GORE TAG Thoracic Branch Endoprosthesis TAC083415ARecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00733132654093), received between Oct 2, 2022 and Mar 19, 2026 — classified as 2 deaths, 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P210032); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) TO TREAT A THORACIC DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAINS. REPORTEDLY THE PATIENT STATED HE RAN OUT OF HIS BLOOD PRESSURE MEDICATION OVER TWO WEEKS AGO. IMAGING REVEALED THE DISSECTION HAD PROGRESSED DISTALLY AND ADJACENT TO THE IMPLANTED TBE DEVICE. A REINTERVENTION WAS DONE TO EXTEND DISTALLY WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24643412 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN CONDITION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT A NEW DISSECTION DISTAL TO THE TBE DEVICE. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO TREAT THE DISSECTION. IT IS UNKNOWN WHAT CAUSED THE NEW DISSECTION, AND THE DISSECTION WAS NOT SEEN ON A PATIENT SCAN COMPLETED ON (B)(6) 2026. THE REINTERVENTION PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24295211 ↗
• InjuryDec 2, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON NOVEMBER 11, 2025, IT WAS REPORTED THAT THERE WAS A TYPE 1A ENDOLEAK. THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO RESOLVE THE ENDOLEAK. NO ADDITIONAL STENTS WERE ADDED.

  Patient problems: Clinical Endoleak

  MAUDE report 23697970 ↗
• DeathSep 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT A TYPE B DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TRI-LOBE BALLOON CATHETER. REPORTEDLY, ALL DEVICES WERE IMPLANTED SUCCESSFULLY WITH THE TBE GRAFT BEING THE MOST PROXIMAL AND ADJACENT TO THE AORTIC ARCH RUPTURE. THERE WAS A VERY SMALL TYPE 1A ENDOLEAK WHICH PHYSICIAN DEEMED COULD HAVE BEEN LEFT ALONE BUT DECIDED TO BALLOON THE PROXIMAL END. AT THIS TIME, PHYSICIAN USED THE GORE® TRI-LOBE BALLOON CATHETER TO BALLOON THE PROXIMAL END AND OVER BALLOONED WHICH ENDED UP RUPTURING THE AORTIC ARCH. FURTHER TREATMENT WAS STOPPED DUE TO PATIENT BEING A JEHOVAH'S WITNESS AND PATIENT CAUSE OF DEATH IS DUE TO BLEEDING INTERNALLY.

  Patient problems: Clinical Endoleak

  MAUDE report 22936705 ↗
• InjuryMay 21, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 3 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC083415A/(B)(6), AORTIC COMPONENT) AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TSB081506A/(B)(6), SIDE BRANCH COMPONENT). RADIAL ACCESS AND A SINGLE SIDED GROIN ACCESS HAD BEEN OBTAINED. IT WAS REPORTED THAT BOTH DEVICES DEPLOYED PROPERLY, WITH ZERO COMPLICATIONS. ON THE FINAL ANGIO RUN, THE LEFT SUBCLAVIAN DISTAL TO THE VERTEBRAL ARTERY LOOKED LIKE IT WAS SPASMING, AND A DISCUSSION REGARDING A POTENTIAL DISSECTION WAS HAD. THE DOCTOR ENDED UP HAVING TO CUT DOWN ON THE ARM BECAUSE THERE WAS NO FLOW. THE PATIENT TOLERATED THE PROCEDURE LATER THIS SAME NIGHT AROUND 6 PM THE PATIENT WAS REPORTED TO HAVE HAD A STROKE. IT WAS BELIEVED THAT THE ARTERY HAD BEEN DISSECTED DURING THE INITIAL ACCESS FROM THE ARM, AND THEY HAD GOTTEN BACK IN TRUE LUMEN SO THE STENT DEPLOYED FROM BELOW WITHIN THE TRUE LUMEN; AND THE REMAINDER OF THE ARM WAS DISSECTED. THE PATIENT TOLERATED THE PROCEDURE,

