title: Registry-Based Prospective, Active Surveillance of Medical-Device Safety.
abstract: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).
  
  
  
  We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.
  
  
  
  We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.
  
  
  
  A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Frederic S
authors.initials: FS
authors.lastname: Resnic
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Arjun
authors.initials: A
authors.lastname: Majithia
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Susan
authors.initials: S
authors.lastname: Robbins
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Henry
authors.initials: H
authors.lastname: Ssemaganda
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Kathleen
authors.initials: K
authors.lastname: Hewitt
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Angelo
authors.initials: A
authors.lastname: Ponirakis
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Nilsa
authors.initials: N
authors.lastname: Loyo-Berrios
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Issam
authors.initials: I
authors.lastname: Moussa
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Joseph
authors.initials: J
authors.lastname: Drozda
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Sharon-Lise
authors.initials: SL
authors.lastname: Normand
authors.affiliation: From the Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center, Burlington (F.S.R., A.M., S.R., H.S.), and Tufts School of Medicine (F.S.R., A.M.) and Harvard Medical School and the Harvard T.H. Chan School of Public Health (S.-L.N.), Boston - all in Massachusetts; the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD (D.M.-D., N.L.-B.); the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC (K.H., A.P.); First Coast Cardiovascular Institute and University of Central Florida College of Medicine, Jacksonville (I.M.); Mercy Health, St. Louis (J.D.); and the Veterans Affairs Tennessee Valley Healthcare System and Vanderbilt University, Center for Population Health Informatics, Departments of Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center - both in Nashville (M.E.M.).
authors.forename: Michael E
authors.initials: ME
authors.lastname: Matheny
mesh_terms: D000368:Aged; D004867:Equipment Design; D004869:Equipment Safety / Q000706:statistics & numerical data; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011159:Population Surveillance; D011446:Prospective Studies; D012042:Registries; D012306:Risk; D018570:Risk Assessment / Q000379:methods; D065506:Vascular Closure Devices / Q000009:adverse effects*