BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 2434396 · Received January 23, 2012

    Report

    Report Number
    1820334-2012-00054
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    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

    (B)(4) - SEPARATES IS NOT LISTED IN THE INSTRUCTIONS FOR USE. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. HE HAD HBV. DIAMETER OF THE ANEURYSM WAS AS BIG AS MAIN BODY AND ILIAC LEG GRAFT COULD BE MIGRATED. ANATOMICAL FORM OF BOTH SIDES OF CIA WAS LIKE OPEN WIDTHWISE. THE PHYSICIAN JUDGED THAT THE PT ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. AFTER MAIN BODY WAS GUIDED BY -AUS2 AND DEPLOYED, THE PHYSICIAN ATTEMPTED TO PLACE CONTRALATERAL (RIGHT) ILIAC LEG GRAFT WITH -AES. HOWEVER, BECAUSE THE DELIVERY SYS WOULD NOT BE ADVANCED, IT WAS PLACED CHANGING THE WIRE GUIDE IN LUNDERQUIST. WHEN THE GREY POSITIONER WAS TO DOCK WITH THE TOP CAP, THE GREY POSITIONER COULD NOT BE ADVANCED BECAUSE THE DELIVERY SYS WAS BENT TO CONTRALATERAL SITE. WHEN THE TOP CAP WAS GOING TO BE WITHDRAWN AFTER CHANGING THE WIRE GUIDE INTO LUNDERQUIST, THE PHYSICIAN NOTICED THAT THE CONTRALATERAL ILIAC LEG GRAFT WAS SEPARATED FROM THE MAIN BODY. IPSILATERAL ILIAC LEG GRAFT WAS PLACED, THEN CONVERTER PLACEMENT WAS TRIED BUT FAILED BECAUSE THE SYS WAS BENT TOWARD CONTRALATERAL SITE. THE CONVERTER DELIVERY SYS COULD NOT BE ADVANCED EVEN THOUGH LUNDERQUIST WAS ADVANCED UP TO ASCENDING AORTA. IPSILATERAL ILIAC LEG GRAFT WAS FOUND SEPARATED FROM MAIN BODY AS WELL. PULL-THROUGH METHOD WAS PERFORMED BY INSERTING WIRE GUIDE FROM BRACHIAL ARTERY AND SNARE FROM BOTH IPSILATERAL AND CONTRALATERAL SITES TO ADDITIONALLY PLACE AN ADD'L ILIAC LEGS; ONE CONTRALATERAL AND ONE IPSILATERAL. SEPARATED PARTS BETWEEN PRE-PLACED ILIAC LEGS AND MAIN BODY WERE COVERED BY THESE GRAFTS. THERE HAS BEEN NO ADVERSE EFFECTS TO THE PT.

    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 F2537475

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other