BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6056508 · Received October 26, 2016

    Report

    Report Number
    3002808486-2016-01292
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 18, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346731
    Removal / Correction Number
    Z-2099-2017
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    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). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION, IT WAS POSSIBLE TO CONFIRM THE REPORTED EVENT. THE THROMBUS DEVELOPED IN TWO LOCATIONS. THE MORE PROXIMAL LOCATION WAS RELATED TO A STEP OFF IN STENT DIAMETER AT THE TEAR SITE AND THE SECOND RELATED TO THE DISTAL GRAFT. THE GRAFT WAS NOT MATCHED TO THE LUMEN DIAMETER BUT OVERSIZED PROXIMALLY 15% AND DISTALLY 25%. RECALL WAS INITIATED AS INDICATION FOR USE FOR BTAI HAS BEEN REMOVED FROM THE PRODUCT LABELING. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION, IT WAS POSSIBLE TO CONFIRM THE REPORTED EVENT. THE THROMBUS DEVELOPED IN TWO LOCATIONS. THE MORE PROXIMAL LOCATION WAS RELATED TO A STEP OFF IN STENT DIAMETER AT THE TEAR SITE AND THE SECOND RELATED TO THE DISTAL GRAFT. THIS APPEARANCE IS SIMILAR TO OTHER CASES OF INTRA-GRAFT THROMBUS. IN THESE CASES THE TWO SITES ARE USUALLY NOT CONNECTED. THE GRAFT WAS NOT MATCHED TO THE LUMEN DIAMETER BUT OVERSIZED PROXIMALLY 15% AND DISTALLY 25%. NO EVIDENCE TO SUGGEST THAT THE DEVICE 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 INITIAL REPORTER: THE PATIENT WAS A (B)(6) BOY AND HE WAS IMPLANTED WITH AN ALPHA 20MM X 105MM. GRAFT THROMBOSED AFTER A SUCCESSFUL SURGERY AND HAD IT FOR 7 MONTHS. PATIENT OUTCOME: THE GRAFT THROMBOSED CAUSING HIM TO DIE AFTER A SUCCESSFUL SURGERY AND A 7 MONTH-PERIOD OF GOOD QUALITY OF LIFE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT WAS A (B)(6) BOY AND HE WAS IMPLANTED WITH AN ALPHA 20 MM X 105 MM. GRAFT THROMBOSED AFTER A SUCCESSFUL SURGERY AND HAD IT FOR 7 MONTHS. PATIENT OUTCOME: THE GRAFT THROMBOSED CAUSING HIM TO DIE AFTER A SUCCESSFUL SURGERY AND A 7 MONTH-PERIOD OF GOOD QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710066 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346731

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Death