BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1573524 · Received December 28, 2009

    Report

    Report Number
    1820334-2009-00721
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    November 27, 2009
    Report Date
    December 3, 2009
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2009. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR. HOWEVER, THE CONTRALATERAL (RIGHT) ACCESS VESSEL WAS TORTUOUS AND HAD PARTIAL STENOSIS, THUS CONVERSION TO CONVERTER PLACEMENT HAD BEEN PLANNED IN ADVANCED TO THE PROCEDURE IF CONTRALATERAL (RIGHT) ACCESS WAS UNABLE. A IPSILATERAL (LEFT) ILIAC LEG WAS PLACED AS PRESCRIBED WITHOUT PROBLEM. HOWEVER, CONTRALATERAL CANNULATION WAS FOUND TO BE DIFFICULT AS EXPECTED. THEREFORE, THE PHYSICIAN PERFORMED CONVERTER PLACEMENT WITH COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. WHEN WITHDRAWING DILATOR AND GRAY POSITIONER OF THE CONVERTER DELIVERY SYSTEM, BLOOD LEAKED OUT FROM THE HEMOSTATIC VALVE. THE PHYSICIAN WITHDREW THE WHOLE DELIVERY SYSTEM, AND PERFORMED FEM-FEM BYPASS WITH LIGATION OF THE RIGHT COMMON ILIAC ARTERY. THE PT DIDN'T SHOW ANY POST PROCEDURE SYMPTOMS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2437481

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR