BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 17324366 · Received July 14, 2023

    Report

    Report Number
    3002808486-2023-00197
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    July 9, 2023
    Report Date
    October 26, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242712
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE GREEN TRIGGER- WIRE RELEASE MECHANISM OF ZDEG-P-30-202-PF (COMPLAINT DEVICE) WAS VERY HARD TO REMOVE. THE PHYSICIAN WAS CONCERNED THAT IT WAS BLOCKED. AFTER SOME ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE TRIGGER-WIRE RELEASE MECHANISM USING MUCH STRENGTH, WHICH RESULTED IN ZDEG WAS BROUGHT DOWN AND LOST ABOUT 1CM OF PROXIMAL SEALING ZONE. THE PHYSICIAN THEN IMPLANTED A GORE C-TAG PROXIMALLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. FOUR STILL IMAGES FROM AN ANGIOGRAPHY PROCEDURE DATED (B)(6) 2023 WERE PROVIDED AND REVIEWED BY AN IMAGING EXPERT. PER THE FINDINGS IN THE IMAGING REVIEW "THE 3RD IMAGE SHOWS A LIMITED SEGMENT OF THE (PRESUMED) DESCENDING THORACIC AORTA. A WIRE TRAVERSES THIS SEGMENT AND THERE IS MINIMAL TORTUOSITY WITH NO SIGNIFICANT ANGULATIONS". 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 AND IMAGING REVIEW IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF (B)(4). SIMILAR TO DEVICE MARKETED UNDER 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.

    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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE GREEN TRIGGER WIRE WAS VERY HARD TO REMOVE; PHYSICIAN WAS CONCERNED THAT IT WAS BLOCKED. AFTER SOME ATTEMPTS, PHYSICIAN WAS ABLE TO REMOVE THE TRIGGER WIRE USING MUCH STRENGTH. PATIENT OUTCOME: ZDEG WAS IMPLANTED BUT LOST ABOUT 1CM OF PROXIMAL SEALING ZONE BECAUSE THE STRENGTH USED TO RELEASE THE TRIGGER WIRE, HAD BROUGHT THE ENDOGRAFT DOWN. AFTER THAT, THE PHYSICIAN IMPLANTED A STENT GRAFT FROM ANOTHER MANUFACTURER PROXIMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208609 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4379005 10827002242712

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention