BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 6348578 · Received February 22, 2017

    Report

    Report Number
    3002808486-2017-00608
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526553
    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: BASED ON THE DESCRIPTION OF EVENT AND SINCE THE 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: FLUSH SOLUTION LEAKED FROM THE HEMOSTATIC VALVE DURING PREPARATION. TO TREAT TYPE IA ENDOLEAK, THE PHYSICIAN PLANNED TO PLACE THE EXTENSION (TBE-40-81-PF). HOWEVER, HE FLUSHED THE DEVICE WHILE PREPARATION, FLUSH SOLUTION LEAKED FROM THE HEMOSTATIC VALVE. THEREFORE, HE GAVE UP ON USING THIS DEVICE AND PERFORMED BALLOONING AT PROXIMAL NECK. THE ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132556 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526553

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR