GORE TAG Conformable Thoracic Stent Graft TGM343415Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00733132646968), received between Oct 11, 2019 and May 28, 2026 — classified as 3 deaths, 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 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) 2026, THE PATIENT UNDERWENT REINTERVENTION AND A COOK DISSECTION STENT WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25318477 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED RUPTURED ANEURYSM AT THE ABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PROCEDURE WAS A TECHNICAL SUCCESS, AND THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, A SPINAL DRAIN WAS PLACED JUST PRIOR TO THE TAMBE PROCEDURE AND THERE WERE DIFFICULTIES WITH THE PLACEMENT. IT WAS REPORTED POST PROCEDURE (DATES ARE UNKNOWN) THAT THE PATIENT HAD A SUBDURAL HEMATOMA OF THE SPINAL CORD SECONDARY TO THE SPINAL DRAIN WITH SPINAL CORD ISCHEMIA. THE PATIENT THEN SUFFERED A STROKE. THE PATIENT HAD BEGUN TO SHOW SIGNS OF RECOVERY BUT THEN SUFFERED FROM ASPIRATION OF FLUID AND SUBSEQUENT INTUBATION. AT THIS TIME, THE PATIENT THEN HAD A HEMORRHAGIC STROKE AND WAS PLACED ON COMFORT CARE AND THEN EXPIRED.

  Patient problems: Stroke/CVA

  MAUDE report 24900735 ↗
• MalfunctionApr 15, 2026Activation Failure

  ON (B)(6), 2026, THIS PATIENT UNDERWENT OPEN/ENDOVASCULAR TREATMENT AND ASCENDING REPAIR WITH A HEMI ARCH AND FROZEN ELEPHANT TRUNK. A HYBRID APPROACH/PROCEDURE, OPEN END AND ENDOVASCULAR WAS PERFORMED. DISSECTION. IT WAS REPORTED THAT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED WITHIN A FROZEN ELEPHANT TRUNK AND WHEN THE PHYSICIAN WENT TO DEPLOY STAGE ONE OF THE ACTIVE CONTROL AND PULLED THE DEPLOYMENT LINE, THE DEVICE DID NOT OPEN AT ALL - 0%. THE PHYSICIAN CONFIRMED HE USED AN AMPLATZ WIRE, THAT THE DEVICE WAS STRAIGHT AND NOT COILED UP TO WHERE THERE'S SLACK WITHIN THE DELIVERY SYSTEM. THE PHYSICIAN THEN WENT ON TO SECONDARY STAGE DEPLOYMENT AND REPORTED THAT THE DEPLOYMENT LINE BROKE NEAR THE HANDLE. THE PHYSICIAN HAD THE IMPRESSION IT HAD RELEASED ¿ BUT STILL NO DEPLOYMENT OF THE GRAFT. SAME WITH THE THIRD STATE OF DEPLOYMENT NOTHING EVER OPENED AND SO HE JUST REMOVED IT AND IT CHANGED IT OUT WITH ANOTHER CTAG-AC WHICH DEPLOYED WITHOUT ISSUE. THE PROCEDURE WAS CONCLUDED WITH GOOD RESULTS AND PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887628 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ANEURYSM. ON (B)(6) 2026, FOLLOW UP IMAGES REVEALED A TYPE IIIA ENDOLEAK (A/E#1). THE PATIENT IS ASYMPTOMATIC. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THERE IS ANEURYSM SAC ENLARGEMENT (32MM) AND NO REINTERVENTION IS PLANNED.

  Patient problems: Aneurysm

  MAUDE report 24422227 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) TO TREAT A THORACIC ANEURYSM. ON (B)(6) 2025, IMAGES REVEALED A SMALL ENDOLEAK. NO REINTERVENTION IS PLANNED. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH, THE EVENT IN ONGOING. REPORTEDLY, ON (B)(6) 2026: THERE IS ANEURYSM SAC ENLARGEMENT REVEALED FROM 6 MONTH FOLLOW UP VISIT, OVER 5MM BASELINE DIAMETER: 53MM FOLLOW UP DIAMETER: 60.8MM. 6MM OF GROWTH.

  Patient problems: Clinical Endoleak

  MAUDE report 24226490 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER AND GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDERS TO TREAT A THORACIC DISSECTION IN ZONE 2 THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON OCTOBER 22, 2025, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT SUFFERED PARALYSIS POST PROCEDURE. REPORTEDLY, THE PATIENT PRESENTED ON (B)(6) 2025, WITH CHEST PAIN AND LEG WEAKNESS, SHE DEVELOPED NEUROLOGIC CHANGES AND REQUIRED INTUBATION AND EVENTUALLY WAS FOUND TO HAVE TYPE B DISSECTIONS WITH MASSIVE MALPERFUSION, VISCERAL RENAL AND LOWER EXTREMITY MALPERFUSION AND POSSIBLY SPINAL MALPERFUSION FROM THE COMPLICATED DISSECTION. TREATMENT FOR THE PARALYSIS ON (B)(6) 2025, PERMISSIVE HYPERTENSION AND LEFT UPPER EXTREMITY SPINAL DRAIN PLACEMENT. POST REINTERVENTION ON (B)(6) 2025, THE PATIENT WAS ABLE TO MOVE THE RIGHT UPPER EXTREMITY AND NOT THE LOWER EXTREMITIES AND HAS BEEN MOVED TO A REHABILITATION FACILITY.

  Patient problems: Vascular Dissection

  MAUDE report 23560256 ↗
• MalfunctionJul 8, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPROTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT A RUPTURED ACUTE TYPE B DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THE CTAGAC (TGM282815) WAS PUT IN DISTALLY FIRST, WHICH COVERED THE PRIMARY ENTRY TEAR BUT NOT THE ENTIRE DISSECTION. IT DEPLOYED PERFECTLY WITHOUT ISSUE. PHYSICIAN THEN INTRODUCED THE CTAGAC (TGM343415) GRAFT PROXIMALLY. DEPLOYED TO 50%, ADDED SOME ANGULATION, THEN DEPLOYED TO 100%, REMOVED THE LOCKWIRE THEN REMOVED THE CATHETER SYSTEM. EVERYTHING DEPLOYED WITHOUT RESISTANCE OR ISSUE. PHYSICIAN THEN REALIZED THE GRAFT WAS STILL CONSTRAINED AT 50% AND WAS NOT FULLY OPEN. PHYSICIAN THEN BALLOONED THE FULL GRAFT (INCLUDING PROXIMAL EDGE) WITH CODA BALLOON STARTING DISTALLY. EACH TIME PHYSICIAN BALLOONED, A SEGMENT POPPED OPEN AFTER ENOUGH BALLOON INFLATION WITH THE EXCEPTION OF THE PROXIMAL EDGE. HE THEN BALLOONED THE PROXIMAL EDGE WITH A TRI-LOBE BALLOON INSTEAD TO GET IT TO "POP" OPEN. PROCEDURE WAS THEN COMPLETED WITH NO FURTHER ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440089 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE FOLLOWING DAY THE PATIENT DEVELOPED ¿SOME SPINAL CORD SYMPTOMS IN THE RIGHT LEG¿ (PARAPARESIS). ON (B)(6) 2025, THE PHYSICIAN REINTERVENED AND PUT IN A SPINAL DRAIN. THE ISSUE WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Movement Disorder

