BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 10075278 · Received May 20, 2020

    Report

    Report Number
    2017233-2020-00375
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 29, 2020
    Report Date
    September 9, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Removal / Correction Number
    2017233.09/09/2020.001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR404015E / 20736773 WAS NOT RETURNED TO GORE. THEREFORE, NO DEVICE EVALUATION WAS PERFORMED. ADDITIONALLY, NO IMAGES COULD BE PROVIDED FOR AN IMAGING EVALUATION. THE REASON FOR RESISTANCE DURING SECONDARY DEPLOYMENT CANNOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION. THE SECONDARY DEPLOYMENT LINE (SDL) MAY HAVE BROKEN DURING SECONDARY DEPLOYMENT. 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.

    Additional Manufacturer Narrative · 0

    H7: SELECTED "NOTIFICATION". H9: ADDITIONAL INFORMATION. H9: FIELD ACTION NUMBER: 2017233.09/09/2020.001-C.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE DISSECTION OF THE AORTIC ARCH AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. NO ISSUES WERE REPORTED DURING DEPLOYMENT OF THE FIRST TGMR ENDOPROSTHESIS TO INTERMEDIATE DIAMETER AND WHEN USING THE ANGULATION CONTROL MECHANISM. AFTER HAVING DEPLOYED THE SECOND DEVICE TO INTERMEDIATE DIAMETER LIKEWISE WITHOUT PROBLEMS, THE GRAFT WOULD NOT DEPLOY TO FULL DIAMETER AS IT WAS NOT POSSIBLE TO PULL THE ENTIRE LENGTH OF THE SECONDARY DEPLOYMENT LINE DUE TO STRONG RESISTANCE. WITH THIS SECOND DEVICE, THE ANGULATION MECHANISM WAS NOT USED. THE PHYSICIAN DECIDED ¿TO REMOVE [THE] LOCKWIRE HANDLE WHICH BLOCKED AT THE LEVEL OF [THE] GRAY SECONDARY DEPLOYMENT HANDLE¿. BY USING STRONG FORCE, THE PHYSICIAN MANAGED TO REMOVE BOTH HANDLES WITH THE ENDOPROSTHESIS STILL INCOMPLETELY DEPLOYED AND THEN REMOVE THE ANGULATION MECHANISM HANDLE. DEPLOYMENT TO FULL DIAMETER WAS ACHIEVED WITH A RELIANT¿ STENT GRAFT BALLOON AB46. DURING FINAL IMAGING, A TYPE III ENDOLEAK WAS OBSERVED BETWEEN THE TWO TMGR THORACIC ENDOPROSTHESIS AND SUBSEQUENTLY RESOLVED WITH A VALIANT¿ THORACIC STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538430 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20736773

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization