GORE TAG Conformable Thoracic Stent Graft TGMR404020Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132646852), received between May 8, 2020 and Jan 5, 2026 — classified as 1 death, 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (P040043); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Device Endoleak

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A TYPE III ENDOLEAK, WHICH PROMPTED AN INTERVENTION. ON (B)(6) 2025, TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED; HOWEVER, THE OVERLAP BETWEEN THE DEVICES WAS NOT BALLOONED, RESULTING IN THE ENDOLEAK. ON (B)(6) 2025, THE DEVICES WERE RELINED AND BRIDGED USING A LARGER GRAFT, AND BALLOONING WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 23967245 ↗
• InjurySep 3, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO ADDRESS A TYPE 1A ENDOLEAK UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. DURING DEPLOYMENT OF THE FIRST (DISTAL) CTAGAC, THE PRIMARY DEPLOYMENT LINE DISCONNECTED FROM THE HANDLE IMMEDIATELY AFTER DEPLOYMENT INITIATION. PRIOR TO OPENING THE ACCESS HATCH, SECONDARY DEPLOYMENT WAS INITIATED AND THE SECONDARY DEPLOYMENT LINE WAS REMOVED, LEAVING THE DEVICE FULLY CONSTRAINED. ONCE THE ACCESS HATCH WAS OPENED AND THE PRIMARY DEPLOYMENT LINE WAS REMOVED, THE DEVICE EXPANDED TO ITS FULL DIAMETER. MINOR DISTAL BIRD-BEAKING WAS OBSERVED, PROMPTING THE PHYSICIAN TO PERFORM BALLOONING USING A GORE® TRI-LOBE BALLOON, WHICH SUCCESSFULLY IMPROVED WALL APPOSITION. IT WAS NOTED THAT AN ATTEMPT WAS MADE TO ANGLE THE DEVICE DOWNWARD, RESULTING IN SLIGHT MOVEMENT; HOWEVER, THE EXACT DISTANCE OF DISPLACEMENT IS UNKNOWN. A SECOND (PROXIMAL) CTAGAC WAS THEN DEPLOYED TO ENHANCE THE SEAL AT THE PROXIMAL EXTENT OF THE TREATMENT ZONE, WITH NO

  Patient problems: Clinical Endoleak

  MAUDE report 22957394 ↗
• MalfunctionJul 22, 2025Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, PATIENT HAS HAD A PRIOR ENDOVASCULAR REPAIR OF THE VISCERAL SEGMENT WITH STENTS IN BOTH RENALS, SMA, AND CELIAC (DATE UNKNOWN) WITH A COOK PHYSICIAN MODIFIED GRAFT. DUE TO THIS PRIOR REPAIR, FEMORAL ACCESS WAS LIMITED AND PHYSICIAN DECIDED HE WANTED TO PLACE A DEVICE FROM A CONDUIT SEWN ONTO THE ASCENDING AORTA THROUGH A 22FR (22X33) DRYSEAL SHEATH, WHICH PHYSICIAN DECIDED TO GO ANTEGRADE THROUGH THE 10MM CONDUIT GRAFT TO THE ASCENDING AORTA IN OFF-LABEL USE. WHEN PHYSICIAN TRIED TO DEPLOY THE CTAGAC, THE 1ST STAGE DEPLOYMENT HANDLE CAME OFF AND THE DEPLOYMENT LINES BROKE OFF WITHIN THE CATHETER HANDLE. WHEN THIS HAPPENED ONLY ROUGHLY THE 1ST 15MM OF THE CTAGAC DEPLOYED WITH THE REMAINING 185MM STILL CONSTRAINED ON THE CATHETER. AT THIS POINT, IT WAS DECIDED TO PULL THE STENT GRAFT BACK INTO THE 22FR DRYSEAL SHEATH AND REMOVE THE DEVICE WITH THE SHEATH THROUGH THE 10MM DACRON CONDUIT. AFTER DEVICE REMOVAL, A DIFFERENT 22FR (22X65 ) DRYSEAL SHEATH WAS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563981 ↗
• InjuryMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE: TAC083415A/(B)(6), TSB081506A/(B)(6), AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC: TGMR404020/(B)(6) AS A DISTAL EXTENSION COUPLED WITH A COOK TAPERED GRAFT 42MM X34MMX 165MM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, POST COMPUTED TOMGRAPH IMAGING DETERMINED A TYPE III ENDOLEAK REPORTED TO ORIGINATE FROM BETWEEN THE COOK TAPERED GRAFT AND THE CTAG-AC DEVICE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION THE AREA OF THE LEAK WAS BALLOONED WITH GORE® TRI-LOBE BALLOON CATHETER AND SUCCESSFULLY TREATED THE TYPE III ENDOLEAK. IT WAS DETERMINED THAT THE TYPE III ENDOLEAK WAS AT THE BASE OF THE COOK DEVICE AND THE END OF THE CTAG-AC. IT APPEARED TO BE CAUSED BY THE COOK GRAFT NOT CONFORMING IN THE BEND PROXIMALLY AND LEAKING ALONG SIDE OUR CTAG-AC DEVICE. CONSEQUENTLY, IT WAS OBSERVED IT WAS MORE OF AN ISSUE WITH THE COOK DEVICE RATHER THAN THE CTAG-AC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22118972 ↗
• InjuryMar 27, 2025Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A NON-GORE GRAFT (MEDTRONIC). ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE ON THE NON-GORE GRAFT FOR ANEURYSM RUPTURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT THE PREVIOUS RUPTURE THAT DUE TO A BIRD BEAK OVER TIME HAD CAUSED A TYPE 1A ENDOLEAK, WHICH GOT LARGE ENOUGH (ANEURYSM SIZE UNKNOWN BUT CONTINUED TO GROW) THAT THE GRAFT PULLED AWAY DISTALLY (DISTANCE UNKNOWN) FROM THE PROXIMAL LANDING ZONE. PATIENT ANATOMY WAS TORTUOUS. PHYSICIAN DID AN OPEN SURGICAL DEBRANCHING PROCEDURE THEN PLACED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INTO THE ASCENDING AORTA COVERING THE ENTIRE ARCH. PATIENT IS DOING OKAY AFTER PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21713593 ↗
• InjuryFeb 5, 2025Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  ON (B)(6) 2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING THORACIC AORTA, UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2025 PATIENT PRESENTED WITH A POSSIBLE PROXIMAL TYPE 1A ENDOLEAK ON A PREVIOUSLY PLACED CTAG DEVICE IMPLANT. A PROXIMAL ENDOLEAK AND A TYPE 3 ENDOLEAK WERE IDENTIFIED VIA ANGIOGRAM AT THE JUNCTION OF THE 2 PREVIOUSLY PLACED DEVICES (TGMR404020 L/S#: (B)(6); TGMR404015 L/S#: (B)(6)). THE PHYSICIAN BELIEVES THE CAUSE OF THE PROXIMAL ENDOLEAK WAS DUE TO DISEASE PROGRESSION AS WELL AS ANGLED ANATOMY IN THE AORTIC ARCH. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION TO TREAT THESE ENDOLEAKS. THE FOLLOWING DEVICE WAS TREATED AS A PROXIMAL EXTENSION TO EXTEND THE SEAL ZONE NEAR THE LEFT SUBCLAVIAN ARTERY: TGM454515 L/S#: (B)(6) (PROXIMAL) AND TGM454515 L/S#: (B)(6). BOTH ENDOLEAKS APPEARED TO RESOLVE AFTER IMPLANTATION OF DEVICES AND BALLOONING. THE PATIENT TOLERATED THE PROCEDURE AND NO FURTHER ISSUES WERE NOTED. NO PATIENT IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21317540 ↗
• MalfunctionJan 23, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT THORACIC AORTIC ANEURYSM ENDOVASCULAR TREATMENT WITH 40 MM X 20 CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CADS DEVICE). THE CADS DEVICE WAS ADVANCED TO POSITION OF AORTA POSTERIOR OF LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN INITIATED THE PRIMARY DEPLOYMENT HANDLE. AFTER THE PRIMARY SLEEVE DEPLOYMENT LINE WAS FULLY PULLED OUT, THE STENT COULDN'T BE DEPLOYED. THEREFORE, THE CADS DEVICE WAS REMOVED WITH SHEATH. ANOTHER CADS DEVICE WITH SAME SIZE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PHYSICIAN COMMENTED THERE WAS NO OBVIOUS RESISTANCE FELT DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214661 ↗
• MalfunctionJul 24, 2024Activation Failure; Activation Failure

