BEUDAMED
    FDA Adverse Event Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2221340 · Received August 17, 2011

    Report

    Report Number
    2017233-2011-00427
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 16, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PT POPULATIONS WITH LEAKING ANEURYSMS (PENDING RUPTURE OR RUPTURED). ADDITIONAL GORE DEVICES RELATED TO THE EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT WAS TREATED EMERGENTLY FOR A RUPTURING ABDOMINAL AORTIC ANEURYSM MEASURING 7 CM. A GORE EXCLUDER AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM WAS DEPLOYED ON THE PT'S RIGHT SIDE. AN AORTO-UNI-ILIAC CONVERSION WAS NECESSARY AS IT BECAME IMPOSSIBLE TO CANNULATE THE GATE WITH THE WIRE WHILE TRYING TO GAIN CONTROL OF THE BLEEDING. A GORE EXCLUDER AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED INSIDE THE FIRST TRUNK AND THEN EXTENDED WITH A GORE EXCLUDER AAA CONTRALATERAL LEG ENDOPROSTHESIS. TWO AMPLATZER PLUGS WERE DEPLOYED IN THE LEFT COMMON ILIAC ARTERY. THE ANEURYSM WAS EXCLUDED; HOWEVER, THE PT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME DURING THE PROCEDURE. THE PT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU) WHERE HE SUBSEQUENTLY CODED AND DIED. THE SURGEON STATED THAT THE DEATH WAS MOST LIKELY SECONDARY TO THE PT'S CARDIAC HISTORY.

    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 8782895

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| O AMPLATZER PLUGS| CARVEDILOL| PLAVIX| INSULIN| GLIPIZIDE