BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12471717 · Received September 14, 2021

    Report

    Report Number
    2017233-2021-02377
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    September 10, 2021
    Report Date
    January 31, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    D8/D9: THE DEVICE WAS RETURNED FOR ANALYSIS. DATE: 09/21/2021. THE DEVICE WAS RETURNED TO GORE FOR ANALYSIS. THE ENGINEERING EVALUATION WAS PERFORMED, AND THE RESULTS ARE AS FOLLOWS: THE FULLY CONSTRAINED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE WAS RETURNED FOR EVALUATION. THE PRIMARY DEPLOYMENT LINE (PDL) WAS IDENTIFIED TO BE BROKEN NEAR THE DISTAL END OF THE DEVICE. THE BROKEN END OF THE PDL CONNECTED TO THE HANDLE WAS ALSO RETURNED. THIS CONFIRMS THE EVENT DESCRIPTION THAT PRIMARY DEPLOYMENT DID NOT OCCUR. BASED ON THE LENGTH OF THE RETURNED SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB THERE WAS NO INDICATION OF AN ISSUE WITH THE SDL. THE DEVICE LIKELY DID NOT OPEN WHEN THE SDL WAS REMOVED DUE TO THE DEVICE REMAINING CONSTRAINED BY THE PRIMARY SLEEVE. BASED ON THE EVALUATION, THE REASON FOR THE INABILITY TO INITIATE PRIMARY SLEEVE DEPLOYMENT IS THAT THE PRIMARY DEPLOYMENT LINE BROKE. EVALUATION OF THE DAMAGE INDICATES A LOCATION THAT IS EXPOSED ON THE EXTERIOR OF THE DEVICE. BASED ON THE EVALUATION IT IS NOT POSSIBLE TO DETERMINE WHEN THE DAMAGE TO THE DEPLOYMENT LINE OCCURRED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO GORE ON THIS EVENT. GORE IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT WITH THE AVAILABLE INFORMATION. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO DELIVERY AND DEPLOYMENT EVENTS (E.G. ACCESS FAILURE; DEPLOYMENT DIFFICULTIES/FAILURES). THE FOLLOWING INFORMATION WAS CORRECTED: D6A: THE DEVICE WAS NOT IMPLANTED. D6B: THE DEVICE WAS NOT EXPLANTED. THE PHYSICIAN HAD SOME FAILURES TO DEPLOY THE DEVICE. THIS DEVICE WAS TAKEN AWAY FROM THE PATIENT AND SET ASIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE FULLY CONSTRAINED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE WAS RETURNED FOR EVALUATION. THE PRIMARY DEPLOYMENT LINE (PDL) WAS IDENTIFIED TO BE BROKEN NEAR THE DISTAL END OF THE DEVICE. THE BROKEN END OF THE PDL CONNECTED TO THE HANDLE WAS ALSO RETURNED. THIS CONFIRMS THE EVENT DESCRIPTION THAT PRIMARY DEPLOYMENT DID NOT OCCUR. BASED ON THE LENGTH OF THE RETURNED SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB THERE WAS NO INDICATION OF AN ISSUE WITH THE SDL. THE DEVICE LIKELY DID NOT OPEN WHEN THE SDL WAS REMOVED DUE TO THE DEVICE REMAINING CONSTRAINED BY THE PRIMARY SLEEVE. BASED ON THE EVALUATION, THE REASON FOR THE INABILITY TO INITIATE PRIMARY SLEEVE DEPLOYMENT IS THAT THE PRIMARY DEPLOYMENT LINE BROKE. EVALUATION OF THE DAMAGE INDICATES A LOCATION THAT IS EXPOSED ON THE EXTERIOR OF THE DEVICE. IT IS POSSIBLE DAMAGE COULD HAVE OCCURRED IN THE CLINIC, HOWEVER THERE IS ALSO POTENTIAL THAT THE FIBER WAS DAMAGED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT WAS UNDERGOING TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DEVICE WAS PREPPED PER IFU AND ADVANCED TO THE TREATMENT ZONE. STAGE 1 DEPLOYMENT WAS ATTEMPTED WITH THE GRAY KNOB, BUT NO DEPLOYMENT OCCURRED. THE SECOND KNOB WAS THEN UTILIZED TO DEPLOY THE DEVICE, BUT THIS DID NOT RESULT IN DEPLOYMENT EITHER. THE BACK-UP HATCH WAS OPENED, AND NO DEPLOYMENT LINES WERE FOUND, SINCE THEY HAD BEEN PULLED OUT, SO THIS CONSTRAINED DEVICE WAS REMOVED THROUGH THE SHEATH AND SET ASIDE. THE PROCEDURE WAS COMPLETED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT WAS UNDERGOING TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DEVICE WAS PREPPED PER IFU AND ADVANCED TO THE TREATMENT ZONE. STAGE 1 DEPLOYMENT WAS ATTEMPTED WITH THE GRAY KNOB, BUT NO DEPLOYMENT OCCURRED. THE SECOND KNOB WAS THEN UTILIZED TO DEPLOY THE DEVICE, BUT THIS DID NOT RESULT IN DEPLOYMENT EITHER. THE BACK-UP HATCH WAS OPENED, AND NO DEPLOYMENT LINES WERE FOUND, SO THIS DEVICE WAS REMOVED AND SET ASIDE. THE PROCEDURE WAS COMPLETED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367634 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male