BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 6334888 · Received February 16, 2017

    Report

    Report Number
    3002808486-2017-00474
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    August 12, 2013
    Report Date
    August 12, 2013
    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: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO IMAGES WERE PROVIDED. THE EVALUATION IS BASED ON THE EVENT DESCRIPTION ONLY. SINCE THE PRODUCT WAS NOT RETURNED IT HAS NOT BEEN POSSIBLE TO DETERMINE IF THE PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. HOWEVER, IT IS LIKELY THAT THE ADVANCEMENT DIFFICULTIES WAS CAUSED BY THE "HIGHLY TORTUOUS AORTA." THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN INSERTED TBE-40-81-PF IN THE PATIENT WITH HIGHLY TORTUOUS AORTA, HOWEVER, HE COULD NOT REACH IT TO THE TARGET SITE. HE REPLACED IT WITH A BACK-UP AND THE REPLACEMENT WAS USED WITHOUT PROBLEM. 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
    118132 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 80 YR