BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1780874 · Received July 30, 2010

    Report

    Report Number
    2953161-2010-00144
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 29, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. PLEASE NOTE: THE PREVIOUSLY SUBMITTED MEDWATCH 2017233-2010-00282 REPORTED SPECIFICALLY ON THE 22FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (B)(4). THIS MEDWATCH IS TO REPORT SPECIFICALLY ON THE (B)(4).

    Description of Event or Problem · 1

    AS PREVIOUSLY REPORTED ON MEDWATCH 2017233-2010-00282, ON (B)(6) 2010, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ANEURYSM OF THE ASCENDING THORACIC AORTA USING GORE TAG THORACIC ENDOPROSTHESES. REMOVAL OF THE 22FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE RESULTED IN TRAUMATIC DISRUPTION OF THE LEFT EXTERNAL ILIAC ARTERY. A CONTRALATERAL LEG COMPONENT (B)(4) WAS USED TO REPAIR THE TRAUMATIC DISRUPTION. BLOOD LOSS WAS LESS THAN 1 LITER. ON (B)(6) 2010, THE PT UNDERWENT OPEN SURGERY, DUE TO BLEEDING FROM THE ANASTOMOSIS BETWEEN THE CONTRALATERAL LEG COMPONENT (B)(4) AND THE EXTERNAL ILIAC ARTERY. THE CONTRALATERAL LEG COMPONENT WAS EXPLANTED AND REPLACED WITH VASCULAR GRAFT. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 6971440

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R