BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 7069913 · Received November 30, 2017

    Report

    Report Number
    3002808486-2017-02305
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 30, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT CONCERNS A PATIENT WITH AN ACUTE THORACIC AORTIC DISSECTION TYPE B. A TYPE A DISSECTION 9 DAYS POST-PROCEDURE WAS PRESENT WHERE THE TEAR ORIGINATED AT ANTERIOR PORTION OF MOST PROXIMAL STENT. IMAGING OR INFORMATION REGARDING THE VASCULAR MORPHOLOGY WAS NOT PROVIDED TO AID IN THE INVESTIGATION. IT HAS THEREFORE NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. IN ADDITION, ACCORDING TO THE IFU THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS/ULCERS OF THE DESCENDING THORACIC AORTA AND HAS NOT BEEN FORMALLY TESTED IN PATIENT POPULATIONS HAVING DISSECTIONS. THUS, THIS DEVICE WAS USED OUTSIDE OF INTENDED USE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2017. PATIENT THEN PRESENTED TO HOSPITAL NINE DAYS POST OP WITH A TYPE A RETROGRADE DISSECTION; TEAR ORIGINATED AT ANTERIOR PORTION OF MOST PROXIMAL STENT. PATIENT UNDERWENT OPEN SURGERY TO REPAIR THE TYPE A DISSECTION. (ENDOVASCULAR REPAIR OF TYPE B DISSECTION IN TRANSVERSE AND DESCENDING AORTA; TRANSPOSITION OF L SUBCLAVIAN WAS PERFORMED TO ACHIEVE OPTIMAL LANDING ZONE) " PATIENT OUTCOME: PATIENT UNDERWENT OPEN SURGERY TO REPAIR THE TYPE A DISSECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849647 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346434

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening