BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6363592 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00636
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002236049
    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: NO PRODUCT IS RETURNED AND WE ARE THEREFORE UNABLE TO IDENTIFY THE ROOT CAUSE OF LEAKAGE. THE PROBLEM WITH LEAKAGE IS HOWEVER KNOWN AND INTERNAL ACTIONS HAS PREVIOUSLY BEEN INITIATED TO ADDRESS THE ISSUE. IT MIGHT BE THE SILICONE DISC USED THAT IS CAUSING THE LEAKAGE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER EXPERIENCED FLUSHING DIFFICULTY AS FLUSHING FLUID LEAKED FROM THE HEMOSTATIC VALVE. AFTER 100CC OF FLUID WAS USED TO FLUSH, HE INSERTED THE DEVICE INTO THE PATIENT AND THE STENT GRAFT WAS DEPLOYED. ADDITIONAL INFORMATION RECEIVED 03JUN2016: THE DELIVERY SYSTEM WAS REPLACED WITH ANOTHER MANUFACTURER'S (GORE'S) DRYSEAL SHEATH 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
    148990 ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002236049

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR