BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6344979 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00531
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE RETURNED DEVICE APPEARS TO BE INTACT. THE STENT GRAFT WAS EASILY DEPLOYED ON THE TABLE. A VISUAL INSPECTION OF BOTH THE GRAFT AND THE INTRODUCER SYSTEM REVEALED NO DAMAGES OR DEFECTS. WITHOUT IMAGES OF THE PATIENTS ANATOMY IT IS NOT POSSIBLE TO DETERMINE WHY THE DEVICE WOULD NOT TRACK OVER THE AORTIC ARCH. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT WAS NOT POSSIBLE TO PUSH THE GRAFT OVER THE AORTIC ARC NO MATTER WHICH WIRE WAS PULLED. PATIENT OUTCOME: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127189 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527116

    Patients

    Seq Age Sex Outcome Treatment
    1