BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 10388913 · Received August 10, 2020

    Report

    Report Number
    2017233-2020-01108
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 13, 2020
    Report Date
    January 11, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646777
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 2: CODE 213 - THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE FULLY DEPLOYED STENT GRAFT WAS RETURNED ON THE DELIVERY CATHETER (WITH LOCKWIRE AND ANGULATION FIBERS STILL INSTALLED). NO ABNORMALITIES WERE NOTICED ON THE STENT GRAFT. THE POSITION OF THE RETURNED STENT GRAFT INDICATES THAT ANGULATION WAS LIKELY USED. THE SECONDARY DEPLOYMENT HANDLE WAS RETURNED WITH THE SECONDARY DEPLOYMENT LINE (SDL) CONNECTED. THE SDL WAS IN THE EXPECTED LENGTH RANGE FOR A FULLY DEPLOYED TGMR313110 DEVICE. THE LOCKWIRE WAS SEPARATED FROM THE LOCKWIRE HANDLE. THE LOCKWIRE WAS PROPERLY ROUTED THROUGH THE CATHETER, DEVICE, AND INTO THE CURVED OLIVE. THE LOCKWIRE HANDLE WAS NOT RETURNED FOR EVALUATION. THE ANGULATION FIBERS WERE SEPARATED FROM THE ANGULATION HANDLE BUT REMAINED ROUTED THROUGH THE DEVICE AND CATHETER. DURING TESTING FOR DESIGN VALIDATION, PROCESS QUALIFICATION, AND ONGOING QUALITY CONTROL TESTING, DEVICES ARE TESTED IN ANATOMICAL MODELS REPRESENTATIVE OF CMDS INDICATED USE. THERE IS POTENTIAL THAT OFF-LABEL USE IN AN ANTEGRADE HYBRID FASHION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED OBSERVATION OF THE DEVICE NOT DEPLOYING TO FULL DIAMETER COULD NOT BE CONFIRMED AS THE ENTIRE SDL WAS REMOVED AND THE DEVICE WAS RETURNED AT FULL DIAMETER. BASED ON THE EVENT DESCRIPTION AND DEVICE EVALUATION NO MANUFACTURING DEFICIENCIES COULD BE CONFIRMED. H.6. CONCLUSIONS CODE 2: CODE 22 - ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS OR COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO, DEPLOYMENT DIFFICULTIES/FAILURES. FURTHERMORE, THE IFU STATES THAT THE SAFETY AND EFFECTIVENESS OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT HAVE NOT BEEN EVALUATED IN PATIENT ETIOLOGIES INCLUDING, BUT NOT LIMITED TO, PREVIOUS STENT OR STENT GRAFT OR PREVIOUS SURGICAL REPAIR IN THE DESCENDING THORACIC AORTIC AREA. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA INCLUDING ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC / FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND = 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION AS WELL AS TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC / FEMORAL ACCESS, = 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED, AND DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: ASKED BUT UNAVAILABLE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN STENT GRAFTING USING ENDOVASCULAR TREATMENT OF THE THORACIC AORTA VIA A MEDIAN STERNOTOMY WITH ANTEGRADE RELEASE OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (FROZEN ELEPHANT TRUNK TECHNIQUE). NO INTRODUCER SHEATH WAS USED DUE TO THE NATURE OF THE OPEN PROCEDURE AND ANTEGRADE DEPLOYMENT. THE DEVICE REPORTEDLY DEPLOYED TO 50% DURING PRIMARY DEPLOYMENT. RESISTANCE WAS NOTED DURING DEPLOYMENT, AND ULTIMATELY THE DEPLOYMENT LINE BROKE WHILE THE DEVICE WAS AT 50% DEPLOYMENT. THE CAUSE OF DEPLOYMENT LINE BREAK WAS UNKNOWN, BUT IT WAS REPORTED THAT IT WAS SUSPECTED TO BE RELATED TO THERE BEING A LOOP IN THE LENGTH OF THE CATHETER. REPORTEDLY THE CATHETER WAS LOOPED AND UNABLE TO BE HELD STRAIGHT DUE TO THE NATURE OF THE ANTEGRADE DEPLOYMENT. IT WAS REPORTED THAT THE DEVICE WAS NOT TORQUED OR ROTATED SIGNIFICANTLY IN EITHER DIRECTION DURING INTRODUCTION OR ADVANCEMENT. NO SIGNIFICANT TORTUOSITY, THROMBUS, OR CALCIFICATION WAS NOTED THAT WAS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT. THE DEVICE WAS SUCCESSFULLY REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851716 GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGMR313110 00733132646777

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR