BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 16680769 · Received April 5, 2023

    Report

    Report Number
    3002808486-2023-00087
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 29, 2023
    Report Date
    July 17, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A PATIENT WAS TREATED FOR TYPE B AORTIC DISSECTION. THE PHYSICIAN PLACED A ZDEG-P-32-202-PF-US (COMPLAINT DEVICE). IT WAS VERY DIFFICULT TO RELEASE THE SAFETY WIRE (TRIGGER WIRES) DURING DEPLOYMENT. THE DEVICE WAS EVENTUALLY DEPLOYED PER INSTRUCTIONS FOR USE (IFU) IN THE PLANNED TARGET ZONE. NO ADVERSE EFFECTS TO THE PATIENT WERE NOTED. THIS COMPLAINT IS RELATED TO ANOTHER COMPLAINT. DEVICE WAS NOT RETURNED AND NO IMAGES WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR THE INVESTIGATION, BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. INTERNAL ACTIONS RELATED TO DIFFICULTIES OR INABILITY IN WITHDRAWING THE TRIGGER WIRE MECHANISM HAS PREVIOUSLY BEEN INITIATED AND RELEVANT PERSONEL HAVE BEEN INFORMED OF THIS COMPLAINT. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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: THE PHYSICIAN HAD A VERY DIFFICULTY TIME RELEASING THE SAFETY WIRE. THE PHYSICIAN WAS UNHAPPY WITH AMOUNT OF FORCE REQUIRED TO SUCCESSFULLY RELEASE THE SAFETY WIRE. THE DEVICE WAS EVENTUALLY DEPLOYED, PER IFU (INSTRUCTIONS FOR USE). THERE WAS NO SEVERE TORTUOSITY. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT 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
    2284991 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47448 E4370475 10827002474489

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown