BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 8810633 · Received July 22, 2019

    Report

    Report Number
    2017233-2019-00544
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    May 17, 2019
    Report Date
    December 10, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1/2/3/4: ADDED PATIENT INFORMATION. ENGINEERING EVALUATION: THE DEVICE WAS RETURNED TO GORE FOR EVALUATION. THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 109.1CM, WHICH IS SHORTER THAN THE EXPECTED LENGTH FROM A FULLY DEPLOYED SECONDARY SLEEVE. THE CORE OF THE FIBER WHERE THE FAILURE OCCURRED APPEARS TO HAVE EXPERIENCED TENSILE FORCES AND IS NOT INDICATIVE OF A CLEAN CUT. THE OUTERWRAP OF THE FIBER AT THE BREAKAGE SHOWS SIGNS OF POSSIBLE PRIOR DAMAGE. THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE HAVING BROKEN BEFORE DEPLOYMENT WAS COMPLETE, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE REMAINING AT 50% OF ITS DIAMETER FOLLOWING SECONDARY DEPLOYMENT. THE ROOT CAUSE FOR SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING AT THE TRAILING END OF THE DEVICE. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES, WITH SOME SIGNS OF POTENTIAL DAMAGE TO THE OUTER WRAP. THE ROOT CAUSE FOR THE SECONDARY DEPLOYMENT LINE BREAK COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    H6: ADDED CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM IN THE THORACIC AORTA. IT WAS STATED THAT THE DEVICE WAS SUCCESSFULLY DEPLOYED TO INTERMEDIATE DIAMETER. AFTER THE SECONDARY DEPLOYMENT HANDLE WAS REMOVED TO DEPLOY THE DEVICE TO FULL DIAMETER, IT WAS REPORTED THAT THE ENDOPROSTHESIS REMAINED AT INTERMEDIATE DIAMETER. THE FOLLOWING DEPLOYMENT STEPS WERE PERFORMED WITHOUT ISSUES AND IT WAS POSSIBLE TO REMOVE THE DEVICE CATHETER. HOWEVER IT WAS STATED THAT THE ENDOPROSTHESIS REMAINED AT INTERMEDIATE DIAMETER. IT WAS POSSIBLE TO ADVANCE A BALLOON INTO THE DEVICE AND ACCORDING TO THE PHYSICIAN THE DEVICE EXPANDED TO FULL DIAMETER RAPIDLY AFTER THE BALLOON WAS INFLATED. IT WAS STATED THAT THE ENDOPROSTHESIS LANDED MORE DISTAL THAN INTENDED, BUT NO VESSELS WERE COVERED. THE IMPLANTATION WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL UNKNOWN ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607363 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 18783841

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other