GORE TAG Conformable Thoracic Stent Graft TGMR404010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132646838), received between Dec 23, 2019 and Mar 24, 2026 — classified as 2 deaths, 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (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.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA24-01 TAMBE POST APPROVAL STUDY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA CLINICAL DATABASE. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH A CONTAINED RUPTURE OF THE PERIVISCERAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2026, ENDOVASCULAR REPAIR OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH A LEFT ILIAC EXTENSION INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED. THERE WAS AN AORTIC CUFF IMPLANTED PROXIMALLY TO THE TAMBE DEVICE TO OVERLAP THIS REGION TO PREVENT A POSSIBLE JUNCTIONAL ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2026 PATIENT DEVELOPED ACUTE KIDNEY FAILURE, THE EVENT IS ONGOING.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24677247 ↗
• InjuryMar 23, 2026Unintended Movement; Device Endoleak

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT CHRONIC DISSECTION WITH FALSE LUMEN ANEURYSMAL GROWTH IN THE THORACIC AORTA UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC124015 AND TSB121506) IN ZONE 2 AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGM343410 AND TGMR404010) EXTENDED DISTALLY. THE PATIENT UNDERWENT MULTIPLE FOLLOW-UP CT SCANS THROUGH 2024 WHICH SHOWED GOOD RESULTS. THE PATIENT WAS DUE FOR THE NEXT FOLLOW-UP IN 2026. ON (B)(6) 2026, THE PATIENT WAS SHOWING SYMPTOMATIC SIGNS OF A RUPTURE, WITH MEDIASTINAL SHIFT, CHEST/BACK PAIN, AND HYPOTENSION. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE. THE PHYSICIAN BELIEVES AT SOME POINT BETWEEN 2024 AND (B)(6) 2026, THE SEPTUM TORE OPEN IN THE EXISTING DISSECTION (DISSECTION FROM INITIAL PROCEDURE) AT THE DISTAL END OF THE TAC124015 (TBE AORTIC COMPONENT), AND THE CTAG DEVICE IMMEDIATELY DISTAL TO THE TBE AORTIC COMPONENT (TGMR404010) DID NOT MAINTAIN APPOSITION TO THE AORTA RESULTING IN A TYPE 3 ENDOLEAK. IT IS UNKNOWN IF THERE WAS FALSE LUMEN EXPANSION. IT IS UNKNOWN IF THERE WAS A RUPTURE. DURING THE REINTERVENTION, ANOTHER CTAG DEVICE WAS IM

  Patient problems: Clinical Endoleak; Low Blood Pressure/ Hypotension; Mediastinal Shift; Pain; Vascular Dissection

  MAUDE report 24665115 ↗
• InjuryOct 20, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: THE PATIENT HAD A PRE-EXISTING ASCENDING AORTIC REPAIR WITH A DACRON GRAFT. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A CHRONIC DISSECTION USING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) AND THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNSPECIFIED DATE, THE DACRON GRAFT BECAME INFECTED, INITIALLY SPARING THE PREVIOUSLY IMPLANTED GORE® DEVICES. SUBSEQUENTLY, CT IMAGING REVEALED THE ANEURYSM HAD GROWN BY 2 CM, AND BY THE FOLLOWING DAY, THE INFECTION HAD WORSENED AND WAS SUSPECTED TO INVOLVE THE GORE® GRAFT(S) (SPECIFIC GRAFT UNKNOWN). THE ANEURYSM HAD FURTHER EXPANDED BY 5 CM. CONCURRENTLY, A TYPE 1B ENDOLEAK WAS NOTED. ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR REINTERVENTION TO ADDRESS THE ANEURYSM AND ENDOLEAK. TWO CTAGAC DEVICES WERE IMPLANTED, EXTENDING FROM THE DISTAL CELIAC ARTERY TO THE PROXIMAL DESCENDING THORACIC AORTA, LANDING WITHIN THE PREVIOUSLY PLACED TBE. A HIGH DOSE OF ANTIBIOTICS WERE ADMINISTERED. IT WAS LATER DETERMINED THAT THE ANEURYSM HAD NOT RUPTURED, ALTH

  Patient problems: Aneurysm expansion; Clinical Endoleak; Medical device site infection

  MAUDE report 23339635 ↗
• InjurySep 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE ON (B)(6), 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6), 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AORTIC COMPONENT AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM MAY HAVE BEEN USED FOR PROXIMAL EXTENSION OF THE DEVICE SYSTEM. IT WAS REPORTED THAT SPINAL CORD ISCHEMIA WAS OBSERVED ON (B)(6), 2025. TREATMENT WAS REQUIRED. THE ADVERSE EVENT WAS NOTED AS RESOLVED ON (B)(6), 2025. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6), 2025.

  Patient problems: Ischemia

  MAUDE report 23132085 ↗
• InjuryAug 5, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2021, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). THREE CTAGAC DEVICES WERE IMPLANTED. ON (B)(6) 2025, IT WAS REPORTED THE FSA WAS NOTIFIED THAT THE PATIENT HAD A TYPE 1B ENDOLEAK. IT WAS ALSO REPORTED PATIENT WILL UNDERGO REINTERVENTION SURGERY ON A LATER DATE. SURGERY DATE HAS NOT BEEN SCHEDULED YET. THE CAUSE OF THE ENDOLEAK REMAINS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 22723170 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) 37 X 15. THE PHYSICIAN SEALED THE ANEURYSM CONSERVATIVELY, WITH NO ENDOLEAK NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, REINTERVENTION (B)(4) WAS PERFORMED TO ADDRESS THE TYPE 1A ENDOLEAK IN ZONE 3, WITH PROXIMAL EXTENSION USING A CTAG 40 X 10. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, PROXIMAL THORACIC AORTIC DEGENERATION WAS OBSERVED. ON (B)(6) 2024, A SECOND REINTERVENTION (B)(4) OCCURRED. ANOTHER CTAG 37 X 15 WAS DEPLOYED PROXIMALLY, AND A CTAG 45 X 20 WAS USED TO BRIDGE INTO THE PREVIOUS CTAG 40 X 10 IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A TYPE 1A ENDOLEAK AND POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, AN EMERGENT ENDOVASCULAR INTERVENTION (B)(4) WAS PERFORMED. ANOTHER CTAG 40 X 10 WAS DEPLOYED PROXIMALLY WITH INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). DUE TO ACCESS LIMITATIONS, A DISTAL CTAG COULD NOT BE PLACED PROXIMAL T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22609590 ↗
• InjuryMar 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT PENETRATING AORTIC ULCER UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2025, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT A PATIENT PRESENTED DURING A ROUTINE 1-YEAR FOLLOW-UP POST IMPLANT OF THE CTAGAC WITH AN AORTIC DISSECTION AT THE PROXIMAL END OF THE STENT GRAFT. PATIENT HAS NO SYMPTOMS AND IT IS UNCLEAR IF A REINTERVENTION WILL OCCUR AS PHYSICIAN IS NOT SURE ON THE NEXT STEPS AS OF YET.

  Patient problems: Vascular Dissection

  MAUDE report 21572613 ↗
• InjuryFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PLL161407) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (TGMR404010) WAS ALSO IMPLANTED PROXIMALLY AS WELL. ON (B)(6)2025, PATIENT PRESENTED WITH A RUPTURED ANEURYSM. AN TYPE 1A ENDOLEAK WAS ALSO IDENTIFIED ON TGMR404010 DEVICE. ON (B)(6)2025, PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH EXCLUDER CONFORMABLE AORTIC EXTENDERS WERE IMPLANTED. PHYSICIAN COVERED THE RENALS WITH AORTIC EXTENDERS INTO THE PREVIOUS TRUNK. NO ENDOLEAK WAS NOTED AFTER THE PROCEDURE. THE EXACT LOCATION OF RUPTURE IS UNKNOWN. PHYSICIAN DOES NOT KNOW WHAT CAUSED THE RUPTURE, BUT BELIEVES IT WAS A RESULT FROM PROXIMAL TYPE 1A ENDOLEAK. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21298819 ↗
• DeathSep 25, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, THIS PATIENT UNDERWENT OPEN/ENDOVASCULAR TREATMENT FOR A TYPE A AORTIC DISSECTION. IT WAS REPORTED THAT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) WAS ADVANCED WITHIN A FROZEN ELEPHANT TRUNK (FET). IT WAS REPORTED BY THE PHYSICIAN THAT STEPS ONE AND TWO OF THE DEPLOYMENT LINES HAD BEEN COMPLETED. IT WAS THE THIRD STEP WHEN THEY WENT TO REMOVE THE RED OUTER CASING WHEN THEY ENCOUNTERED THE WIRE BREAKING/LINE BREAK AND IT DID NOT DISCONNECT FROM THE DELIVERY CATHETER. THE DEVICE WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE EXPIRED THIS DATE ALSO. AS THE PROCEDURE WAS OFF LABEL AND NOT SUPPORTED BY A GORE ASSOCIATE, FURTHER INVESTIGATION IS ONGOING TO DETERMINE IF THE CTAG AC WAS LOADED ON A GUIDEWIRE PER THE IFU AND INQUIRE AS TO THE CAUSE OF DEATH FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306394 ↗
• InjuryAug 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, PATIENT WAS TREATED FOR A DESCENDING THORACIC ANEURYSM UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2022, PATIENT WAS ALSO TREATED FOR AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON (B)(6) 2024, UPON REVIEWING A CT FOR THIS PATIENT, A DISTAL TYPE 1B ENDOLEAK WAS OBSERVED ON CTAGAC DEVICE TGMR404010. IT IS UNKNOWN IF THERE WAS ANY ANEURYSM GROWTH. THE CAUSE OF THIS ENDOLEAK REMAINS UNKNOWN. IT WAS LATER REPORTED THAT ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET A 22FR SHEATH DUE TO SMALL ACCESS. PHYSICIAN WAS AWARE OF THIS GOING INTO THE PROCEDURE. PHYSICIAN IMPLANTED A 8MMX39MM GORE® VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE LEFT EXTERNAL ILIAC. PHYSICIAN STILL WAS NOT ABLE TO GET SHEATH OR GRAFT IN. PHYSICIAN ATTEMPTED TO PUT IN A CTAGAC DEVICE, BUT WAS NOT ABLE TO IMPLANT DUE TO SMALL ACCESS. PHYSICIAN IS BRINGING PATIENT BACK FOR ANOTHER PROCEDURE TO DO A CUTDOWN AND SEW A CONDUIT TO HER COMMON ILIAC ARTERY, AS A MEANS TO BE ABLE TO GET THE DEVICE IN. ON (B)(6) 2024, PATIENT UNDERWENT

