BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3060531 · Received March 26, 2013

    Report

    Report Number
    2017233-2013-00169
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED. ATTEMPTS TO ACQUIRE INFO REQUIRED FOR THIS FORM WERE MADE BY GORE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM TREATMENT WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM AND A CONTRALATERAL LEG COMPONENT. AFTER THE DEPLOYMENT OF THE CONTRALATERAL LEG COMPONENT, THE PHYSICIAN MET RESISTANCE RETRACTING DELIVERY CATHETER THROUGH THE GORE DRYSEAL SHEATH. THE PHYSICIAN USED AN EXCESSIVE FORCE TO REMOVE THE DELIVERY CATHETER AND AS A RESULT THERE WAS A TEARING ON THE DELIVERY CATHETER. THE PHYSICIAN DECIDED TO TAKE OUT THE GUIDEWIRE, GORE PXC DELIVERY CATHETER AND GORE DRYSEAL SHEATH TOGETHER. THERE WAS NO HARM TO THE PT. IT WAS STATED THAT THE PHYSICIAN FOLLOWED THE IFU AND THE STEPS FOR THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123060 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11009676

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR