GORE TAG Conformable Thoracic Stent Graft TGM454520Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00733132647002), received between Dec 17, 2019 and Jul 30, 2025 — classified as 2 deaths, 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ON (B)(6) 2025, THIS PATIENT UNDERWENT AN EMERGENT PROCEDURE FOR TREATMENT OF AN ACUTE AORTIC DISSECTION AND RUPTURE OF THE THORACIC AORTA. UPON DELIVERY OF TGM454520 GRAFT INTO THE THORACIC AORTA AT THE LEVEL OF LSA ON A LUNDERQUIST WIRE, THE DEVICE DID NOT DEPLOY AND THE DEPLOYMENT LINE SNAPPED. WE ENTERED THE HATCH OF THE DEVICE HANDLE AND ATTEMPTED TO PULL LINE #1 WHICH ALSO SNAPPED AND DID NOT DEPLOY DEVICE. THE DEVICE WAS REMOVED THRU THE 24FR SHEATH AND WAS NOT USED IN THE PATIENT. AFTER THE CASE, THE DEPLOYMENT HANDLE THAT WAS REMOVED WAS INSPECTED AND PICTURES WERE TAKEN. NO PATIENT SEQUELAE RESULTED FROM THIS UNDEPLOYED GRAFT. THE PATIENT TOLERATED THE PROCEDURE, THE UNDEPLOYED GRAFT WAS DISCARDED AT THE SITE.

  Patient problems: Rupture

  MAUDE report 22667796 ↗
• MalfunctionJul 24, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM USING A GORE® TAG ®CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). A 373715 CTAG WAS FIRST ADVANCED SO THE DISTAL END WAS JUST PROXIMAL OF THE SMA, AND IT WAS SUCCESSFULLY DEPLOYED. THE CTAG WAS THEN FENESTRATED AT THE LEVEL OF THE CELIAC, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS PLACED IN THE FENESTRATION. A 454520 CTAG WAS THEN ADVANCED SO THAT THE PROXIMAL END WAS JUST DISTAL TO THE LEFT SUBCLAVIAN. WHEN THE DEPLOYMENT LINE WAS PULLED, IT WAS OBSERVED THAT THE MIDDLE PORTION OF THE DEVICE DID NOT DEPLOY. WHEN THE DELIVERY CATHETER WAS WITHDRAWN, A DEPLOYMENT LINE REMAINED OUTSIDE OF THE SHEATH. A RELIANT BALLOON WAS ADVANCED, AND THE DEVICE WAS ABLE TO BE EXPANDED TO FULL DIAMETER. HOWEVER, THE STENT STRUCTURE AT THAT POINT LOOKED STRANGE, AND THE PHYSICIAN WAS UNSURE ABOUT THE INTEGRITY OF THE GRAFT, SO ANOTHER CTAG WAS ADVANCED TO RELINE THE DEVICE. THE PROCEDURE COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES. THE CATHETER AND DEPLOYMENT LINE ARE BEING RETURNED. IT WAS REPORTED THAT AS THE PROXIMAL END OF THE 4520 CTAG WAS PASSING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587035 ↗
• InjuryOct 17, 2024Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ANEURYSM IN ZONE 4 OF THE DESCENDING THORACIC AORTA USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL (CTAG) AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSF). THE PHYSICIAN BEGAN BY INSERTING A 24FR SHEATH INTO THE PATIENT THROUGH THE RIGHT FEMORAL ARTERY. ALTHOUGH THERE WAS SUPPOSED TO BE PLENTY OF ROOM IN THE ACCESS VESSEL, THE PHYSICIAN HAD DIFFICULTY INSERTING THE DSF. HOWEVER, HE WAS ABLE TO GET THE DSF IN PLACE. THE PHYSICIAN THEN INSERTED THE 1ST CTAG DEVICE. THE PHYSICIAN NOTED DIFFICULTY IN ADVANCING THE DEVICE THROUGH THE SHEATH, BUT EVENTUALLY GOT THE DEVICE INTO PLACE. THE FIRST TWO STAGES OF THE DEVICE DEPLOYED SUCCESSFULLY. WHEN ATTEMPTING TO REMOVE THE ANGULATION FIBERS, THE FIBERS WOULD NOT COME OUT. AS THE PHYSICIAN PULLED ON THE HANDLE, THE WIRE BROKE. THE PHYSICIAN OPENED THE BACK-UP DEPLOYMENT HATCH AND PULLED ON THE WIRE. IT REQUIRED A GREAT DEAL OF FORCE, BUT EVENTUALLY THE WIRE WAS ABLE TO BE REMOVED. HOWEVER, DURING REMOVAL, THE DEVICE WAS PULLED DISTALLY. ORIGINALLY, THE PHYSICIAN HAD PLANNED TO TREAT WITH ONE CTAG DEVICE, BUT BECAUSE OFF THE MOVEMENT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478056 ↗
• MalfunctionAug 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 2 DISSECTION WITH MALPERFUSION UTILIZING TBE AND TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC). THE CTAGAC DEVICE WAS USED TO EXTEND DISTALLY TO THE CELIAC ARTERY FOR A TYPE B DISSECTION. UPON PRIMARY DEPLOYMENT OF THE CTAGAC DEVICE, ONLY HALF OF THE GRAFT WENT TO 50% DEPLOYMENT. THERE WAS ABOUT 10CM THAT DID NOT DEPLOY. PHYSICIAN THEN ATTEMPTED TO PULL THE SECONDARY HANDLE AND LOCK WIRE KNOB TO SEE IF ANY OF THOSE WORKED, AND SECONDARY HANDLE WOULD NOT DEPLOY THE DEVICE, AND LOCK WIRE WOULD NOT RELEASE THE GRAFT. THE BACK UP HATCH WAS OPENED, AND SINCE THE OTHER HANDLE AND LOCK WIRE KNOB WAS PULLED, THERE WAS NOT ENOUGH FIBERS AND WIRE TO PULL IN THE BACK UP HATCH. SINCE THIS WAS A TBE CASE, PHYSICIAN OBTAINED THE WIRE THAT WENT THROUGH THE ARM, AND PUT IT THROUGH THE PORTAL, AND INTO THE PARTIALLY DEPLOYED CTAGAC DEVICE. PHYSICIAN PUT A BALLOON INTO THE CTAGAAC DEVICE, AND BALLOONED IT, IN AN ATTEMPT TO BREAK THE STITCHING THAT WAS STILL CONSTRAINING THE CTAGAC DEVICE. THE CTAGAC DEVICE WAS EXPANDED TO FULL DIAMETER. PATIENT TOLERATED THE PROCEDURE AND THERE WERE NO PATIENT ADVERSE EV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907028 ↗
• MalfunctionJul 15, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN FROZEN ELEPHANT TRUNK PROCEDURE TO TREAT AN ASCENDING AORTIC ANEURYSM UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, A TERUMO STENT GRAFT WAS USED ALONG WITH THE CTAGAC BY DOING ANASTOMOSIS OF THE TWO GRAFTS. THE CTAGAC WAS DEPLOYED ANTEGRADE INTO THE AORTA AND THE FIRST TWO DEPLOYMENTS CAME OFF SUCCESSFULLY BUT THE 3RD DEPLOYMENT STEP DID NOT DEPLOY PROPERLY AS THE LOCKWIRE BROKE FROM THE HANDLE. AS THE HANDLE CAME OFF (BROKE) AND THE DEPLOYMENT LINE WOULD NOT DEPLOY AS THE LOCKWIRE WAS NOT RELEASED YET, SO THE PHYSICIAN HAD TO CUT THE LINE WITH SCISSORS AND PULL TO RELEASE THE LOCKWIRE LINE (DID NOT USE THE BACKUP HATCH FOR DEPLOYMENT). AT THE 4TH DEPLOYMENT STEP, THE WIRE GOT HUNG AND IT WOULD NOT DEPLOY, HENCE, PHYSICIAN HAD TO GO BACK TO STEP 3 AND CUT THE CONSTRAINING WIRE THEN BACK TO STEP 4 OF DEPLOYMENT AND FINISH PULLING THE STRING TO COMPLETE THE DEPLOYMENT AND OFF THE CATHETER. THERE WAS LOT OF TENSION FELT DURING THE 3RD AND 4TH DEPLOYMENT STEPS (CATHETER WAS CURVED AND GUIDEWIRE WAS NOT USED BY PHYSICIAN BUT WAS RECOMMENDED BY THE

  Patient problems: Reduced Blood Flow

  MAUDE report 19740958 ↗
• InjuryJun 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION DUE TO DISEASE PROGRESSION. IT WAS REPORTED THAT, DUE TO THE PROXIMAL EXTENSION OF THE ANEURYSM, IT WAS NECESSARY TO OBTAIN DEVICE SEAL IN THE AORTIC ARCH. THE DEVICE WAS EXTENDED PROXIMALLY USING TWO ADDITIONAL CTAG A/C DEVICES. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 17187572 ↗
• MalfunctionMay 1, 2023Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR ZONE 2 THORACIC AORTIC ANEURYSM WITH ABERRANT LSA WITH KOMMERELL DIVERTICULUM. THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN A RIGHT-SIDED ARCH JUST DISTAL TO THE RCCA. THE FIRST TWO STEPS IN THE DEPLOYMENT WENT FINE, (50% AND 100%), BUT WHEN THE PHYSICIAN WENT TO RELEASE THE LOCK PIN, THE SUTURE LINES BROKE. THE PHYSICIAN WAS UNSURE IF IT WAS STILL ATTACHED, SO HE TRIED PULLING IT BACK, AND THE GRAFT ACCORDIONED ON ITSELF. THE BROKEN SUTURE LINE WAS FOUND IN THE HANDLE, AND IT WAS PULLED USING A HEMOSTAT. THE LOCK PIN RELEASED, AND A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADDED TO COVER THE PROXIMAL END OF THE FIRST GRAFT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE DELIVERY SYSTEM OF THE FIRST GRAFT WAS RECEIVED BY HISTOLOGY FOR EVALUATION. THE EVENT HAD NOT BEEN REPORTED TO MEDCOMPLAINTS AT THAT TIME, SO THE FSA WAS CONTACTED FOR INFORMATION ON THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844916 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION IN ZONE 2. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT REPORTED TO THE HOSPITAL, AND WAS REPORTED TO BE HYPOTENSIVE. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THERE WAS A RUPTURE, BUT THE FALSE LUMEN WAS SEEN TO BE FILLING. TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WERE IMPLANTED. THE PHYSICIAN IS MONITORING THE PATIENT TO ENSURE THE ISSUE HAS BEEN CORRECTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16184177 ↗
• InjurySep 19, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2022, THE PATIENT UNDERWENT TEVAR FOR TREATMENT OF A DISSECTION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2022, COMPUTE TOMOGRAPHY (CT) IMAGING WAS CONDUCTED AND A TYPE 1B ENDOLEAK HAD BEEN IDENTIFIED. IT WAS REPORTED THAT THERE WAS ANEURYSM DEGENERATION AROUND THE DISTAL EDGE OF THE GRAFT. REPORTEDLY, THIS WAS CAUSED BY THE INITIAL GRAFT BEING LANDED SLIGHTLY HIGH RESULTING IN AN INCOMPLETE DISTAL SEAL. AS REPORTED, THE EXTENT OF AORTIC GROWTH IS UNKNOWN. AS REPORTED, EVALUATION AND CASE PLANNING IS ONGOING FOR A REINTERVENTION TO EXTEND THE EXISTING GRAFT. PATIENT IMAGING WAS PROVIDED FOR CONSIDERATION. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THERE IS CONTRAST OUTSIDE OF THE IMPLANTED GRAFT ON BOTH THE ARTERIAL AND THE DELAY PHASE. THERE IS A LACK OF WALL APPOSITION FOR > 4 CM AT THE DISTAL END OF IMPLANTED GRAFT. A TYPE 1B ENDOLEAK IS CONSISTENT WITH THE FINDING OF CONTRAST IN THE ANEURYSM SAC ON THE DELAY PHASE THROUGH MUCH OF THE DEVICE AND ON BOTH ARTERIAL AND DELAY PHASES NEAR THE DISTAL END OF THE IMPLANTED DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 15447791 ↗
• DeathJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE THIS PATIENT WAS IMPLANTED WITH MEDRTRONIC DEVICES FOR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A PETTICOAT TECHNIQUE. NO ADDITIONAL INFORMATION IS KNOWN. ON (B)(6) 2022, THIS PATIENT UNDERWENT TREATMENT OF A TYPE I-A ENDOLEAK ASSOCIATED WITH THE MEDTRONIC DEVICE(S). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT AND A GORE® CONTRALATERAL LEG COMPONENT WERE IMPLANTED TO RELINE THE PREVIOUS STENT GRAFTS. BOTH DEVICES WERE SUCCESSFULLY PLACED WITHOUT ISSUE. DURING CLOSING THE PATIENT CODED AND EXPIRED INTRAPROCEDURE. THE DEATH IS BELIEVED TO BE DUE TO A COLLAPSE OF THE LEFT LUNG. THE PHYSICIAN REPORTED ALL THE GORE DEVICES PERFORMED AS INTENDED AND THERE WAS NO DEVICE DEFICIENCY. THE PATIENT HAD MARFAN'S SYNDROME BUT IT IS UNKNOWN MARFANS CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Aneurysm

  MAUDE report 15089345 ↗
• DeathJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE THIS PATIENT WAS IMPLANTED WITH MEDTRONIC DEVICES FOR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A PETTICOAT TECHNIQUE. NO ADDITIONAL INFORMATION IS KNOWN. ON (B)(6) 2022, THIS PATIENT UNDERWENT TREATMENT OF A TYPE I-A ENDOLEAK ASSOCIATED WITH THE MEDTRONIC DEVICE(S). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT AND A GORE® CONTRALATERAL LEG COMPONENT WERE IMPLANTED TO RELINE THE PREVIOUS STENT GRAFTS. BOTH DEVICES WERE SUCCESSFULLY PLACED WITHOUT ISSUE. DURING CLOSING THE PATIENT CODED AND EXPIRED INTRA-PROCEDURE. THE DEATH IS BELIEVED TO BE DUE TO A COLLAPSE OF THE LEFT LUNG. THE PHYSICIAN REPORTED ALL THE GORE DEVICES PERFORMED AS INTENDED AND THERE WAS NO DEVICE DEFICIENCY. THE PATIENT HAD MARFAN'S SYNDROME BUT IT IS UNKNOWN MARFANS CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Aneurysm

  MAUDE report 15089252 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND WAS TREATED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM [TGM454515 (L/S#:(B)(4)) AND TGM454520 L/S# ((B)(4)). ON (B)(6) 2022, THE PHYSICIAN PERFORMED AN ANGIOGRAM TO IDENTIFY A POSSIBLE ENDOLEAK AND PERFORMED A SUBSEQUENT DEBRANCHING OF THE THORACIC AORTIC ARCH TO IDENTIFY DISEASE PROGRESSION PROXIMAL TO THE ORIGINAL CTAG GRAFT PLACEMENT AND DETERMINE IF FURTHER TREATMENT WAS WARRANTED. AT THE TIME OF SURGERY, IT WAS DETERMINED BY THE PHYSICIAN THAT THE APPROPRIATE TREATMENT WAS TO EXTEND PROXIMAL SEAL USING AN ADDITIONAL CTAG DEVICE. A CTAG [TGM454515 L/S#: (B)(4)] WAS PLACED AS A PROXIMAL EXTENSION, AND THE LEAK WAS NOTED TO RESOLVE. THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 14876025 ↗
• InjuryFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MID-DESCENDING THORACIC AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG A/C). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK FROM THE PREVIOUSLY PLACED DEVICE AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE TAG DEVICE WAS EXTENDED TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A CONTINUED TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE DEVICE WAS PLACED TO PARTIALLY COVER THE LEFT SUBCLAVIAN ARTERY DUE TO THE CONTINUED TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT A CAROTID-CAROTID AND CAROTID-SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596468 ↗
• InjuryJun 16, 2021Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN TREATMENT OF A THORACIC AORTIC DISSECTION WHEREBY A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) WAS DELIVERED ANTEGRADE INTO THE PATIENT'S ASCENDING AORTA FOLLOWING AORTIC ARCH DEBRANCHING. AFTER DEPLOYMENT OF THE CTAG A/C DEVICE, THE TREATMENT SITE WAS CONFIRMED USING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE. THERE WERE NO REPORTED ISSUES. IT WAS REPORTED THAT APPROXIMATELY AN HOUR AND 20 MINUTES LATER THE PHYSICIANS WERE PREPARING TO CLOSE. REPORTEDLY A TEE PROBE WAS USED AGAIN TO VERIFY THE TREATMENT SITE PRIOR TO CLOSURE. IT WAS REPORTED THAT A TYPE A DISSECTION WAS OBSERVED. REPORTEDLY THE ENTRY TEAR WAS UNABLE TO BE OBSERVED. THE DISSECTION WAS DESCRIBED AS A DELAYED TEAR AND THERE WAS NO SUSPECTED CAUSE FOR HOW OR WHY THE TEAR APPEARED. THE PHYSICIANS RE-OPENED THE SITE. A PIECE OF FELT WAS SEWN TO A SECTION OF THE GRAFT AND A SECTION OF THE DISSECTION IN ORDER TO BRIDGE THE AREA. THE DISSECTION WAS RESOLVED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 12013724 ↗
• MalfunctionJan 11, 2021Premature Activation; Premature Activation

  ON (B)(6) 2020 THE PATIENT UNDERWENT PHASE II OF THORACIC AORTIC TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT ONE WEEK PRIOR THE PATIENT HAD UNDERGONE OPEN REPAIR AND TOTAL ARCH REPLACEMENT USING A FROZEN ELEPHANT TRUNK TECHNIQUE. PHASE II WAS PERFORMED TO TREAT A THORACIC AORTIC ANEURYSM AND DISSECTION. A 300CM GLIDEWIRE GUIDEWIRE WAS USED WITH A THROUGH AND THROUGH TECHNIQUE FROM THE PATIENT'S RIGHT BRACHIAL ARTERY TO THE RIGHT COMMON FEMORAL ARTERY. IT WAS REPORTED THAT A 24FR. GORE® DRYSEAL FLEX SHEATH WAS ADVANCED ON THE PATIENT'S RIGHT SIDE THROUGH THE COMMON FEMORAL ARTERY. REPORTEDLY AN ATTEMPT WAS MADE TO PLACE A CTAG A/C IN THE PREVIOUSLY IMPLANTED FROZEN ELEPHANT TRUNK DEVICE. IT WAS REPORTED THAT THE PATIENT HAD TWO 180 DEGREE BENDS IN THE AORTA (DESCRIBED AS AN "S" CURVE). IT WAS REPORTED THAT THE PHYSICIAN WAS PULLING TENSION ON THE THROUGH WIRE. AS THE CTAG A/C WAS EXITING THE INTRODUCER SHEATH IT WAS REPORTED THAT THE FIRST AORTIC BEND WAS SUCCESSFULLY NAVIGATED, BUT AS THE DEVICE WAS ADVANCED FURTHER THE LEADING OLIVE TIP AND DEVICE BEGAN TO SEPARATE AT THE JUNCTION. REPORTEDLY THE LEADING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11147725 ↗
• MalfunctionJan 11, 2021Premature Activation; Premature Activation

  ON (B)(6) 2020 THE PATIENT UNDERWENT PHASE II OF THORACIC AORTIC TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT ONE WEEK PRIOR THE PATIENT HAD UNDERGONE OPEN REPAIR AND TOTAL ARCH REPLACEMENT USING A FROZEN ELEPHANT TRUNK TECHNIQUE. PHASE II WAS PERFORMED TO TREAT A THORACIC AORTIC ANEURYSM AND DISSECTION. A 300CM GLIDEWIRE GUIDEWIRE WAS USED WITH A THROUGH AND THROUGH TECHNIQUE FROM THE PATIENT'S RIGHT BRACHIAL ARTERY TO THE RIGHT COMMON FEMORAL ARTERY. IT WAS REPORTED THAT A 24FR. GORE® DRYSEAL FLEX SHEATH WAS ADVANCED ON THE PATIENT'S RIGHT SIDE THROUGH THE COMMON FEMORAL ARTERY. REPORTEDLY AN ATTEMPT WAS MADE TO PLACE A CTAG A/C IN THE PREVIOUSLY IMPLANTED FROZEN ELEPHANT TRUNK DEVICE. IT WAS REPORTED THAT THE PATIENT HAD TWO 180 DEGREE BENDS IN THE AORTA (DESCRIBED AS AN "S" CURVE). IT WAS REPORTED THAT THE PHYSICIAN WAS PULLING TENSION ON THE THROUGH WIRE. AS THE CTAG A/C WAS EXITING THE INTRODUCER SHEATH IT WAS REPORTED THAT THE FIRST AORTIC BEND WAS SUCCESSFULLY NAVIGATED, BUT AS THE DEVICE WAS ADVANCED FURTHER THE LEADING OLIVE TIP AND DEVICE BEGAN TO SEPARATE AT THE JUNCTION. REPORTEDLY THE LEADING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11147601 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2020, THE PATIENT PRESENTED WITH POSSIBLE TYPE III COMPONENT DISCONNECT ENDOLEAK. A REINTERVENTION WAS PERFORMED WHEREBY TWO ADDITION CONFORMABLE GORE® TAG® THORACIC STENT GRAFT DEVICES WERE IMPLANTED TO TREAT THE SUSPECTED ENDOLEAK. THE REINTERVENING PHYSICIAN SUSPECTS THE OVERLAP BETWEEN THE TWO ORIGINAL DEVICES MAY NOT HAVE BEEN SUFFICIENT, THUS CONTRIBUTING TO THE SUSPECTED TYPE III ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11127253 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A PROCEDURE TO TREAT A THORACIC AORTIC DISSECTION ON (B)(6) 2009. CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS 05309934/TG4020 AND 05276991/TG4010 WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED FOR A PROCEDURE TO TREAT A PROXIMAL EXTENSION OF THE PREVIOUSLY TREATED THORACIC AORTIC DISSECTION. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED, WITH THE PROXIMAL END LANDING AT THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THE DISSECTION WAS PART OF NATURAL DISEASE PROGRESSION.

  Patient problems: Vascular Dissection

  MAUDE report 9482123 ↗

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-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm