BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2232915 · Received July 21, 2011

    Report

    Report Number
    2953161-2011-00158
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 20, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    THE PT HAD NOTEWORTHY TORTUOSITY AND CALCIFICATION IN HIS ARTERIES. THE PHYSICIAN ADVISED THE CONTRALATERAL LEG COMPONENT WITH A SHEATH, HOWEVER, WAS UNABLE TO REACH THE CONTRALATERAL GATE WITH THE SHEATH. THE PHYSICIAN THEN ADVANCED THE DEVICE CATHETER OUTSIDE THE SHEATH TO DEPLOY THE DEVICE. THE DEVICE DEPLOYED 1 CM LOWER THAN INTENDED. THE DEPLOYMENT STRING BROKE BEFORE THE DEVICE COULD BE FULLY DEPLOYED. THE PHYSICIAN WAS ABLE TO SNARE THE OLIVE AND FURTHER DEPLOY THE GRAFT. THE PHYSICIAN THEN BALLOONED THE ENDOGRAFT AND WAS ABLE TO OPEN IT COMPLETELY. THE PROCEDURE WAS COMPLETED. THE ANEURYSM WAS EXCLUDED AND THE PT TOLERATED THE PROCEDURE WITH NO ADVERSE EVENT. THE DEVICE CATHETER WAS DISCARDED AT THE FACILITY. FILMS WERE READ IN THE FIELD. THE PHYSICIAN DID NOT REQUEST A RESPONSE.

    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 8931279

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PREDNISONE| HIGROTON| ALDACTONE| LORITAB| CUMADIN