BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 2042048 · Received March 29, 2011

    Report

    Report Number
    3002808486-2011-00011
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE ANEURYSM EXTENDED PAST THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. THEREFORE THE CASE PLANNING INVOLVED PERFORMING A CAROTID SUBCLAVIAN BYPASS. THE PROXIMAL PORTION OF THE TX2 WOULD BE PLACED JUST DISTAL TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. THE FIRST DEVICE WAS PLACED AND THE PHYSICIANS WANTED TO USE THE CODA BALLOON TO AID IN THE APPOSITION OF THE GRAFT TO THE AORTIC WALL. THE AREA REP EXPLAINED THAT THE TENSION OF THE BALLOONING COULD PULL THE GRAFT BACK AS WELL AS HAVE OTHER NEGATIVE CONSEQUENCES. THE PHYSICIANS PROCEEDED WITH BALLOONING THE DEVICE. THE BALLOONING OF THE MID-PROXIMAL PORTION OF THE GRAFT CAUSED THE GRAFT TO JUMP BACK INTO THE ANEURYSM SAC. AT THIS POINT, THE PHYSICIANS REQUESTED A PROXIMAL CUFF TO EXTEND THE LANDING ZONE BACK TO THE ORIGIN OF THE LEFT CAROTID. AFTER STENT PLACEMENT, AN ANGIOGRAM WAS PERFORMED THROUGH THE LEFT CAROTID. AT THAT TIME, IT WAS NOTED THAT THERE APPEARED TO BE A DISSECTION IN THE ASCENDING AORTA. THIS BELIEF WAS CONFIRMED WITH IVUS. THE PROCEDURE WAS CONVERTED TO AN OPEN OPERATION AND THE TWO TX2 GRAFTS WERE EXPLANTED. IT IS THE AREA REP'S BELIEF (AND PHYSICIAN'S BELIEF) THAT THE DISSECTION OCCURRED WHILE BALLOONING THE FIRST DEVICE. IT IS BELIEVED THAT WHEN THE BALLOON CAUSED THE DEVICE TO JUMP BACK, THE PROXIMAL FIXATION CAUSED THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE NA E2687966

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening