BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 14546072 · Received May 31, 2022

    Report

    Report Number
    3002808486-2022-00752
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 19, 2022
    Report Date
    July 21, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: A 74-YEAR-OLD MALE UNDERWENT A SURGERY, WHERE A ZDEG-PT-40-32-165-PF-US (COMPLAINT DEVICE) WAS TO BE IMPLANTED. THE PATIENT´S ANATOMY WAS REPORTED TO HAVE A LITTLE BIT OF CALCIFICATION, TORTUOSITY AND NARROWING AT THE INTERNAL ILIAC AND COMMON ILIAC. PHYSICIAN STATES THAT THIS DIDN¿T APPEAR ON CT. IT WAS REPORTED THAT THE DEVICE WOULD NOT PASS THROUGH THE RIGHT COMMON ILIAC ARTERY. A DIFFERENT COOK DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. NO DEVICE WAS RETURNED, AND NO IMAGES WERE RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. BASED ON THE PROVIDED INFORMATION TORTUOUS ANATOMY, CALCIFICATION AND NARROWING IN THE INTERNAL ILIAC AND COMMON ILIAC MIGHT HAVE CONTRIBUTED TO THE ADVANCEMENT INABILITY. 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 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: DEVICE WOULD NOT PASS THROUGH THE RIGHT COMMON ILIAC ARTERY. A LITTLE BIT OF CALCIFICATION AND TORTUOSITY. A DIFFERENT COOK DEVICE WAS USED. PATIENT OUTCOME: THE COMPLAINANT 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
    2678491 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47485 E4230857 10827002474854

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male