BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 14405820 · Received May 16, 2022

    Report

    Report Number
    3002808486-2022-00314
    Event Type
    Injury
    Date Received
    May 16, 2022
    Date of Event
    August 28, 2018
    Report Date
    June 29, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002231723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 70-YEAR - OLD MALE PATIENT WHO WAS ENROLLED IN FRENCH REIMBURSEMENT STUDY UNDERWENT ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2017, WHERE A ZDEG-PT-32-24-158-PF (COMPLAINT DEVICE) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS REPORTED TO BE 10%. PRIMARY INDICATION WAS STABLE AORTIC DISSECTION. THE PRIMARY TEAR AND THE PROXIMAL LOCATION OF THE DISSECTION WAS IN THE DESCENDING AORTA, DISTALLY TO THE LEFT SUBCLAVIAN ARTERY. THE DISTAL LOCATION WAS RIGHT AND THE LEFT COMMON ILIAC ARTERIES. THERE WAS NO TORTUOSITY, OCCLUSIVE DISEASE, CALCIFICATION, OR THROMBUS PRESENT IN THE PROXIMAL LANDING ZONE. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AT THE END OF THE PROCEDURE. THE ABDOMINAL FALSE LUMEN WAS PATENT DUE TO A SECONDARY TEAR NOTED TO BE LOCATED ¿INTER RENAL.¿ ON (B)(6) 2018 (476 DAYS POST-PROCEDURE), A CT REVEALED A TYPE 1A ENDOLEAK. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2018 (562 DAYS POST-PROCEDURE) A SECONDARY INTERVENTION WAS PERFORMED, WHERE A PROXIMAL GRAFT EXTENSION AND A DISTAL GRAFT EXTENSION WERE IMPLANTED. THE SECONDARY INTERVENTION WAS REPORTED TO BE SUCCESSFUL. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. ACCORDING TO IFU, ENDOLEAK IS A POTENTIAL ADVERSE EVENT. NO MEDICAL IMAGING WAS PROVIDED FOR THE INVESTIGATION. SEVERAL REQUESTS WERE SENT TO OBTAIN ADDITIONAL INFORMATION WITHOUT RECEIVING REPLY. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. BASED ON THE LIMITED PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. COOK WILL REOPEN THIS COMPLAINT IF THE ADDITIONAL INFORMATION WILL BE PROVIDED. 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 STUDY: (B)(6) 2017, DURING THE INDEX PROCEDURE, A ZDEG-PT-32-24-158-PF (LOT# E3517294) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS 10%. PRIMARY INDICATION FOR IMPLANT WAS STABLE AORTIC DISSECTION. THE PRIMARY TEAR AND THE PROXIMAL LOCATION OF THE DISSECTION WAS IN THE DESCENDING AORTA, DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DISTAL LOCATION WAS THE RIGHT COMMON ILIAC (CIA) AND LEFT COMMON ILIAC (CIA). THERE WAS NO TORTUOSITY, OCCLUSIVE DISEASE, CALCIFICATION OR THROMBUS PRESENT WITHIN THE PROXIMAL LANDING ZONE. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AT THE END OF THE PROCEDURE. THE ABDOMINAL FALSE LUMEN WAS PATENT DUE TO A SECONDARY TEAR NOTED TO BE LOCATED, ¿INTER RENAL.¿ ON (B)(6) 2018 (476 DAYS POST-PROCEDURE), A CT REVEALED A TYPE IA (PROXIMAL) ENDOLEAK. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2018 (562 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WAS COMPLETED TO PLACE A PROXIMAL GRAFT EXTENSION AND DISTAL GRAFT EXTENSION. PATIENT OUTCOME: THE SECONDARY INTERVENTION WAS REPORTED TO BE SUCCESSFUL.

    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
    1474630 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3517294 10827002231723

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention