BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION

    MDR report key: 6363473 · Received February 28, 2017

    Report

    Report Number
    3002808486-2017-00669
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526416
    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. THE EVALUATION IS BASED ON THE EVENT DESCRIPTION. DESCRIPTION OF EVENT STATE THAT MIGRATION HAPPENED DUE TO "THE PHYSICIAN PULLED THE DELIVERY SYSTEM SWIFTLY WITHOUT REMOVING A TRIGGER WIRE", WHICH IS PRESUMED TO BE THE ROOT CAUSE OF THIS EVENT. 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: A (B)(6) MALE PATIENT UNDERWENT TAA REPAIR WITH ANOTHER MANUFACTURER¿S STENT GRAFT (RELAY, MANUFACTURED BY (B)(4) LIFELINE) FROM THE RIGHT FEMORAL ARTERY. TX2 EXTENSION DEVICE WAS SELECTED AS A BACK-UP DEVICE. THE PATIENT HAD BLOOD VESSEL PROSTHESIS IMPLANTATION CONDUCTED IN THE ABDOMINAL ARTERY DUE TO AAA BEFORE. THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. THE EXTENSION DEVICE WAS ADDITIONALLY PLACED IN THE DISTAL SIDE OF THE RELAY STENT GRAFT AS TWO STENTS OF THE EXTENSION OVERLAPPED THE RELAY AND ONE STENT OF THE EXTENSION DID NOT OVERLAP IT. AFTER PLACING THE EXTENSION, THE PHYSICIAN PULLED THE DELIVERY SYSTEM SWIFTLY WITHOUT REMOVING A TRIGGER WIRE. AS A RESULT, THE EXTENSION DEVICE WAS MIGRATED DOWN TO THE ABDOMINAL ARTERY. THEN, THE EXTENSION DEVICE WAS REMOVED FROM THE VESSEL PROSTHESIS WITH OPEN SURGERY. ANOTHER TX2 EXTENSION DEVICE (ESBE-34-77-T-JP/ (B)(4)) WAS INSERTED FROM ABDOMINAL ARTERY AND ADDITIONALLY PLACED IN THE DESIRED POSITION. PATIENT OUTCOME: THE PATIENT HAS NOT RECOVERED YET AFTER OPEN SURGERY AS OF (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED (B)(4) 2013: ON (B)(6) 2013:, THE PATIENT HAS HAD A FAVOURABLE OUTCOME AFTER THE PROCEDURE AND HE HAS RECOVERED AS MUCH AS HE CAN EAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147405 ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526416

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R