BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 17601656 · Received August 23, 2023

    Report

    Report Number
    3002808486-2023-00222
    Event Type
    Death
    Date Received
    August 23, 2023
    Date of Event
    October 22, 2020
    Report Date
    September 19, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002236131
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). DEVICE UPDATED TO ZTEG-2PT-42-32-165-PF. DEVICE IS NOT SIMILAR TO A DEVICE MARKETED IN US AND EVENT IS THEREFORE NOW CONSIDERED NOT REPORTABLE TO FDA 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). G4) PMA/510(K): P140016. H6) ANNEX A: A050408 - ENDOLEAKS. 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 STUDY: FROM FOLLOW-UP CT/MRI. ENDOLEAKS: TYPE I = YES. IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO. 1-MONTH FOLLOW-UP-VISIT, (B)(6) 2020: TYPE IB (DISTAL) ENDOLEAK PRESENT ON THE 1-MONTH FOLLOW-UP CT/MRI. NO ENDOLEAK NOTED ON THE PROCEDURE ANGIOGRAPHY. ADDITIONAL INFORMATION RECEIVED ON 21AUG2023: PRIMARY INDICATION FOR THORACIC ENDOVASCULAR AORTIC REPAIR: THORACIC AORTIC ANEURYSM (TAA) INTERVENTION CLASSIFICATION WAS PLANNED. THERE WAS NO AORTIC RUPTURE, THE PATIENT WAS HEMODYNAMICALLY STABLE, AND THE PATIENT WAS NOT SYMPTOMATIC. THE ONLY DIFFICULTY NOTED WAS "DEPLOYING IN THE INTENDED LOCATION" WITH THE COMMENT, "AFTER TOP-CAP RELEASE KINK OF ZTA, NO SEALING." PATIENT OUTCOME: NO SECONDARY INTERVENTION PERFORMED TO TREAT THE ENDOLEAK. ON (B)(6) 2021 (103 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED AN AORTIC RUPTURE DISTAL TO THE STUDY STENT. TREATMENT WAS OPEN GRAFT IMPLANTATION. ON THE SAME DAY, THE PATIENT EXPERIENCED PARAPARESIS AND RENAL FAILURE. ON (B)(6) 2021 (125 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED RESPIRATORY INSUFFICIENCY AND MULTI-ORGAN FAILURE. THE PATIENT DIED (B)(6) 2021 (126 DAYS POST-PROCEDURE) FROM MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264101 ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3892275 10827002236131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death