BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6338547 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00537
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    November 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527130
    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 AVAILABLE INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT; HOWEVER THE MOST LIKELY CAUSE CAN BE RELATED TO THE STENOSED ILIAC ARTERY. AS SPECIFIED IN THE PACKAGE INSERT, THE ACCESS VESSEL DIAMETER AND MORPHOLOGY SHOULD BE COMPATIBLE WITH THE USED DELIVERY SYSTEM. NO EVIDENCE TO SUGGEST THAT PRODUCT 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 USER INSERTED THE DELIVERY SYSTEM FROM THE RIGHT FEMORAL BUT COULD NOT PASS VERY STENOSED RIGHT ILIAC ARTERY. TO AVOID CAUSING ADVERSE EFFECTS, THE USER DECIDED TO UNCONTINUE THE PROCEDURE. ANOTHER ATTEMPT WILL BE PLANNED WITH THE DIFFERENT APPROACH. 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
    121486 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention