BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6155304 · Received December 8, 2016

    Report

    Report Number
    3002808486-2016-01471
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    December 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION OF RETURNED PRODUCT CONFIRMED THE ISSUE OF LEAKAGE, AND TEARS ON THE SILICONE DISC WERE DETECTED. ACTION HAS PREVIOUSLY BEEN INITIATED TO ADDRESS VALVE LEAKAGE AND NO FURTHER ACTION IS CURRENTLY FOUND NECESSARY SINCE PRODUCT WAS MANUFACTURED BEFORE ANY INTERNAL ACTIONS. IT IS NOTED THAT THE EVENT DID NOT HARM THE PATIENT AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: REP HAS ADVISED THAT THE VALVE WAS LEAKING BLOOD, NOT FROM THE BACK END BUT IT CAME FROM THE MIDDLE. BLOOD WAS LEAKING FROM WHAT APPEARED TO BE BETWEEN THE CLEAR PORT AND THE BLACK GRIPPER (LOST ABOUT 500 ML OF BLOOD). PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    805214 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002347226

    Patients

    Seq Age Sex Outcome Treatment
    1