  MAUDE report 21909756 ↗
• InjuryOct 3, 2024Collapse; Collapse

  THE FOLLOWING WAS REPORTED TO GORE: PHYSICIAN NEVER NOTIFIED THE GORE FIELD SALES ASSOCIATE OF THIS EVENT. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT THE DISSECTION IN THE PROXIMAL PART FIRST BY UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2024, THE PATIENT WAS BROUGHT BACK IN TO COMPLETE THE PROCEDURE BY LANDING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS INTO THE CTAGAC AND COVERING THE DISTAL PART OF THE DISSECTION. AFTER ONE WEEK FROM THE PROCEDURE, THE FIELD SALES ASSOCIATES (FSA) WERE NOTIFIED BY THE PHYSICIAN THAT PATIENT HAD CONTRAST INDUCED NEPHROPATHY AND THAT PATIENT WOULD BE ON DIALYSIS BUT THE BLOOD FLOW WAS NORMAL AND EVERYTHING WAS FUNCTIONING PROPERLY WITH THE DEVICES. AT THIS POINT, NO FURTHER INFORMATION WAS RELAYED BY THE PHYSICIAN TO FSA. ON (B)(6) 2024, IT WAS REPORTED DURING A SYMPOSIUM THAT THE TAMBE HAD COMPRESSED (COLLAPSED) DUE TO THE PRESSURE FROM THE FALSE LUMEN. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN STATED THAT THE DEVICE THAT COLLAPSED WAS THE CTAGAC NOT TAMBE. ON AN UNKNOWN DATE (SOMETIME PRIOR TO (B)(6) 2024), THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358163 ↗
• InjurySep 27, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2022, THE PATIENT UNDERWENT A STAGED ENDOVASCULAR PROCEDURE PRIOR TO TREATMENT OF A 63MM THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG A/C) WERE IMPLANTED IN THE PATIENT'S THORACIC AORTA. ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING THE TAMBE DEVICE SYSTEM. AN ADDITIONAL CTAG A/C DEVICE WAS PLACED IN THE PATIENT'S THORACIC AORTA. ON (B)(6) 2022, 1-MONTH FOLLOW-UP CT IMAGING WAS PERFORMED AND A TYPE II ENDOLEAK WAS OBSERVED WITH LUMBAR ARTERY INVOLVEMENT. THE MAXIMUM DIAMETER OF THE TAAA WAS 63.6MM. ON (B)(6) 2023, 6-MONTH FOLLOW-UP CT IMAGING WAS PERFORMED AND THE TYPE II ENDOLEAK WAS VISUALIZED AGAIN. THE MAXIMUM DIAMETER OF THE TAAA WAS 62.9MM. ON (B)(6) 2023, 12-MONTH FOLLOW-UP CT IMAGING WAS PERFORMED AND THE TYPE II ENDOLEAK WAS VISUALIZED. THE MAXIMUM DIAMETER OF THE TAAA WAS 63.5MM. ON (B)(6) 2024, 24-MONTH FOLLOW-UP CT IMAGING WAS PERFORMED AND THE TYPE II ENDOLEAK WAS VISUALIZED. THE MAXIMUM DIAMETER OF THE TAAA WAS 66.7MM. ON (B)(6) 2024, A REINTERVENTION WAS PERFORME

  Patient problems: Clinical Endoleak

  MAUDE report 20328653 ↗
• MalfunctionSep 11, 2024Material Invagination; Material Invagination

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN ZONE 3. IT WAS REPORTED THAT AN ISSUE OCCURRED DURING POSSIBLE OVER ANGULATION OF THE DEVICE. WHEN THE PHYSICIAN ANGULATED THE DEVICE, THE GRAFT INFOLDED ON ITSELF ON THE DISTAL PORTION OF THE GRAFT. THEY DECIDED TO EXTEND WITH A SECOND PIECE PROXIMALLY TO BE SAFE. WHEN THEY TOOK AN ANGIOGRAM, EVERYTHING LOOKED OKAY. THE PHYSICIAN DOES NOT KNOW THE EXACT CAUSE OF THE INFOLDING BUT BELIEVES IT WAS RELATED TO THE ANGULATION OF THE DEVICE. THE INFOLDING WAS NOT DUE TO ANATOMIC CONSTRAINTS. THE PATIENT'S ANATOMY WAS STANDARD. NO PATIENT HARM OCCURRED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193040 ↗
• DeathJun 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT PRESENTED WITH AN ACUTE TYPE B DISSECTION WITH MALPERFUSION OF THE LOWER EXTREMITIES AND SELECT VISCERAL VESSELS. THE PHYSICIAN PLANNED TO TREAT THE DISSECTION AND MALPERFUSION VIA A ZONE 2 TEVAR PROCEDURE USING A COOK DISSECTION STENT EXTENSION TO THE INFRARENAL AORTA. SIZING WAS ASSESSED ON PRE-OPERATIVE CTA AND, FOLLOWING ADDITIONAL IVUS ASSESSMENT, A TGM343415 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) WAS SELECTED FOR ZONE 2 TREATMENT. A 22FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY OVER A LUNDERQUIST DOUBLE CURE WIRE, WITH CONTRALATERAL ACCESS FOR A 5FR. MARKER PIGTAIL. ANGIOGRAPHY WAS PERFORMED AND ARCH VESSELS WERE REFERENCED. FOLLOWING THE FIRST STAGE OF DEPLOYMENT FOR THE CTAG A/C, THE DEVICE APEX OF THE PROXIMAL STENT MARGIN CAME BACK TO THE LEFT SUBCLAVIAN ARTERY (LSA) OSTIUM. FOLLOWING ANGULATION INPUT AT FIRST STAGE/50% IT WAS DETERMINED THAT A ZONE 2 POSITION COULD NOT BE REESTABLISHED AND SECOND STAGE/100% DEPLOYMENT WAS COMPLETED IN THE STANDARD FASHION. ANGIOGRAPHY WAS PERFORMED AND MINOR FILLING OF THE LSA AND PRIMARY ENTRY TEAR WAS OBSERVED. PROXIMAL EXTEN

  Patient problems: Stroke/CVA

  MAUDE report 19544035 ↗
• InjuryNov 28, 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 THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT PRESENTED IN THE EMERGENCY DEPT (B)(6) 2023 WITH CHEST PAIN THAT STARTED 2 DAYS PREVIOUSLY WHICH WORSENED THAT MORNING. A CTA OF THE CHEST WAS DONE WHICH SHOWED PROXIMAL, RETROGRADE TYPE A DISSECTION. THE PATIENT UNDERWENT A TOTAL ARCH REPAIR DUE TO AN ACUTE ASCENDING AORTIC TEAR INTO THE SINOTUBULAR RIDGE WITH HEMATOMA. THE AORTIC ROOT WAS FOUND TO BE NORMAL AT THAT TIME. THE PREVIOUSLY IMPLANTED DEVICES WERE NOT EXPLANTED. IT WAS NOTED THAT A CT OF THE CHEST TWO WEEKS AFTER THE INDEX PROCEDURE SHOWED NO DISSECTION AT THAT TIME.

  Patient problems: Vascular Dissection

  MAUDE report 18222834 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 DISSECTION AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A LEFT COMMON CAROTID ARTERY (LCCA) TO LEFT SUBCLAVIAN ARTERY (LSA) BYPASS WAS ALSO PERFORMED. IT WAS REPORTED THAT INITIALLY POST DEPLOYMENT OF THE GRAFT THE LCCA ARTERY DIDN'T FILL WELL. IT WAS THEN IT WAS REALIZED THEY STILL HAD THE CATHETER FROM THE DEPLOYED DEVICE IN THE PATIENT. IT WAS THEN REMOVED AND THE LCCA LOOKED LIKE IT FILLED MUCH BETTER AND WE SAW MUCH MORE DYE. THE PROCEDURE WAS CONCLUDED, THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, THEY MEASURED THE PATIENT¿S PRESSURE AND WERE MADE AWARE THE PATIENT¿ LEFT ARM WAS NUMB. THE PHYSICIAN RE-INTERVENED AND THEY IMPLANTED A CAROTID STENT IN THE LCCA. AS OF RIGHT NOW THE PHYSICIAN REPORTS THEY BELIEVE THE PATIENT IS DOING WELL AND DOES NOT BELIEVE FURTHER REINTERVENTION WILL BE NEEDED.

  Patient problems: Vascular Dissection

  MAUDE report 17694518 ↗
• DeathJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, ON SAME DAY THE PATIENT DIED. DETAILS OF THE EVENT REMAIN UNKNOWN AND THE PHYSICIAN WILL NOT PROVIDE ANY ADDITIONAL DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 17106275 ↗
• InjuryMar 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT EMERGENT TREATMENT OF A THORACIC AORTIC ANEURYSM RUPTURE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD NO MOTOR OR SENSORY FUNCTION IN HER LEGS POST PROCEDURE. THIS WAS SUSPECTED TO BE DUE TO DEVICE PLACEMENT AND LACK OF BLOOD FLOW TO THE SPINAL CHORD. THE GORE REPRESENTATIVE BECAME AWARE OF THE EVENT ON FEBRUARY 15, 2023. A SPINAL DRAIN WAS PLACED 1-HOUR POST PROCEDURE AND THE PATIENT'S BLOOD PRESSURE WAS ELEVATED TO HELP WITH PROFUSION. THE EVENT IS ONGOING AND THE PATIENT STATUS HAS NOT IMPROVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16506559 ↗
• DeathFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 (10:30 P.M.) THIS PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL FOR TREATMENT OF A TRAUMATIC THORACIC AORTIC TRANSECTION. ON (B)(6) 2023, (12:30 A.M.) THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN ZONE 2. THE DEVICE WAS SUCCESSFULLY DEPLOYED JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY; INTENTIONALLY COVERING THE LEFT SUBCLAVIAN ARTERY AND EXTENDED DOWN INTO THE DESCENDING THORACIC AORTA. DURING CLOSE, THE PATIENT¿S PRESSURE DROPPED AND THE PHYSICIAN RE-STUCK THE PATIENT AND ADVANCED A PIG TAIL CATHETER BACK UP AND TOOK 2-3 SET OF PICTURES TO MAKE SURE EVERYTHING LOOKED GOOD AND TO CONFIRM NO BLEEDING. ALL LOOKED GOOD IN THE THORACIC AORTA, SO THE PHYSICIAN TOOK PICTURES OF THE ABDOMINAL AORTA, INCLUDING THE FEMORAL ARTERY AND THE PELVIS AREA. ALL LOOKED LOOKED GOOD, WITH NO BLEEDING SEEN. THE PHYSICIAN CHECKED BOTH THORACIC AND ABDOMINAL AORTA MULTIPLE TIMES AND COULD SEE NO BLEEDING OR OTHER ISSUES. THE PATIENT WAS CLOSED AND THE PROCEDURE WAS CONCLUDED. ON (B)(6) 2023, DURING ANOTHER CASE WITH THE PHYSICIAN HE REPORTED THAT THE TRAUMA PATIENT FROM THE PREVIOUS DAY HAD REQUIRED RE-INTUBATION AND HAD BEEN

  Patient problems: Vascular Dissection

  MAUDE report 16432974 ↗
• MalfunctionDec 30, 2022Break; Activation Problem

  FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT UNDERWENT UNKNOWN PROCEDURE UTILIZING A CTAG DEVICE. THE TGM343415 DID NOT FULLY DEPLOY WHEN BEING IMPLANTED AND HAD TO BE REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE TGMR373710 DID NOT DEPLOY CORRECTLY AS THE RED HANDLE BROKE OFF AND THE LOCKWIRE NEEDED TO BE MANUALLY PULLED AND DEVICE WAS SUCCESSFULLY IMPLANTED. THE DEPLOYMENT HANDLE WAS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16079531 ↗
• InjuryOct 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, THIS PATIENT UNDERWENT TREATMENT FOR AN ZONE 0 ASCENDING ARCH ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT DURING THE SECONDARY DEPLOYMENT OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM THE DEPLOYMENT LINE BROKE AND THE DEVICE DID NOT FULLY DEPLOY (ONLY 50% DEPLOYMENT REPORTED). A BALLOON CATHETER WAS ADVANCED TO FULLY EXPAND THE DEVICE TO COMPLETE DEPLOYMENT. THERE WAS NO ADVERSE EVENT TO THE PATIENT WHO TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 15611553 ↗
• InjuryJun 3, 2022Adverse 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® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® AFTERMARKET DEVICES, AS WELL AS THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). DURING THE PROCEDURE THREE DRYSEAL FLEX INTRODUCER SHEATH WERE USED, AS WELL AS A GORE® MOB BALLOON, A GORE® TRI-LOBE BALLOON AND A GORE® TRI LUMEN CATHETER. GORE WAS UNABLE TO DETERMINE WHICH OF THE IMPLANTED DEVICES OR GORE ACCESSORIES WERE INVOLVED IN THE EVENT. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH FEMORAL COMPARTMENT SYNDROME (UNKNOWN IF IT WAS ON THE LEFT OR RIGHT SIDE). THE PHYSICIAN REINTERVENED AND PERFORMED A FASCIOTOMY. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 14597393 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT WAS TREATED EMERGENTLY FOR A THORACIC DISSECTION. THE PHYSICIAN IMPLANTED TWO GORE¿ TAG¿ CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT REPORTED THE ONSET OF PARAPLEGIA. THE PHYSICIAN IMPLANTED 3 PROTEGE BARE METAL STENTS TO TREAT THE EVENT, WHICH WAS REPORTED TO BE DUE TO POSSIBLE OBSTRUCTION OF A BLOOD VESSEL. THE PATIENT IS STILL REPORTED TO BE SUFFERING FROM PARAPLEGIA.

  Patient problems: Paraplegia

  MAUDE report 12422401 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2021, THE FIELD SALES ASSOCIATE (FSA) WAS SUPPORTING A CASE TO REINTERVENE ON A PSEUDOANEURYSM OF THE PROXIMAL ANASTOMOSIS SITE OF A 24MM INFRARENAL AORTOBIFEMORAL SURGICAL GRAFT. THE PATIENT IS BELIEVED TO HAVE INITIALLY PRESENTED IN 2017 OR 2018 WITH A TYPE A DISSECTION WITH EXTENSION INTO THE ILIAC ARTERIES, AND HAD THE FOLLOWING PROCEDURES PRIOR TO THE PLANNED REINTERVENTION OF THE PROXIMAL ANASTOMOSIS SITE: AORTIC VALVE AND ASCENDING SURGICAL REPLACEMENT. REDO STERNOTOMY FOR SURGICAL ARCH REPLACEMENT WITH A 32MM DACRON ELEPHANT TRUNK. PLACEMENT OF A CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHESIS (TGU404020/(B)(4)) IN THE ELEPHANT TRUNK (PERFORMED ON (B)(6) 2018). INFRARENAL AORTOBIFEMORAL SURGICAL GRAFT. ON (B)(6) 2020, TWO OTHER CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHESES (TGM343415/(B)(4) AND TGMR404015/(B)(4)) WERE PUT IN DISTAL TO THE TGU404020 DEVICE. IT IS UNKNOWN WHAT THE PHYSICIAN WAS TREATING AT THAT TIME. ON (B)(6) 2021, THERE WAS A REINTERVENTION, A CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHESIS (TGM313120) WAS PLACED ACROSS THE PROXIMAL ANASTOMOSIS SITE OF THE INFRARENAL GRAFT. THE CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHE

  Patient problems: Insufficient Information; Pseudoaneurysm

  MAUDE report 12409327 ↗
• InjuryFeb 15, 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 UNDERWENT STAGE 1 TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM IN THE TAMBE CLINICAL TRIAL. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) WAS IMPLANTED. ON (B)(6) 2021 THIS PATIENT UNDERWENT STAGE 2 TREATMENT WITH THE TAMBE INVESTIGATIONAL DEVICE. ON (B)(6) 2021 A TYPE B AORTIC DISSECTION WAS OBSERVED. ON (B)(6) 2021 THE DISSECTION WAS TREATED BY MEANS OF A LEFT CAROTID SUBCLAVIAN BYPASS AND IMPLANTATION OF A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS PROXIMAL TO THE ORIGINALLY PLACED CTAG. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11330430 ↗
• InjuryJul 23, 2020Use of Device Problem; Use of Device Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ANEURYSM. AN ELEPHANT TRUNK TECHNIQUE WAS BEING USED AS WELL AS IMPLANTING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT WHILE DEPLOYING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WHEN THE RED LOCKWIRE HANDLE WAS UTILIZED THE LOCKWIRE SNAPPED AND SEPARATED FROM THE HANDLE. THE BACK UP HATCH WAS UTILIZED. THE DEVICE WAS IMPLANTED SUCCESSFULLY AND THERE WAS NO CONSEQUENCES OR INJURY TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THERE WAS RESISTANCE MET WHILE ATTEMPTING TO DEPLOY THE DEVICE. THIS WAS AN OFF LABEL CASE AND THE DEVICE WAS USED OUTSIDE OF INSTRUCTIONS FOR USE. THE DEVICE WAS ADVANCED BAREBACK OVER THE GUIDEWIRE THROUGH THE ASCENDING THORACIC AORTA WHILE AIMING TO POSITION THE DEVICE IN THE DESCENDING THORACIC AORTA.

  Patient problems: Aneurysm

  MAUDE report 10317192 ↗
• InjuryMar 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE INITIAL PROCEDURE ON (B)(6) 2019 WAS TO TREAT A THORACIC AORTIC ANEURYSM AND AN AORTIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON AN UNKNOWN DATE, REPORTED AS TOWARDS THE END OF (B)(6) 2020, A DISSECTION WAS NOTED, AND A REINTERVENTION WAS PLANNED. REPORTEDLY THE PHYSICIAN STATED THAT THE DISSECTION WAS NOT SUSPECTED TO BE RELATED TO THE INITIAL PROCEDURE. IT WAS UNCLEAR WHERE THE DISSECTION ORIGINATED IN RELATION TO THE IMPLANTED DEVICE. THE PHYSICIAN REPORTEDLY COMMENTED THAT IT WAS UNFORTUNATE THAT THE TEAM DID NOT ADVANCE THE DEVICE FURTHER TOWARDS THE PATIENT'S LEFT SUBCLAVIAN ARTERY DURING THE INITIAL PROCEDURE, AND THAT PERHAPS THE EVENT MAY HAVE BEEN PREVENTED IF THE TEAM WAS MORE AGGRESSIVE DURING THE INITIAL PROCEDURE. THE REINTERVENTION, PERFORMED (B)(6) 2020, TO TREAT THE DISSECTION USED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO EXTEND THE ORIGINAL DEVICE. THE PATIENT TOLERATED THE PROCEDURE AND REPORTEDLY HAD A FAVORABLE OUTCOME.

  Patient problems: Aortic Dissection

  MAUDE report 9825972 ↗

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