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

  MAUDE report 22065517 ↗
• InjuryMay 9, 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 TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, ALL THREE DEVICES WERE IMPLANTED SUCCESSFULLY WITH NO DEPLOYMENT ISSUES AND FULLY COVERED THE DISSECTION AREA. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT HAD SUFFERED A RIGHT SIDED STROKE. THE INITIAL PROCEDURE HAD GONE AS PLANNED AND PHYSICIAN IS NOT SURE WHAT CAUSED THE STROKE AS THEY WERE NOT OPERATING IN THAT AREA WHICH LED TO THE STROKE. THE PATIENT IS CURRENTLY EXPERIENCING LEFT ARM WEAKNESS AND SLURRED SPEECH. ON (B)(6) 2025, IT WAS REPORTED THAT PATIENT IS GETTING BETTER AND CAUSE OF STROKE REMAINS UNKNOWN.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21997592 ↗
• InjuryMar 12, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 THORACIC ACUTE AORTIC DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT) (TAC083415A/(B)(6)) WAS ADVANCED UP TO THE INTENDED LOCATION AND LINED UP. THE PRIMARY HANDLE DEPLOYMENT WAS DEPLOYED, AND THE VERY FIRST PROXIMAL SLEEVE UNZIPPED, HOWEVER THE REST DID NOT. ADDITIONALLY, IT WAS REPORTED THAT BOTH DEPLOYMENT STRINGS/LINES CAME ALL THE WAY OUT OF THE GRAFT. IT WAS REPORTED THAT THE DEPLOYMENT STRING/LINE FOR THE SECONDARY DEPLOYMENT WAS BELIEVED TO BROKEN. IT IS UNKNOWN IF IT BROKE AT THE PORTAL, OR AT THE DISTAL END OF THE GRAFT. THE PHYSICIAN CAREFULLY DRAGGED THE GRAFT THROUGH THE AORTA DOWN TO A 22FR GORE® DRYSEAL HYDRO FLEX INTRODUCER SHEATH (DSF2233/(B)(6) OR DSF2233/(B)(6) (DSF). THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK INTO THE DSF (EXCEPT FOR THE PROXIMAL PORTION THAT HAD ALREADY BEEN DEPLOYED OPEN). IN DOING SO THE LEFT COMMON ILIAC ARTERY (LCIA) AND A PORTION OF THE EXTERNAL ILIAC ARTERY (LCEIA) SUFFERED A DISSECTION. NEXT, THE PHYSICIAN ADVANCED ANOTHER 22FR DSF UP THE RIGHT GROIN AND TWO G

  Patient problems: Vascular Dissection

  MAUDE report 21590365 ↗
• InjuryMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A BORDERLINE MYCOTIC THORACIC ANEURYSM LOCATED AT THE DISTAL EDGE OF LSCA USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG). THE TBE SYSTEM WAS DEPLOYED SUCCESSFULLY. THE PORTAL WAS BALLOONED, BUT THE MAIN GRAFT WAS NOT. THE COMPLETION ANGIOGRAPH SHOWED NO ENDOLEAKS. ON (B)(6) 2025, THE FOLLOW-UP CT SHOWED AN ENDOLEAK - IT WAS UNKNOWN WHETHER IT WAS TYPE I OR TYPE III. THE PHYSICIAN REINTERVENED FEBRUARY 13TH TO TRY BALLOONING THE GRAFT TO RESOLVE THE ENDOLEAK, BUT THAT WAS NOT SUCCESSFUL. ON FRIDAY, (B)(6) 2025 THE PHYSICIAN REINTERVENED AGAIN. FIRST, THE PHYSICIAN USED A CODA BALLOON PROXIMAL TO THE GRAFT. THIS SEEMED TO RESOLVE THE LEAK, BUT WHEN THE BALLOON WAS REMOVED AN ENDOLEAK COULD STILL BE SEEN IN STEEP RAO PROJECTION. THE PHYSICIAN THEN DECIDED TO TRY TO RULE OUT A TYPE III ENDOLEAK USING A CTAG AND A 10X10 VIABAHN PERISCOPE FROM THE PORTAL INTO THE DISTAL GRAFT, BUT THE COMPLETION ANGIO STILL SHOWED A LEAK. FINALLY, THE PHYSICIAN TRIED BALLOONING IN THE PORTAL WHILE ALSO BALLOONING THE CTAG AGGRESSIVELY WITH A GOR

  Patient problems: Stroke/CVA

  MAUDE report 21589149 ↗
• InjuryMar 7, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A BORDERLINE MYCOTIC THORACIC ANEURYSM LOCATED AT THE DISTAL EDGE OF LSCA USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG). THE TBE SYSTEM WAS DEPLOYED SUCCESSFULLY. THE PORTAL WAS BALLOONED, BUT THE MAIN GRAFT WAS NOT. THE COMPLETION ANGIOGRAPH SHOWED NO ENDOLEAKS. ON (B)(6) 2025, THE FOLLOW-UP CT SHOWED AN ENDOLEAK; IT WAS UNKNOWN WHETHER IT WAS TYPE I OR TYPE III. THE PHYSICIAN REINTERVENED (B)(6) TO TRY BALLOONING THE GRAFT TO RESOLVE THE ENDOLEAK, BUT THAT WAS NOT SUCCESSFUL. ON FRIDAY, (B)(6) 2025 THE PHYSICIAN REINTERVENED AGAIN. FIRST, THE PHYSICIAN USED A CODA BALLOON PROXIMAL TO THE GRAFT. THIS SEEMED TO RESOLVE THE LEAK, BUT WHEN THE BALLOON WAS REMOVED AN ENDOLEAK COULD STILL BE SEEN IN STEEP RAO PROJECTION. THE PHYSICIAN THEN DECIDED TO TRY TO RULE OUT A TYPE III ENDOLEAK USING A CTAG AND A 10X10 VIABAHN PERISCOPE FROM THE PORTAL INTO THE DISTAL GRAFT, BUT THE COMPLETION ANGIO STILL SHOWED A LEAK. FINALLY, THE PHYSICIAN TRIED BALLOONING IN THE PORTAL WHILE ALSO BALLOONING THE CTAG AGGRESSIVELY WITH A GORE® TRI-L

  Patient problems: Clinical Endoleak

  MAUDE report 21548558 ↗
• InjuryMar 4, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) (AORTIC COMPONENT AND SIDE BRANCH) IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), CTA SCANS WERE TAKEN AND IT WAS NOTED THAT A POSSIBLE ENDOLEAK OCCURRED. THE PHYSICIAN WAS NOT SURE WHICH TYPE OF ENDOLEAK OCCURRED. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE POSSIBLE ENDOLEAK UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH) IN ZONE 3. IT WAS REPORTED THAT THE PORTAL WAS REALIGNED WITH A NEW SIDE BRANCH AND THEN BALLOONED. THERE WERE NO ALLEGATIONS AGAINST THE AORTIC COMPONENT AT THIS TIME. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR BUT BELIEVES IT MAY BE AN ISSUE WITH THE GRAFT (POSSIBLE IIIB ENDOLEAK). ON (B)(6) 2025, A CTA SCAN WAS TAKEN WHICH SHOWED THE LEAK PERSISTED. ALSO, THE FALSE LUMEN HAD GROWN 5MM. ON AN UNKNOWN DATE, IT WAS DETERMINED THAT IT WAS NOT THE SIDE BRANCH, BUT IT WAS THE AORTIC COMPONENT, THAT CONTRIBUTED TO THE REPORTED EVENT PERSISTING. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROC

  Patient problems: Clinical Endoleak

  MAUDE report 21518619 ↗
• InjuryFeb 18, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  THE PATIENT WAS TRANSFERRED TO RECOVERY AND WAS MONITORED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ischemia; Paralysis; Stroke/CVA

  MAUDE report 21396024 ↗
• MalfunctionDec 3, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 3. IT WAS REPORTED THAT THE PROCEDURE WAS CONDUCTED IN A STANDARD MANNER PER THE INSTRUCTIONS FOR USE. THE DEPLOYMENT KNOB WAS PULLED AND THE TBE AORTIC COMPONENT PARTIALLY DEPLOYED. THE PHYSICIAN REMOVED THE PARTIALLY DEPLOYED COMPONENT FROM THE PATIENT AND OBTAINED ANOTHER TBE AORTIC COMPONENT TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN IS UNAWARE OF WHAT CAUSED THE REPORTED ISSUE TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831865 ↗
• InjuryFeb 21, 2024Adverse 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: Chest Pain; Vascular Dissection

