BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 10166765 · Received June 18, 2020

    Report

    Report Number
    2017233-2020-00443
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 22, 2020
    Report Date
    August 5, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B6: ADDED IMAGING EVALUATION RESULTS. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR404010E / 21176299 WAS RETURNED TO GORE AND AN ENGINEERING EVALUATION WAS PERFORMED. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 141.5CM. THIS IS SIMILAR TO THE APPROXIMATE 140CM SDL ATTACHED TO THE DEPLOYMENT KNOB OF A FULLY DEPLOYED SECONDARY SLEEVE ON A SEPARATE 40X40X10 DEVICE. THE CLEAN CUT END OF THE FIBER WAS LIKELY CUT DURING MANUFACTURING. BASED ON THE IMAGING EVALUATION, IT WAS IDENTIFIED THAT THERE IS SIGNIFICANT ANGULATION OF THE AORTIC ARCH AND ANOTHER DEVICE IMPLANTED IN THE LEFT SUBCLAVIAN ARTERY. THE POST DEPLOYMENT IMAGE ILLUSTRATES LACK OF DISTAL WALL APPOSITION. BASED ON EVALUATION OF THE RETURNED SDL AND OBSERVATIONS MADE IN THE IMAGING EVALUATION, THE REPORT OF THE DISTAL PORTION OF THE STENT GRAFT NOT OPENING TO FULL DIAMETER WAS NOT CONFIRMED. BASED ON THE EVALUATION, NO MANUFACTURING DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THIS PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR404010E TO TREAT A PENETRATING AORTIC ULCER. IT WAS PLANNED TO UTILIZE CHIMNEY TECHNIQUE WITH THE TGMR404010E COMPONENT TO SUPPLY THE PATIENT¿S CORONARY BYPASS VIA THE SUBCLAVIAN ARTERY. INITIAL DEPLOYMENT OF THE TGMR404010E ENDOPROSTHESIS WENT WITHOUT ISSUES. DURING SECONDARY DEPLOYMENT, THE DISTAL PORTION OF THE STENT WOULD NOT OPEN TO FULL DIAMETER AND REMAINED AT INTERMEDIATE DIAMETER. THE PHYSICIAN ESTIMATED THE LENGTH OF THE UNDEPLOYED SECTION AT APPROXIMATELY 3 CM. REPORTEDLY, THE ENTIRE LENGTH OF THE SECONDARY DEPLOYMENT LINE WAS PULLED WITHOUT RESISTANCE, SO A BREAK WAS NOT SUSPECTED OR BELIEVED TO HAVE OCCURRED. HOWEVER, THE PATIENT¿S ANATOMY SHOWS AN ANGULATED AORTIC ARCH OF OVER 90 DEGREES AND WITH THE THORACIC ENDOPROSTHESIS FOLLOWING THE ANATOMY DURING DEPLOYMENT, THE UNDEPLOYED GRAFT SECTION APPEARS TO COINCIDE WITH THE POINT OF ARCH ANGULATION. AN ATTEMPT TO AID THE DISTAL PORTION OF THE TGMR404010E COMPONENT WITH THE HELP OF A MEDTRONIC BALLOON TO FULL DEPLOYMENT WAS UNSUCCESSFUL. THE PROCEDURE CONCLUDED WITH A GOOD OVERALL RESULT AND BLOOD FLOW TOWARDS DISTAL FROM THE DEVICE SECTION REMAINING AT 50% INTERMEDIATE DIAMETER WAS CONSIDERED NOT AN ISSUE. A REINTERVENTION IS CURRENTLY NOT INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632032 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 21176299

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization