BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2634281 · Received June 25, 2012

    Report

    Report Number
    2953161-2012-00127
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    June 15, 2012
    Report Date
    June 15, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - PER GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTION FOR USE (IFU): THE AORTIC AND ILIAC EXTENDER ENDOPROSTHESES ARE INTENDED TO BE USED AFTER DEPLOYMENT OF THE GORE EXCLUDER AAA ENDOPROSTHESIS. THESE EXTENSIONS ARE INTENDED TO BE USED WHEN ADDITIONAL LENGTH AND / OR SEALING FOR ANEURYSMAL EXCLUSION IS DESIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT ENDOVASCULAR REPAIR OF AN INFRARENAL ABDOMINAL AORTIC COARCTATION USING ILIAC EXTENDER ENDOPROSTHESIS. AFTER DEPLOYMENT OF THE PXL DEVICE, A TOUCH-UP BALLOONING WAS PERFORMED. AT THAT TIME, NARROWING PORTION OR THE AORTA RUPTURED. THE PHYSICIAN IMPLANTED ANOTHER TWO PXL DEVICES TO RESOLVE THE RUPTURE. THE PT TOLERATED THE PROCEDURE.

    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 9928288

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R