GORE TAG Conformable Thoracic Stent Graft TGMR373720Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00733132646821), received between Dec 4, 2019 and Apr 28, 2026 — classified as 21 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

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

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN AORTIC DISSECTION IN THE MORNING BUT WAS NOT TREATED UNTIL LATER THAT EVENING. DURING THIS PERIOD, THERE WAS NO BLOOD FLOW TO THE PATIENT¿S LEFT LEG AS A RESULT OF THE DISSECTION. THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, WHICH RESTORED BLOOD FLOW TO THE LEFT LEG. ADDITIONAL INFORMATION INDICATED THAT THE LEFT SUBCLAVIAN ARTERY (LSA) WAS ALSO INVOLVED IN THE DISSECTION AND WAS THEREFORE COVERED. THE PHYSICIAN ALSO ELECTED TO STENT THE LEFT COMMON ILIAC ARTERY AND LEFT EXTERNAL ILIAC ARTERY USING BARE METAL SELF-EXPANDING STENTS. DURING THIS PROCESS, THE BARE METAL STENT IN THE COMMON ILIAC COLLAPSED AND BECAME SIGNIFICANTLY COMPRESSED, RESULTING IN FLOW OCCLUSION. A GORE® VIABAHN® VBX DEVICE WAS ALSO PLACED TO RESTORE FLOW. AT APPROXIMATELY 3:00 AM THE FOLLOWING MORNING, THE PATIENT REPORTED AN INABILITY TO FEEL THE RIGHT LEG; HOWEVER, THIS INFORMATION WAS NOT COMMUNICATED TO THE VASCULAR TEAM. AT 7:00 AM DURING PHYSICIAN ROUNDS, IT WAS NOTED THA

  Patient problems: Paralysis

  MAUDE report 25019340 ↗
• InjuryDec 9, 2025Insufficient Device Problem Information; Device Endoleak; Insufficient Device Problem Information; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR PROCEDURE TO TREAT A TYPE B THORACIC AORTIC DISSECTION DISTAL TO LEFT SUBCLAVIAN ARTERY USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL DEVICES. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2025, A DISTAL TYPE I ENDOLEAK FROM THE TGMR373720/30614639 WAS NOTICED. ACCORDING TO THE SITE, THE CAUSE OF THE ENDOLEAK REMAINED UNKNOWN. THE PHYSICIAN DID NOT NOTICE ANY ANEURYSM ENLARGEMENT. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A TGMR404010/29722960 DEVICE AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS GRAFTS. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2025.

  Patient problems: Clinical Endoleak

  MAUDE report 23759341 ↗
• InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL. ON (B)(6) 2025, DURING A 6 MONTH CT IMAGING FOLLOW-UP, A GREATER THAN 5MM ANEURYSM ENLARGEMENT WAS OBSERVED FROM THE SITE (BASELINE MEASUREMENT: 37MM, 6 MONTH FOLLOW-UP: 45MM). ON (B)(6) 2025, DURING A 12 MONTH CT IMAGING FOLLOW-UP, A GREATER THAN 5MM ANEURYSM ENLARGEMENT WAS OBSERVED FROM THE SITE (BASELINE MEASUREMENT: 37MM, 12 MONTH FOLLOW-UP: 55.3MM). AS PER MEDRIO DATABASE, THE EXACT LOCATION OF THE ANEURYSM ENLARGEMENT IS UNKNOWN.

  Patient problems: Aneurysm expansion

  MAUDE report 23483134 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR THORACIC REPAIR TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, LATER IN THE AFTERNOON, PATIENT HAD A STROKE AND WAS PARALYZED. CAUSE OF THE STROKE IS UNKNOWN. ON (B)(6) 2025, FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN OF THE STROKE AND PATIENT IS FEELING SOME MOVEMENT IN HIS LEGS AND IS DOING BETTER.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 23294970 ↗
• InjuryAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES. THE TOTAL TREATMENT LENGTH WAS 300-350MM, STARTING JUST DISTAL TO THE LEFT SUBCLAVIAN, AND TERMINATING 2CM PROXIMAL TO THE SHARED TAKE-OFF FOR THE CELIAC AND SMA. ACCESS WAS SOLELY THROUGH THE RIGHT FEMORAL ARTERY. NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. LATER ON (B)(6) 2025, WHEN THE PATIENT WOKE UP FOLLOWING THE PROCEDURE, THEY WERE UNABLE TO MOVE THEIR RIGHT SIDE. REPORTEDLY, THE PATIENT IS STABLE, BUT STILL UNABLE TO MOVE THEIR RIGHT SIDE. IT IS REPORTED THAT THE CAUSE OF THE PARALYSIS WAS A STROKE.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 22872684 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THERE WAS TORTUOSITY IN THE LEFT SUBCLAVIAN ARTERY (LSA) THAT APPEARED TO BE SIGNIFICANT; HOWEVER, THE PROCEDURE WENT WELL WITH DEPLOYMENT AND PATIENT WAS DOING FINE. ON (B)(6) 2025, IT WAS REPORTED BY PHYSICIAN TO FIELD SALES ASSOCIATE THAT THE LEFT SUBCLAVIAN ARTERY SIDE BRANCH IS THROMBOSING POST PROCEDURE SCAN FOLLOW UP (DATE UNKNOWN). PATIENT IS CURRENTLY FEELING LEFT ARM PAIN AND PHYSICIAN PLANS TO PERFORM A CAROTID SUBCLAVIAN ARTERY BYPASS. ON (B)(6) 2025, ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN THAT PATIENT HAS A THORACIC OUTLET SYNDROME (TOS) THAT LED TO THE THROMBOSIS OF THE SIDE BRANCH. THERE IS NO BLOOD FLOW ISSUES AS OF NOW WITH THROMBOSED GRAFT. CURRENTLY, PATIENT'S SYMPTOMS AREN¿T AS BAD SO A REINTERVENTION MAY NOT BE DONE DUE TO THORACIC OUTLET SYNDROME. ON (B)(6) 2025, ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN THAT PATIENT'S SYMPTOM HAVE RESOLVED WITH THE LEFT ARM

  Patient problems: Clinical Endoleak; Vascular Dissection

  MAUDE report 22671383 ↗
• InjuryJun 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT AN ANEURYSM RUPTURE UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY COVERED BY THE GRAFT DURING THE PROCEDURE AS THE RUPTURE WAS CLOSE TO THE SUBCLAVIAN ARTERY AND THE PROCEDURE ENDED WELL. POST PROCEDURE, PATIENT WAS AWAKE AND MOVING. ON (B)(6) 2025, PATIENT HAD A CARDIAC ARREST AND WAS INTUBATED. WHEN PATIENT WOKE UP, IT WAS NOTED DURING EVALUATION THAT THE PATIENT'S LEGS WERE PARALYZED AND PHYSICIAN ORDERED AN MRI WHICH SHOWED A T2 THROUGH T6 INFARCT. AFTER WHICH, PHYSICIAN DID A CAROTID/SUBCLAVIAN ARTERY BYPASS. ON (B)(6) 2025, PHYSICIAN NOTIFIED THE FIELD SALES ASSOCIATE (FSA) OF THE EVENT AND STATED THE TWO GRAFTS COVERED THE RUPTURE AND LANDED ABOUT 5CM PROXIMAL TO THE CELIAC ARTERY. THE CAUSE OF CARDIAC ARREST COULD BE DUE TO LACK OF PERFUSION AND UNSURE, IF DEVICES LED TO THE CARDIAC ARREST OR THE PROCEDURE AS PATIENT WAS FINE TILL NEXT DAY. ON (B)(6) 2025, PHYSICIAN NOTIFIED THE FSA THAT PATIENT IS RECOVERING AND IS ABLE TO MOVE ONE LEG BUT N

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Paralysis

  MAUDE report 22304769 ↗
• InjuryMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THIS PATIENT UNDERWENT SURGICAL/ENDOVASCULAR TREATMENT FOR AN ANEURYSM IN ZONE 2 (LEFT COMMON CAROTID ARTERY) AND A HYBRID FROZEN ELEPHANT TRUNK (FET) PROCEDURE WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) (TGMR373720/(B)(6) WAS DEPLOYED WITHIN THE FET. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A SUSPECTED DISTAL TYPE I ENDOLEAK OF THE DISTAL ASPECT OF THE PREVIOUSLY IMPLANTED CTAG DEVICE. THE DEVICE WAS BELIEVED TO HAVE LOST APPOSITION AND NO LONGER HAD GOOD SEAL, RESULTING IN ENLARGEMENT OF THE ANEURYSM SAC (AMOUNT UNKNOWN). AN ADDITIONAL CTAG (TGMR404020/(B)(6) DEVICE WAS IMPLANTED DISTALLY TO REINFORCE THE SEAL AND PROVIDE ADDITIONAL COVERAGE. FINAL ANGIOGRAPHY SHOWED NOTHING LEAKING BACK; OR LOSS OF APPOSITION OF THE DISTAL END OF THE DEVICE SEEN PREVIOUSLY, OR ANY ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21997489 ↗
• InjuryMay 6, 2025Device Endoleak; Device Endoleak

  ON AN UNKNOWN DATE IN (B)(6) 2024, A PATIENT WAS SEEN FOR A TEVAR PROCEDURE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG). ON AN UNKNOWN DATE IN (B)(6) 2025, A CT SCAN SHOWED CONTRAST IN THE ANEURYSM SAC. THE ENDOLEAK WAS NOT CONFIRMED, BUT THE PHYSICIAN SUSPECTED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2025, A REINTERVENTION OCCURRED. NO CONTRAST WAS SEEN ON THE ANGIO PRIOR TO THE DEVICE BEING PLACED. THE PHYSICIAN IMPLANTED A CTAG DEVICE PROXIMALLY, EXTENDING TO THE LEFT SUBCLAVIAN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21972676 ↗
• InjuryApr 17, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A BRANCHED ENDOVASCULAR REPAIR (BEVAR) PROCEDURE UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 3 AS PART OF A STAGED PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT THE REMAINDER OF THE STAGED PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN ZONE 5. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT A TYPE 3 ENDOLEAK THAT FORMED BETWEEN ONE OF THE CTAG DEVICES AND THE TAMBE DEVICE UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN ZONE 5. DURING DEPLOYMENT IN THE TORTUOUS AORTA, THE LOCK WIRE BROKE OFF THE CTAG HANDLE. THE PHYSICIAN OPENED THE BACK-UP HATCH, PULLED THE LOCK WIRE AND SUCCESSFULLY COMPLETED DEPLOYMENT. THE ENDOLEAK WAS SEALED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUS

  Patient problems: Clinical Endoleak

  MAUDE report 21860540 ↗
• InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE), AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC). ON (B)(6) 2024 POST-PROCEDURE, A STROKE WAS OBSERVED. A CT IMAGING WAS PERFORMED ON (B)(6)2024, WHICH SHOWED OCCLUSION OF LEFT VERTEBRAL ARTERY. AN MRI OF THE BRAIN SHOWED MULTIPLE SMALL ACUTE INFARCTIONS IN THE BILATERAL CEREBELLAR HEMISPHERES. AS TREATMENT, THE PATIENT RECEIVED A HIGH DOSE HEPARIN INFUSION. PATIENT THEN DEVELOPED A NECK HEMATOMA. A CTA OF THE NECK AND HEAD SHOWED NEW PSEUDOANEURYSM OF THE LEFT DISTAL CAROTID SUBCLAVIAN BYPASS WITH A HEMATOMA. THIS WAS REPAIRED OPERATIVELY ON (B)(6)2024. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 21627800 ↗
• MalfunctionJan 13, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS TO BE IMPLANTED WITH 37MM X 20CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CADS DEVICE) TO TREAT AORTIC DISSECTION. AFTER ADVANCING TO TARGET LESION, THE PHYSICIAN PULLED OUT THE PRIMARY DEPLOYMENT HANDLE. AFTER THE PRIMARY SLEEVE DEPLOYMENT LINE WAS FULLY PULLED OUT, THE STENT COULDN'T BE DEPLOYED FROM PROXIMAL TO DISTAL. THE PHYSICIAN TRIED TO DEPLOY THE SECONDARY SLEEVE. THE STENT STILL COULDN'T OPEN. THEREFORE, IT WAS REMOVED OUT OF PATIENT. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN COMMENTED THAT NO ABNORMAL RESISTANCE WAS FELT DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135029 ↗
• MalfunctionNov 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH 37MM X 20CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG DEVICE) TO TREAT B THORACIC AORTIC DISSECTION. THE CTAG DEVICE WAS ADVANCED TO TARGET LESION VIA 22FR DSF SHEATH. THE STENT WAS SUCCESSFULLY EXPANDED. AFTER THE CATHETER WAS WITHDREW OUT OF PATIENT, IT WAS FOUND THE DISTAL OLIVE WAS DETACHED AND FELL INTO THE DEEP PART OF LEFT INTERNAL ILIAC ARTERY. IT COULDN'T BE REMOVED AND LEFT INSIDE OF PATIENT. THE PATIENT TOLERATED THE PROCEDURE AND NO FEVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20755453 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE INITIAL PROCEDURE. PRE-TREATMENT IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 64MM. DURING THE PROCEDURE, THERE WAS A CONCERN FOR DEVELOPMENT OF A TYPE II ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY (LSA). ON (B)(6) 2023, THE PREVENTION TREATMENT FOR A SUSPECTED TYPE II ENDOLEAK WAS DONE. THE PATIENT UNDERWENT THE COIL EMBOLIZATION PROCEDURE USING AN AMPLATZER PLUG TO TREAT THE SUSPECTED TYPE II ENDOLEAK. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2023.

  Patient problems: Aneurysm

  MAUDE report 16344722 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY TREATMENT OF A SYMPTOMATIC ZONE 0 DISSECTING ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER WERE USED AS ACCESSORIES IN THE PROCEDURE. THE PATIENT'S ANATOMY WAS REPORTED TO BE EXTENSIVELY TORTUOUS. ON (B)(6) 2022, THE GORE REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD SPINAL CORD ISCHEMIA WHICH WAS OBSERVED ON THE EVENING OF THE INDEX PROCEDURE. IT WAS REPORTED THAT A NON-PROPHYLACTIC SPINAL DRAIN WAS PLACED POST-PROCEDURE AND A PLAN WAS MADE TO DISCHARGE THE PATIENT TO A REHAB CENTER. THE SPINAL CORD ISCHEMIA IS ONGOING. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS ARE IMPROVING.

  Patient problems: Ischemia

  MAUDE report 15592766 ↗
• InjuryAug 30, 2022Failure to Seal; Failure to Seal

  ON (B)(6) 2020, THIS PATIENT UNDERWENT TREATMENT OF A TYPE B THORACIC DISSECTION AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED DEGENERATION OF THE PROXIMAL SEAL OF THE MOST PROXIMAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT, AND AN EXTENSION OF THE DISSECTION PROXIMALLY ON THE INNER CURVE AT THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY (LSA). THE PHYSICIAN BELIEVES THE EXTENSION OF THE DISSECTION WAS CAUSED/RELATED TO THE ANASTAMOSIS IN THE ARCH AREA NEAR THE LSA. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION AND THE EXTENSION OF THE DISSECTION GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH GREAT RESULTS.

  Patient problems: Vascular Dissection

  MAUDE report 15322611 ↗
• InjuryJun 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESES. A TGMR373720 WAS THE MOST PROXIMAL DEVICE, HAVING BEEN PLACED AT THE LEFT COMMON CAROTID ARTERY WITH A SNORKEL WITHIN THE LEFT SUBCLAVIAN ARTERY. THE EXPOSED STENT APICESPATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK (DATE OF ONSET UNKNOWN) AND AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR373715) WAS PLACED PROXIMALLY. THE PHYSICIAN REPORTED THAT THE DEVICE WAS DEPLOYED AGGRESSIVELY ON TARGET AND NEEDED TO BE RETRACTED DUE TO PARTIAL COVERAGE OF THE INNOMINATE ARTERY. THE DEVICE WAS RETRACTED SUCCESSFULLY WITH LOCK WIRE IN PLACE, BUT IT IS SUSPECTED THAT IT MIGRATED PROXIMALLY WHEN THE LOCK WIRE WAS REMOVED DUE TO STORED ENERGY AND MANEUVERING THROUGH THE PREVIOUSLY PLACED TGMR DEVICE. THE DEVICE WAS SUCCESSFULLY RETRACTED TO A SATISFACTORY POSITION WITH A GORE TRI-LOBE BALLOON. NO INJURY WAS NOTED TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE

  Patient problems: Aneurysm

  MAUDE report 14755268 ↗
• InjuryJun 10, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2022 THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED THORACIC ANEURYSM AND WAS IMPLANTED WITH 3 GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2022 THE PATIENT WAS OBSERVED TO BE EXPERIENCING PARALYSIS IN THEIR LEGS. AS REPORTED, THE PATIENT WAS BROUGHT IN, WAS EMERGENTLY TREATED AND THE IDENTIFIED CAUSE OF THE PARALYSIS WAS DUE TO THE PROCEDURE AS IT INVOLVED EXTENSIVE COVERAGE OF THE ANEURYSM AND THERE WAS NO TIME TO ADMINISTER A SPINAL DRAIN UNTIL THE MORNING OF (B)(6) 2022. REPORTEDLY, THE PROCEDURE INVOLVED COVERAGE OF THE SUBCLAVIAN ARTERY AS WELL. THE PATIENT ALSO REPORTED NUMBNESS IN THE ARMS, BUT THIS SYMPTOM WAS PRESENT BEFORE THE TREATMENT OF THE RUPTURE ON (B)(6) 2022. THE PATIENT IS CURRENTLY BEING EVALUATED TO DETERMINE THE CAUSE OF THE NUMBNESS AND TO DETERMINE IF THERE ARE ADDITIONAL CONTRIBUTING CONDITIONS THAT MAY BE PRESENT. AS REPORTED ON (B)(6) 2022, THE PATIENT WAS DOING OK, THE PATIENT WAS IDENTIFIED AS WEAK BUT HAVING REGAINED FUNCTION OF THEIR LEGS. THE PATIENT IS GOING TO REHAB AND WILL BE COMING BACK FOR OPEN INTRARENAL REPAIR.

  Patient problems: Paralysis; Paraplegia

  MAUDE report 14655224 ↗
• InjuryMar 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT TEVAR FOR TREATMENT OF A DISSECTION AND WAS IMPLANTED WITH 2 GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS. ON (B)(6) 2022 THE PATIENT UNDERWENT A REINTERVENTION. AS REPORTED, THE FALSE LUMEN FROM THE PRE-EXISTING DISSECTION CONTINUED TO FILL. IT IS UNCLEAR IF THE CAUSE WAS DUE TO A TYPE III ENDOLEAK OR A TEAR OR A HOLE IN THE GRAFT FABRIC AT THE LOCATION OF THE OVERLAP. AS REPORTED, THE PHYSICIAN INDICATED THAT HE BELIEVED IT TO BE RELATED TO A SMALL PIN HOLE IN THE GRAFT. AS REPORTED BY THE PHYSICIAN, THE PLAN OF CARE WAS TO RELINE THE GRAFT. HOWEVER THE PATIENT REFUSED ANY PROCEDURE REQUIRING OVERNIGHT ADMISSION. INSTEAD THE PHYSICIAN WENT UP TO THE FALSE LUMEN AND COIL EMBOLIZED IT. AFTER THIS THE PHYSICIAN PROCEEDED TO COIL EMBOLIZE THE FALSE LUMEN AT THE DISTAL ASPECT OF THE TEVAR BY THE VISCERAL ARTERIES TO HOPEFULLY CUT OFF BOTH THE SOURCE AND THE OUTFLOW, IN THE HOPES OF IMPROVING THE PATIENTS CHANCES OF THROMBOSIS. FOLLOW UP IMAGING IS PLANNED FOR 3 MONTHS FROM THE DATE OF SURGERY. AS REPORTED, IMAGING WILL NOT BE SHARED WITH GORE. A SCREENSHOT/PHOTO FROM THE IMAGING OF THE IDENTIFIED LEAK WAS SHARED FOR CONSIDERATION. CONFIRMATION ON C

