BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 13318141 · Received January 21, 2022

    Report

    Report Number
    2017233-2022-02684
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    January 18, 2022
    Report Date
    April 12, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646937
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: LUNG DISEASE, OSTEOPENIA, GLAUCOMA. PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: ALBUTEROL, BUDESONIDE, CARVEDIOL ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® TAG® THORACIC ENDOPROSTHESIS; ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO INCLUDE: STENT GRAFT: INCOMPLETE DEPLOYMENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE DELIVERY CATHETER AND DEPLOYMENT SYSTEM WERE RETURNED TO GORE FOR EVALUATION AND SHOWED THE FOLLOWING: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 114.5CM. THIS IS SIGNIFICANTLY SHORTER THAN THE APPROXIMATE 144.4CM SDL ATTACHED TO THE DEPLOYMENT KNOB OF A FULLY DEPLOYED SECONDARY SLEEVE ON A SEPARATE DEVICE. THE CORE AND OUTERWRAP OF THE FIBER APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE BREAKING, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE WAS NOT FULLY DEPLOYED 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. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. NO PROCESS FAILURE MODE COULD BE CONFIRMED, AND NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED DURING THE DEVICE EVALUATION. NO CAPA REQUEST IS REQUIRED AND EVENTS WILL CONTINUE TO BE MONITORED BY GORE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) WAS IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN LOOSENED AND TURNED THE GRAY SECONDARY DEPLOYMENT HANDLE AND PULLED BACK TO DEPLOY THE DEVICE TO IT¿S FULL DIAMETER BUT THE DEPLOYMENT LINE GOT STUCK AFTER HAVING ONLY BEEN PULLED OUT ABOUT AN INCH. THE PHYSICIAN THEN PULLED BACK HARDER AND THE DEPLOYMENT LINE BROKE. THE LOCKWIRE AND ANGULATION ASSEMBLIES WERE REMOVED WITH THE DEVICE DELIVERY SYSTEM. A BALLOON CATHETER WAS THEN ADVANCED TO BALLOON THE DEVICE TO FULL EXPANSION. THE PROCEDURE WAS CONCLUDED WITH FULL EXPANSION OF THE DEVICE AND SUCCESSFUL PLACEMENT WHERE INTENDED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93196 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGM282810 00733132646937

    Patients

    Seq Age Sex Outcome Treatment
    1 Male