BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3801599 · Received May 9, 2014

    Report

    Report Number
    2017233-2014-00239
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    \:A REVIEW OF THE STERILIZATION AND MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR A LEFT COMMON ILIAC ANEURYSM 29MM IN DIAMETER, AND WAS IMPLANTED WITH GORE EXCLUDER ENDOPROSTHESES FEATURING THE C3 DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED DUE TO A RIGHT INGUINAL HEMATOMA. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS. ON (B)(6) 2014, THE PATIENT SUFFERED ON VENTRICULAR TACHYCARDIA AND WAS TREATED WITH ATP (ANTI TACHYCARDIA PACING) AND DC SHOCK (CARDIAC DEFIBRILLATOR). ON (B)(6) 2014, THE PATIENT SUFFERED ON BILATERAL INGUINAL INFECTIONS AND WAS TREATED WITH A DRAINAGE AND DRESSING OF THE BILATERAL GROINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280377 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12144234

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R PLC 161000 LOT# 12098893PXA 230300 LOT# 10253293