BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1172423 · Received September 20, 2008

    Report

    Report Number
    2953161-2008-00271
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 19, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Product Problem
    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. A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    IN 2008, THE PT WAS TREATED FOR AN INFRARENAL ABDOMINAL ANEURYSM WITH A GORE EXCLUDER AAA ENDOPROSTHESIS. THE PHYSICIAN REMOVED AN ILIAC EXTENDER FROM THE BOX, FLUSHED WITH SALINE AND TRIED TO ADVANCE THE DELIVERY CATHETER OVER THE GUIDE WIRE. THE GUIDE WIRE WOULD NOT ADVANCE THROUGH THE DELIVERY CATHETER AND WAS STUCK HALFWAY UP THE CATHETER. A DIFFERENT ILIAC EXTENDER WAS USED AND IMPLANTED SUCCESSFULLY. ACCORDING TO THE FIELD SALES ASSOCIATE, THE DEVICE WAS HANDLED WITH CARE BY THE PHYSICIAN AND STAFF. THE DEVICE WILL BE SENT TO GORE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 05842260

    Patients

    Seq Age Sex Outcome Treatment
    1