BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 3810676 · Received March 24, 2014

    Report

    Report Number
    3002808486-2014-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY DELIVERY SYSTEM RETURNED. STENT REMAINS IN PATIENT. (B)(4) OCCURRED DURING THE SAME PROCEDURE. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PHYSICIAN COMMENTED ON WHAT HE CONSIDERED EXCESSIVE BLOOD LOSS THROUGH Z-TRAZ PLUS HEMOSTASIS VALVES. THE PATIENT WAS GIVEN 2 UNITS OF TRANSFUSED BLOOD DURING PROCEDURE. AFTER THE ZTEG-2PT-38-202-PF-US WAS PLACED, IT WAS DECIDED TO EXTEND BY USING THE TBE-38-77-PF-US. PATIENT OUTCOME: (B)(6) 2014: ACCORDING TO THE PHYSICIAN, THE PATIENT DID "VERY WELL" OVERNIGHT AND IT IS ANTICIPATED THAT THE PATIENT WOULD BE DISCHARGED HOME ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172555 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION MIH WILLIAM COOK EUROPE E3098204

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR