BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 5743935 · Received June 23, 2016

    Report

    Report Number
    3002808486-2016-00599
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 3, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346649
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT WAS ONLY BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT FILE. NO PRODUCT OR IMAGING WAS RECEIVED TO SUPPORT THE OUTPUT OF THIS INVESTIGATION. BASED ON THE COMPLAINT HISTORY THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS RELATED TO THE STEPS IN DEPLOYMENT SEQUENCE WHERE IT CAN BE ASSUMED THAT THE SHEATH WAS NOT PULLED BACK AFTER UNLOCKING THE GRAY SAFETY-LOCK KNOB. SKIPPING THIS STEP CAN LIKELY RESULT IN UNSHEATHING THE DISTAL END OF THE BARE STENT AS THE SHEATH COVERS PART OF THE BOTTOM CAP. 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 COMPLAINANT: DURING THE PROCEDURE, THEY WERE UNABLE TO RELEASE THE DISTAL TRIGGER WIRE. THEY USED SOME FORCE AND TIME TO TRY TO FIX IT. TURN SCREEWS, HANDLE ETC. AFTER SOME TIME IT WAS POSSIBLE TO TURN THE HANDLE. THE GRAFT WAS THEN POSITIONED 3CM LOWER THAN INTENDED, FORTUNATELY NOT CAUSING ISSUE WITH VISCERAL VESSELS. DUE TO LEAKAGE IN THE MIDDLE, THEY HAD TO USE AN EXTRA GRAFT TO OVERLAP. PATIENT OUTCOME: THE PATIENT DID REQUIRE A ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: DUE TO LEAKAGE IN THE MIDDLE, THEY HAD TO USE AN EXTRA GRAFT TO OVERLAP.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE, THEY WERE UNABLE TO RELEASE THE DISTAL TRIGGER WIRE. THEY USED SOME FORCE AND TIME TO TRY TO FIX IT. TURN SCREWS, HANDLE ETC. AFTER SOME TIME IT WAS POSSIBLE TO TURN THE HANDLE. THE GRAFT WAS THEN POSITIONED 3CM LOWER THAN INTENDED, FORTUNATELY NOT CAUSING ISSUE WITH VISCERAL VESSELS. DUE TO LEAKAGE IN THE MIDDLE, THEY HAD TO USE AN EXTRA GRAFT TO OVERLAP. PATIENT OUTCOME: THE PATIENT DID REQUIRE A ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: DUE TO LEAKAGE IN THE MIDDLE, THEY HAD TO USE AN EXTRA GRAFT TO OVERLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399142 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346649

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening