{"id":"https://openalex.org/W4377262220","doi":"https://doi.org/10.1016/j.jvs.2023.03.456","title":"The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device","display_name":"The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device","publication_year":2023,"publication_date":"2023-05-22","ids":{"openalex":"https://openalex.org/W4377262220","doi":"https://doi.org/10.1016/j.jvs.2023.03.456"},"language":"en","primary_location":{"id":"doi:10.1016/j.jvs.2023.03.456","doi":"https://doi.org/10.1016/j.jvs.2023.03.456","is_oa":true,"landing_page_url":"http://dx.doi.org/10.1016/j.jvs.2023.03.456","pdf_url":"http://www.jvascsurg.org/article/S0741521423009709/pdf","source":{"id":"https://openalex.org/S104135014","display_name":"Journal of Vascular Surgery","issn_l":"0741-5214","issn":["0741-5214","1085-875X","1097-6809"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-2","ki-jl-2","medline","norway-2"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Vascular Surgery","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"http://www.jvascsurg.org/article/S0741521423009709/pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5113230735","display_name":"Douglas Hogan","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210091810","display_name":"Medtronic (United States)","ror":"https://ror.org/00grd1h17","country_code":"US","type":"company","lineage":["https://openalex.org/I4210091810"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Doug Hogan","raw_affiliation_strings":["The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN","institution_ids":["https://openalex.org/I4210091810"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036155904","display_name":"Diana M. Otoya","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210091810","display_name":"Medtronic (United States)","ror":"https://ror.org/00grd1h17","country_code":"US","type":"company","lineage":["https://openalex.org/I4210091810"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Diana Otoya","raw_affiliation_strings":["The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN","institution_ids":["https://openalex.org/I4210091810"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049322573","display_name":"Kedar S. Lavingia","orcid":"https://orcid.org/0000-0001-6664-267X","observed_orcids":["https://orcid.org/0000-0001-6664-267X"]},"institutions":[{"id":"https://openalex.org/I4210091810","display_name":"Medtronic (United States)","ror":"https://ror.org/00grd1h17","country_code":"US","type":"company","lineage":["https://openalex.org/I4210091810"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kedar Lavingia","raw_affiliation_strings":["The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN","institution_ids":["https://openalex.org/I4210091810"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5069242705","display_name":"Michael Fiore Amendola","orcid":"https://orcid.org/0000-0003-4097-0397","observed_orcids":["https://orcid.org/0000-0003-4097-0397"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Michael Amendola","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":4010,"currency":"USD","value_usd":4010},"apc_paid":null,"fwci":0.2413,"has_fulltext":true,"cited_by_count":1,"citation_normalized_percentile":{"value":0.51056058,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":94},"biblio":{"volume":"77","issue":"6","first_page":"e331","last_page":"e332"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10926","display_name":"Peripheral Artery Disease Management","score":0.4465000033378601,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10926","display_name":"Peripheral Artery Disease Management","score":0.4465000033378601,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.3537999987602234,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.08139999955892563,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/atherectomy","display_name":"atherectomy","score":0.6850000023841858},{"id":"https://openalex.org/keywords/product-recall","display_name":"product recall","score":0.6039999723434448},{"id":"https://openalex.org/keywords/peripheral-arterial-disease","display_name":"peripheral arterial disease","score":0.8709999918937683},{"id":"https://openalex.org/keywords/maude-database","display_name":"MAUDE database","score":0.8009999990463257},{"id":"https://openalex.org/keywords/medtronic","display_name":"Medtronic","score":0.6159999966621399}],"concepts":[{"id":"https://openalex.org/C100660578","wikidata":"https://www.wikidata.org/wiki/Q18733","display_name":"Recall","level":2,"score":0.920201301574707},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.876960277557373},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6718531250953674},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.519934356212616},{"id":"https://openalex.org/C2777209855","wikidata":"https://www.wikidata.org/wiki/Q755475","display_name":"Atherectomy","level":4,"score":0.5161836743354797},{"id":"https://openalex.org/C77088390","wikidata":"https://www.wikidata.org/wiki/Q8513","display_name":"Database","level":1,"score":0.38349878787994385},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.31591343879699707},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.25533443689346313},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.2540971636772156},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.08952072262763977},{"id":"https://openalex.org/C2778283817","wikidata":"https://www.wikidata.org/wiki/Q6590597","display_name":"Restenosis","level":3,"score":0.0},{"id":"https://openalex.org/C2778583881","wikidata":"https://www.wikidata.org/wiki/Q1325542","display_name":"Stent","level":2,"score":0.0},{"id":"https://openalex.org/C41895202","wikidata":"https://www.wikidata.org/wiki/Q8162","display_name":"Linguistics","level":1,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1016/j.jvs.2023.03.456","doi":"https://doi.org/10.1016/j.jvs.2023.03.456","is_oa":true,"landing_page_url":"http://dx.doi.org/10.1016/j.jvs.2023.03.456","pdf_url":"http://www.jvascsurg.org/article/S0741521423009709/pdf","source":{"id":"https://openalex.org/S104135014","display_name":"Journal of Vascular Surgery","issn_l":"0741-5214","issn":["0741-5214","1085-875X","1097-6809"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-2","ki-jl-2","medline","norway-2"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Vascular Surgery","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1016/j.jvs.2023.03.456","doi":"https://doi.org/10.1016/j.jvs.2023.03.456","is_oa":true,"landing_page_url":"http://dx.doi.org/10.1016/j.jvs.2023.03.456","pdf_url":"http://www.jvascsurg.org/article/S0741521423009709/pdf","source":{"id":"https://openalex.org/S104135014","display_name":"Journal of Vascular Surgery","issn_l":"0741-5214","issn":["0741-5214","1085-875X","1097-6809"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-2","ki-jl-2","medline","norway-2"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Vascular Surgery","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9537000060081482}],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.5899999737739563}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4377262220.pdf","grobid_xml":"https://content.openalex.org/works/W4377262220.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4253188965","https://openalex.org/W4319826244","https://openalex.org/W4226002596","https://openalex.org/W4285899981","https://openalex.org/W2014768390","https://openalex.org/W4225391170","https://openalex.org/W1944379814","https://openalex.org/W1979010569","https://openalex.org/W2809074730","https://openalex.org/W4213358861"],"abstract_inverted_index":null,"counts_by_year":[{"year":2024,"cited_by_count":1}],"updated_date":"2026-09-25T08:18:29.962427","created_date":"2025-10-10T00:00:00"}