BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12981603 · Received December 11, 2021

    Report

    Report Number
    2017233-2021-02606
    Event Type
    Injury
    Date Received
    December 11, 2021
    Date of Event
    November 12, 2021
    Report Date
    May 4, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2. ADDED H6: 213-INVESTIGATION FINDINGS AND 4315-CONCLUSION CODE. PRODUCT EVALUATION: -THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 95.3CM. 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 APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. -THE LENGTH OF THE RETURNED SDL IS INDICATIVE OF THE LINE BREAKING, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE WAS NOT FULLY DEPLOYED FOLLOWING SECONDARY DEPLOYMENT. -SECONDARY DEPLOYMENT NOT OCCURRING IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO TENSILE FORCES. THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. -NO PROCESS FAILURE MODE COULD BE CONFIRMED AND NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED DURING THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    A SEVERE INJURY, ILLNESS OR IMPAIRMENT WHICH REQUIRES HOSPITALIZATION OR MEDICAL INTERVENTION. PROBLEM ASSOCIATED WITH DELAYED OR DIFFICULT ACTIVATION OF THE DEVICE. PROBLEM WITH ALL OR PART OF AN IMPLANTED OR INVASIVE DEVICE MOVING FROM ITS INTENDED LOCATION WITHIN THE BODY. TUBULAR SUPPORT PLACED INSIDE A BLOOD VESSEL, CANAL, OR DUCT TO AID HEALING OR RELIEVE AN OBSTRUCTION. THE INVESTIGATION INVOLVED THE ANALYSIS OF RELEVANT PRODUCTION RECORDS IN VIEW OF SUPPORTING THE IDENTIFICATION OF POSSIBLE CAUSES FOR THE ADVERSE EVENT. THE INVESTIGATION INVOLVED COMMUNICATION/INTERVIEWS (EITHER INTERPERSONAL OR THROUGH TECHNICAL MEANS, E.G. PHONE, E-MAIL) WITH PERSONS CLOSE TO THE ADVERSE EVENT, E.G. HEALTHCARE PROFESSIONALS (DOCTORS, NURSES ETC.), THE AFFECTED PATIENT(S) OR OTHER USERS INCLUDING, WHERE APPROPRIATE, RELATIVES OR OTHERS ENGAGED IN CARING FOR THE AFFECTED PATIENT. INVESTIGATION IS ONGOING, AND RESULTS ARE NOT YET AVAILABLE. (DO NOT USE THIS CODE IF THE INVESTIGATION IS COMPLETE). A CONCLUSION HAS YET TO BE ESTABLISHED AS THE INVESTIGATION IS INCOMPLETE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. 3 DEBRANCH BYPASS FOR THE AORTIC ARCH BRANCH VESSELS WERE PERFORMED AT THE SAME TIME, AND THE DEVICE (B)(4) WAS DEPLOYED FROM ZONE 0. AFTER THE PRIMARY DEPLOYMENT STEP WAS COMPLETED, THE SECONDARY DEPLOYMENT HANDLE WAS REMOVED, BUT THE PROXIMAL SIDE OF THE CTAGAC APPEARED TO BE ONLY HALF DEPLOYED. IT WAS REPORTED THAT THERE WAS A RESISTANCE DURING THE SECONDARY DEPLOYMENT AND THE HANDLE WAS REMOVED WITH A STRONG FORCE. THE LOCK WIRE AND ANGULATION FIBER WERE THEN REMOVED AND NO RESISTANCE REPORTED AT THAT OPERATION. THE ANGIOGRAPHY AFTER REMOVAL OF THE DELIVERY CATHETER CONFIRMED THAT THE PROXIMAL SIDE OF THE CTAGAC WAS NOT FULLY DEPLOYED (SEE THE IMAGE OF ATTACHED CASE REPORT). A GORE® TRI-LOBE BALLOON CATHETER WAS USED TO EXPAND THE CTAGAC, BUT DURING BALLOON TOUCHING-UP, THE DEVICE MIGRATED DISTALLY ABOUT 2 CM, SO AN ADDITIONAL CTAGAC WAS PLACED INTO THE PROXIMAL SIDE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879625 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 74 YR Male Required Intervention