BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 7107417 · Received December 12, 2017

    Report

    Report Number
    3002808486-2017-02406
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 21, 2017
    Report Date
    February 26, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). 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) SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE THORACIC GRAFT WAS DEPLOYED AS PER IFU, THE HANDLE WAS FULLY ROTATED WHICH SHOULD HAVE RELEASED THE SAFETY WIRES. WHEN THE PHYSICIAN WENT TO REMOVE THE INNER DILATOR FROM THE DELIVERY SYSTEM, THE GRAFT WAS STILL ATTACHED TO IT, SO THEY ENDED UP INVERTING THE GRAFT AS THEY TRIED TO REMOVE THE DILATOR. ONCE THEY REALISED WHAT WAS HAPPENING, THEY WERE ABLE TO ADVANCE THE DILATOR AND REALIGN THE GRAFT TO THE DESIRED POSITION. THEY THEN HAD TO GO TO THE BAIL OUT OPTION AND DISMANTLE THE ROTATION HANDLE IN ORDER TO REMOVE THE SAFETY WIRES FROM THE DEVICE. THEY WERE THEN ABLE TO CONTINUE WITH THE PROCEDURE". 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

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT IS BASED ON DESCRIPTION OF EVENT, THE RETURNED PRODUCT AND IMAGING REVIEW. THE COMPLAINT CONCERNS A PATIENT WITH TAA WHO UNDERWENT TEVAR. THE REPORTED INFORMATION STATES THAT THE PHYSICIAN DEPLOYED THE GRAFT AND FULLY ROTATED THE HANDLE, THINKING THAT THE RELEASE WIRES WERE RELEASED AS WELL. HOWEVER, AS THE PHYSICIAN TRIED TO REMOVE THE INNER SYSTEM FROM THE SHEATH, THE GRAFT WAS STILL ATTACHED TO THE TRIGGER WIRES AND THE GRAFT WAS INVERTED. THE STENT GRAFT WAS CORRECTED AND DEPLOYED. THE STENT GRAFT WAS RELEASED USING THE TROUBLESHOOTING METHOD. AS DESCRIBED IN THE DESCRIPTION OF EVENT, THE INNER SYSTEM WAS REMOVED WHILE THE STENT GRAFT WAS STILL ATTACHED TO IT. THIS CAUSED THE STENT GRAFT TO INVERT AND COULD LIKELY HAVE BEEN PREVENTED IF FLUOROSCOPY HAD BEEN USED DURING DEPLOYMENT, TO CONFIRM PROPPER PLACEMENT OF THE GRAFT AND DESIRED PROCEDURAL OUTCOME AS DESCRIBED IN THE SENT IFU (4.5 IMPLANT PROCEDURE FLUOROSCOPY SHOULD BE USED DURING INTRODUCTION AND DEPLOYMENT TO CONFIRM PROPER OPERATION OF THE INTRODUCTION SYSTEM COMPONENTS, PROPER PLACEMENT OF THE GRAFT, AND DESIRED PROCEDURAL OUTCOME). THE INNER SYSTEM OF THE DEVICE WAS RETURNED WITHOUT THE ROTATION HANDLE AND THE RELEASE WIRES. THE EXAMINATION OF THE INNER SYSTEM DID NOT SHOW ANY ABNORMALITIES. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE CANNOT BE DETERMINED. HOWEVER, PER COMPLAINT HISTORY THE BLACK SAFETY LOCK KNOB MAY BE THE CAUSE FOR THE EXPERIENCED DIFFICULTY IN REMOVING THE RELEASE WIRES. IT IS PREVIOUSLY SEEN THAT THE ROTATION HANDLE STOPS BEFORE COMPLETING THE ROTATION DUE TO A LOCKED POSITION OF THE BLACK SAFETY LOCK KNOB. THE IFU RECOMMENDS VERIFYING THE POSITION OF THE BLACK SAFETY LOCK KNOB DURING DEPLOYMENT TO INSURE IT IS ON ITS UNLOCKED POSITION. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888903 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002347042

    Patients

    Seq Age Sex Outcome Treatment
    1