  Patient problems: Vascular Dissection

  MAUDE report 13715365 ↗
• InjuryDec 28, 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 DESCENDING THORACIC AORTIC (ZONE 2) DISSECTION WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT HAD LEFT LOWER EXTREMITY PARALYSIS. RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR A BODY FUNCTION. ON (B)(6) 2021, A LUMBAR DRAIN WAS IMPLANTED. THE PARALYSIS RESOLVED AND THE PATIENT WAS DISCHARGE (B)(6) 2021. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 13094196 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN EMERGENCY THORACIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING ADVANCEMENT OF THE DEVICE ONTO THE DOUBLE CURVE LUNDERQUIST WIRE (.035X260), IT WAS DIFFICULT TO ADVANCE THE DEVICE OVER THE WIRE. DURING DEPLOYMENT, WHEN THE LOCK WIRE HANDLE WAS RELEASED, THE WIRES WERE NOT ATTACHED TO THE DEVICE. IT IS UNKNOWN IF THE WIRES WERE NOT ATTACHED TO BEGIN WITH OR IF THEY SNAPPED DURING ATTEMPTS TO RELEASE AND PULL THE HANDLE. THERE WAS RESISTANCE WHEN ATTEMPTING TO PULL THE HANDLE AND SOME FORCE WAS USED. THE BACK UP HATCH WAS UTILIZED, AND THE NUMBER THREE AND NUMBER FOUR WIRES WERE PULLED. THE DEVICE RELEASED FROM THE DELIVERY CATHETER. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND THERE WAS NO INJURY TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 12849068 ↗
• MalfunctionJul 6, 2021Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN AORTIC ARCH REPLACEMENT DUE TO AORTIC ARCH ATHEROMA USING ANTEGRADE DEPLOYMENT OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS REPORTED THAT NO GUIDEWIRE WAS USED DURING DEVICE PLACEMENT. THE DELIVERY CATHETER WAS INSERTED INTO THE OPEN AORTA. THE FIRST TWO DEPLOYMENT STEPS WERE PERFORMED WITH NO REPORTED ISSUES. IT WAS REPORTED THAT, AS THE PHYSICIAN ATTEMPTED TO INITIATE REMOVAL OF THE LOCKWIRE FROM THE CATHETER, THE RED LOCKWIRE HANDLE SEPARATED FROM THE DELIVER CATHETER. REPORTEDLY THERE WAS NO ISSUE TURNING THE RED LOCKWIRE HANDLE AND INITIATING REMOVAL OF THE LOCKWIRE, BUT AFTER A SHORT DISTANCE A RESISTANCE WAS NOTED FOLLOWED BY THE LOCKWIRE HANDLE BREAKING. IT WAS REPORTED THAT THE LOCKWIRE WAS NOT PULLED WITH FORCE, AND THAT THE BREAK OCCURRED DIRECTLY AFTER THE RESISTANCE WAS NOTED. THE BACKUP DEPLOYMENT HATCH WAS OPENED AND THE PHYSICIAN ATTEMPTED TO COMPLETE REMOVAL OF THE LOCKWIRE HANDLE BY PULLING THE LOCKWIRE. HOWEVER, THE LOCKWIRE WAS UNABLE TO BE PULLED AND REMOVED FROM THE HATCH. LIKEWISE IT WAS REPORTED THAT THE ANGULATION FIBER WAS UNABLE TO BE REMOVED. IT WAS NOTED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125528 ↗
• InjuryMar 18, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A CHRONIC DISSECTION OF THE DESCENDING THORACIC AORTA AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THIS PATIENT UNDERWENT SURGICAL CONVERSION FOR PERSISTENT FALSE LUMEN PERFUSION OF THE CHRONIC DISSECTION AND THE CTAG-AC DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11517107 ↗
• InjuryOct 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR ON A TYPE B DISSECTION USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL (CTAG/AC). THE DEVICE WAS IMPLANTED AT THE LEVEL OF THE CAROTID ARTERY; HOWEVER, IT WAS REPORTED THAT THERE WAS INSUFFICIENT HEALTHY TISSUE IN THE PROXIMAL LANDING ZONE. ON AN UNKNOWN DATE POST PROCEDURE, FOLLOW UP REVEALED A RETROGRADE DISSECTION INTO THE ASCENDING AORTA AND INNOMINATE ARTERY. AT SOME POINT BETWEEN (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REPAIR TO TREAT THE NEW RETROGRADE DISSECTION. THERE WAS NO ISSUE FOUND WITH THE CTAG/AC DURING THE OPEN REPAIR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 10678026 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON, (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION WITH GORE® TAG® THORACIC ENDOPROSTHESES. THE PROCEDURE CONCLUDED WITH THE SUCCESSFUL REPAIR OF THE DISSECTION AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE. IT WAS REPORTED, POST-OPERATIVELY ON (B)(6), 2020, THE PATIENT PRESENTED WITH MALPERFUSION AND WAS REPORTED TO HAVE SUFFERED A STROKE (DETAILS UNKNOWN). REPORTED EVIDENCE OF A RETROGRADE DISSECTION PROXIMAL (OUTSIDE OF TREATMENT AREA) TO THE PREVIOUSLY IMPLANTED TAG DEVICE AND A NEW ENTRY TEAR ORIGINATING AT THE AORTIC ROOT WERE IDENTIFIED. THE CAUSE OF THE DISSECTION IS REPORTEDLY UNKNOWN, HOWEVER, THE PHYSICIAN STATED THE NEW DISSECTION IS UNRELATED TO THE ORIGINAL DISSECTION TREATED IN (B)(6) 2020, AND THERE WERE NO REPORTED ISSUES WITH THE IMPLANTED TAG® DEVICES. ON (B)(6)2020, AN OPEN SURGICAL REPAIR WAS PERFORMED TO TREAT THE NEW DISSECTION. ACCORDING TO THE REPORT THE DISSECTION WAS SUCCESSFULLY REPAIRED AND THE PATIENT WAS REPORTED DOING WELL AFTER THE PROCEDURE.

  Patient problems: Aortic Dissection

  MAUDE report 10174078 ↗

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-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · 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