BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6338508 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00508
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: AN INVESTIGATION WAS PERFORMED BASED ON THE AVAILABLE INFORMATION, BUT UNFORTUNATELY IT WAS NOT POSSIBLE TO CONCLUDE AN ROOT CAUSE FOR THIS EVENT. IT SEEMS HOWEVER LIKELY THAT THE OBSERVED ADVANCEMENT DIFFICULTIES ARE RELATED TO PATIENT TORTUOUS ANATOMY. 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: THE ACCESS ROUTE (LEFT) WAS SLIGHTLY TORTUOUS AND THE AORTA WAS TORTUOUS. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM TO THE TARGET SITE BUT FAILED DUE TO TORTUOUS AORTA. HE REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. 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
    120964 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526973

    Patients

    Seq Age Sex Outcome Treatment
    1