BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6010390 · Received October 7, 2016

    Report

    Report Number
    3002808486-2016-01203
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526928
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION WAS ONLY BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT FILE, AS NO IMAGING OR PRODUCT WAS PROVIDED. THE SAFETY, EFFECTIVENESS AND PERFORMANCE OF THE ZENITH TX2 TAA ENDOVASCULAR GRAFT HAS NOT BEEN EVALUATED IN PATIENTS WITH TRAUMATIC AORTIC INJURY. THEREFORE, IT IS NOT POSSIBLE TO EVALUATE WHETHER THIS CIRCUMSTANCE CONTRIBUTED TO THE REPORTED EVENT. IT SHOULD BE STATED THAT THE ESBE-DEVICE IS INTENDED FOR DISTAL EXTENSION AND NOT AS IN THIS CASE FOR PROXIMAL EXTENSION. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT TEVAR FOR TRAUMATIC AORTIC DISSECTION. THE PATIENT WAS NOT SUITABLE FOR THE PROCEDURE, BUT THE PHYSICIAN JUDGED TO PERFORM TEVAR SINCE IT IS USEFUL AND MINIMALLY INVASIVE FOR THE PATIENT WHO HAD TRAUMA. ESBE-32-80-T-PF WAS PLACED FIRST, THEN ZTEG-2P-36-202-PF WAS PLACED. THE BALLOONING WAS PERFORMED. WHEN ANGIOGRAPHY WAS PERFORMED, EXCESSIVE AMOUNT OF BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE WAS CONFIRMED. TOTAL AMOUNT OF HEMORRHAGE WAS 500CC AT SURGICAL OPERATION AND MOST HEMORRHAGE WAS DUE TO LEAKAGE FROM THE HEMOSTATIC VALVE ((B)(4)). ALSO, IT WAS SLIGHTLY OBSERVED PROXIMAL TYPE I ENDOLEAK. TO TREAT ENDOLEAK, ESBE-38-77-T-PF WAS PLACED ADDITIONALLY. NO ENDOLEAK WAS CONFIRMED AFTER PLACED THE EXTENSION ((B)(4)). PATIENT OUTCOME: THE PATIENT HAS BEEN TAKEN WAIT-AND-SEE APPROACH.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT TEVAR FOR TRAUMATIC AORTIC DISSECTION. THE PATIENT WAS NOT SUITABLE FOR THE PROCEDURE, BUT THE PHYSICIAN JUDGED TO PERFORM TEVAR SINCE IT IS USEFUL AND MINIMALLY INVASIVE FOR THE PATIENT WHO HAD TRAUMA. ESBE-32-80-T-PFWAS PLACED FIRST, THEN ZTEG-2P-36-202-PF WAS PLACED. THE BALLOONING WAS PERFORMED. WHEN ANGIOGRAPHY WAS PERFORMED, EXCESSIVE AMOUNT OF BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE WAS CONFIRMED. TOTAL AMOUNT OF HEMORRHAGE WAS 500 CC AT SURGICAL OPERATION AND MOST HEMORRHAGE WAS DUE TO LEAKAGE FROM THE HEMOSTATIC VALVE ((B)(4)). ALSO, IT WAS SLIGHTLY OBSERVED PROXIMAL TYPE I ENDOLEAK. TO TREAT ENDOLEAK, ESBE-38-77-T-PF WAS PLACED ADDITIONALLY. NO ENDOLEAK WAS CONFIRMED AFTER PLACED THE EXTENSION ((B)(4)). PATIENT OUTCOME: THE PATIENT HAS BEEN TAKING WAIT-AND-SEE APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663365 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526928

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening