BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 5764248 · Received July 1, 2016

    Report

    Report Number
    3002808486-2016-00640
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 7, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347004
    PMA / PMN Number
    P140016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. E2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO A DEVICE IN US WITH THE 510(K): P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: EXAMINATION OF THE PRODUCT SHOWED THAT INITIALLY, IT WAS NOT POSSIBLE TO DEPLOY THE GRAFT. THE SHEATH WAS TRANSVERSELY CUT BEHIND THE GRAFT. SUBSEQUENTLY, THE PART OF THE SHEATH NOT COVERING GRAFT WAS EASILY RETRACTED. THE PART OF THE SHEATH COVERING THE GRAFT WAS STUCK, POSSIBLY DUE TO DRIED BLOOD. AFTER FLUSHING THE DEVICE, IT WAS POSSIBLE TO DEPLOY THE GRAFT. NO OTHER DEVIATIONS WERE SEEN. IMAGING OF PATIENT ANATOMY WAS REQUESTED, BUT NOT PROVIDED. IMAGING WOULD BE HELPFUL IN DETERMINE WHETHER PATIENT ANATOMY AFFECTED DEPLOYMENT IN THIS CASE. AS PER IFU CERTAIN ANATOMIC ELEMENTS MAY RESULT IN DIFFICULTY WHEN ATTEMPTING TO WITHDRAW THE SHEATH. WITHOUT IMAGING IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THIS EVENT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. THE COMPLAINT FILE CAN BE REOPENED IF FURTHER INFORMATION IS PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN TRYING TO RELEASE THE CARRIER IT BROKE DOWN. THERE WAS A PROBLEM WITH THE PULL BACK WHEN DEPLOYING THE GRAFT. IT WAS IMPOSSIBLE DUE TO MUCH RESISTANCE. ADDITIONAL INFORMATION RECEIVED 29JUN2016: THE EVENT WAS DURING THE PROCEDURE, GRAFT WAS IN THE PATIENT. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: WHEN TRYING TO RELEASE THE CARRIER IT HAS BROKEN DOWN. THEY HAD PROBLEM WITH THE PULL BACK WHEN DEPLOYING THE GRAFT . IMPOSSIBLE TO MUCH RESISTANCE. ADDITIONAL INFORMATION RECEIVED 29JUN2016: THE EVENT WAS DURING THE PROCEDURE, GRAFT WAS IN THE PATIENT. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420350 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002347004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other