BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 5610882 · Received April 27, 2016

    Report

    Report Number
    3002808486-2016-00238
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 6, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346595
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE WITH 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED TILT/KINK. OF THE IMAGES IT WAS POSSIBLE TO DETERMINE THE EXISTENCE OF A SECOND DEVICE; HOWEVER THE PLACEMENT OF THIS DEVICE WAS CONSTRICTED BY THE ORIGINAL GRAFT KINK. IN ADDITION, THE KINKING SHORTENED THE AVAILABLE LENGTH FOR THE SECOND DEVICE TO SEAL ALONG THE INNER AORTIC CURVATURE ALLOWING A TYPE IA ENDOLEAK TO OCCUR. NO EVIDENCE TO SUGGEST THAT THE PRODUCT 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 COMPLAINANT: THE DEVICE TILTED DURING RELEASE FROM THE DELIVERY SYSTEM, DUE TO THE PRO-FORM SUTURE. PATIENT OUTCOME: ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE TILTED DURING RELEASE FROM THE DELIVERY SYSTEM, DUE TO THE PRO-FORM SUTURE. PATIENT OUTCOME: ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266064 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346595

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening