BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6363475 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00643
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: VISUAL INSPECTION FOUND CAPTOR VALVE TORN WHICH IS ASSUMED TO BE THE ROOT CAUSE OF THIS EVENT. BASED ON WHAT IS REPORTED AND THE RESULTS OF THE INVESTIGATION UNKNOWN HOW AND WHEN THE DISK WAS TORN, HOWEVER THIS TEARING OF DISCS MOST LIKELY HAPPENED SOMEWHERE DURING THE PROCEDURE. INTERNAL ACTIONS HAVE BEEN INITIATED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER ATTEMPTED TO FLUSH THE DEVICE AS DIRECTED BY IFU BUT COULD NOT REMOVE AIR FROM THE DEVICE DUE TO LARGE AMOUNT OF FLUSHING FLUID LEAKAGE FROM THE HEMOSTATIC VALVE. HE THEN PRESSED THE VALVE AND MANAGED TO MAKE A LITTLE FLUID OUT FROM THE SHEATH TIP AND USED IT FOR THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147406 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527130

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR