BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 9486164 · Received December 18, 2019

    Report

    Report Number
    2017233-2019-01254
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 19, 2019
    Report Date
    March 5, 2020
    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

    D10: ADDED INFORMATION. H3; DEVICE EVALUATED: SELECTED "YES". H6: CODE 213 - THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE 22 - ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO: DEPLOYMENT FAILURE. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR373720E/20830735 WAS RETURNED TO GORE AND AN ENGINEERING EVALUATION WAS PERFORMED. DURING THE INVESTIGATION IT WAS FOUND THAT THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 112.6CM. THIS IS SIGNIFICANTLY SHORTER THAN THE APPROXIMATE 168.5CM SDL ATTACHED TO THE DEPLOYMENT KNOB OF A FULLY DEPLOYED SECONDARY SLEEVE ON A SEPARATE 37X37X20 DEVICE. THE CORE AND OUTERWRAP OF THE FIBER 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 POTENTIAL 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. 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 CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B AORTIC DISSECTION AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT PRESENTED WITH A VERY STEEP AORTIC ARCH AND VERY SMALL TRUE LUMEN IN THE DISTAL LANDING ZONE. HAVING ADVANCED A TGMR373720E COMPONENT THROUGH A GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF (22/65), THE COMPONENT WAS POSITIONED AND DEPLOYED WITHOUT ISSUES TO INTERMEDIATE DIAMETER. THE DEPLOYMENT LINE REPORTEDLY BROKE AFTER IT HAD BEEN PULLED OUT FOR A LENGTH OF ABOUT 20 CM. THE ENDOPROSTHESIS¿ DIAMETER HAD NOT CHANGED AND REMAINED AT INTERMEDIATE DIAMETER. THE DEPLOYMENT LINE ACCESS HATCH WAS THEN OPENED AND THE REMAINDER OF THE DEPLOYMENT LINE WAS PULLED, BUT THE DIAMETER OF THE GRAFT WOULD STILL NOT CHANGE. TO REMEDY THE SITUATION, THE PHYSICIAN MANAGED TO SUCCESSFULLY BALLOON THE TGMR373720E COMPONENT WITH A GORE® TRI-LOBE BALLOON CATHETER FROM DISTAL TO PROXIMAL. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281229 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20830735

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization