BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22289556 · Received June 19, 2025

    Report

    Report Number
    2017233-2025-06327
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 17, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132646944
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION SHOWED THE FOLLOWING: ¿ THE FULLY DEPLOYED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE WAS RETURNED FOR EVALUATION. THE LINE THAT REMAINED CONNECTED TO THE PRIMARY DEPLOYMENT KNOB WAS IDENTIFIED TO BE RETURNED AT FULL LENGTH, WITH NO INDICATION OF A TENSILE BREAK. THE OBSERVATIONS OF THE DEVICE EVALUATION ARE CONSISTENT WITH THE REPORT OF FAILURE TO INITIATE PRIMARY DEPLOYMENT. ¿ THERE IS POTENTIAL FOR THE REPORT OF FAILED PRIMARY DEPLOYMENT TO BE ATTRIBUTED TO THE PRIMARY AND SECONDARY DEPLOYMENT LINES BEING SWITCHED AND ATTACHED TO THE INCORRECT DEPLOYMENT KNOBS, BUT THE ROOT CAUSE OF THE FAILED PRIMARY DEPLOYMENT COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. ¿ BASED ON THIS INVESTIGATION, THERE IS POTENTIAL FOR THE FAILURE MODE TO BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THE EVALUATED DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF ADDITIONAL CONTROLS IN WHICH THE SDL AND SDL CONNECTOR COLORS WERE CHANGED TO BLUE. THE WORST-CASE SEVERITY OF HARM THAT IS REASONABLY FORESEEABLE FOR THIS SCENARIO IS MINOR; THEREFORE, NO CAPA REQUEST IS REQUIRED. EVENTS WILL CONTINUE TO BE MONITORED BY GORE.

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING AN ENDOVASCULAR PROCEDURE INVOLVING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, THE DEVICE WAS ADVANCED TO THE INTENDED DEPLOYMENT SITE. THE PHYSICIAN INITIATED THE FIRST STAGE OF DEPLOYMENT BY TURNING THE PRIMARY DEPLOYMENT HANDLE 90° COUNTER-CLOCKWISE AND PULLING IT TO DEPLOY THE DEVICE TO ITS INTERMEDIATE DIAMETER. HOWEVER, THE DEVICE REMAINED FULLY CONSTRAINED, AND NO DEPLOYMENT OCCURRED. ALTHOUGH THE PRIMARY DEPLOYMENT LINE DETACHED ALONG WITH THE HANDLE, THE STENT GRAFT DID NOT EXPAND TO ITS INTERMEDIATE DIAMETER. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE DEVICE FROM THE PATIENT. A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER INCIDENT. IT WAS NOTED THAT THE BACKUP HATCH HAD BEEN OPENED, BUT NO PRIMARY DEPLOYMENT LINE WAS PRESENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE INITIAL DEVICE WAS RETAINED AND WILL BE RETURNED TO GORE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724216 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132646944

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male