BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6363468 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00630
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526997
    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 PRODUCT 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 SILICON DISCS. INTERNAL ACTIONS WERE IMPLEMENTED AND THIS SPECIFIC DEVICE WAS MANUFACTURED BEFORE IMPLEMENTATION. 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 FLUSHING THE DELIVERY SYSTEM FROM THE SIDE PORT WITH SALINE, BUT THE SALINE LEAKED FROM THE HEMOSTATIC VALVE. HE TURNED THE VALVE TO 'CLOSE' AND REPEATEDLY FLUSHED. FINALLY HE CONFIRMED THE SALINE CAME OUT FROM THE TIP AND THE STENT GRAFT WAS PLACED IN THE PATIENT. 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
    147404 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526997

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR