GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis ATAA43720160ARecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00733132659685), received between Jul 2, 2024 and Sep 21, 2026 — classified as 10 deaths, 49 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

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 67 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Obstruction of Flow

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50842351 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ischemia

  MAUDE report 50797009 ↗
• InjurySep 16, 2026Patient-Device Incompatibility

  Patient problems: Clinical Endoleak

  MAUDE report 50787630 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient referenced in this event file is enrolled in the AAA 24-01 TAMBE Post Approval Study. The following information was reported from the iMedidata Clinical Database:On (b)(6) 2026, a patient underwent treatment for a thoracoabominal aortic aneurysm utilizing a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) system of components. On (b)(6) 2026, the patient was suffering for lower extremity weakness. MRI showed no evidence of spinal cord ischemia. Treatment was a spinal drain, and vasopressor support. The weakness was improving upon discharge on (b)(6) to inpatient rehab.

  Patient problems: Paresis

  MAUDE report 50022044 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED AFTER THE IMPLANT PROCEDURE; THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS AND THAT PROGRESSED INTO LOWER EXTREMITY PARALYSIS. THERE WAS NO INTERVENTION, THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT. REPORTEDLY A SPINAL DRAIN WAS PLACED PRE-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 25448305 ↗
• DeathMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THREE OF THE FOUR VISCERAL VESSELS WERE DEPLOYED, WHEN THE PHYSICIAN WAS AT THE FINAL STAGE OF DEPLOYING THE TAMBE DEVICE, THEY NOTICED THE PROXIMAL END OF THE DEVICE HAD PULSATILE MOVEMENT. IVIS WAS DONE AND DETERMINED THERE WAS A RETROGRADE DISSECTION. THE DISSECTION STARTED FROM THE TOP OF THE TAMBE GRAFT (LANDED APPROXIMATELY 65 CM ABOVE CELIAC ARTERY) AND WENT INTO THE ASCENDING THORACIC AORTA. THERE WAS NO PRE-EXISTING DISSECTION. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL, AND AN OPEN REPAIR WAS DONE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FOLLOW UP CT REVEALED THE FALSE LUMEN WAS STILL PRESSURIZED. A REINTERVENTION OCCURRED, AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. THE LEFT SUBCLAVIAN ARTERY WAS COVERED AND PLANNED; THIS WAS A STAGED SURGERY. THERE WAS A PLAN TO PERFORM A BYPASS SURGERY OF THE LEFT SUBCLAVIAN ARTERY ON A DIFFERENT DATE. THE PATIENT TOLERATED THE PRO

  Patient problems: Vascular Dissection

  MAUDE report 25112463 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. DURING THE PROCEDURE, ILIAC ACCESS WAS INADEQUATE (8MM) FOR THE 22 FR DSF, AND THE PHYSICIAN STRUGGLED TO ADVANCE THE SHEATH, BUT WAS EVENTUALLY ABLE TO GAIN ACCESS. THE REST OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT WAS NO LONGER ABLE TO MOVE THEIR LEGS. THEIR PULSE WAS LOW, AND THEIR LEGS WERE COLD. A THROMBECTOMY WAS PERFORMED ON BOTH LEGS, DISTAL TO THE GORE GRAFTS. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR A POST-OP SPINAL DRAIN - HOWEVER, NO FLUID WAS ABLE TO BE DRAINED, SO THE PROCEDURE WAS UNSUCCESSFUL. ON AN UNKNOWN DATE, A CT SCAN WAS TAKEN, SHOWING A TYPE B DISSECTION WITH ENTRY TEAR AT THE LEFT SUBCLAVIAN, AND EXTENDING DOWN THE DESCENDING THORACIC TO THE PROXIMAL END OF THE TAMBE. NO CHEST CT HAD BEEN TAKEN PRIOR TO THE PROCEDURE, AND THE PHYSICIAN COULD NOT RULE OUT THAT IT WAS PRESENT PRIOR TO THE PROCEDURE. HOWEVER, THE DISSECTION APPEARED TO BE NEW. THE PHYSICIAN DECIDED TO MEDICALLY MANAGE THE DISSECTION. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM TO A REHAB FACIL

  Patient problems: Ischemia

  MAUDE report 24925622 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED RUPTURED ANEURYSM AT THE ABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PROCEDURE WAS A TECHNICAL SUCCESS, AND THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, A SPINAL DRAIN WAS PLACED JUST PRIOR TO THE TAMBE PROCEDURE AND THERE WERE DIFFICULTIES WITH THE PLACEMENT. IT WAS REPORTED POST PROCEDURE MARCH 10, 2026, THAT THE PATIENT HAD A SUBDURAL HEMATOMA OF THE SPINAL CORD SECONDARY TO THE SPINAL DRAIN WITH SPINAL CORD ISCHEMIA. THIS WAS NOTED POST-OP WHEN ANESTHESIA OPENED THE DRAIN TO INITIATE DRAINING. ON MARCH 10, 2026, THE PATIENT PRESENTED WITH BILATERAL LOWER EXTREMITY WEAKNESS UPON ARRIVAL AT THE ICU AT 2300. THE PATIENT EXHIBITED SIGNS OF STROKE AND UPON EXTUBATION THE PATIENT WAS APHASIC AT 0000. ON (B)(6) 2026, SUBDURAL HEMATOMA OF SPINE CONFIRMED BY MRI. ISCHEMIC STROKE WAS NOTED ALSO. ON (B)(6) 2026, LATER IN THE DAY, THE PATIENT HAD BEGUN TO SHOW SIGNS OF RECOVERY. IMPROVEMENT OF UPPER EXTREMITY WEAKNESS AND BEGAN TO SPEAK SOME WORDS. ON (B)(6) 2026, THE PATIENT SUFFERED FROM ASPIRATION OF FLUID AND SUBSEQUENT INTUBATION. AT TH

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24900540 ↗
• InjuryApr 8, 2026Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL ANEURYSM IV USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, INCLUDING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE. MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES AND MULTIPLE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) DEVICES WERE PLACED IN THE VISCERAL VESSELS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, AT ONE-MONTH FOLLOW-UP, CT SHOWED THE FOLLOWING: A TYPE 1B ENDOLEAK ON THE EXCLUDER RIGHT ILIAC LIMB, DUE TO STENT RETRACTION INTO ANEURYSMAL ILIAC; AND A TYPE IIIC ENDOLEAK BETWEEN THE TAMBE AND THE VBX DEVICE IN THE CELIAC PORTAL. REPORTEDLY, THE STENT WITHIN THE CELIAC ARTERY PORTAL WAS PROXIMALLY CRUSHED. ON (B)(6) 2026, A REINTERVENTION OCCURRED. A STENT GRAFT WAS PLACED EXTENDING THE RIGHT ILIAC LIMB. ADDITIONALLY, ON (B)(6) 2026, THE PHYSICIAN NOTED THAT THE PATIENT IS SCHEDULED TO UNDERGO FURTHER INTERVENTION TO INTERROGATE THE CELIAC STENT AND EXTEND THE RIGHT ILIA

  Patient problems: Clinical Endoleak

  MAUDE report 24816747 ↗
• InjuryApr 1, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED FROM THE AAA 24-01 TAMBE POST APPROVAL STUDY AND INFORMATION WAS OBTAINED FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE THORACIC AORTA WAS COVERED FROM ZONES 2-5, WITH A TBE SIDE BRANCH BEING PLACED IN THE LEFT SUBCLAVIAN. ON (B)(6) 2026, A PATIENT WAS TREATED FOR A SECONDARY INTERVENTION ON A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS, INCLUDING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICE PLACED DISTALLY TO THE TAMBE. ALL DEVICES WERE NAVIGATED INTO POSITION AND DEPLOYED SUCCESSFULLY. ON (B)(6) 2026, SPINAL CORD ISCHEMIA WAS OBSERVED. THIS EVENT IS LISTED AS PROCEDURE RELATED. THE ISCHEMIA WAS TREATED WITH A SPINAL DRAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO INPATIENT REHAB ON (B)(6) 2026. ON (B)(6) 2026, A SPINAL CORD ISCHEMIA SCALE ASSESSMENT GRADED THE PATIENT AS 3C - NONAMBULATORY (WHEELCHAIR BOUN

  Patient problems: Ischemia

  MAUDE report 24756314 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA24-01 TAMBE POST APPROVAL STUDY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA CLINICAL DATABASE. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH A CONTAINED RUPTURE OF THE PERIVISCERAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2026, ENDOVASCULAR REPAIR OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH A LEFT ILIAC EXTENSION INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED. THERE WAS AN AORTIC CUFF IMPLANTED PROXIMALLY TO THE TAMBE DEVICE TO OVERLAP THIS REGION TO PREVENT A POSSIBLE JUNCTIONAL ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2026 PATIENT DEVELOPED ACUTE KIDNEY FAILURE, THE EVENT IS ONGOING.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24682803 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED AS SOON AS THE TAMBE DEVICE WAS INTRODUCED, BLOOD STARTED LEAKING OUT OF CATHETER, WHERE THE WHITE HANDLE MEETS THE CATHETER. THE CAUSE OF THE BLOOD LEAKAGE IS UNKNOWN, AND IT WAS REPORTED THAT NOTHING APPEARED TO BE BROKEN OR LOOSE. NO SHEATH ISSUES WERE OBSERVED. IT WAS ALSO REPORTED BLOOD WAS LEAKING OUT OF THE DEPLOYMENT HANDLE FOR THE DURATION OF THE TAMBE PORTION OF THE PROCEDURE. THE LEAKAGE STARTED SLOW AND INCREASED THROUGHOUT THE CASE. THE PATIENT LOST ABOUT 1 LITER OF BLOOD. IT WAS REPORTED THE PROCEDURE WAS NOT HURRIED BY THE PHYSICIAN, NOR WAS IT PROLONGED DUE TO THE BLEEDING. THE FSA REPORTED IT IS UNKNOWN IF THERE WAS A BLOOD TRANSFUSION AS HE WAS NOT PRESENT BUT BELIEVES VERY LIKELY DUE TO THE AMOUNT OF BLOOD LOSS. THERE WERE NO OTHER TAMBE OR PROCEDURE RELATED ISSUES REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24603936 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, DURING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY ACCESSING THE RIGHT RENAL ARTERY. DESPITE ATTEMPTS, THE ARTERY COULD NOT BE CANNULATED. AS A RESULT, THE PHYSICIAN ELECTED TO PLUG THE RENAL PORTAL WITH AN AMPLATZER 14 MM PLUG. THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS RELATED TO THE GORE DEVICE(S). NO RENAL COMPLICATIONS WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT DEVELOPED PARAPARESIS. A RESCUE SPINAL DRAIN WAS PLACED, AFTER WHICH THE PATIENT BEGAN SLOWLY IMPROVING.

  Patient problems: Paresis

  MAUDE report 24591169 ↗
• InjuryMar 13, 2026No Apparent Adverse Event

  THE FOLLOWING EVENT IS FROM THE AAA 24-01 TAMBE POST APPROVAL STUDY AND INFORMATION WAS OBTAINED FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS. ON (B)(6) 2025, A STROKE WAS REPORTED. REPORTEDLY, THE STROKE WAS PROCEDURE RELATED, AND REQUIRED EXTENDED HOSPITALIZATION, BUT NO TREATMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. AT DISCHARGE, ALL ITEMS ON THE NIH STROKE SCALE WERE RECORDED AS 0.

  Patient problems: Stroke/CVA

  MAUDE report 24590325 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, FOLLOW UP IMAGES REVEALED A TYPE I C ENDOLEAK. ON (B)(6) 2026, THE PHYSICIAN REINTERVENED AND BALLOONED THAT AREA AND STENTED THE RENAL ARTERY GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24422517 ↗
• InjuryFeb 17, 2026Obstruction of Flow

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) DEVICES WERE USED IN THE PATIENT'S AORTA WITH THE TAMBE DEVICE. DURING THE INDEX PROCEDURE, A RIGHT AND LEFT ACCESSORY RENAL ARTERIES COIL EMBOLIZATION PROCEDURE WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, SPINAL CORD ISCHEMIA WAS NOTED. TREATMENT LISTED IS A LUMBAR DRAIN AND BLOOD PRESSURE AUGMENTATION.

  Patient problems: Ischemia

  MAUDE report 24372941 ↗
• InjuryFeb 17, 2026Obstruction of Flow; Patient Device Interaction Problem

  THIS REPORT WAS SENT AS A RETRACTION: BASED ON THE INFORMATION PROVIDED THAT THERE WAS SUPERIOR VENA CAVA (SVC) THROMBUS FROM PATIENT'S PRIOR CENTRAL LINE, AND NO GORE DEVICES WERE OCCLUDED, AND RENAL AND/OR MESENTERIC ARTERY STENOSIS AND THE THROMBECTOMY AND EXTENSION OF SMA STENT PROCEDURE WERE NOT ATTRIBUTED TO THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, THERE IS NO ALLEGATION AGAINST THIS DEVICE AND THE EVENT IS NOT REPORTABLE.

  Patient problems: Reduced Blood Flow; Stenosis; Thrombosis/Thrombus

  MAUDE report 24372687 ↗
• MalfunctionFeb 12, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). REPORTEDLY, THE TAMBE WAS INSERTED THROUGH A 22 FR SHEATH AND ADVANCED TO THE TARGET LOCATION WITHOUT ISSUE. THE FIRST STAGE OF DEPLOYMENT WITH THE WHITE OUTER DEPLOYMENT KNOB WAS COMPLETED SUCCESSFULLY. NEXT, THE PHYSICIAN ATTEMPTED TO UNCONSTRAIN THE TAMBE PROXIMAL END BY TURNING THE GRAY CONSTRAINING DIAL COUNTERCLOCKWISE; HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO TURN THE GRAY CONSTRAINING DIAL BOTH CLOCKWISE AND COUNTERCLOCKWISE MULTIPLE TIMES, BUT THE TAMBE PROXIMAL END WOULD NOT OPEN OR MOVE. IT IS UNKNOWN WHY THE GRAY CONSTRAINING DIAL WAS NOT WORKING; HOWEVER, THE BLACK NUT INSIDE THE TRANSPARENT KNOB MOVED AS NORMAL WHEN THE DIAL WAS ROTATED. THE PHYSICIAN THEN ELECTED TO DISENGAGE THE CONSTRAINING MECHANISM BY SLIDING THE RED SAFETY LOCK BACK WHILE ROTATING THE TRANSPARENT KNOB 90 DEGREES COUNTERCLOCKWISE, BUT THE TRANSPARENT KNOB WAS NOT YET REMOVED. THIS ACTION CAUSED THE TAMBE PROXIMAL STENT ROW TO FULLY OPEN, WITH THE MID-SECTION STILL PARTIALLY CONSTRAINED, AND THE DISTAL END FULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327025 ↗
• MalfunctionFeb 12, 2026Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). REPORTEDLY, THE TAMBE WAS INSERTED INTO THE VALVE OF A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH, WHEN ONE PHYSICIAN ASSISTING WITH GUIDEWIRES NOTICED THERE WAS A GAP BETWEEN THE LEADING OLIVE (NOSE CONE) AND THE PROXIMAL END OF THE TAMBE DEVICE. THE PHYSICIAN INSERTING THE TAMBE INTO THE SHEATH PULLED THE DEVICE BACK TO EXAMINE THE REPORTED GAP AND THEN THE LEADING OLIVE TIP BROKE OFF THE DEVICE. THE CAUSE FOR THE OLIVE TIP BREAKAGE IS UNKNOWN. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN OLIVE TIP FROM THE SHEATH BUT WAS UNSUCCESSFUL AND HAD TO REMOVE THE SHEATH FROM THE PATIENT. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE TAMBE IN THE SHEATH. IT WAS REPORTED THE TAMBE DEVICE WAS NOT ROTATED IN THE SHEATH. A NEW SHEATH AND TAMBE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326758 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED TO TREAT THE ABDOMINAL AND THORACIC AORTA. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT DEVELOPED PARAPLEGIA AND UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN BELIEVES POOR MANAGEMENT OF THE PATIENT¿S HYPOTENSION AND A MAP IN THE 60¿S FOR A FEW HOURS PRECEDING THE PARAPLEGIA WERE CONTRIBUTORY FACTORS AND NOT DEVICE RELATED BUT A NEUROLOGICAL DEFICIT.

  Patient problems: Paraplegia

  MAUDE report 24310042 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE NEXT DAY, THE PATIENT LOST BILATERAL LOWER EXTREMITY MOTOR FUNCTION. A SPINAL DRAIN WAS PLACED PRE-OPERATIVELY AS A PRECAUTION, AND WAS FUNCTIONING CORRECTLY. IT WAS ALSO REPORTED THERE WERE NO ISSUES OBSERVED DURING THE PROCEDURE WITH ANY OF THE GORE DEVICES. THE PHYSICIAN ATTRIBUTES THIS PARALYSIS DUE TO TOTAL COVERAGE OF THE THORACIC AND ABDOMINAL AORTA AT SAME STAGE, AND DOES NOT BELIEVE THE GORE DEVICES CAUSED THE PARALYSIS. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 24292947 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). REPORTEDLY, AS SOON AS THE TAMBE DEVICE WAS INTRODUCED INTO THE 22FR DRYSEAL SHEATH, BLOOD STARTED LEAKING OUT OF THE SEAM ON THE WHITE DEPLOYMENT HANDLE NEAR WHERE THE WHITE HANDLE IS ATTACHED TO THE BLUE CATHETER. BLOOD WAS NOT LEAKING OUT OF THE TUOHY BORST VALVE. THE CAUSE OF THE BLOOD LEAKING IS UNKNOWN, AND IT WAS REPORTED THAT NOTHING APPEARED TO BE BROKEN OR LOOSE. BLOOD WAS LEAKING OUT OF THE DEPLOYMENT HANDLE FOR THE DURATION OF THE TAMBE PORTION OF THE PROCEDURE, WHICH WAS ABOUT 2 HOURS. IT WAS REPORTED THE PROCEDURE WAS NOT HURRIED BY THE PHYSICIAN, NOR WAS IT PROLONGED DUE TO THE BLEEDING. THE PATIENT REQUIRED A BLOOD TRANSFUSION. TOTAL BLOOD LOSS AMOUNT IS UNKNOWN. THERE WERE NO OTHER TAMBE OR SHEATH ISSUES REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24259882 ↗
• InjuryFeb 3, 2026Partial Blockage; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM (UNKNOWN). ON (B)(6) 2025, THE PATIENT EXPERIENCED AN ACUTE BLOOD LOOS ANEMIA AND ON (B)(6) 2025 HAD A TREATMENT USING A UNIT OF PACKED RED BLOOD CELLS (PRBC). ON (B)(6) 2025, IT WAS NOTICED THAT THE PATIENT HAD A LOWER EXTREMITY REDUCED PERFUSION. IT WAS REPORTED THAT IT WAS POTENTIALLY RELATED TO A GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT WAS TREATED BY 5000 UNITS HEPARIN IV, A LEFT COMMON FEMORAL ARTERY ENDARTERECTOMY AND 1 CM BOVINE PATCH. ON (B)(6) 2025, THERE WAS AN ACUTE KIDNEY INJURY NOTICED AND WAS TREATED BY COIL X 2 PLACEMENT IN PERFORATED BRANCH AND INTENTIONAL OCCLUSION OF THE LEFT RENAL ARTERY WITH A VASCULAR PLUG AND STENT. THE ISSUE WAS RELATED PROCEDURES. ON (B)(6) 2025, THE PATIENT HAD SPINAL CORD ISCHEMIA AND A BILATERAL LOWER EXTREMITY MOTOR LOSS WAS NOTED. THE PATIENT WAS TREATED BY THE LUMBAR DRAIN. ACCORDING TO THE SITE, IT WAS A PROCEDURE RELATED EVENT. ON (B)(6) 2025, THERE WERE LEFT RENAL INFARCT AND MULTIPLE ACUTE RIGHT RENAL CORTICAL INFARCTS. PROCEDURE RELATED. NO TREATMENT WAS REQUIRED. ON (B)(6) 202

  Patient problems: Anemia; Ischemia; Movement Disorder; Paresis; Reduced Blood Flow; Renal Impairment

  MAUDE report 24254913 ↗
• DeathJan 19, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED FROM AAA24-01 STUDY: ON (B)(6) 2025, A STUDY PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE (TAMBE) USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES. ON THE SAME DAY, IT WAS REPORTED MOBILIZATION OF THE RIGHT COLON AND RESECTION OF THE CECUM AND APPENDIX AND APPENDIX LEFT IN DISCONTINUITY. ON (B)(6) 2025, EXPLORATORY LAPAROTOMY WITH RESECTION OF APPROXIMATELY 90 CM OF SMALL BOWEL AND RESECTION OF THE RIGHT COLON WAS DONE. ON (B)(6) 2025, EXPLORATORY LAPAROTOMY WITH RESECTION OF APPROXIMATELY 45 CM OF SMALL BOWEL WAS DONE. IT WAS REPORTED THERE WAS NO INTERVENTION RELATED TO TAMBE DEVICE OR THE VBX DEVICES. ON (B)(6) 2025, THE PATIENT DIED DUE TO ACUTE MESENTERIC ISCHEMIA. THIS WAS REPORTED AS PROCEDURE RELATED.

  Patient problems: Ischemia

  MAUDE report 24109067 ↗
• InjuryJan 9, 2026Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT HAD A HISTORY OF UNDERGOING A PROCEDURE IN WHICH A PHYSICIAN MODIFIED GRAFT (PMEG) WAS IMPLANTED. IT WAS REPORTED A NON-GORE STENT WAS ALSO IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA) DURING THIS PROCEDURE. IT WAS REPORTED THE PMEG WAS LEAKING INTO THE ANEURYSM. TO ADDRESS THE ANEURYSM GROWTH, PLANS WERE MADE TO USE A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) TO RELINE THE EXISTING MODIFIED GRAFT. ON (B)(6) 2025, THE PATIENT UNDERWENT THE TAMBE PROCEDURE. A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED. IT WAS REPORTED AFTER THE TAMBE AORTIC COMPONENT DEVICE WAS IMPLANTED, DURING CANNULATION OF THE SMA, THE PHYSICIAN INADVERTENTLY CAUSED A DISSECTION WHILE ADVANCING THE GUIDEWIRE INTO THE EXISTING NON-GORE STENT. AS REPORTED, THE DISSECTION WAS COVERED WITH DEPLOYMENT OF THE VBX DEVICE INTO PORTAL OF THE TAMBE DEVICE. THE VBX DEVICE WAS DEPLOYED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES, AND THE PATIENT TOLERATED THE PROCEDURE IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT DIED DUE TO

  Patient problems: Ischemia

  MAUDE report 24031069 ↗