  MAUDE report 18754111 ↗
• InjuryFeb 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, PATIENT UNDERWENT TREATMENT FOR AN ACUTE TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE-TAC083415A). PROCEDURE WAS COMPLETED AND A SMALL TYPE 1A ENDOLEAK WAS IDENTIFIED. PHYSICIAN DECIDED TO MONITOR THIS LEAK. ON AN UNKNOWN DATE, A CT SCAN WAS PERFORMED WHICH REVEALED A LARGER LEAK, VERY LIKELY A TYPE 1A ENDOLEAK. PHYSICIAN STILL DECIDED TO MONITOR THIS LEAK, WITH NO PLANS FOR REINTERVENTION SURGERY. ON (B)(6) 2023, AN ADDITIONAL CT SCAN WAS PERFORMED. THE TYPE 1A ENDOLEAK SEEMED TO MOSTLY RESOLVE, HOWEVER THERE WAS STILL A SMALL LEAK THAT REMAINED. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO THIS SMALL RESIDUAL TYPE 1 ENDOLEAK. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC EXTENDER) WAS IMPLANTED TO EXTEND PROXIMALLY. PHYSICIAN BELIEVES THIS ENDOLEAK IS LIKELY DUE TO PATIENT ANATOMY AND DISEASE PROGRESSION. FSA ALSO REPORTS PATIENT MEASUREMENTS ARE NOT AVAILABLE, BUT MEASUREMENTS WERE IN ACCORDANCE WITH IFU. PATIENT TOLERATED THE PROCEDURE. NO PATIENT IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 18658265 ↗
• InjuryJan 11, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). A THORACIC AORTIC COMPONENT AND A SIDE BRANCH COMPONENT WERE IMPLANTED. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE AORTIC COMPONENT, SO AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK REMAINED, SO THE PHYSICIAN OPTED TO RELINE THE TBE SYSTEM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE SIDE BRANCH PORTAL WAS INTENTIONALLY COVERED AND A VBX DEVICE WAS USED TO EXTEND FROM THE PORTAL DISTALLY IN A PERISCOPE TECHNIQUE. IT WAS NOTED THAT THE DISTAL END OF THE VBX DEVICE WAS ALIGNED WITH THE DISTAL END OF THE CTAG A/C DEVICE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18498917 ↗
• InjuryDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN ZONE 2- LEFT COMMON CAROTID ARTERY (LCC) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THERE APPEARS TO BE A RETROGRADE TYPE A DISSECTION (RTAD) FROM A PROXIMAL SINE STENT GRAFT INDUCED NEW ENTRY TEAR ON THE APPROXIMATE EDGE OF THE GRAFT (AORTIC COMPONENT). ITS NOT PROPAGATING INTO THE ASCENDING, SO NOT SURE AT THIS TIME IF ITS A PROXIMAL SINE OR A RTAD IN THE NEW ENTRY TEAR. PATIENT CAME IN LAST NIGHT (ON (B)(6) 2023) WITH SOME PAIN AND IS CURRENTLY STABLE AND BEING MONITORED, IT IS NOT KNOWN IF PATIENT CAME IN TO EMERGENCY ROOM OR DURING A REGULAR FOLLOW UP TO THE HOSPITAL. PHYSICIAN AT SOME POINT PLANS TO DO A REINTERVENTION WITH OPEN SURGERY TO REPAIR THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18378937 ↗
• DeathAug 7, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2023, THIS PATIENT UNDERWENT PART ONE OF A PLANNED STAGED ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL AORTIC ARCH ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TSB081506A / (B)(6) AND TAC083415A / (B)(6) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGM343420 / (B)(6) USING A GORE® DRYSEAL SHEATH. POST DEPLOYMENT OF THE DEVICES THE PATIENT EXPERIENCED A SHOWER OF EMBOLI DUE TO PLAQUE DISLODGEMENT. EMBOLI AND PLAQUE WERE REPORTED TO TRAVEL DISTALLY AND DEPOSIT WITHIN THE PATIENT¿S ARMS, VISCERAL VESSELS, AND THE DISTAL AORTA. THE PHYSICIAN PERFORMED CUTDOWNS ON THE PATIENT¿S ARMS AND CLEARED AND SUCTIONED OUT CLOTS AND EMBOLI FROM THE VISCERAL VESSELS AND DISTAL AORTA. A RENAL ARTERY WAS STENTED. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE EMBOLI SHOWER WAS REPORTED TO BE DUE TO TORTUOSITY AND A SUBSTANTIAL AMOUNT OF PLAQUE BUILD UP IN THE PATIENT¿S MID DESCENDING THORACIC AORTA. IT WAS REPORTED THAT A GREAT AMOUNT OF MANIPULATION OF THE SHEATH AND DELIVERY CATHETER HAD BEEN REQUIRED TO ADVANCE THE (TAC083415A / (B)(6) PAST THIS AREA TO GET IT TO PROPERLY LINE UP FOR DEPLOYMENT. IT WAS ESTIMA

  Patient problems: Aneurysm

  MAUDE report 17475037 ↗
• InjuryJun 19, 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 TRAUMATIC AORTIC INJURY TO THE LEFT SUBCLAVIAN ARTERY (LSA) DUE TO A FALL ON HER ARM AND SHOULDER A WEEK PREVIOUS. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT THE PATIENT HAD BOVINE ARCH. IT WAS REPORTED THAT THE PROCEDURE WENT SMOOTHLY AND ACCORDING TO PLAN; ALL DELIVERY DEVICES WERE REMOVED INTACT; ALL WIRES, CATHETERS, SHEATHS WERE REMOVED INTACT; VESSEL CLOSURE DEVICES WERE UTILIZED FOR 24F SHEATH ACCESS SITE; WITH MANUAL PRESSURE WAS HELD ON LT BRACHIAL ARM ACCESS SITE. DURING THE TIME PRESSURE WAS BEING HELD AND ANESTHESIA WAS WAKING THE PATIENT UP, THE PATIENT WENT INTO DISTRESS. COMPRESSIONS WERE BEGUN AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHEREIN IT WAS DISCOVERED THAT THE PATIENT HAD A TYPE A DISSECTION (WHICH HAD NOT BEEN PRESENT BEFORE THE CASE HAD BEGUN). COMPRESSIONS WERE CONTINUED AND AS THE THORACIC SURGEON WAS GETTING READY TO OPEN THE CHEST TO PUT THE PATIENT ON BYPASS; THE SURGEON ENCOUNTERED DIFFICULTY GETTING THE TROCARS PLACED. COMPRESSIONS CONTINUED AND IT WAS NOTED THAT THE PATIENT¿S STOMACH STARTED DISTENDING INCREDIBLY FAST

  Patient problems: Crushing Injury

  MAUDE report 17153656 ↗
• InjuryMay 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT PRESENTED TO EMERGENCY ROOM WITH A SYMPTOMATIC TYPE B AORTIC DISSECTION, UPON WHICH PROCEDURE WAS DONE UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC083415A), GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH TSB081206A) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO EXTEND DISTALLY (TGM343415). PATIENT WAS DISCHARGED, SYMPTOMS RESOLVED WITH AN UNEVENTFUL POSTOPERATIVE COURSE. ON (B)(6) 2023, REPORTEDLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR REINTERVENTION PROCEDURE WITH A RETROGRADE TYPE A DISSECTION, WHERE THE PROXIMAL END OF THE STENT GRAFT CLEARLY DISRUPTED THE AORTA AT THE LEVEL OF THE LEFT COMMON CAROTID IN ZONE-01 WHERE THE ASCENDING WAS DISSECTED. PATIENT RECEIVED SURGERY WITH AN OPEN ASCENDING REPAIR IN ZONE-2 ARCH WHERE THEY SEWED THE DACRON GRAFT AND BYPASSING THE HEAD VESSELS IN ORDER TO SEW DIRECTLY TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICE WHICH WAS PLACED PREVIOUSLY. THE PATIENT WAS COMPLAINT WITH HER FOLLOW UP, CAME IN FOR POSTOPERATIVE CT SCANS AND FOLLOW-UP APPOINTMENTS. IT IS A STENT INDUCED RETROGRADE TYPE A DISSECTION PER IMAGI

  Patient problems: Vascular Dissection

  MAUDE report 16992857 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 DISSECTION INVOLVING THE LEFT COMMON CAROTID ARTERY AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2023, IT WAS REPORTED THAT FOLLOW-UP IMAGING (DATE UNKNOWN) DETERMINED A TYPE A RETROGRADE DISSECTION. THE PHYSICIAN PLANS TO PERFORM AN OPEN REPAIR, HOWEVER IT IS UNKNOWN WHEN OR IF THIS HAS BEEN SCHEDULED.

  Patient problems: Vascular Dissection

  MAUDE report 16380460 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 TYPE B DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TACO83415A/ 25556648) AND (TSB081206A/ 25292681). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN, BELIEVED TO BE NOT RELATED TO THE THORACIC AORTA DISSECTION. IMAGING PERFORMED AT THIS TIME SHOWED SLIGHT FILLING OF THE FALSE LUMEN AND THE PHYSICIAN CHOSE TO EXTEND COVERAGE DISTALLY AND IMPLANTED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THERE WAS NO COMPLAINT CONCERNING ANY OF THE DEVICES, ALL LOOKED GOOD, HE JUST CHOSE TO EXTEND COVERAGE.

  Patient problems: Vascular Dissection

  MAUDE report 16153538 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). IT WAS REPORTED THAT THE PATIENT HAD A MILD STROKE POSTOP WITH LEFT SIDED WEAKNESS. REPORTEDLY, THE TBE DEVICE NEVER CROSSED THE INNOMINATE ARTERY DURING THE PROCEDURE. IT WAS FURTHER NOTED THAT THE PATIENT WAS APPROPRIATELY HEPARINIZED DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 16092097 ↗
• InjuryOct 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL SPECIALIST (CS) REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TBE) TO TREAT A ZONE 2 TYPE B THORACIC DISSECTION. IT WAS REPORTED THAT THE IMPLANT PROCEDURE AND DEPLOYMENT WENT AS PLANNED. AFTER DEPLOYMENT, IMAGING CONFIRMED A TYPE A ASCENDING THORACIC AORTA DISSECTION "FLAP". IVUS (INTRAVASCULAR ULTRASOUND) WAS PERFORMED AFTER TBE IMPLANT, THEN THE TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) FOLLOWED. BOTH THESE IMAGING MODALITIES SHOWED AN ASCENDING AORTIC FLAP. REPORTEDLY DURING THE PROCEDURE, THE DELIVERY DEVICE HAD TO BE PUSHED FORWARD AND THERE WAS SOME RESISTANCE. THIS MANEUVER IS PART OF THE PROCEDURAL STEPS, ADVANCING/PUSHING UN-DEPLOYED DEVICE BEYOND TARGET LOCATION TO RELIEVE STORED ENERGY (¿WHAT WAS UNUSUAL, WAS THE HIGHER RESISTANCE & GIVE THAT PROPELLED THE DEVICE FORWARD ~2-3CM¿). REPORTEDLY ON (B)(6) 2022, THE PATIENT WAS EXTUBATED. A CONVERSATION BETWEEN PATIENT AND PHYSICIAN OCCURRED, IT WAS DECIDED TO ABORT THE OPEN PROCEDURE, DUE TO THE SCAR TISSUE. THE SPINAL DRAIN IS GOING TO BE REMOVED AND CONTINUAL MANAGEMENT OF PATIENT MEDICALLY. THE SURGEON STATED THE PATIENT WOULD NOT SU

  Patient problems: Vascular Dissection

  MAUDE report 15526246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P210032. One submission often covers many models, so check the product and lot details in each record.

• Z-2672-2026 · May 19, 2026 · Open, Classified
  GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB08