BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION

    MDR report key: 6313396 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00372
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526430
    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 INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. IT IS HOWEVER CONSIDERED HIGHLY UNLIKELY THAT THIS PRODUCT WAS MANUFACTURED WITH A BENDED STYLET. IT IS EXTREMELY DIFFICULT TO ADVANCE A BENDED STYLET THROUGH THE NEEDLE WIRE. IT IS MOST LIKELY THAT THE DAMAGE TO THE PRODUCT HAPPENED DURING SHIPPING OR AT THE HOSPITAL. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AT A PREPARATION, THE USER ATTEMPTED TO REMOVE THE STYLET FROM THE DELIVERY SYSTEM BUT THE STYLET WOULD NOT BE REMOVED. THERE WAS NO BACK-UP, SO THE PROCEDURE WAS FINISHED WITHOUT USING THIS PRODUCT. PATIENT OUTCOME: PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97801 ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526430

    Patients

    Seq Age Sex Outcome Treatment
    1