BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 14049467 · Received April 8, 2022

    Report

    Report Number
    3002808486-2022-00239
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 10, 2022
    Report Date
    August 1, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE GREEN TRIGGER WIRE MECHANISM WOULD NOT COME OFF, WHY TROUBLESHOOTING TO REMOVE THE WIRES. THE GRAFT DISLODGED FROM LANDING ZONE AND FOLLOWING ANOTHER PIECE WAS PUT IN. THE ZDEG DEVICE WITHOUT SHIPPING STYLET, PEEL AWAY, PROTECTING TUBE, AND STENT GRAFT WAS RETURNED AND DUE TO THE REPORTED TROUBLESHOOTING THE HANDLE MAIN BODY HAD SEPARATED FROM THE INTRODUCER SYSTEM. THE GREEN RELEASE KNOB WAS LOCATED 13.5MM DOWN THE HANDLE MAIN BODY AND ROTATED APPROX. 95° COUNTERCLOCKWISE FROM THE HUB. THIS COMBINED WITH GROOVES NOTED IN THE HANDLE MAIN BODY CLOSE TO THE WIRE HOLE AND COUNTERCLOCKWISE AGAINST THE BACK OF THE HANDLE, INDICATES THAT THE GREEN RELEASE KNOB HAD BEEN ROTATED DURING RETRACTION. SAID ROTATION MAY HAVE CAUGHT THE NITINOL WIRES BETWEEN THE HANDLE AND THE KNOB AND CAUSED THE RELEASE KNOB TO STICK AND CONSEQUENTLY THE REPORTED DIFFICULTIES IN REMOVING THE TRIGGER WIRES. THEREFORE, REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE SPECIFYING NOT TO ROTATE THE GREEN TRIGGER WIRE KNOB DURING WITHDRAWAL. HOWEVER, APPROPRIATE ACTIONS HAVE BEEN INITIATED, TOO, TO ADDRESS THE DIFFICULTIES IN WITHDRAWING THE GREEN TRIGGER WIRE MECHANISM. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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: AFTER FULLY UNSHEATHING OF ZDEG, WHITE THUMBSCREW WAS REMOVED FROM GREEN TRIGGER WIRE MECHANISM & PHYSICIAN ATTEMPTED PULLED GREEN TRIGGER MECHANISM. MECHANISM WOULD NOT COME OFF. HAD TO TROUBLESHOOT TO REMOVE WIRES, DISLODGING GRAFT FROM ORIGINAL LANDING ZONE. PUT ANOTHER PIECE IN FOLLOWING. (B)(4).

    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
    1967493 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47448 E4202789 10827002474489

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention