BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 16320660 · Received February 8, 2023

    Report

    Report Number
    3002808486-2023-00039
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    December 29, 2022
    Report Date
    February 8, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) P180001. SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT UNDERWENT TEVAR WHERE A ZDEG-P-36-204-PF-US WAS USED, TO TREAT A DESCENDING AORTIC DISSECTION. IT IS REPORTED THAT DURING THE PROCEDURE THE TRIGGER WIRES WERE ALL TWISTED UP AROUND THE DEVICE. IT TOOK 15 TO 20 MINUTES TO REMOVE THE TRIGGER WIRES. THEY EVENTUALLY REALIZED THE WIRES WERE TWISTED AROUND THE DEVICE. ONE PHYSICIAN LATER SAID THAT HE SAW THE OTHER PHYSICIAN TWISTING THE TRIGGER WIRES INSTEAD OF PULLING THEM OUT. FOR CLARIFICATION THE FOLLOWING WAS REQUESTED ¿IS IT CORRECT UNDERSTOOD THAT THE GREEN KNOB WAS TWISTED WHICH MADE THE TRIGGER WIRE TO TWIST AROUND THE DEVICE?¿ AND THIS WAS CONFIRMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE PROVIDED INFORMATION AN EXACT CAUSE FOR WHY THE TRIGGER-WIRE KNOB COULD NOT BE PULLED CANNOT BE DETERMINED, BUT IF ROTATED, THE WIRES MAY GET CAUGHT BETWEEN THE HANDLE AND THE KNOB AND CONSEQUENTLY THE RELEASE KNOB MAY STICK. INSTRUCTIONS FOR USE STATES ¿WITHDRAW THE TRIGGER-WIRE IN CONTINUOUS MOVEMENT UNTIL THE PROXIMAL END OF THE DEVICE OPENS. DO NOT ROTATE THE GREEN TRIGGER-WIRE KNOB.¿ AN INTERNAL ACTION IS IN PROGRESS TO HANDLE DIFFICULTIES/INABILITIES IN WITHDRAWING THE GREEN TRIGGER WIRE MECHANISM. NO EVIDENCE TO SUGGEST THAT THE DEVICE IS 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 TRIGGER WIRES WERE ALL TWISTED UP AROUND THE DEVICE. IT TOOK 15 TO 20 MINUTES TO REMOVE THE TRIGGER WIRES. THEY EVENTUALLY REALIZED THE WIRES WERE TWISTED AROUND THE DEVICE. ONE PHYSICIAN LATER SAID THAT HE SAW THE OTHER PHYSICIAN TWISTING THE TRIGGER WIRES INSTEAD OF PULLING THEM OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312927 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47455 E4301559 10827002474557

    Patients

    Seq Age Sex Outcome Treatment
    1 Male