BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3231837 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00301
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PER COMPLAINT EMAIL: ORIGINAL IMPLANT 9 YEARS AGO WENT WELL ACCORDING TO OP NOTES. DISEASE PROGRESSED PROXIMALLY AND ERODED THE PROXIMAL SEAL ZONE. THE ENTIRE ENDOGRAFT WAS LEFT IN PLACE, IT WAS RELINED WITH A NEW ENDOGRAFT. THE PT HAD ANOTHER MANUFACTURER'S GRAFT PLACED WITHIN THE ZENITH GRAFT. THE OTHER MANUFACTURER'S GRAFT WAS CHOSEN BECAUSE OF THEIR APPROVAL OF A 7MM INFRARENAL AORTIC NECK, WHICH IS WHAT THIS PT HAD. THE SECONDARY INTERVENTION WAS NOT SUCCESSFUL AND THE TYPE 1 ENDOLEAK PERSISTS. PER SALES REP: MIGRATED ZENITH ENDOGRAFT WAS DETECTED DURING ROUTINE FOLLOW-UP. SECONDARY INTERVENTION WAS ATTEMPTED BUT UNSUCCESSFUL. NOT SURE IF SECONDARY INTERVENTION COUNTS AS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323686 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1405184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other