BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10016313 · Received April 30, 2020

    Report

    Report Number
    2017233-2020-00284
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    July 24, 2017
    Report Date
    May 13, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: MANUFACTURING REPORT # 2017233-2020-00284 WAS SENT IN ERROR. ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH WILL BE RETRACTED. CORRECTED DATA: H6 CONCLUSION CODE 1. PRE-1938 AND OTC PRODUCT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. SEE MFR REPORT #2017233-2020-00285 FOR INVESTIGATION OF A PSEUDOANEURYSM. SEE MFR REPORT #2017233-2020-00286 FOR INVESTIGATION OF INTERVENTION AS A RESULT OF A PULMONARY EMBOLUS.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: 'HYBRID REVASCULARIZATION COMBINING ILIOFEMORAL ENDARTERECTOMY AND ILIAC STENT GRAFTING FOR TRANSATLANTIC INTER-SOCIETY CONSENSUS C AND D AORTOILIAC OCCLUSIVE DISEASE'; JULIET J. RAY, SARAH A. EIDELSON, CHARLES A. KARCUTSKIE, JONATHAN P. MEIZOSO, HILENE DEAMORIM, LEE J. GOLDSTEIN, JOHN KARWOWSKI, AND ARASH BORNAK; ANN VASC SURG 2018; 50: 73¿79; HTTPS://DOI.ORG/10.1016/J.AVSG.2017.11.061; PUBLISHED BY ELSEVIER INC.; MANUSCRIPT RECEIVED: JULY 24, 2017; MANUSCRIPT ACCEPTED: NOVEMBER 19, 2017; PUBLISHED ONLINE: 24 FEBRUARY 2018. THE PURPOSE OF THE STUDY WAS A RETROSPECTIVE REVIEW EXAMINING THE OUTCOMES OF HYBRID REVASCULARIZATION COMBINING ILIOFEMORAL ENDARTERECTOMY AND ILIAC ARTERY STENTING USING COVERED STENTS IN TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) C AND D AORTOILIAC OCCLUSIVE DISEASE (AIOD) INVOLVING THE COMMON FEMORAL ARTERY (CFA). ALL EXTERNAL ILIAC ARTERIES WERE TREATED USING A GORE® VIABAHN® ENDOPROSTHESIS. THE ARTICLE IDENTIFIES ON PAGE 76 A RE-INTERVENTION FOR A BILATERAL GROIN SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479670 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other