prioritize":[205],"investigations":[206],"medical-device-related":[208],"However,":[213],"results":[215],"do":[216],"not":[217],"indicate":[218],"earlier":[219],"or":[220],"superior":[221],"signal":[222],"relative":[224],"authorities.":[227],"Further":[228],"research":[229],"needed":[231],"assess":[233],"CPA's":[234],"applicability":[235],"devices":[239],"malfunctions.":[241]},"counts_by_year":[],"updated_date":"2026-04-29T09:16:38.111599","created_date":"2026-04-23T00:00:00"}
