BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 8861787 · Received August 5, 2019

    Report

    Report Number
    2017233-2019-00599
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    November 23, 2018
    Report Date
    October 25, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B2 - OUTCOMES ATTRIBUTED TO ADVERSE EVENT B3 - DATE OF EVENT B5 - DESCRIBE EVENT OR PROBLEM H6 - PATIENT CODE 1 H6 - PATIENT CODE 2 H6 - PATIENT CODE 3. ADDITIONAL MANUFACTURER NARRATIVE: A1 - PATIENT IDENTIFIER A2 - AGE AT TIME OF EVENT A3 - SEX G5 - COMBINATION PRODUCT G5 - PRE-1938 G5 - OTC PRODUCT.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: "ENDOVASCULAR RECONSTRUCTION OF SUBCLAVIAN ARTERY ANEURYSMS IN PATIENTS WITH ATRIAL THORACIC OUTLET SYNDROME" (MEENA ARCHIE, M.D.; HUGH GELAGERT, M.D.; PRESENTED AT THE SOUTHERN CALIFORNIA VASCULAR SURGICAL SOCIETY 2018 MEETING IN LOS ANGELES; ANN VASC SURG 2019; 57: 10-15; PUBLISHED ONLINE: 23 NOVEMBER 2018) WAS REVIEWED. THIS REPORT CAPTURES 1 PATIENT WHO SUFFERED EARLY STENT THROMBOSIS AT 6 WEEKS POSTOPERATIVELY. THIS WAS SUCCESSFULLY RECANALIZED WITH OVERNIGHT CATHETER-DIRECTED THROMBOLYSIS. ADDITIONALLY, 1 STENT-GRAFT THROMBOSIS WAS NOTED AT 43 MONTHS IN A PATIENT WHO HAD DISCONTINUED HIS ANTIPLATELET MEDICATION. THROMBOSIS WAS MANAGED WITH OVERNIGHT CATHETER-DIRECTED THROMBOLYSIS. THE PATIENT HAS BEEN MAINTAINED ON CLOPIDOGREL WITH NO RECURRENT SYMPTOMS. NOTE: BOTH WALLSTENT¿ ENDOPROSTHESIS (BOSTON SCIENTIFIC, NEWTON, MA) AND GORE® VIABAHN® ENDOPROSTHESIS (W.L.GORE, FLAGSTAFF, AZ) WERE IMPLANTED DURING THE STUDY.

    Additional Manufacturer Narrative · 1

    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. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. NOTE: ARTICLE PUBLISH DATE IS 23 NOVEMBER 2018. PUBLISH DATE WILL BE USED AS THE DATE OF EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: "ENDOVASCULAR RECONSTRUCTION OF SUBCLAVIAN ARTERY ANEURYSMS IN PATIENTS WITH ATRIAL THORACIC OUTLET SYNDROME" (MEENA ARCHIE, M.D.; HUGH GELAGERT, M.D.; PRESENTED AT THE SOUTHERN CALIFORNIA VASCULAR SURGICAL SOCIETY 2018 MEETING IN LOS ANGELES; ANN VASC SURG 2019; 57: 10-15; PUBLISHED ONLINE: 32 NOVEMBER 2018) WAS REVIEWED. THE AIM OF THE STUDY WAS TO REPORT THE RESULTS WITH ENDOVASCULAR SUBCLAVIAN ARTERY RECONSTRUCTION IN ARTERIAL THORACIC OUTLET SYNDROME (TOS) PATIENTS OVER A 10-YEAR PERIOD WITH ATTENTION TO SURGICAL APPROACH AND LATE RESULTS. THE ARTICLE IDENTIFIES TWO PATIENTS REQUIRED REINTERVENTION FOR STENT THROMBOSIS (1.5 MONTHS, 36 MONTHS) AND 1 REQUIRED BALLOON ANGIOPLASTY FOR IN-STENT RESTENOSIS (24 MONTHS). WALL-STENTS (BOSTON SCIENTIFIC, NEWTON, MA) AND VIABAHN WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655372 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R