GORE TAG Thoracic Branch EndoprosthesisRecalls & reported problems across all models

We found 30 models of GORE TAG Thoracic Branch Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2022 and Sep 30, 2026 — classified as 14 deaths, 126 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GORE TAG Thoracic Branch Endoprosthesis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 19, 2026Class IIOpen, Classified

   Due to catheter separation

   Z-2672-2026 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗

Most reported GORE TAG Thoracic Branch Endoprosthesis problems

GORE TAG Thoracic Branch Endoprosthesis models

30 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE TAG Thoracic Branch Endoprosthesis TSB081206A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death17 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB081506A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death13 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB121506A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death11 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB121706A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death9 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB081006A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall7 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB122006A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall3 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC083415A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC083715A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths15 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC084015A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  10 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC123415A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC124015A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths7 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC123715A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths6 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC124515A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death6 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC084515A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death5 reports
• GORE TAG Thoracic Branch Endoprosthesis TE4043A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC083115A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE TAG Thoracic Branch Endoprosthesis TE3442A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE TAG Thoracic Branch Endoprosthesis TE3742A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB081706A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE TAG Thoracic Branch Endoprosthesis TE3140A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE TAG Thoracic Branch Endoprosthesis TE4546A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Thoracic Branch Endoprosthesis TSB080806A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Thoracic Branch Endoprosthesis TAC082615A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC082815A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC083420A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC123115A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC123420A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC123720A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC124020A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Branch Endoprosthesis TAC124520A

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE TAG Thoracic Branch Endoprosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953838 ↗
• InjuryJul 29, 2026Device Endoleak

  The following was reported to Gore: On (b)(6), 2026, the patient underwent an endovascular reintervention to treat a Type IA endoleak associated with a previously implanted GORE® TAG® Thoracic Branch Endoprosthesis (TBE). To address the endoleak, the physician elected to reline the previously implanted zone 2 TBE with a zone 0 TBE. As part of the repair, the side branch needed to be extended beyond the distal end of the newly implanted zone 0 TBE component. A GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Device) and a GORE® VIABAHN® FORTEGRA Venous Stent (FORTEGRA Device) were deployed through the portal of the previously implanted zone 2 TBE and extended below the trailing end of the zone 0 TBE. The physician elected to use the VIABAHN Device and the FORTEGRA Device to reinforce the TBE side branch and aid in radial force.During the procedure, the VIABAHN Device was implanted fist then the FORTEGRA Device. When withdrawing the FORTEGRA delivery catheter, the catheter tip appeared to have gotten stuck on the VIABAHN Device and pulled on both the VIABAHN Device and FORTEGRA Device back, creating a gap. The physician was unable to remove the FORTEGRA delivery

  Patient problems: Clinical Endoleak

  MAUDE report 50075152 ↗
• MalfunctionJun 5, 2026Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR THE TREATMENT OF AN AORTIC DISSECTION INVOLVING ZONE 1 (LEFT COMMON CAROTID ARTERY) USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES. IT WAS REPORTED THAT, UPON REMOVAL OF A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) SIDE BRANCH (SB) COMPONENT DELIVERY CATHETER, THE LEADING OLIVE OF THE DELIVERY CATHETER SEPARATED FROM THE MAIN CATHETER SHAFT. IT WAS FURTHER REPORTED THAT THE ANATOMY WAS NOT SIGNIFICANTLY TORTUOUS, WITH ONLY MINOR NARROWING OF THE AORTIC ARCH. THE USER REPORTED NO EXCESSIVE FORCE, TWISTING, OR DIFFICULT MANIPULATION DURING DEVICE USE, AND STATED THAT THE PROCEDURE WAS OTHERWISE STRAIGHTFORWARD. FOLLOWING IDENTIFICATION OF THE SEPARATION, AN INITIAL ATTEMPT TO RETRIEVE THE SEPARATED COMPONENT USING A SNARE WAS UNSUCCESSFUL. THE DEVICE FRAGMENT WAS SUBSEQUENTLY RETRIEVED VIA ARM ACCESS USING A LONG CATHETER TO ADVANCE THE SEPARATED COMPONENT OUT THROUGH THE 20 FR SHEATH. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR ADVERSE CLINICAL OUTCOMES ASSOCIATED WITH THIS EVENT, AND THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415178 ↗
• InjuryJun 4, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, THE PATIENT UNDERWENT A 2ND STAGED ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT RETURNED FOR A REINTERVENTION BASED ON CT FINDINGS THAT SUGGESTED A TYPE IA ENDOLEAK AT THE PROXIMAL TBE GRAFT. THE INTERVAL CT SCAN BETWEEN THE TBE AND TAMBE PROCEDURES HAD SHOWN NO EVIDENCE OF ENDOLEAK; HOWEVER, THE POST TAMBE CT SCAN RAISED CONCERN FOR A PROXIMAL TYPE IA LEAK. DURING THE PROCEDURE, AN ARTERIOGRAM WAS PERFORMED TO IDENTIFY THE SOURCE OF THE SUSPECTED TYPE IA ENDOLEAK. NO TYPE IA ENDOLEAK WAS VISUALIZED. INSTEAD, A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECTION WAS IDENTIFIED BETWEEN THE TBE MAIN GRAFT AND A TBE EXTENDER. A SECOND EXTENDER WAS PLACED, BUT THIS DID NOT RESOLVE THE LEAK. THE PHYSICIAN THEN ELECTED TO USE A 9 × 7.5 CM VIABAHN TO EXTEND THE TBE SIDE BRANCH BACK INTO THE AORTA, FOLLOWED BY PLACEMENT OF A 37 × 10 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIV

  Patient problems: Clinical Endoleak

  MAUDE report 25391565 ↗
• InjuryJun 4, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, THE PATIENT UNDERWENT A 2ND STAGED ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT RETURNED FOR A REINTERVENTION BASED ON CT FINDINGS THAT SUGGESTED A TYPE IA ENDOLEAK AT THE PROXIMAL TBE GRAFT. THE INTERVAL CT SCAN BETWEEN THE TBE AND TAMBE PROCEDURES HAD SHOWN NO EVIDENCE OF ENDOLEAK; HOWEVER, THE POST TAMBE CT SCAN RAISED CONCERN FOR A PROXIMAL TYPE IA LEAK. DURING THE PROCEDURE, AN ARTERIOGRAM WAS PERFORMED TO IDENTIFY THE SOURCE OF THE SUSPECTED TYPE IA ENDOLEAK. NO TYPE IA ENDOLEAK WAS VISUALIZED. INSTEAD, A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECTION WAS IDENTIFIED BETWEEN THE TBE MAIN GRAFT AND A TBE EXTENDER. A SECOND EXTENDER WAS PLACED, BUT THIS DID NOT RESOLVE THE LEAK. THE PHYSICIAN THEN ELECTED TO USE A 9 × 7.5 CM VIABAHN TO EXTEND THE TBE SIDE BRANCH BACK INTO THE AORTA, FOLLOWED BY PLACEMENT OF A 37 × 10 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIV

  Patient problems: Clinical Endoleak

  MAUDE report 25391555 ↗
• InjuryJun 1, 2026Failure to Advance

  ON (B)(6) 2026, THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT HAD A DEBRANCHING PROCEDURE FOR THE INNOMINATE ARTERY AND CAROTID ARTERY THREE DAYS PRIOR IN PREPARATION FOR THE TEVAR PROCEDURE. REPORTEDLY, THE TBE AORTIC COMPONENT COULD NOT BE ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO USE A NEW TBE AORTIC COMPONENT AND STILL COULD NOT ADVANCE THE DEVICE TO THE TARGET LOCATION. THE CAUSE OF THE ADVANCEMENT ISSUES IS UNKNOWN. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO USE TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) TO COMPLETE THE PROCEDURE. AS THERE WERE ADVANCEMENT ISSUES WHEN INSERTING DEVICES FROM THE PATIENT'S GROIN, THE PHYSICIAN RE-OPENED THE PATIENT'S CHEST FROM THE DEBRANCH PROCEDURE AND DELIVERED THE FIRST CTAG DEVICE THROUGH THE SURGICAL GRAFT IN THE ASCENDING AORTA, LANDING DISTAL TO THE ANASTOMOSIS OF THE SURGICAL GRAFT FROM THE DEBRANCH PROCEDURE. THE SECOND CTAG WAS DELIVERED SUCCESSFULLY FROM THE GROIN; HOWEVER, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED, SO THE PHYSICIAN COMPLETED A CAROTID-SUBCLAVIAN BYPASS. THE PROCEDURE WAS SUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353951 ↗
• DeathJun 1, 2026Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR TO TREAT AN ANEURYSM, UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT). IT WAS REPORTED DURING ADVANCEMENT OF THE TBE DEVICE THROUGH THE 24 FR SHEATH, IT WAS NOTED THAT THE SYSTEM¿S THROUGH-WIRE HAD INADVERTENTLY PASSED BEHIND A PREVIOUSLY IMPLANTED PALMAZ STENT. THE TBE AND THE 24 FR SHEATH WERE REMOVED AS ONE UNIT. IT WAS ALSO REPORTED THE ANGULATION THROUGHOUT THE DESCENDING AORTA AND ARCH WAS QUITE EXTENSIVE. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC) STENT GRAFT WAS SUBSEQUENTLY DEPLOYED TO SECURE AND ENTRAP THE EXISTING PALMAZ STENT, FOLLOWED BY BALLOONING OF THE CTAGAC DEVICE TO OPTIMIZE WALL APPOSITION. ALLEGEDLY WHILE ATTEMPTING TO REINTRODUCE A LUNDERQUIST WIRE, THE PATIENT'S BLOOD PRESSURE DROPPED. CARDIOPULMONARY RESUSCITATION WAS INITIATED IMMEDIATELY. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED VIA THE EXISTING 24 × 65 DRYSEAL SHEATH. TRANSESOPHAGEAL ECHOCARDIOGRAPHY DEMONSTRATED NO PERICARDIAL EFFUSION. CORONARY ANGIOGRAPHY REVEALED EXTENSIVE THROMBUS WITHIN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. M

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 25352591 ↗
• MalfunctionJun 1, 2026Premature Activation; Improper or Incorrect Procedure or Method

  ON AN UNKNOWN DATE IN THE PAST, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN CONDITION IN THE DESCENDING THORACIC AORTA UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). ON (B)(6) 2026, THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE THAT THE PATIENT DEVELOPED A DISSECTION, ORIGINATING PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) IN THE THORACIC AORTA, AND THE PHYSICIAN WAS PLANNING TO TREAT IT. ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT THE DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). IT WAS REPORTED THAT THE TBE AORTIC COMPONENT WAS ADVANCED THROUGH THE SHEATH TO THE PROPER LOCATION OF DEPLOYMENT, AND THEN THE DEVICE TWISTED WITH PROXIMAL WIRE WRAP. THE PHYSICIAN THEN BROUGHT THE DEVICE MOST OF THE WAY BACK INTO THE SHEATH, INSIDE THE PREVIOUSLY IMPLANTED CTAG DEVICE IN THE DESCENDING THORACIC AORTA, THEN PARTIALLY ROTATED THE TBE, AND IT STARTED SELF-DEPLOYING. THE PHYSICIAN WAS ABLE TO REMOVE THE TBE DEVICE AND SHEATH TOGETHER FROM THE PATIENT. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH USED WAS 24 FR, WHICH IS THE CORRECT SIZE FOR THE TBE AORTIC COMPONENT DEVICE US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348038 ↗
• InjuryMay 29, 2026Failure to Advance

  ON (B)(6) 2026, THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT HAD A DEBRANCHING PROCEDURE FOR THE INNOMINATE ARTERY AND CAROTID ARTERY THREE DAYS PRIOR IN PREPARATION FOR THE TEVAR PROCEDURE. REPORTEDLY, THE TBE AORTIC COMPONENT COULD NOT BE ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO USE A NEW TBE AORTIC COMPONENT AND STILL COULD NOT ADVANCE THE DEVICE TO THE TARGET LOCATION. THE CAUSE OF THE ADVANCEMENT ISSUES IS UNKNOWN. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO USE TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) TO COMPLETE THE PROCEDURE. AS THERE WERE ADVANCEMENT ISSUES WHEN INSERTING DEVICES FROM THE PATIENT'S GROIN, THE PHYSICIAN RE-OPENED THE PATIENT'S CHEST FROM THE DEBRANCH PROCEDURE AND DELIVERED THE FIRST CTAG DEVICE THROUGH THE SURGICAL GRAFT IN THE ASCENDING AORTA, LANDING DISTAL TO THE ANASTOMOSIS OF THE SURGICAL GRAFT FROM THE DEBRANCH PROCEDURE. THE SECOND CTAG WAS DELIVERED SUCCESSFULLY FROM THE GROIN; HOWEVER, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS COVERED, SO THE PHYSICIAN COMPLETED A CAROTID-SUBCLAVIAN BYPASS. THE PROCEDURE WAS SUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332301 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION FOR TREATMENT OF A PENETRATING AORTIC ULCER (PAU) FOLLOWING PRIOR TEVAR, WITH A ZONE 0 (BRACHIOCEPHALIC ARTERY [BCA]/ASCENDING AORTA) REPAIR UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. AT THE SIX-MONTH FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) IMAGING DEMONSTRATED NO ABNORMALITIES. ON (B)(6) 2026, A ONE-YEAR FOLLOW-UP CT SCAN IDENTIFIED A RETROGRADE TYPE A AORTIC DISSECTION ORIGINATING AT THE SINOTUBULAR JUNCTION (STJ). THE FINDING WAS SUBSEQUENTLY REPORTED TO GORE ON (B)(6) 2026. THE EXACT ONSET DATE OF THE DISSECTION IS UNKNOWN. THE REPORTER INDICATED THAT THE EVENT OCCURRED AT AN INDETERMINATE TIME BETWEEN THE SIX-MONTH AND ONE-YEAR FOLLOW-UP INTERVALS. AT THE TIME OF REPORTING, THE PATIENT WAS DESCRIBED AS CLINICALLY STABLE. NO DEFINITIVE CAUSE FOR THE DISSECTION HAS BEEN ESTABLISHED. THE TREATING PHYSICIAN IS CURRENTLY EVALUATING TREATMENT OPTIONS. POTENTIAL MANAGEMENT MAY INCLUDE OPEN SURGICAL REPAIR; HOWEVER, NO INTERVENTION HAD BEEN SCHEDULED AT THE TIME OF REPORTING.

  Patient problems: Vascular Dissection

  MAUDE report 25285828 ↗
• InjuryMay 6, 2026Device Endoleak

  ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A TYPE B DISSECTION WITH LEFT LOWER EXTREMITY MALPERFUSION. THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE ON THE SAME DATE UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). REPORTEDLY, THE PATIENT HAD AN ANGULATED BOVINE ARCH; HOWEVER, THE PATIENT HAD ADEQUATE ANATOMY FOR THE TBE DEVICE, AND THE DEVICE SIZING WAS ON-LABEL. IT WAS REPORTED THE TBE DEVICE (AORTIC COMPONENT) LANDED AND DEPLOYED ACCURATELY, BUT THEN THE PROXIMAL END OF THE DEVICE BIRD BEAKED ON THE INNER CURVE TOWARD THE BOVINE INNOMINATE ARTERY. THERE WAS NO CLEAR EVIDENCE OF AN ENDOLEAK ASSOCIATED WITH THE BIRD BEAKED TBE DEVICE, AND THE PHYSICIAN ELECTED TO LEAVE IT AS IS, DISCHARGING THE PATIENT WITHIN 48 HOURS. ON (B)(6) 2026, THE PATIENT RETURNED TO THE ER WITH CHEST PAIN. THE PATIENT RECEIVED A CT SCAN WHICH SHOWED A TYPE IA ENDOLEAK ON THE PROXIMAL END OF THE TBE DEVICE AND AN INTRAMURAL HEMATOMA (IMH) IN THE ASCENDING AORTA/AORTIC ARCH. THE ENDOLEAK IS SUSPECTED TO BE CAUSED BY THE BIRD BEAKING OF THE DEVICE DURING THE INITIAL IMPLANT, BUT THE CAUSE OF THE IMH IS UNKNOWN. ON (B)(6) 2026, THE PATIENT UNDERWENT OPEN REPAIR WHERE THE

  Patient problems: Chest Pain; Clinical Endoleak; Hematoma

  MAUDE report 25098627 ↗
• MalfunctionApr 30, 2026Material Frayed; Off-Label Use; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A ZONE 0 CHRONIC DISSECTION USING A PHYSICIAN MODIFIED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE DEVICE WAS MODIFIED TO CREATE FENESTRATIONS FOR THE LEFT COMMON CAROTID AND LEFT SUBCLAVIAN. IN THE PROCESS OF PERFORMING THIS MODIFICATION, THE PRIMARY SLEEVE WAS OPENED FOR A 3 CM SEGMENT ON THE SIDE OF THE DEVICE ADJACENT TO THE PORTAL. AFTER ADVANCING THE DEVICE TO THE TRANSVERSE THORACIC AORTA, THEY REALIZED THE DEVICE HAD WIRE WRAP WITH THE INNOMINATE WIRE. THEY ROTATED 2-3 TIMES COUNTER-CLOCKWISE, REALIZED THAT WAS THE WRONG DIRECTION, AND ROTATED THE OTHER WAY. AFTER 10 MINUTES, THE TBE WAS ABLE TO BE ADVANCED THROUGH THE SHEATH. ONCE IN POSITION, THEY PULLED THE DEPLOYMENT LINE. HOWEVER, THE DEVICE DID NOT DEPLOY AND REMAINED CONSTRAINED. THE PHYSICIAN TRIED TO SNARE THE PARTIALLY OPEN END OF THE TBE DEVICE, AND PULL IT BACK INTO THE DSF, BUT AFTER 45 MINUTES THEY ABANDONED THIS. THEY THEN REMOVED THE DSF AND TBE TOGETHER. THE RIGHT EXTERNAL AND COMMON ILIACS WERE DAMAGED BY THE GRAFT AND REPAIRED USING A PATCH ENDARTERECTOMY. THE PROCEDURE WAS ABORTED, AND NO DEVICES WERE IMPLANTED. THE PA

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25049241 ↗
• 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 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 2 OF THE AORTIC ARCH. REPORTEDLY, THE PARTIALLY UNCOVERED BARE METAL STENT OF THE PROXIMAL AORTIC COMPONENT SEPARATED FROM THE REMAINDER OF THE COMPONENT IMMEDIATELY FOLLOWING DEPLOYMENT. THE CAUSE OF THE SEPARATION IS UNKNOWN; HOWEVER, NOTHING OCCURRED DURING THE PROCEDURE THAT APPEARED TO CONTRIBUTE TO THE SEPARATION. THERE DID NOT APPEAR TO BE WIRE FRACTURE, ONLY SEPARATION OF THE PROXIMAL STENT ROW. THE PHYSICIAN ELECTED TO LEAVE THE TBE AORTIC COMPONENT WITH THE SEPARATED STENT ROW IN THE PATIENT AS IS AND CONTINUED TO COMPLETE THE PROCEDURE AS NORMAL. THERE WAS NO DAMAGE REPORTED DURING PREPARATION OF THE AORTIC COMPONENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910606 ↗
• MalfunctionApr 10, 2026Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Damaged by Another Device

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN ZONE 0 OF THE ASCENDING AORTA AND AORTIC ARCH UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC123715 AND TSB122006). REPORTEDLY, THERE WAS DIFFICULTY ADVANCING THE SIDE BRANCH COMPONENT THROUGH THE AORTIC COMPONENT PORTAL, BUT THE PHYSICIAN WAS ABLE TO ADVANCE THE SIDE BRANCH COMPONENT SUCCESSFULLY TO THE INTENDED LOCATION. THE SIDE BRANCH COMPONENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, THE LEADING OLIVE TIP GOT STUCK ON THE PROXIMAL END OF A BALLOON CATHETER COMING IN FROM THE OPPOSITE DIRECTION OF THE INNOMINATE ARTERY. AS THE PHYSICIAN BEGAN TO REMOVE THE SIDE BRANCH COMPONENT DELIVERY CATHETER, THE LEADING OLIVE BROKE OFF AND WAS STUCK ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO GET THE BROKEN OLIVE TIP INTO THE SHEATH AND USE A SNARE TO REMOVE IT. THERE WERE NO PATIENT ADVERSE EVENTS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845452 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports