BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)

    MDR report key: 9118196 · Received September 25, 2019

    Report

    Report Number
    2017233-2019-00905
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    August 30, 2019
    Report Date
    November 12, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED CONCLUSION CODE. IMAGING EVALUATION RESULTS: INTRAOPERATIVE ANGIOGRAPHIC VIDEO WAS RECEIVED BY GORE FROM THE FACILITY AND AN IMAGING EVALUATION WAS PERFORMED. MOV. 1: A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG WITH ACTIVE CONTROL) IS BEING DEPLOYED IN THE DESCENDING THORACIC AORTA, WITH THE PROXIMAL EXTENT LANDING WITHIN A NON-GORE DEVICE AND THE DISTAL EXTENT LANDING WITHIN A GORE® AORTIC EXTENDER ENDOPROSTHESIS. THE CTAG WITH ACTIVE CONTROL DEVICE APPEARS TO DEPLOY FIRST TO ITS INTERMEDIATE DIAMETER, THEN FULL DEPLOYMENT IS ACHIEVED. THERE APPEARS TO BE A CTAG STENT GRAFT ALREADY IMPLANTED IN THE AORTIC ARCH. MOV. 2: LOCK WIRE IS NOT VISIBLE. THE PROXIMAL ALIGNMENT MARKER WITHIN THE OLIVE IS CLEARLY VISIBLE AND UPON CATHETER RETRACTION THE PROXIMAL STENT GRAFT APPEARS TO DEFORM OR FOLD IN ON ITSELF. AS THE CATHETER IS ADVANCED TO ITS STARTING POSITION, THE STENT GRAFT APPEARS TO REGAIN ITS ORIGINAL SHAPE. AT APPROXIMATELY 5:30 INTO THE MOVIE, THE DEVICE IS BEING BALLOONED AT THE PROXIMAL ASPECT. MOV. 3: ADDITIONAL ATTEMPTS APPEAR TO BE MADE TO BALLOON THE PROXIMAL ASPECT OF THE DEVICE AND FREE THE CATHETER FROM THE STENT GRAFT. AT APPROXIMATELY 3:30-3:43, THE PROXIMAL NITINOL STENT ROW APPEARS TO SEPARATE FROM THE PROXIMAL GRAFT AS THE CATHETER IS MOVED UP AND DOWN. THE NITINOL ANOMALY APPEARS TO OCCUR AT THE POINT OF ATTACHMENT TO THE CATHETER, AS THE REST OF THE GOLD BAND ON THE PROXIMAL END OF THE STENT GRAFT APPEARS TO STAY IN PLACE. AS ADDITIONAL ATTEMPTS ARE MADE TO BALLOON AND MOVE THE CATHETER, THE STENT GRAFT APPEARS TO BE IMMOBILE, WHILE THE STENT APEX OF THE GRAFT IS IN MOTION. AT APPROXIMATELY 5:54, THE CATHETER APPEARS TO BE ROTATED SIDE TO SIDE AND THE ALIGNMENT MARKER IS OBSERVED TO MOVE LEFT AND RIGHT. THE NITINOL APPEARS TO BE MOVING AS WELL WITH THE CATHETER. MOV 4: A SNARE CATHETER IS ADVANCED. MULTIPLE ATTEMPTS ARE MADE TO RELEASE THE OLIVE FROM THE STENT USING THE SNARE. MOV 5: MULTIPLE ATTEMPTS ARE MADE TO RELEASE THE OLIVE FROM THE STENT USING THE SNARE. MOV 6: MULTIPLE ATTEMPTS ARE MADE TO RELEASE THE OLIVE FROM THE STENT USING THE SNARE. AT APPROXIMATELY 5:55, IT APPEARS THE CATHETER IS ADVANCED PROXIMAL TO THE GRAFT, BEYOND THE NITINOL STENT FRAME. IT APPEARS THE OLIVE TIP WAS SUCCESSFULLY SEPARATED FROM THE STENT. BASED ON THE PROXIMAL ALIGNMENT MARKER WHICH MEASURES 10 MM, THE DISTANCE BETWEEN THE DISTAL ASPECT OF THE MARKER AND THE PROXIMAL EXTENT OF THE NITINOL STENT APPEAR TO BE ABOUT 10 MM BY VISUAL ASSESSMENT. MOV 7: A WIRE AND CATHETER ARE ADVANCED, AND IT APPEARS TO CANNULATE THE NITINOL ¿LOOP¿/ANOMALY. MULTIPLE BALLOON INFLATIONS ARE VISUALIZED. IT APPEARS THE BALLOON IS BEING USED TO CREATE A PATH FOR REMOVAL OF THE OLIVE TIP AND CATHETER. MOV 8: AT APPROXIMATELY 7:30, SUCCESSFUL CANNULATION OF NITINOL ¿LOOP¿/ ANOMALY IS VISUALIZED. MOV 9: AT APPROXIMATELY 1:30, THE INFLATED BALLOON WAS ABLE TO SUCCESSFULLY OPEN THE NITINOL ¿LOOP¿/NITINOL ANOMALY. IT APPEARS THE OLIVE AND CATHETER WERE SUCCESSFULLY RETRACTED. AT APPROXIMATELY 4:28, THE PROXIMAL END OF STENT GRAFT IS BALLOONED. THE STENT FRAME APPEARS TO REMAIN AS ONE CONTINUOUS WIRE. THE ANOMALY/DEFORMATION IS STILL PRESENT, HOWEVER, NO EVIDENCE OF WIRE FRACTURE IS VISUALIZED. THE PROXIMAL STENT ROW APICES APPEAR TO BE VISUALIZED SEPARATE FROM AND PROXIMAL TO THE GOLD BAND. THERE APPEARS TO BE A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS BEING ADVANCED AND DEPLOYED TO BRIDGE AND RELINE PREVIOUSLY IMPLANTED GRAFTS. MOV 10: TOUCH UP BALLOONING OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS IS VISUALIZED. ENGINEERING EVALUATION RESULTS: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DELIVERY CATHETER WAS RECEIVED BY GORE FROM THE FACILITY AND AN ENGINEERING EVALUATION WAS PERFORMED. THE FINDINGS FROM THE EVALUATION WERE CONSISTENT WITH THE REPORTED PROCEDURAL OBSERVATIONS. DURING INVESTIGATION, DAMAGE WAS IDENTIFIED ON THE CURVED OLIVE, INDICATING THAT A PARTIALLY UNCOVERED PROXIMAL APEX WAS WEDGED BETWEEN THE OLIVE AND DELIVERY CATHETER. A WEDGED APEX WOULD PREVENT THE CATHETER FROM DISENGAGING FROM THE DEVICE POST DEPLOYMENT. THE ROOT CAUSE FOR THE CATHETER REMAINING ATTACHED TO THE ENDOPROSTHESIS FOLLOWING DEPLOYMENT IS THAT ONE OF THE PARTIALLY UNCOVERED PROXIMAL APICES WAS MECHANICALLY WEDGED BETWEEN THE CATHETER AND OLIVE AND DID NOT SEPARATE DURING DEPLOYMENT. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WITH ACTIVE CONTROL (CTAG) WERE IMPLANTED AS PART OF A SECONDARY ENDOVASCULAR INTERVENTION PROCEDURE TO TREAT STENT GRAFT-INDUCED NEW ENTRY IN THE DESCENDING AORTA CAUSED BY A NON-GORE MANUFACTURED STENT GRAFT. DURING THE PROCEDURE, A 20FR SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, AND A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT WAS PLACED JUST ABOVE THE CELIAC ARTERY. THEN THE GORE® TAG® DEVICE WAS ADVANCED AND DEPLOYED PROXIMALLY, OVERLAPPING WITH THE AORTIC EXTENDER COMPONENT. IT WAS REPORTED THAT, UPON ATTEMPT TO REMOVE THE GORE® TAG® DELIVERY CATHETER, THE CATHETER WAS CAUGHT ON THE PARTIAL UNCOVERED STENT ON THE PROXIMAL END OF THE GORE® TAG® STENT GRAFT. A 12FR SHEATH WAS INSERTED FROM THE LEFT FEMORAL ARTERY, AND A CODA BALLOON CATHETER WAS INSERTED. THE STENT GRAFT WAS BALLOONED AND AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY CATHETER, BUT WITHOUT SUCCESS. A SNARE WAS REPORTEDLY USED TO ATTEMPT TO GRASP THE GORE® TAG® STENT GRAFT AND FREE THE DELIVERY CATHETER, BUT WAS ALSO UNSUCCESSFUL. DURING THESE MANIPULATIONS, A PORTION OF THE STENT AND GRAFT REPORTEDLY BECAME PARTIALLY SEPARATED. UPON ROTATING THE DELIVERY CATHETER, THE STENT GRAFT WAS REPORTEDLY RELEASED FROM THE DELIVERY CATHETER WITH BREAKAGE OF THE PARTIAL UNCOVERED STENT. THE STENT GRAFT WAS THEN REPORTEDLY EXPANDED WITH THE CODA BALLOON, AND THE GORE® TAG® DELIVERY CATHETER WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THE DAMAGED PORTION OF THE STENT GRAFT WAS COVERED BY IMPLANTING AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER REPORTED COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914857 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 20417582

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR