BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 7595222 · Received June 13, 2018

    Report

    Report Number
    3002808486-2018-00694
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 18, 2018
    Report Date
    October 10, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) DEVICE IS SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGESS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# PR228504. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. H6) EC METHOD CODE: 4109 - HISTORICAL DATA ANALYSIS 4114 - DEVICE NOT RETURNED EC CONCLUSIONS CODE: 4315 - CAUSE NOT ESTABLISHED. SUMMARY OF INVESTIGATIONAL FINDINGS: THE PROXIMAL WIRES (STEP 3) DID NOT RELEASE WHEN THE HANDLE WAS ROTATED TO THE END. BAIL OUT WAS PERFORMED AND THE STENT GRAFT WAS RELEASED. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURENCE. NO IMAGES WERE PROVIDED AND THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE, AND THE CAUSE CANNOT BE DETERMINED. FURTHERMORE, THE REPORTED DIFFICULTY WAS SOLVED BY FOLLOWING THE IFU. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. 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: THE PROXIMITY WIRE DID NOT RELEASE THE HANDLE WAS TOTALLY TO THE END. THE SOLUTION WAS TO DISASSEMBLE THE HANDLE. ISU BAIL OUT. LAST STEP - RELEASING THE PROX. TRIGGER WIRES DIDN'T WORK WHEN ROTATING THE HANDLE. THE HANDLE WAS ROTATED TO THE END, GRAFT WAS STILL ATTACHED. USING THE BAIL OUT PROCEDURE (DISASSEMBLING THE HANDLE) WORKED AND GRAFT RELEASED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438014 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3526661 10827002346472

    Patients

    Seq Age Sex Outcome Treatment
    1