BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 16830363 · Received April 28, 2023

    Report

    Report Number
    3002808486-2023-00124
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 16, 2023
    Report Date
    June 8, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). ADDITIONAL INFORMATION RECEIVED ON 12MAY2023 FROM THE ORIGINATOR OF THIS COMPLAINT CONFIRMS THAT THIS EVENT CONCERNING TYPE 1B ENDOLEAK WAS CREATED BY A MISTAKE. NO TYPE 1B ENDOLEAK IS RELATED TO THE ZDEG-P-24-117-PF. THEREFORE THIS EVENT DOES NOT CONSTITUTE A VALID COMPLAINT AND WILL BE CANCELLED. 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) 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: ON (B)(6) 2018 DURING THE INDEX PROCEDURE THREE ZDEG DEVICES WERE IMPLANTED: ZDEG-PT-24-117-PF, ZDEG-PT-28-142-PF AND ZDEG-P-28-142-PF WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. A BALLOON WAS USED DURING THE PROCEDURE TO FACILITATE ANATOMIC COMPLIANCE AT THE JUNCTION OF OVERLAP BETWEEN THE GRAFT AND DISTAL GRAFT. THERE WERE NO ADDITIONAL PROCEDURES PERFORMED AND NO OTHER DEVICES WERE PLACED DURING THE STUDY PROCEDURE. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION. THE PRIMARY TEAR DESCENDING AORTA, DISTAL TO LEFT SUBCLAVIAN. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN DESCENDING AORTA, DISTAL TO THE LEFT SUBCLAVIAN. THE DISTAL LOCATION OF THE DISSECTION WAS AT THE AORTA AT CELIAC. THERE WERE NO REPORTED RE-ENTRY TEARS. THERE WAS NO TORTUOSITY, OCCLUSIVE DISEASE, CALCIFICATION AND THERE WAS PARTIAL THROMBUS AT THE PROXIMAL SEAL ZONE OF THE GRAFT. THE GRAFTS WERE IMPLANTED WITHIN ZONE 3. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICES WERE PATENT WITHOUT DEVICE INTEGRITY ISSUES AT THE END OF THE PROCEDURE. THE FALSE LUMEN WAS COMPLETELY THROMBOSED AND THERE WAS NO EVIDENCE OF VESSEL OBSTRUCTION AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. (B)(6) 2018 (SEVEN DAYS POST PROCEDURE) CLINICAL ASSESSMENT WAS DONE WITHOUT IMAGING. (B)(6) 2018 (48 DAYS POST-PROCEDURE) COMPUTED TOMOGRAPHY (CT) IMAGING WAS DONE. THE CT SHOWED ANTEGRADE PROGRESSION OF DISSECTION. NO NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. (B)(6) 2018 (143 DAYS POST PROCEDURE) 6-MONTH IMAGING WAS DONE. NO PROGRESSION OF DISSECTION OR DEVELOPMENT OF NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. (B)(6) 2019 (321 DAYS POST-PROCEDURE) 12-MONTH IMAGING WAS DONE. NO PROGRESSION OF DISSECTION OR DEVELOPMENT OF NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. (B)(6) 2020 (684 DAYS POST-PROCEDURE) 2 YEAR CT IMAGING FOLLOW UP WAS DONE. NO PROGRESSION OF DISSECTION OR DEVELOPMENT OF NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION OR EVIDENCE OF DEVICE INTEGRITY ISSUES. (B)(6) 2021 (1076 DAYS POST PROCEDURE) 3-YEAR CT IMAGING FOLLOW-UP WAS DONE. NO PROGRESSION OR DISSECTION OR DEVELOPMENT OF NEW ENTRY TEARS. THERE WAS PATENT FALSE LUMEN FLOW FROM THE SECONDARY TEAR WITHIN THE SUPRACELIAC. ALL VESSELS WERE PATENT. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. 4 YEAR ASSESSMENT AS NOT DONE. (B)(6) 2023 (1791 DAYS POST PROCEDURE) 5 YEAR CT IMAGING FOLLOW-UP WAS DONE. NO PROGRESSION OF DISSECTION OR DEVELOPMENT OF NEW ENTRY TEARS. ALL VESSELS WERE PATENT. THERE WAS FALSE LUMEN FLOW FROM THE PRIMARY TEAR-TYPE IB-DISTAL ENDOLEAK. THE STUDY DEVICES WERE PATENT WITH NO SEPARATION, MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489086 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3692205 10827002242538

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female