BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1671943 · Received April 29, 2010

    Report

    Report Number
    2953161-2010-00067
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 28, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL EXPLANTED DEVICES: PXC141000/7369642, PXA280300/7039630, PXA280300/7039635.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ADDITIONAL AORTIC EXTENDERS WERE PLACED TO ADDRESS A PROXIMAL TYPE I ENDOLEAK, AND A Z-MED (NON-COMPLIANT 30X2) BALLOON WAS USED FOR FINAL BALLOONING OF THE AREA. THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THAT EVENING, HOWEVER, THE PT UNDERWENT EMERGENT OPEN REPAIR OF THE ANEURYSM, AND AN AXILLOBIFEMORAL BYPASS WAS PERFORMED. THE PHYSICIAN SUSPECTED CALCIUM WITHIN THE PROXIMAL AORTIC NECK HAD LACERATED THE AORTIC WALL DURING FINAL BALLOONING. THE PT TOLERATED THE PROCEDURE. ON (B) (6) 2010, THE PT EXPIRED. THE CAUSE OF DEATH IS UNK.

    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 WLG325 06417895

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| L| R