BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 10009056 · Received April 29, 2020

    Report

    Report Number
    2017233-2020-00278
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 3, 2020
    Report Date
    September 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Removal / Correction Number
    2017233.09/09/2020.001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B6: ADDED IMAGING RESULTS. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR404015E/20763423 WAS RETURNED TO GORE AND AN ENGINEERING EVALUATION WAS PERFORMED. DURING THE DEVICE EVALUATION, THE FOLLOWING WAS FOUND: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 109.8CM. THIS IS SIGNIFICANTLY SHORTER THAN THE APPROXIMATE 156.5CM SDL ATTACHED TO THE DEPLOYMENT KNOB OF A FULLY DEPLOYED SECONDARY SLEEVE ON A SEPARATE 40X40X15 DEVICE. THE CORE AND OUTER WRAP OF THE FIBER APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. A POTENTIAL PUNCTURE TO THE INNER CORE IS PRESENT WHICH MAY HAVE RESULTED IN A WEAKENED FIBER. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE BREAKING, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE REMAINING AT INTERMEDIATE DIAMETER FOLLOWING SECONDARY DEPLOYMENT. SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES, WITH SOME SIGNS OF POTENTIAL PUNCTURE DAMAGE TO THE INNER CORE. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. H6, CODE 22: ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO: DEPLOYMENT FAILURE.

    Additional Manufacturer Narrative · 0

    H7: SELECTED "NOTIFICATION." H9: ADDITIONAL INFORMATION: FIELD ACTION NUMBER 2017233.09/09/2020.001-C.

    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 UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B ACUTE THORACIC AORTIC DISSECTION AND WAS IMPLANTED WITH THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. AS THE MOST DISTAL DEVICE, A TGM343415E COMPONENT WAS DEPLOYED FIRST IN THE AORTA WITHOUT ISSUES. PROXIMAL TO IT, A TGMR404015E COMPONENT WAS PLACED JUST BELOW THE LEFT SUBCLAVIAN ARTERY AND DEPLOYED TO INTERMEDIATE DIAMETER. THE ANGULATION MECHANISM WAS SUBSEQUENTLY UTILIZED TO ACCOMMODATE THE PATIENT¿S ANATOMY. WHILST INITIATING SECONDARY DEPLOYMENT HOWEVER, STRONG RESISTANCE WAS ENCOUNTERED WHEN THE SECONDARY DEPLOYMENT LINE WAS PULLED. IN AN ATTEMPT TO OVERCOME THE POINT OF GREATEST RESISTANCE WHERE THE PULL HAD COME TO A HALT, IT WAS DECIDED TO PULL THE LINE AGAIN WITH GREATER FORCE, WHICH RESULTED IN THE BREAKAGE OF THE LINE AT THE PROXIMAL LEVEL OF THE DEVICE CATHETER. AT THAT TIME, NO PORTION OF THE DEVICE HAD OPENED TO MORE THAN 50% OF THE DIAMETER AND THE POSITION OF THE DEVICE WAS CORRECTED TO APPROXIMATELY 1 CM TOWARDS DISTAL AS A PRECAUTIONARY MEASURE, ALLOWING FOR A PROXIMAL DEVICE TO BE ADDITIONALLY IMPLANTED. NEXT, A MEDTRONIC® RELIANT® BALLOON WAS USED TO OPEN THE TGMR404015E ENDOPROSTHESIS AND A SLIGHT LACK OF PROXIMAL WALL APPOSITION WAS OBSERVED TO REMAIN. BOTH THE RED LOCKWIRE AND THE ANGULATION MECHANISM HANDLES WERE REMOVED AND THE CATHETER WAS SUCCESSFULLY RETRACTED FROM THE PATIENT. FINALLY, A TGMR404010E COMPONENT WAS IMPLANTED AS THE MOST PROXIMAL DEVICE TO ACHIEVE OPTIMUM SEAL RIGHT UP TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473207 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20763423

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization