GORE TAG Thoracic Branch Endoprosthesis TSB081206ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132654376), received between Jun 29, 2023 and Apr 24, 2026 — classified as 1 death, 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 19, 2026Class IIOpen, Classified

   Due to catheter separation

   Z-2672-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Difficult or Delayed Positioning

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 ANEURYSM RUPTURE AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES. THE AORTIC COMPONENT (TBE) WAS SUCCESSFULLY IMPLANTED; HOWEVER, THE PHYSICIAN HAD OPTED NOT TO OBTAIN THROUGH-AND-THROUGH WIRE ACCESS. THE GORE® TAG® SIDE BRANCH COMPONENT WAS THEN ADVANCED AND THE PHYSICIAN STRUGGLED WHEN ATTEMPTING CANNULATION OF THE LEFT SUBCLAVIAN ARTERY (LSA). AFTER MULTIPLE ATTEMPTS AT ROTATING THE DEVICE ANTERIORLY WITH EXCESSIVE FORCE AND PUSHING THE TSB WAS FINALLY ABLE TO BE DEPLOYED WITHIN THE LSA WITH GOOD RESULTS. THE DELIVERY CATHETER AND SHEATH WERE REMOVED FROM THE PATIENT. EXAMINATION AT THE TIME OF SHEATH/DELIVERY CATHETER REMOVAL NOTED THAT THE DELIVERY CATHETER WAS BROKEN AT THE TRAILING END AT THE LEVEL OF WHERE THE DISTAL END OF THE DEVICE WOULD HAVE BEEN LOCATED. BREAKAGE OF THE TRAILING END OF THE CATHETER IS BELIEVED TO HAVE BEEN DUE TO ALL THE EXCESSIVE MANIPULATIONS OF THE DEVICE DURING CANNULATION OF THE LSA. THERE WAS NO ADVERSE EVENT TO THE PATIENT, THE PROCEDURE WAS CONCLUDED WITH GREAT RESULTS.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24983849 ↗
• InjuryMar 31, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION USING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND A VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). DURING THE CASE, THE AORTIC COMPONENT OF THE TBE WAS DEPLOYED TOO PROXIMALLY, AND THE PHYSICIAN ATTEMPTED TO REPOSITION IT USING A TRILOBE BALLOON. THIS MANEUVER TEMPORARILY COVERED TWO THIRDS OF THE PATIENT¿S BOVINE INNOMINATE ARTERY, THOUGH BLOOD FLOW REMAINED ADEQUATE. THE PATIENT ALSO HAD AN EARLY LEFT VERTEBRAL ARTERY TAKEOFF, AND TO MAINTAIN PERFUSION TO THE VERTEBRAL ARTERY, THE PHYSICIAN POSITIONED PART OF THE SIDE BRANCH OUTSIDE THE TBE PORTAL WITHIN THE AORTIC COMPONENT. THIS RESULTED IN AN IMPERFECT SEAL INTO THE LEFT SUBCLAVIAN ARTERY. AN INTRAOPERATIVE ENDOLEAK WAS VISUALIZED, AND AN 11 MM VBX WAS IMPLANTED IN AN ATTEMPT TO RESOLVE IT. ALTHOUGH THE COMPLETION ANGIOGRAM DID NOT DEMONSTRATE A REMAINING ENDOLEAK, A 30 DAY CT IDENTIFIED A TYPE 1B ENDOLEAK. ON (B)(6) 2026, THE PATIENT RETURNED FOR TREATMENT OF THE KNOWN TYPE 1B ENDOLEAK, AND THE SIDE BRANCH WAS EXTENDED USING ANOTHER TBE SIDE BRANCH AND GORE® T

  Patient problems: Clinical Endoleak

  MAUDE report 24748853 ↗
• InjuryMar 18, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR A ZONE 2 THORACIC ANEURYSM USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, A REINTERVENTION OCCURRED TO PERFORM A CAROTID-SUBCLAVIAN BYPASS TO RESTORE FLOW TO THE ARM. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE SIDE BRANCH COMPONENT IN THE LSA WAS OCCLUDED. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE OCCLUSION, ALTHOUGH IT WAS NOTED THAT THE DEVICE WAS NOT COMPRESSED OR KINKED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24626960 ↗
• MalfunctionJan 26, 2026Break; Entrapment of Device; Difficult to Remove; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS BEING TREATED FOR A THORACIC AORTIC ANEURYSM, LOCATED DISTAL OF THE RIGHT SUBCLAVIAN ARTERY (RSA), USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) SYSTEM OF COMPONENTS AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES. THE PATIENT HAD AN ABERRANT RSA AND A BOVINE DOUBLE CAROTID. A PREVIOUS AORTIC SURGERY HAD TIED OFF THE RSA AND BYPASSED FROM THE CAROTID. IN THIS SURGERY, THE TBE AORTIC COMPONENT WAS PLACE COVERING THE RSA, WITH THE SIDE BRANCH PORTAL TOWARDS THE LEFT SUBCLAVIAN ARTERY (LSA). CTAG DEVICES WERE THEN PLANNED TO COVER THE AORTA DOWN TO THE CELIAC ARTERY. THE AORTIC COMPONENT WAS SUCCESSFULLY ADVANCED AND DEPLOYED. THE SIDE BRANCH WAS THEN SUCCESSFULLY ADVANCED AND DEPLOYED. HOWEVER, WHEN TRYING TO REMOVE THE DELIVERY CATHETER, THE LEADING OLIVE GOT STUCK IN THE PORTAL. THE PHYSICIAN ATTEMPTED TO APPLY TENSION FROM BOTH ENDS BUT WAS UNABLE TO GET THE DEVICE UNSTUCK. THE PHYSICIAN THEN ATTEMPTED TO BREAK OFF THE OLIVE TIP IN THE PORTAL, BUT WAS UNABLE TO DO SO. THEN, THE FELLOW PULLED HARD ON THE CATHETER, WHICH SHIFTED THE ENTIRE SYSTEM (AORTIC COMPONENT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182527 ↗
• MalfunctionOct 22, 2025Entrapment of Device; Entrapment of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). REPORTEDLY, THE THORACIC BRANCH AORTIC COMPONENT PORTAL LANDED SIDEWAYS AT 9'0 CLOCK POSITION INSTEAD OF 12'O CLOCK POSITION, WHICH IS THE IDEAL POSITION. AFTER DEPLOYING, THE SIDE BRANCH DEVICE INSIDE THE TBE MAIN BODY GRAFT, THEY COULD NOT REMOVE THE CATHETER. IT ENDED UP BREAKING THE TOP OF THE CATHETER AND LEAVING THE OLIVE TIP INSIDE OF THE GRAFT. THE OLIVE TIP WAS RETRIEVED AND PATIENT IS DOING GOOD AFTER PROCEDURE. THE 9'O CLOCK POSITION WAS DUE TO PATIENT ANATOMY AND POSSIBLE MISALIGNMENT DURING DEPLOYMENT AS IT WAS TORTUOUS. THE FINAL POSITIONING OF THE SIDE BRANCH WAS PATENT WITH EFFICIENT BLOOD FLOW AND WERE ABLE TO BALLOON AS PART OF THE PROCEDURE TO MAKE SURE IT STAYED OPEN. THE MAIN BODY ALSO REMAINED PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361920 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 PSEUDOANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT DEVELOPED AN INFECTION WITHIN THE TBE DEVICES AND THE DEVICES WERE EXPLANTED. THE CAUSE OF THE INFECTION WAS NOT KNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 22516122 ↗
• MalfunctionMay 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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. IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH, WHEN ADVANCING THE BALLOON, UNDER ANGIOGRAM, IT WAS OBSERVED THAT AN OLIVE WAS STILL ON THE GUIDEWIRE. THE FSA CONFIRMED AFTER LOOKING AT DELIVERY CATHETER THAT THE OLIVE WAS NOT ATTACHED. DUE TO BRACHIAL ACCESS DURING THE PROCEDURE, THE PHYSICIAN PUSHED THE OLIVE BACK INTO THE SHEATH AND REMOVED IT. THE PATIENT TOLERATED THE PROCEDURE. ROOT CAUSE FOR OLIVE SEPARATION IS UNKNOWN. ANATOMY WAS NOT TORTUOUS AND NO ISSUES ADVANCING OR WITHDRAWING THE DELIVERY CATHETER

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

  MAUDE report 21998729 ↗
• MalfunctionApr 22, 2025Break; Break

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 3 DISSECTION WITH MALPERFUSION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). POST DEPLOYMENT OF THE GORE® TAG® THORACIC SIDE BRANCH COMPONENT (TSB), IT WAS REPORTED THE TSB DEVICE DELIVERY CATHETER LEADING OLIVE (NOSE CONE) WOULD NOT PASS THROUGH THE PROXIMAL END OF THE PORTAL. MULTIPLE VIEWS WERE TAKEN OF THE DEVICE, HOWEVER NO KINK OR PINCH IN THE BRANCH WAS IDENTIFIED. THE PHYSICIAN TRIED MANY TECHNIQUES TO RELEASE THE LEADING OLIVE VIA WIRE MANIPULATION AND ADVANCING THE 5FR SHEATH FROM THE ARM ACCESS. THE PHYSICIAN WAS FINALLY SUCCESSFUL GETTING THE LEADING OLIVE THROUGH THE PORTAL. THE PHYSICIAN WATCHED THE REMOVAL OF THE DEVICE CATHETER UNDER FLUOROSCOPY GUIDANCE, WHICH DETERMINED THAT THE DEVICE DELIVERY CATHETER WAS COMING OUT; BUT THE LEADING OLIVE REMAINED ON THE WIRE. THE PHYSICIAN REMOVED THE DEVICE CATHETER AND THEN ADVANCED A DIAGNOSTICS CATHETER FROM THE ARM ACCESS, WHICH PUSHED THE LEADING OLIVE INTO A GORE® DRYSEAL HYDRO FLEX INTRODUCER SHEATH AND IT WAS REMOVED IT OUT OF THE BODY VIA THE SHEATH. THE PATIENT TOLERATED THE PROCEDURE. THE TSB DELIVERY CATHETER AND DETA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885143 ↗
• 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 21518728 ↗
• InjuryDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXPRESSIVE APHASIA. THE PATIENT RECEIVED AN MRI AND IT WAS CONFIRMED THAT THE PATIENT EXPERIENCED A STROKE. THERE ARE NO PLANS TO RE-INTERVENE ON THE PATIENT. THE PATIENT IS BEING MONITORED AS OF NOW. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE EVENT TO OCCUR. CODE 1001-E: UNKNOWN: TO CAPTURE STROKE INCIDENT WITH UNKNOWN CAUSE.

  Patient problems: Ischemia Stroke

  MAUDE report 21037095 ↗
• InjuryOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 THORACIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024 THE PATIENT UNDERWENT REINTERVENTION FOR A SMALL LATE FILLING ENDOLEAK (TYPE/ORIGIN UNKNOWN) BUT BELIEVED TO BE NEAR THE PORTAL. THE PORTAL AND THE (TSB) WERE RE-BALLOONED AND THE PHYSICIAN CHOSE TO RELINE AND EXTEND THE AORTIC COMPONENT ALSO. A LATE SMALL FILLING ENDOLEAK WAS STILL OBSERVED AND THE PHYSICIAN CHOSE TO CONCLUDE THE PROCEDURE AS HE STILL WAS UNABLE TO DETERMINE (TYPE/ORIGIN). HE WILL MONITOR THE PATIENT AND FOLLOW-UP WITH ANOTHER CT. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 20413143 ↗
• InjuryJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRACH ENDOPROSTHESES (AORTIC COMPONENT, AORTIC EXTENDER, AND AORTIC SIDE BRANCH), GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED ALL 3 TBE DEVICES WITHOUT ANY ISSUES. AN ANGIOGRAM WAS TAKEN AFTER THE CASE. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE FSA RECEIVED A CALL FROM THE PHYSICIAN. THE PATIENT WAS HAVING DIFFICULTY MOVING THE LEFT SIDE OF THEIR BODY. THE PHYSICIAN PERFORMED A CAT SCAN AND DETERMINED THAT THE PATIENT EXPERIENCED A STROKE. THE PATIENT WAS PUT ON THE HOSPITAL¿S STROKE PROTOCOL IMMEDIATELY. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE ISSUE. THE FSA STATED THAT PRIOR TO THE PROCEDURE, THE PATIENT HAD A SPINAL DRAIN IN PLACE. THE FSA STATED THAT PRIOR TO DEVICE IMPLANTATION, THE PHYSICIAN PERFORMED A LEFT SUBCLAVIAN ARTERY TO LEFT COMMON CAROTID EXTRA-ANATOMIC BYPASS. THE BYPASS WAS PERFORMED BECAUSE THE ANEURYSM WAS LOCATED IN A PLACE THAT WOULD OF HAVE REQUIRED THE PHYSICIAN TO EXTEND OVER THE TOP OF THE LEFT C

  Patient problems: Stroke/CVA

  MAUDE report 19839899 ↗
• MalfunctionJul 8, 2024Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A ZONE 2 THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT TAC083715A, AND THEN A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH TSB081206A. WHILE IMPLANTED THE TSB DEVICE, IT GOT HUNG UP ON THE PORTAL OF THE TAC. THE PHYSICIAN ROTATED AND TORQUED THE DEVICE AND WAS FINALLY ABLE TO GET IT THROUGH THE AORTIC DEVICE AND DEPLOYED IN THE DESIRED POSITION. WHEN HE REMOVED THE DELIVERY CATHETER, IT WAS NOTICED THAT THE LEADING OLIVE HAD BROKEN OFF OF THE CATHETER. THE PHYSICIAN WAS ABLE TO SNARE IT AND REMOVE IT VIA THE FEMORAL ARTERY. THE PHYSICIAN THEN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGMR373720 TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER AND LEADING OLIVE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693696 ↗
• InjuryJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR PROCEDURE IN ZONE 2 (LEFT COMMON CAROTID ARTERY) TO TREAT A TYPE B DISSECTION GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (BRANCH AORTIC COMPONENT AND SIDE BRANCH). REPORTEDLY, DURING THE PROCEDURE, THE SIDE BRANCH TIP (PROXIMAL END OF THE SIDE BRANCH CATHETER) GOT WEDGED IN THE 5FR CATHETER FLEXOR CHECK-FLO INTRODUCER (NON-GORE DEVICE) AND UPON TRYING TO SEPARATE IT, SIDE BRANCH TIP BROKE OFF AND REMAINED ON THE 5FR DILATOR (NON-GORE SHEATH). DEPLOYMENT WAS NOT AFFECTED. THE DOCTORS PULLED IT OUT OF THE BRACHIAL ARTERY SINCE THE PROCEDURE WAS A CUTDOWN. THERE WAS NO ADVERSE EVENT AND PATIENT IS DOING GREAT. THE OVERALL PROCEDURE WAS A BIG SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595078 ↗
• DeathMar 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN EXPANDING PENETRATING AORTIC ULCER DISTAL TO THE LEFT SUBCLAVIAN ARTERY. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT (TAC083715A), TBE SIDE BRANCH COMPONENT (TSB081206A), AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR404015) WERE IMPLANTED. THE PROCEDURE WAS REPORTED AS ON LABEL AND PERFORMED PER THE DEVICES' INSTRUCTIONS FOR USE. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATELY TWO HOURS POST-OPERATIVELY, THE PATIENT REPORTEDLY CODED. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM WHERE THE TEAM PERFORMED COMPRESSIONS AND RESUSCITATIVE MEASURES FOR APPROXIMATELY ONE HOUR. THERE WAS NO REPORTED RUPTURE OR OTHER ISSUE OBSERVED RELATED TO THE DEVICE IMPLANT. THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE PATIENT DEATH REMAINS UNKNOWN.

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 19009001 ↗
• InjuryFeb 26, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ASCENDING THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). THE ENTRY TEAR WAS OBSERVED IN THE AORTIC ARCH AT THE LEVEL OF THE DISTAL ANASTOMOSIS PROXIMAL TO THE PATIENT'S LEFT SUBCLAVIAN ARTERY (LSA). THE LENGTH FROM THE DISTAL BORDER OF THE LSA TO THE BEGINNING OF THE ENTRY TEAR WAS APPROXIMATELY 27MM BY OUTER CURVE LENGTH. A THORACIC AORTIC COMPONENT (TAC083415) AND A SIDE BRANCH COMPONENT (TSB081206) WERE IMPLANTED. THE PROXIMAL SEGMENT LENGTH ON THE TAC083415 IS 20MM AND, THEREFORE, LANDED IN DISSECTED TISSUE AND DID NOT COVER THE PRIMARY ENTRY TEAR. THE PHYSICIAN EXTENDED PROXIMALLY WITH AN AORTIC EXTENDER COMPONENT (TE3742). THERE WAS INSUFFICIENT OVERLAP BETWEEN THE AORTIC EXTENDER AND AORTIC COMPONENT LEADING TO A TYPE III ENDOLEAK. TO TREAT THIS ENDOLEAK, THE PHYSICIAN OPTED TO RELINE THE TBE SYSTEM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE PROXIMAL END OF THE CTAG A/C WAS WITHIN THE AORTIC EXTENDER. THE SIDE BRANCH (SB) PORTAL WAS INTENTIONALLY COVERED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS US

  Patient problems: Clinical Endoleak

  MAUDE report 18784095 ↗
• InjuryJun 29, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION IN ZONE 2. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY ORIENTING THE PORTAL OF THE AORTIC COMPONENT (AC) TO THE OSTIUM OF THE PATIENT'S LEFT SUBCLAVIAN ARTERY. UPWARDS OF SIX PASSES ACROSS THE AORTIC ARCH WERE MADE WITH THE AC DEVICE IN AN ATTEMPT TO ACHIEVE THE DESIRED ORIENTATION. EVENTUALLY, THE PHYSICIAN ACCEPTED THE AC ORIENTATION AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF BOTH THE AC AND A SIDE BRANCH DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 17222658 ↗