BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 9528121 · Received December 27, 2019

    Report

    Report Number
    2017233-2019-01280
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 13, 2019
    Report Date
    February 19, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED ADDITIONAL CONCLUSION CODE. H6: CODE 4117: NO DEVICE EVALUATION COULD BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THEREFORE THE EVENT DESCRIPTION OF THE SECONDARY DEPLOYMENT LINE (SDL) LOCKING UP COULD NOT BE EVALUATED. PER THE MANUFACTURING EVALUATION THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS AND THERE ARE NO CAPAS OR NCRS RELATED TO THIS EVENT. PER THE IMAGING EVALUATION A RELATIONSHIP TO THIS EVENT COULD NOT BE EVALUATED BASED ON THE AVAILABLE IMAGES. A ROOT CAUSE FOR THE SECONDARY DEPLOYMENT LINE (SDL) LOCKING UP CANNOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION. DUE TO THE DEPLOYMENT LINE LOCKING UP DURING DEPLOYMENT, THERE IS POTENTIAL FOR THE FAILURE MODE TO BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THE WORST-CASE SEVERITY OF HARM THAT IS REASONABLY FORESEEABLE FOR THIS SCENARIO IS SERIOUS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS; ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO INCLUDE: STENT GRAFT MIGRATION OR REALIGNMENT, DEPLOYMENT FAILURE A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH DISSECTION AND WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. PRE-IMPLANT, A RIGHT CAROTID ARTERY TO LEFT CAROTID ARTERY BYPASS WAS PERFORMED. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) WAS THEN IMPLANTED PROXIMALLY WITHIN THE ASCENDING AORTA, FOLLOWED BY A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) WHICH WAS LANDED 5 MM DISTAL TO THE BRACHIOCEPHALIC ARTERY AND EXTENDED DISTALLY TO THE AORTIC CURVE AND OVERLAPPED INSIDE A PREVIOUSLY IMPLANTED VALIANT® THORACIC STENT GRAFT. THE PRIMARY DEPLOYMENT OF THE CTAGAZ TO THE INTERMEDIATE DIAMETER WAS COMPLETED WITHOUT ISSUE, AND THE DEPLOYMENT HANDLE WAS PULLED TO INITIATE THE SECONDARY STAGE OF DEPLOYMENT; BUT THE DEPLOYMENT LINE WAS REPORTED TO HAVE BECOME STUCK AND COULD ONLY BE PULLED ABOUT HALFWAY RESULTING IN THE PROXIMAL END FAILING TO FULLY DEPLOY. THE DEPLOYMENT LINE WAS PULLED WITH FORCE BUT WAS UNABLE TO BE PULLED OUT. ACCORDING TO THE PHYSICIAN, THE DEPLOYMENT LINE WAS BELIEVED TO HAVE BEEN STUCK AT THE INNER AORTIC CURVATURE DUE TO THE ACUTE ANGLE OF THE PATIENT'S AORTIC CURVE WHERE THE ASCENDING/DESCENDING AORTA MEET; AND ALSO THE AREA OF OVERLAP ZONE OF THE CTAGAC AND THE VALIANT GRAFT. AT THIS TIME THE PHYSICIAN PULLED THE LOCK WIRE HANDLE FIRST AND REMOVED THE DELIVERY CATHETER AND THE DEPLOYMENT LINE WAS SUCCESSFULLY REMOVED FROM THE PATIENT; BUT THE PROXIMAL END STILL REMAINED ONLY PARTIALLY DEPLOYED. A GORE® TRI-LOBE BALLOON CATHETER WAS USED TO DEPLOY THE PROXIMAL END OF THE CTAGAC HOWEVER DURING TOUCH-UP, THE CTAGAC MIGRATED/MOVED DISTALLY APPROXIMATELY 4 CM. AS A RESULT OF THE MIGRATION, INFOLDING OF THE DEVICE WAS VISUALIZED AND AN ADDITIONAL CTAG WAS IMPLANTED WITHIN THIS AREA, HOWEVER IT DID NOT RESOLVE THE INFOLDING. RESOLVED. THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317474 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20863281

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR