BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 14191706 · Received April 25, 2022

    Report

    Report Number
    3002808486-2022-00268
    Event Type
    Injury
    Date Received
    April 25, 2022
    Report Date
    August 1, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A PATIENT WITH UNKNOWN GENDER AND UNKNOWN AGE UNDERWENT AN EMERGENCY OPERATION IN WHICH A ZDEG-P-22-79-PF (COMPLAINT DEVICE) WAS USED IN ABDOMINAL AORTA (NOT IN IFU CONDITION). THERE IS AN ENDOLEAK TYPE 1A ON THE 6 MONTHS CT SCAN CONTROL. PATIENT OUTCOME IS UNKNOWN. NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED. NO FURTHER INFORMATION REGARDING QUESTIONS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE PROVIDED AND LIMITED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF AN ENDOLEAK, EVEN THOUGH IFU STATES THAT ENDOLEAK IS A KNOWN ADVERSE EVENT. FURTHERMORE IT IS MENTIONED IN PATIENT EVENT THAT "ABDOMINAL AORTA NOT IN IFU CONDITION". IT HAS NOT BEEN POSSIBLE TO CLARIFY THIS BUT USE OUTSIDE IFU COULD HAVE CONTRIBUTED TO THE EVENT. COOK WILL REOPEN THE COMPLAINT 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: CUSTOMER USED A THORACIC COMPONENT IN ABDOMINAL AORTA (NOT IN IFU CONDITION). IT WAS CERTAINLY DONE IN EMERGENCY, BUT I DON¿T HAVE MORE DETAIL YET. THE DEVICE IS A ZDEG-P-22-79-PF AND WAS IMPLANTED 6 MONTHS AGO. THERE IS AN ENDOLEAK TYPE 1A ON THE 6 MONTHS CT SCAN CONTROL.

    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
    200134 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening