BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5982372 · Received September 28, 2016

    Report

    Report Number
    3002808486-2016-01168
    Event Type
    Injury
    Date Received
    September 28, 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 Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: CORRECTIVE AND PREVENTIVE ACTIONS WERE LAUNCHED TO MITIGATE THIS TYPE OF EVENT. THIS DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE CORRECTIVE AND PREVENTIVE ACTIONS. SINCE THE IMPLEMENTATION OF THE CORRECTIVE AND PREVENTIVE ACTIONS, THE COMPLAINT RATE FOR THIS ISSUE HAS DECREASED. THE CORRECTIVE AND PREVENTIVE ACTIONS ARE STILL IN PROGRESS. NO EVIDENCE TO SUGGEST THAT THE 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 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. (B)(4) 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, (B)(4) 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-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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635208 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