BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1914944 · Received November 29, 2010

    Report

    Report Number
    2017233-2010-00531
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE WARNS AGAINST ADVANCING THE DEVICE OUTSIDE THE INTRODUCER SHEATH; THE SHEATH WILL PROTECT THE DEVICE FROM CATHETER BREAKAGE OR PREMATURE DEPLOYMENT WHILE TRACKING IT INTO POSITION. COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: IMPROPER COMPONENT PLACEMENT AND ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. THE GORE EXCLUDER AAA TRUNK-IPSILATERAL LEG WAS PLACED WITHOUT INCIDENT. THE CONTRALATERAL GATE WAS CANNULATED WITHOUT DIFFICULTY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE GORE EXCLUDER AAA CONTRALATERAL LEG WITHOUT ADVANCING THE 18 FR INTRODUCER SHEATH ON THE CONTRALATERAL SIDE. THE DEVICE SEEMED TO HANG UP ON THE PREVIOUSLY PLACED TRUNK-IPSILATERAL LEG. THE DECISION WAS MADE TO WITHDRAW THE CONTRALATERAL LEG AND REINTRODUCE THE DEVICE AFTER ADVANCING THE SHEATH. HOWEVER, WHILE THE DEVICE WAS BEING REMOVED, IT DEPLOYED AND INADVERTENTLY COVERED THE LEFT INTERNAL ILIAC. A SECOND CONTRALATERAL LEG WAS THEN USED TO BRIDGE THE 3-4 CM GAP BETWEEN THE CONTRALATERAL GATE AND THE PROXIMAL PORTION OF THE FIRST CONTRALATERAL LEG. THE DEVICE WAS DEPLOYED WITHOUT INCIDENT. THE PT IS DOING FINE.

    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 7289781

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O ASPIRIN| AMLODIPINE (NORVASC)