  ON 27-JUN-2024, THE PATIENT WAS TREATED FOR A ZONE 2 THORACIC AORTIC DISSECTION. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT TAC123715A AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT TSB121506A. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR404020. USING THE GRAY PRIMARY DEPLOYMENT HANDLE, THE PHYSICIAN DEPLOYED THE DEVICE TO ITS INTERMEDIATE DIAMETER. THE PHYSICIAN THEN USED THE SECONDARY DEPLOYMENT HANDLE TO FULLY OPEN THE DEVICE, BUT ONLY ABOUT 50% OF THE DEVICE OPENED TO THE FULL DIAMETER. THE PHYSICIAN USED A GORE® MOLDING & OCCLUSION BALLOON CATHETER TO COMPLETE DEPLOYMENT OF THE DEVICE. THE DEVICE OPENED QUICKLY AND EASILY USING THE BALLOON, AND WAS FULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN HAS NO OPINION ON THE CAUSE OF THE DEPLOYMENT ISSUE. THE DELIVERY SYSTEM WAS DISCARDED AT THE FACILITY. THE PHYSICIAN WAS UNAWARE OF ANY MALFUNCTION OR BREAK IN THE DEPLOYMENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816479 ↗
• MalfunctionAug 14, 2023Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TO BE IMPLANTED WITH A 40MM X 20CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS DEVICE) TO TREAT ANEURYSM AT AORTIC ARCH. CMDS DEVICE WAS PLANNED TO BE PLACED AT ASCENDING AORTA, AND "CHIMNEY" TECHNIQUE WAS USED TO RESERVE SOME BRANCHES OF THE ARCH. AFTER INSERTING THE DSF2233 SHEATH AND DELIVERING CMDS DEVICE TO TARGET LESION, PHYSICIAN PULLED THE FIRST DEPLOYMENT HANDLE. UNDER DSA FLUOROSCOPY, CMDS DEVICE WAS NOT EXPANDED. PHYSICIAN CONTINUED TO PULL THE SECOND DEPLOYMENT HANDLE, CMDS DEVICE WAS STILL NOT EXPANDED. NO ABNORMAL RESISTANCE WAS FELT WHEN PULLING THE DEPLOY HANDLE. PHYSICIAN CAREFULLY RETRACTED CMDS DEVICE INTO SHEATH AND REMOVED OUT OF BODY. ANOTHER CMDS DEVICE WAS USED AND WAS SUCCESSFULLY DEPLOYED. THE REMAINING PROCEDURE WAS COMPLETED ACCORDING TO THE PREOPERATIVE PLAN. THE PROCEDURE WAS SMOOTH, AND THE PATIENT'S CONDITION WAS STABLE AND WAS RETURNED TO THE WARD SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547416 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A ZONE 0 ASCENDING AORTIC DISSECTION. THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, AND THE PATIENT TOLERATED THE PROCEDURE. A DEBRANCHING OF THE ARCH VESSELS HAD PREVIOUSLY BEEN PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED A FURTHER DISSECTION AND RUPTURE. THE PHYSICIAN EXTENDED BOTH PROXIMALLY AND DISTALLY USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16762559 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ZONA 4 CHRONIC DISSECTION. IT WAS REPORTED THAT AFTER DEPLOYMENT THE EXPOSED STENT APICES WERE PARTIALLY COVERING THE LEFT COMMON CAROTID OSTIUM. THERE WAS DIMINISHED FLOW ON FOLLOW UP ANGIOGRAM. ON FINAL ANGIOGRAM THERE WAS NO FLOW SHOWING IN THE LEFT COMMON CAROTID ARTERY. THE PHYSICIAN PERFORMED AN OPEN BYPASS OF THE LEFT SUBCLAVIAN ARTERY TO THE LEFT COMMON CAROTID ARTERY. THE LEFT COMMON CAROTID ARTERY WAS ALSO STENTED AT THE ORIGIN OF COVERAGE BY EXPOSED STENT APICES WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 16746878 ↗
• InjuryJan 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 4 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO EXTEND COVERAGE PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. THERE WAS NO ANEURYSM ENLARGEMENT REPORTED.

