BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 17630019 · Received August 28, 2023

    Report

    Report Number
    3002808486-2023-00225
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    May 28, 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

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE UNDER PMA/510(K) P140016. H6) A050408 - ENDOLEAKS. INVESTIGATION IS STILL IN PROGRESS. 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

    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: TYPE IB (DISTAL) ENDOLEAK PRESENT ON THE PROCEDURE ANGIOGRAPHY AND REMAINED PRESENT ON THE 12-MONTH ANGIOGRAPHY. THE DEVICES PLACED DURING THIS PATIENT¿S INDEX PROCEDURE ARE A PROXIMAL TAPERED ZTA COMPONENT (ZTA-PT-44-40-179) AND A ZTEG COMPONENT (ZTEG-2PT-42-32-165-PF). THE PRIMARY INDICATION FOR THORACIC ENDOVASCULAR AORTIC REPAIR WAS THORACIC AORTIC ANEURYSM (TAA). THE TAA WAS FUSIFORM. THE INTERVENTION WAS ROUTINE (PLANNED). THERE WAS NO AORTIC RUPTURE. THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS SYMPTOMATIC WITH BACK PAIN. THE SITE INDICATED THAT ACCESS OF THE TARGET LESION AND DEPLOYMENT OF THE ZENITH ALPHA THORACIC GRAFT IN THE INTENDED LOCATION WAS SUCCESSFUL, AND ALSO INDICATED THAT NO SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DEVELOPED DURING THE STUDY PROCEDURE. PATIENT OUTCOME: NO SECONDARY INTERVENTION PERFORMED TO TREAT THE ENDOLEAK REPORTED AS OF (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337553 ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3959774 10827002236131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown