BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1083278 · Received July 25, 2008

    Report

    Report Number
    1820334-2008-00450
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION - STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMALE WHO HAD CALCIFICATION AND STENOSIS OF BOTH EXTERNAL ILIAC ARTERIES UNDERWENT AAA REPAIR IN 2008. THE MAIN BODY WAS INTRODUCED VIA THE LEFT SIDE BUT THE DELIVERY SYSTEM DID NOT GO UP. THE PHYSICIAN DILATED THE IPSILATERAL ARTERY WITH A PTA BALLOON (7MM-8MM) BUT WAS NOT ABLE TO ADVANCE THE DELIVERY SYSTEM. THEN THE DELIVERY SYSTEM WAS INSERTED FROM THE RIGHT SIDE BUT AGAIN THE DELIVERY SYSTEM DID NOT GO UP. PTA WAS PERFORMED IN THE CONTRALATERAL LIMB, WITH NO RESOLUTION OF THE PROBLEM. PTA WAS PERFORMED WITH CUTTING BALLOONS IN THE NARROWED AREA OF THE LEFT EXTERNAL ILIAC ARTERY. AFTER THAT, ANGIOGRAPHY REVEALED A RUPTURE OF THE LEFT EXTERNAL ARTERY. DAMAGED AREAS WERE CLAMPED IN OPEN SURGERY AND THE MAIN BODY WAS INTRODUCED VIA THE LEFT COMMON ILIAC ARTERY. UPON COMPLETION OF GRAFT PLACEMENT, THE RUPTURED VESSEL WAS REPAIRED BY REPLACING IT WITH A PROSTHESIS. PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2173754

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention