BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1911373 · Received November 24, 2010

    Report

    Report Number
    2017233-2010-00530
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED THE PHYSICIAN REMOVED THE CATHETER WITH NO RESISTANCE AND NOTICED THE DISTAL SHAFT OF THE CATHETER WAS DETACHED. ANGIOGRAM IMAGES CONFIRMED THAT THE DISTAL SHAFT REMAINED ON THE GUIDEWIRE AND WAS STILL INSIDE THE PT. THE PHYSICIAN PERFORMED A SNARE TECHNIQUE TO REMOVE THE DISTAL SHAFT PORTION OF THE CATHETER. THE DISTAL SHAFT WAS REMOVED SUCCESSFULLY AND THE PT TOLERATED THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 WLG425 8122694

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SIMVASTATIN| CLONIDINE| DILAUDID| CALCIUM| BUPIVACAINE| ATENOLOL| PLETAL