  Patient problems: Aneurysm

  MAUDE report 16259223 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN AORTIC DISSECTION. THE PHYSICIAN IMPLANTED TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ENLARGING HEMATOMA OUTSIDE A FALSE LUMEN IN THE ARCH. NO ACTIVE BLEEDING WAS IDENTIFIED. TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED. IN ADDITION, ARCH DEBRANCHING OF THE LEFT CAROTID AND INNOMINATE WERE PERFORMED, AS WELL AS A LEFT CAROTID-LEFT AXILLARY BYPASS AND A COILING OF THE LEFT SUBCLAVIAN ORIGIN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 15601738 ↗
• MalfunctionMar 29, 2022Break; Break

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR A THORACIC AORTIC ANEURYSM (TAA). AS REPORTED, DURING THE PROCEDURE THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DID NOT ANGULATE IN THE APPROPRIATE PLANE (1960-E:-OTHER/UNKNOWN). THE HORIZONTAL BAR IN OLIVE TIP APPEARED TO BE SEPARATED AND SUPERIOR TO THE CENTRAL WIRE LUMEN (LUNDERQUIST.) ANGULATION AND STENT NESTING OCCURRED IN EITHER THE 9:00 OR 3:00 POSITION INSTEAD OF THE INNER CURVE AS DESIRED. THE ISSUE WAS NOT OBSERVED TO BE RELATED TO ANY ANATOMICAL FACTORS. THE PATIENT¿S ARCH WAS STEEP AND THERE WAS SLIGHT ANTERIOR ¿ POSTERIOR POSITIONING OF THE ASCENDING TO TRANSVERSE ARCH. THE PATIENT WAS TREATED SUCCESSFULLY AND TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938649 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT OF A THORACIC ANEURYSM IN ZONE 0 - PROXIMAL TO THE BRACHIOCEPHALIC TRUNK, DISTAL TO THE SINOTUBULAR JUNCTION. THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED A LEFT HEMISPHERIC STROKE. THE EVENT IS ONGOING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12857663 ↗
• DeathJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT WAS UNDERGOING TREATMENT OF AN ASCENDING AORTIC ANEURYSM AS A SUBJECT IN THE SSB 1102 CLINICAL STUDY. THE PROCEDURE INCLUDED THE USE OF FOUR GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. DURING THE PROCEDURE A SERIES OF ADVERSE EVENTS OCCURRED WHICH LED TO EVENTUAL INTRAPROCEDURAL DEATH. THE PHYSICIAN STATED THE FOLLOWING: ¿IN SUMMARY, I BELIEVE SHE SUFFERED A SERIES OF STRESSES THAT CUMULATIVELY RESULTED IN HER ARREST WHEN SHE BECAME HYPOXEMIC DURING THE REINTUBATION EVENT. THE SERIES OF STRESSED INCLUDED THE INTERMITTENT HYPOTENSION FROM THE WIRE, TREATED WITH PRESSORS FOR SEVERAL HOURS. HER LEFT PELVIS/LEG WERE ISCHEMIC FOR ABOUT 3.5 HOURS. THE DIFFICULTY ESTABLISHING DISTAL SEAL IN THE DTA, THE LEFT FEMORAL CUT-DOWN ALL CAUSED PROLONGATION OF THE OPERATION. SHE HAD AN ACUTE BLEED FROM THE ACCESS SITE COMPLICATION, WHICH ALTHOUGH IMMEDIATELY RECOGNIZED AND TREATED WAS YET ANOTHER HIT. AFTER ALL THESE EVENTS, I SUSPECT THAT HER HYPOXEMIA EXHAUSTED HER PHYSIOLOGIC RESERVE AND SHE CODED. THE DEVICE PERFORMED AS ANTICIPATED A

  Patient problems: Hypoxia

  MAUDE report 12132541 ↗
• MalfunctionMay 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL. THE PHYSICIAN ADVANCED THE SHEATH SLOWLY UNTIL HE FELT RESISTANCE. HE STOPPED ADVANCING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH AT THE PROXIMAL END OF THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 5.5MM-6MM. THE RIGHT COMMON ILIAC ARTERY MEASURED 8MM. THE PHYSICIAN THEN STARTED TO INTRODUCE THE CTAG/AC THROUGH THE SHEATH AND THEN OUTSIDE THE SHEATH THROUGH THE RIGHT COMMON ILIAC ARTERY. RESISTANCE WAS FELT BUT HE KEPT ADVANCING THE DEVICE SLOWLY UNTIL PASSED THE RIGHT COMMON ILIAC ARTERY AND THE AORTIC BIFURCATION AND REACHED THE THORACIC AORTA. WHEN THE DEVICE WAS IN THE DESIRED LOCATION, IT WAS OBSERVED THE PATIENT¿S BLOOD PRESSURE DROPPED. IT WAS DISCOVERED THAT THE RIGHT COMMON ILIAC ARTERY HAD RUPTURED. (THIS WAS REPORTED ON MFR REPORT # 3007284313-2021-01425). AT THAT MOMENT THE PHYSICIAN STARTED THE STEPS TO DEPLOY THE DEVICE QUICKLY. AFTER THE FIRST 50% WAS DEPLOYED THE FSA NOTICED THAT THE DISTAL END HAD NOT DEPLOYED, BUT THE PHYSICIAN KEPT FOLLOWING THE DEPLOYMENT STEPS TO FULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813866 ↗
• MalfunctionMar 31, 2021Break; Difficult or Delayed Activation; Break; Difficult or Delayed Activation

