BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 8601380 · Received May 10, 2019

    Report

    Report Number
    2017233-2019-00341
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 11, 2019
    Report Date
    February 21, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H4: UPDATED FIELDS. H6. METHOD CODE 2: ADDED CODE.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION?: SELECTED "YES". THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM343410E / 18829570 WAS RETURNED TO GORE TOGETHER WITH THE SECONDARY KNOB AND THE ATTACHED DEPLOYMENT LINE FOR AND ENGINEERING EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 106.8CM, WHICH IS SHORTER THAN THE EXPECTED LENGTH FROM A FULLY DEPLOYED SECONDARY SLEEVE. THE END OF THE FIBER WHERE THE FAILURE OCCURRED APPEARS TO BE A MOSTLY CLEAN CUT WITH A SMALL PART THAT FAILED DUE TO TENSILE FORCES. ON SCANNING ELECTRON MICROSCOPE (SEM) IMAGES, A NICK IS APPARENT ADJACENT TO THE BREAK SURFACE ON THE RETURNED SECONDARY DEPLOYMENT FIBER. 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. THERE IS EVIDENCE OF DAMAGE ON THE BREAK SURFACE OF THE SDL, CONSISTENT WITH DAMAGE OBSERVED WHEN A SHARP OBJECT SEPARATES MOST OF THE FIBER. THE REMAINING PORTION OF THE FIBER BREAK SURFACE APPEARED TO FAIL IN TENSION. TO FURTHER INVESTIGATE POTENTIAL FACTORS CONTRIBUTING TO THIS MEDICAL DEVICE INCIDENT, GORE CONTACTED THE PHYSICIAN FOR INTRA-OPERATIVE IMAGES BUT REPORTEDLY, THE C-ARM DEVICE USED DURING THE ENDOVASCULAR PROCEDURE DOES NOT PERMIT ELECTRONIC IMAGE STORAGE. ADDITIONALLY, THE IMPLANTING PHYSICIAN DOES NOT RECALL EXPERIENCING SIGNIFICANT RESISTANCE DURING THE DEPLOYMENT AND THE SURGICAL TEAM ATTENDING THE PROCEDURE DOES NOT RECALL ANY DIFFICULTY WITH REMOVAL OF THE PACKAGING SHEATH WHEN PREPARING THE DEVICE FOR IMPLANT.

    Additional Manufacturer Narrative · 0

    D10. RETURNED TO MANUFACTURER ON: ADDED DATE. H4.DEVICE MANUFACTURE DATE: CORRECTED DATE.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE: IT HAS BEEN DECIDED THAT THE MEDWATCH REPORT SENT TO YOU ON MAY 10, 2019, BE RETRACTED. REASON: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM343410E, LOT#: 18829570, UDI: (B)(4), WAS NOT COMMERCIALLY AVAILABLE IN THE US ON THE DATE GORE AWARE OF EVENT ON (B)(6) 2019, AND WAS THEREFORE NOT REPORTABLE TO THE US AT THE TIME.

    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) 2019, THIS PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR AND WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT PRESENTED WITH A RIGHT ABERRANT SUBCLAVIAN ARTERY AND WAS TREATED FOR AN ANEURYSM AT ITS DISTAL ORIGIN. AS IT WAS PLANNED TO PLACE THE TGM343410E COMPONENT DISTAL TO THE LEFT SUBCLAVIAN ARTERY, THE RIGHT SUBCLAVIAN ARTERY WAS CLOSED WITH A PLUG PRIOR TO THE IMPLANT PROCEDURE. USING A GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF (22/33), THE DEVICE WAS ADVANCED TO THE INTENDED LOCATION AND DEPLOYED TO INTERMEDIATE DIAMETER WITHOUT ISSUES. THIS WAS FOLLOWED BY PROXIMAL GRAFT REPOSITIONING BY APPROXIMATELY 2 MM AND DEVICE ANGULATION. DURING THE SUBSEQUENT REMOVAL ATTEMPT OF THE SECONDARY DEPLOYMENT HANDLE HOWEVER, NO DEPLOYMENT ACTION AT ALL ENSUED, WITH THE DEVICE REMAINING AT INTERMEDIATE DIAMETER. IT WAS SUSPECTED THAT THE SECOND DEPLOYMENT LINE MIGHT HAVE BEEN BROKEN DURING THE ATTEMPTED DEPLOYMENT. THEREFORE, THE DEPLOYMENT LINE ACCESS HATCH OF THE HANDLE WAS OPENED BUT A LINE BREAKAGE COULD NOT BE VERIFIED. ALSO, NO RESISTANCE WAS REPORTEDLY FELT WHEN THE SECONDARY DEPLOYMENT HANDLE WAS PULLED. THE PHYSICIAN THEN DECIDED TO COMPLETE THE DEPLOYMENT PROCEDURE BY BALLOONING THE TGM343410E COMPONENT AND REMOVED BOTH THE LOCKWIRE AND ANGULATION ASSEMBLY HANDLES. YET IT APPEARED THE GRAFT WAS STILL ATTACHED TO THE CATHETER AND A CATHETER RETRACTION ATTEMPT RESULTED IN THE DISTAL MOVEMENT OF THE DEVICE FOR A LENGTH OF ABOUT 6 CM. TRYING SEVERAL TIMES TO MOVE THE DEVICE TOWARDS PROXIMAL AND BACK INTO THE TARGET ZONE WAS NOT ACCOMPLISHED. BY FURTHER, CAREFUL MANIPULATION, THE PHYSICIAN HOWEVER MANAGED TO REMOVE THE DEVICE CATHETER. TO OPEN THE GRAFT TO FULL DIAMETER, THE PHYSICIAN SUCCEEDED WHEN STARTING TO BALLOON THE GRAFT AT ITS DISTAL END AND THEN THROUGHOUT THE ENTIRE DEVICE. AFTER HAVING DEPLOYED THE DEVICE TO FULL DIAMETER, INTRA-OPERATIVE IMAGING SHOWED A TYPE 1A ENDOLEAK AND AN ADDITIONAL TGM343410E COMPONENT WAS IMPLANTED TO REPAIR THE ENDOLEAK. A SECOND, ADDITIONAL TGM343415E COMPONENT WAS USED AS A DISTAL EXTENSION. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394732 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 18829570

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization