BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1102964 · Received August 8, 2008

    Report

    Report Number
    2017233-2008-00448
    Event Type
    Death
    Date Received
    August 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    August 8, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. ANEURYSM RUPTURE DUE TO EXCESSIVE BALLOONING.

    Description of Event or Problem · 1

    IN 2008, THIS PT WAS IMPLANTED WITH A GORE EXCLUDER AA ENDOPROSTHESIS. AFTER IMPLANTING THE TRUNK-IPSILATERAL LEG COMPONENT AND AORTIC EXTENDER COMPONENT, THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICES WITH A 27MM COOK CODA BALLOON CATHETER. AS REPORTED, THE PHYSICIAN ATTEMPTED THREE TIMES TO BALLOON THE DEVICES, CAUSING THE ANEURYSM TO RUPTURE. THE PT EXPIRED ON THE TABLE. THE DEVICES WERE EXPLANTED AND SENT TO GORE FOR EVAL. NO DISRUPTIONS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325 05769647

    Patients

    Seq Age Sex Outcome Treatment
    1 Death