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT THE FIRST CTAG A/C DEVICE WAS DEPLOYED WITH NO REPORTED ISSUES. A SECOND CTAG A/C DEVICE WAS PLACED AS A DISTAL EXTENSION OF THE FIRST. THE PRIMARY AND SECONDARY STAGES OF DEPLOYMENT WERE PERFORMED FOR THE SECOND CTAG A/C DEVICE WITH NO REPORTED ISSUES. REPORTEDLY, WHEN THE RED LOCKWIRE HANDLE WAS ROTATED 90 DEGREES, THE HANDLE WAS UNABLE TO BE PULLED FOR LOCKWIRE REMOVAL. REPORTEDLY THE HANDLE WAS ROTATED WITH NO ISSUE, BUT WAS UNABLE TO BE REMOVED. IT WAS REPORTED THAT, AFTER MULTIPLE ATTEMPTS TO PULL AND REMOVE THE RED LOCKWIRE HANDLE, THE HANDLE BROKE OFF OF THE DEPLOYMENT HANDLE ASSEMBLY. IT WAS REPORTED THAT THE DEPLOYMENT LINE ACCESS HATCH WAS OPENED. THE ANGULATION FIBER WAS CUT AND REMOVED, BUT REPORTEDLY WAS UNABLE TO RELEASE FROM THE DEVICE. THE ANGULATION FIBER SEPARATED FROM THE DEPLOYMENT HANDLE. REPORTEDLY THE LOCKWIRE WAS CUT AND PULLED USING A HEMOSTAT. THE WIRE WAS PULLED ABOUT 3CM AND RESISTANCE WAS NOTED. REPORTEDLY THE PHYSICIAN PULLED THE WIRE HARD AND THE WIRE RELEASED. THE LOCKWIRE AND ANG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600202 ↗
• InjuryNov 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. UPON CT FOLLOW-UP APPROXIMATELY 4 WEEKS AFTER THE ORIGINAL PROCEDURE IT WAS REPORTED THAT CONTRAST WAS OBSERVED IN THE ANEURYSM SAC WITH ANEURYSM SAC ENLARGEMENT. IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION OF A TYPE III ENDOLEAK BETWEEN TWO OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT IS REPORTEDLY UNCLEAR WHICH DEVICES WERE INVOLVED WITH THE TYPE III ENDOLEAK. REPORTEDLY THE PROXIMAL END OF THE MOST PROXIMAL CTAG A/C DEVICE, PLACED NEAR THE PATIENT'S AORTIC ARCH, DID NOT HAVE FULL CIRCUMFERENTIAL APPOSITION, AND IT WAS SUSPECTED THAT THIS MAY HAVE CONTRIBUTED TO THE TYPE III ENDOLEAK. IT WAS REPORTED THAT THE AREA WHERE THE TYPE III ENDOLEAK OCCURRED WAS RELINED WITH AN ADDITIONAL TGM454515 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 10819421 ↗
• InjuryNov 2, 2020Component Incompatible; Component Incompatible

  ON (B)(6) 2020, THIS PATIENT UNDERWENT TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK AND WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE TREATMENT PLAN WAS TO EXTEND SEAL AND COVERAGE PROXIMALLY TO THE LEFT COMMON CAROTID ARTERY(LCCA). THE DEVICE WAS LOADED ONTO THE LUNDERQUIST WIRE AND ADVANCED TO THE AORTIC ARCH WITHOUT ISSUE AND ADVANCED PROXIMAL TO TARGET LANDING ZONE, AND THEN REPOSITIONED TO TARGET DEPLOYMENT LOCATION. THE FIRST STAGE OF DEPLOYMENT WAS COMPLETED; THE STRING WAS FULLY REMOVED AND THE DEVICE OPENED TO 50% PROXIMALLY FOR THE FIRST 2CM THEN WAS CONSTRAINED AND THEN OPENED UP AGAIN DISTALLY. THE SECOND STAGE DEPLOYMENT WAS THEN COMPLETED SUCCESSFULLY, BUT THE MID SEGMENT OF THE GRAFT STILL DID NOT OPEN UP. NEUROMONITORING SAID PRESSURES HAD THEN DROPPED IN THE FEMORALS, SO AN ANGIO WAS DONE TO SHOW THE CONSTRAINED SEGMENT OF THE GRAFT. A GORE® TRI-LOBE BALLOON CATHETER WAS

  Patient problems: Aneurysm

  MAUDE report 10772559 ↗
• InjuryMay 8, 2020Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON AN UNKNOWN DATE ESTIMATED TO BE ON OR ABOUT (B)(6) 2020 THE PATIENT UNDERWENT RE-INTERVENTION AND A MEDTRONIC NAVIEN GRAFT WAS PLACED TO TREAT THE MIGRATION AND EXTEND COVERAGE. PATIENT WAS TREATED SUCCESSFULLY ACCORDING TO PHYSICIAN.

  Patient problems: Aortic Dissection

  MAUDE report 10040718 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm