BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 5531104 · Received March 29, 2016

    Report

    Report Number
    3002808486-2016-00148
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    March 7, 2016
    Report Date
    March 7, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346885
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PRODUCT IS NOT RETURNED AND WE ARE THEREFORE NOT ABLE TO EXAMINE THE PRODUCT TO IDENTIFY THE ROOT CAUSE OF THE LEAKAGE. IT IS NOTED THAT THE PATIENT REQUIRED BLOOD TRANSFUSION, THAT NO OTHER ADVERSE EVENT HAPPENED DUE TO THE INCIDENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW DEVICE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE DELIVERY SYSTEM WAS PLACED AS USUAL BUT DURING THE PROCEDURE THE HEMOSTATIC VALVE IS BLEEDING TO MUCH BLOOD AND WHEN THE GRAFT IS GOING TO BE RELEASED THE BLEEDING DOES NOT STOP AND OPPOSITE TO THIS THE BLEED INCREASES CONSIDERABLY. IMMEDIATELY THE DOCTOR REMOVED THE DEVICE AND DECIDED TO USE A OTHER DEVICE. PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: BLOOD TRANSFUSION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE DELIVERY SYSTEM WAS PLACED AS USUAL BUT DURING THE PROCEDURE THE HEMOSTATIC VALVE IS BLEEDING TO MUCH BLOOD AND WHEN THE GRAFT IS GOING TO BE RELEASED THE BLEEDING DOES NOT STOP AND OPPOSITE TO THIS THE BLEED INCREASES CONSIDERABLY. IMMEDIATELY THE DOCTOR REMOVED THE DEVICE AND DECIDED TO USE A OTHER DEVICE. PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: BLOOD TRANSFUSION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189270 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346885

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R