  Patient problems: Clinical Endoleak

  MAUDE report 20064568 ↗
• InjuryJun 9, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 DISSECTION IN THE DESCENDING THORACIC AORTA AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH AORTIC ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN UNDERWENT REINTERVENTION FOR DISTAL MIGRATION OF THE CTAG-AC AND WAS IMPLANTED WITH AN ADDITIONAL CTAG-AC TO REINFORCE THE OVERLAP BETWEEN THE TBE AND CTAG-AC. THE CAUSE OF THE MIGRATION WAS NOT DETERMINED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17100585 ↗
• InjuryFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2022, DURING A FOLLOW-UP CT SCAN, A TYPE 1A ENDOLEAK WAS DISCOVERED GOING INTO THE DIVERTICULUM OF THE ABERRANT RIGHT SUBCLAVIAN ARTERY. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 2- LCC ARCH UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. REPORTEDLY, DURING THE PROCEDURE, THERE WAS A DEPLOYMENT INACCURACY OF THE AORTIC COMPONENT WITH THE TBE DEVICE. THE INITIAL DEPLOYMENT OF THE DEVICE OCCLUDED THE INNOMINATE ARTERY; HOWEVER, THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK TO ALLOW FLOW INTO THE INNOMINATE ARTERY. THE IMPLANT WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE. IMAGING EVALUATION: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: POST-IMPLANT CTA SUBMITTED FOR EVALUATION, ARTERIAL PHASE ONLY. RE-INTERVENTION IMAGES NOT AVAILABLE. PATIENT HAS A BOVINE ARCH. LENGTH FROM THE LSA TO THE PROXIMAL END OF THE DEVICE MEASURES ~ 8.5 MM ON CENTERLINE, ~ 12.5 MM ON THE OUTER CURVE. THERE IS A LACK OF WALL APP

  Patient problems: Clinical Endoleak

  MAUDE report 16372605 ↗
• DeathNov 28, 2022Malposition of Device; Mechanical Jam; Malposition of Device; Mechanical Jam

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM IN ZONE 0. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AFTER A SUCCESSFUL INITIAL DEPLOYMENT STEP, THE RCA WAS COVERED PROXIMALLY, AND THE PHYSICIAN ATTEMPTED TO CANNULATE. IT WAS THEN NOTED THAT THE DEPLOYMENT SLEEVE WASN'T RELEASING PROPERLY. THE PHYSICIAN DECIDED TO DO AN OPEN CONVERSION. DURING THE CONVERSION SURGERY, THE PATIENT DIED. THE PHYSICIAN BELIEVES THE PATIENT DEATH WAS DUE TO COMPLICATIONS RELATED TO THE SURGERY. IMAGES OF THE EXPLANTED DEVICE AND CT IMAGES WERE RETURNED FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 15869406 ↗
• MalfunctionJul 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR AN UNKNOWN ISSUE ON (B)(6) 2022. AS PART OF THE PROCEDURE, A FROZEN ELEPHANT TRUNK WAS PERFORMED. WHILE TRYING TO DEPLOY THE GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, THE DEPLOYMENT STRING BROKE APPROXIMATELY HALFWAY THROUGH THE DEPLOYMENT PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRACT THE DEVICE AND CATHETER. A SECOND DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114086 ↗
• InjuryJun 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021 THE PATIENT UNDERWENT A STAGED PROCEDURE PRIOR TO ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C) WERE USED DURING THE STAGED PROCEDURE. IT WAS NOTED THAT NO DISSECTION WAS PRESENT AT THE TIME OF DEVICE PLACEMENT. ON (B)(6) 2021 AN AORTIC DISSECTION WAS OBSERVED DIRECTLY ADJACENT TO THE PROXIMAL END OF THE MOST PROXIMAL CTAG A/C DEVICE. DISSECTION WAS ALSO OBSERVED IN THE PATIENT'S LEFT SUBCLAVIAN ARTERY. ACCESS OF THE SUBCLAVIAN ARTERY WAS THE REPORTED SUSPECTED CAUSE OF THE DISSECTION. IT WAS NOTED THAT THE DISSECTION DID NOT EXTEND DISTALLY TO THE AREA OF THE FIRST CTAG DEVICE OVERLAP. NO TREATMENT WAS PERFORMED OR IS PLANNED. THERE WERE NO REPORTED PATIENT ADVERSE EVENTS OBSERVED IN RELATION TO THE DISSECTION. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Vascular Dissection

  MAUDE report 14655956 ↗
• InjuryApr 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT TOLERATED THE REVASCULARIZATION AND CAROTID TO LSA BYPASS WITH GOOD RESULTS AND IS DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 11712151 ↗
• MalfunctionNov 2, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  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 10772267 ↗
• InjuryOct 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT PRESENTED EMERGENTLY FOR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PHYSICIAN CHOSE TO TREAT USING A FROZEN ELEPHANT TRUNK PROCEDURE, (OFF LABEL). THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED, BUT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE, THE DEPLOYMENT WIRE BROKE. THE PHYSICIAN HAD TO CUT DOWN IN ORDER TO CUT, AND REMOVE THE WIRE. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PHYSICIAN HAD NO OPINION REGARDING THE CAUSE OF THE BREAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10730518 ↗
• InjuryJul 17, 2020Adverse 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 DISSECTION AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE MOST PROXIMAL DEVICE WAS PLACED A BIT TOO PROXIMAL AND UNINTENTIONALLY COVERED THE SUPRA AORTIC BRANCH VESSELS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10292730 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ON (B)(6) 2020 TO TREAT A THORACIC AORTIC ANEURYSM. ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION FROM THE FSA STATED THAT THE REINTERVENTION WAS PERFORMED TO TREAT FURTHER MALPERFUSION. PER THE PHYSICIAN, IT WAS UNRELATED TO THE CTAG DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040851 ↗
• MalfunctionDec 23, 2019Activation Problem; Activation Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC DISSECTION USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL®. DURING PREPARATION OF THE DEVICE ON THE BACK TABLE, IT WAS REPORTED THAT THE PACKAGING SHEATHS ON THE DEVICE WERE EXTREMELY DIFFICULT TO REMOVE. IT WAS NOTICED DURING FLUSHING OF THE DEVICE THAT IT APPEARED A SUTURE ON THE CONSTRAINED DEVICE LOOKED "STRETCHED". IT WAS DECIDED THAT THE DEVICE WOULD BE USED. THE DEVICE WAS THEN ADVANCED INTO THE DESIRED LOCATION. IT WAS REPORTED THAT THE PATIENT HAD VERY STRAIGHT ANATOMY. THERE WAS NO RESISTANCE IN ADVANCING AND POSITIONING OF THE DEVICE. THE DEPLOYMENT SEQUENCE WAS THEN INITIATED. THE GRAY PRIMARY DEPLOYMENT HANDLE WAS TURNED 90 DEGREES COUNTER-CLOCKWISE AND THE PHYSICIAN PULLED THE HANDLE. WHILE THE HANDLE WAS BEING PULLED, IT WAS NOTICED ON IMAGING THAT THE DEVICE DID NOT SEEM TO BE DEPLOYING. THE PHYSICIAN KEPT PULLING, BUT THE DEVICE WOULD NOT DEPLOY. THE PHYSICIAN REPORTED THAT WHEN APPROXIMATELY TWO FEET OF DEPLOYMENT LINE HAD BEEN PULLED FROM THE DELIVERY HANDLE, THE LINE BECAME TIGHT, AND THEN "SNAPPED". THE DEVICE DID NOT DEPLOY. THE DEVICE WAS THEN REMOVED FROM THE PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511876 ↗

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