BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10021573 · Received May 4, 2020

    Report

    Report Number
    2017233-2020-00302
    Event Type
    Death
    Date Received
    May 4, 2020
    Date of Event
    September 3, 2013
    Report Date
    June 26, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 - CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON PUBLICATION DATE OF THE ARTICLE. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5. DESCRIBE EVENT OR PROBLEM

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: 'OUTCOMES OF ENDOVASCULAR AND CONTEMPORARY OPEN SURGICAL REPAIRS OF POPLITEAL ARTERY ANEURYSM'; YING HUANG, M.D., PHD; PETER GLOVICZKI, M.D.; GUSTAVO S. ODERICH, M.D.; AUDRA A. DUNCAN, M.D.; MANJU KALRA, MBBS; MARK FLEMING, M.D.; WILLIAM S. HARMSEN, MS; AND THOMAS C. BOWER, M.D.; DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY AND DEPARTMENT OF HEALTH SCIENCE RESEARCH, MAYO CLINIC; COPYRIGHT 2014 BY THE SOCIETY FOR VASCULAR SURGERY; HTTP://DX.DOI.ORG/10.1016/J.JVS.2014.03.257; PRESENTED AT THE THIRTY-SEVENTH ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY, CHICAGO, ILL, SEPTEMBER 6-8, 2013. THE PURPOSE OF THIS STUDY WAS TO COMPARE OUTCOMES AFTER ENDOVASCULAR REPAIR AND CONTEMPORARY OPEN REPAIR OF POPLITEAL ARTERY ANEURYSMS. CLINICAL DATA OF POPLITEAL ARTERY ANEURYSM PATIENTS TREATED BETWEEN 2005 AND 2012 WAS REVIEWED. THE GORE® VIABAHN® ENDOPROSTHESIS WAS THE DEVICE USED FOR ENDOVASCULAR REPAIR. THE ARTICLE REPORTED ON PAGE 634 AMPUTATION OCCURRED IN ONE PATIENT, AND THAT PATIENT LATER DIED 3 DAYS POST-OP AFTER EMERGENT ENDOVASCULAR REPAIR. THE PATIENT HAD ONE-VESSEL RUNOFF SEEN AFTER CATHETER-DIRECTED THROMBOLYSIS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. #2017233-2020-00300 - FOR THE TYPE I ENDOLEAK INVESTIGATION, #2017233-2020-00301 - FOR THE INFOLDING INVESTIGATION, #2017233-2020-00303 - FOR THE EARLY AMPUTATION INVESTIGATION, #2017233-2020-00304 - FOR THE EARLY DEATH INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: 'OUTCOMES OF ENDOVASCULAR AND CONTEMPORARY OPEN SURGICAL REPAIRS OF POPLITEAL ARTERY ANEURYSM'; YING HUANG, M.D., PHD; PETER GLOVICZKI, M.D.; GUSTAVO S. ODERICH, M.D.; AUDRA A. DUNCAN, M.D.; MANJU KALRA, MBBS; MARK FLEMING, M.D.; WILLIAM S. HARMSEN, MS; AND THOMAS C. BOWER, M.D.; DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY AND DEPARTMENT OF HEALTH SCIENCE RESEARCH, MAYO CLINIC; COPYRIGHT 2014 BY THE SOCIETY FOR VASCULAR SURGERY; HTTP://DX.DOI.ORG/10.1016/J.JVS.2014.03.257; PRESENTED AT THE THIRTY-SEVENTH ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY, CHICAGO, ILL, SEPTEMBER 6-8, 2013. THE PURPOSE OF THIS STUDY WAS TO COMPARE OUTCOMES AFTER ENDOVASCULAR REPAIR AND CONTEMPORARY OPEN REPAIR OF POPLITEAL ARTERY ANEURYSMS. CLINICAL DATA OF POPLITEAL ARTERY ANEURYSM PATIENTS TREATED BETWEEN 2005 AND 2012 WAS REVIEWED. THE GORE® VIABAHN® ENDOPROSTHESIS WAS THE DEVICE USED FOR ENDOVASCULAR REPAIR. THE ARTICLE REPORTED ON PAGE 634 ONE PATIENT EXPERIENCED EARLY MAJOR AMPUTATION LEADING TO AN EARLY DEATH AT 3 DAYS POST OP. THE PATIENT HAD ONE-VESSEL RUNOFF SEEN AFTER CATHETER-DIRECTED THROMBOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484322 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death