BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6363465 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00621
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526850
    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: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO IMAGES WERE PROVIDED. BASED ON THE DESCRIPTION OF EVENT AND SINCE DEVICE WAS NOT RETURNED IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT, HOWEVER IT MIGHT HAVE RELATED PROBLEMS WITH THE CAPTOR VALVE IRIS OR THE SILICONE DISCS. INTERNAL ACTIONS HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AT PREPARATION, THE PHYSICIAN EXPERIENCED FLUSHING DIFFICULTY DUE TO SALINE LEAKAGE FROM THE HEMOSTATIC VALVE. THE DEVICE WAS USED FOR THE PROCEDURE SINCE HE MANAGED TO EXIT SALINE FROM THE PORT NEAR THE TIP. 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
    147217 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526850

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR