BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 6348583 · Received February 22, 2017

    Report

    Report Number
    3002808486-2017-00601
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: 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. 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: A (B)(6) FEMALE PATIENT UNDERWENT TEVAR ON (B)(6) 2014. UPON FLUSHING THE DEVICE, IT WAS NOTED THAT THE VALVE WAS LEAKING. THE PROCEDURE CONTINUED AND THE PHYSICIAN USED THE DEVICE ANYWAY AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE COMPLAINT DEVICE. DURING THE OPERATION THE PATIENT HAD MINOR BLOOD PRESSURE DROP. PATIENT OUTCOME: THE PATIENT WAS FINE AND IN RECOVERY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132472 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526485

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR