BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2111132 · Received May 25, 2011

    Report

    Report Number
    1820334-2011-00251
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PATIENT OUTCOME NOT PROVIDED BY REPORTER. (B)(4): ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2011. THOUGH THE PATIENT HAD HIGH TORTUOSITY AT PROXIMAL NECK, THE PHYSICIAN JUDGED THAT HIS ANATOMICAL FORM (PROXIMAL NECK FORM AND ANGLE) WAS WITHIN A RANGE WRITTEN ON IFU OF ZENITH. PTRA WAS CONDUCTED TO THE RIGHT RENAL ARTERY BY BALLOONING AFTER THE AAA REPAIR JUST TO PREVENT OCCLUSION. ALSO, ANOTHER MANUFACTURER'S STENT WAS PLACED TO THE RIGHT ILIAC LEG JUST TO ENSURE THE SEALING. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK. OTHER MANUFACTURER'S AORTIC EXTENDER (26MM X 3.3) WAS PLACED AND IT WAS SEALED WITH MAXI BALLOON (25MM). THEN, THE ENDOLEAK WAS SOLVED (1820334-2011-00250). THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED A NOTABLE TYPE IV ENDOLEAK FROM THE MAIN BODY. THERE WAS NO TREATMENT CONDUCTED TO THE ENDOLEAK (1820334-2011-00251). THE PATIENT ACT: BEFORE THE PROCEDURE: 132 / DURING THE PROCEDURE: 234 -->311. THERE HAS BEEN NO PATIENT OUTCOME PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2536280

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR