BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 12777478 · Received November 9, 2021

    Report

    Report Number
    3002808486-2021-01941
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    November 3, 2021
    Report Date
    April 8, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT WITH A THORACIC AORTIC DISSECTION UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR), WHERE A ZDEG-PT-34-199-PF (COMPLAINT DEVICE) WAS USED. THE DELIVERY SYSTEM WAS ADVANCED BY LEFT FA (FEMORAL ARTERY) APPROACH. THE PATIENT´S ANATOMY WAS WITHOUT TORTUOSITY. THE PHYSICIAN COULD NOT WITHDRAW THE GREEN TRIGGER WIRE WHICH CAUSED THE PROXIMAL END OF THE GRAFT BECAME ENFOLDED. THE PHYSICIAN WAS ABLE TO REMOVE THE GREEN TRIGGER WIRE A LITTLE BIT WITH A MOSQUITO FORCEPS AND PULL EACH WIRE ONE BY ONE WITH MUCH FORCE. THE PHYSICIAN WAS ABLE TO RESOLVE THE INFOLDINGS BY IMPLANTING A ZDEG-PT-34-159 INSIDE THE STENT. THE REPLACEMENT PRODUCT WAS DELIVERED WITHOUT ANY PROBLEMS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER THE INSTRUCTIONS FOR USE, THE GREEN TRIGGER WIRE KNOB SHOULD BE WITHDRAWN IN A CONTINUOUS MOVEMENT WITHOUT ANY ROTATION OF THE GREEN TRIGGER-WIRE KNOB. ALSO PER IFU, DO NOT ROTATE THE GREEN TRIGGER-WIRE KNOB. NO PRODUCT WAS RETURNED, AND NO IMAGING WAS PROVIDED. BASED ON THE PROVIDED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED FAILURE. HOWEVER, UNINTENDED USER ERROR COULD POSSIBLY CONTRIBUTE TO THE REPORTED EVENT. 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 THE INITIAL REPORTER: THEY CANNOT REMOVE THE SECURE TRIGGER WIRES AND THAT MAKES THE INFOLDING OF THE PROXIMAL PORTION OF THE GRAFT AND THEY NEED TO EXTRACT ONE BY ONE EVERY WIRE THE PHYSICIAN EXPLAIN THAT HE CAN¿T REMOVE IT BY PULLING THE GREEN TRIGGER WIRE, SO HE JUST REMOVE IT A LITTLE BIT WITH A MOSQUITO AN THEN PULL EACH WIRE ONE BY ONE, BY APPLYING MUCH FORCE. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. BUT A NEW ZDEG-PT-34-159-PF WAS IMPLANTED DURING THE PROCEDURE. 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
    1682160 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4065827 10827002242590

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention