GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis ATAA43120160ARecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00733132659678), received between Jul 2, 2024 and Sep 30, 2026 — classified as 7 deaths, 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (4 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951348 ↗
• InjurySep 16, 2026Device Endoleak

  Patient problems: Clinical Endoleak

  MAUDE report 50793846 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449422 ↗
• DeathMay 7, 2026No Apparent Adverse Event

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED IN THE ABDOMINAL AND THORACIC AORTA ALONG WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT EXPIRED; THE PHYSICIAN REPORTS THE CAUSE OF DEATH WAS DEAD BOWL/BOWEL ISCHEMIA. THE PHYSICIAN DOES NOT ALLEGE ANY DEFICIENCY OF THE GORE DEVICES AND STATES THEY ALL PERFORMED AS INTENDED AND THE PROCEDURE HAD BEEN CONCLUDED WITH GOOD TECHNICAL RESULTS. FOLLOW-UP COMPUTED TOMOGRAPHY HAD SHOWN ALL DEVICES TO BE PATENT, WITH NO ENDOLEAK OR INDICATION OF DISSECTION.

  Patient problems: Ischemia

  MAUDE report 25117339 ↗
• InjuryMay 6, 2026Insufficient Device Problem Information

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA 24-01 TAMBE POST APPROVAL STUDY. THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA CLINICAL DATABASE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A DEGENERATIVE THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS. REPORTEDLY, DURING THE PROCEDURE THE PATIENT SUFFERED AN ACUTE KIDNEY INJURY. THE CAUSE IS LISTED AS PROCEDURE RELATED, AND NOT RELATED TO A GORE DEVICE. THE PATIENT STARTED DIALYSIS (B)(6), AND THAT IS LISTED AS ONGOING. IT SHOULD BE NOTED THAT PRIOR TO THE PROCEDURE, THE RIGHT RENAL ARTERY WAS STENOSED, AND THE CASE PLAN SHOWED THAT THEY DID NOT PLAN TO PLACE A STENT IN IT.

  Patient problems: Renal Impairment

  MAUDE report 25094067 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6), 2024, 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. IT WAS REPORTED THAT ON (B)(6), 2026, THERE WAS A REINTERVENTION FOR ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE CAUSE OF THE ENLARGEMENT IS UNKNOWN, COULD NOT BE CONFIRMED FROM IMAGES (POSSIBLY A PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK). THE PHYSICIAN IMPLANTED A DEVICE PROXIMALLY OF THE TAMBE DEVICE AND EXTENDED THE STENT (VBX) IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. REPORTEDLY, THE PATIENT HAD EXTREMELY TORTUOUS ANATOMY.

  Patient problems: Clinical Endoleak

  MAUDE report 25037955 ↗
• InjuryApr 28, 2026Insufficient Device Problem Information

  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) 2026, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT WAS LISTED AS HAVING AN ACUTE KIDNEY INJURY. THE EVENT IS LISTED AS PROCEDURE RELATED, AND THE EVENT IS ONGOING, BUT NO TREATMENT IS LISTED. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED HOME. THE RENAL ARTERIES WERE PATENT PRIOR TO THE PROCEDURE. IT IS UNKNOWN IF ANY DEVICES WERE PLACED IN THE RENAL ARTERIES. ON THE RISK ASSESSMENT FORM, PRIOR TO PROCEDURE RENAL STATUS IS GIVEN A SCORE OF 2, INDICATING PATIENT CREATININE LEVELS ARE ELEVATED, BETWEEN 2.5 AND 5.9 MG/DL. AT DISCHARGE, 5 DAYS POST-OP THE CREATININE LEVEL WAS 1.25 MG/DL.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 25018103 ↗
• InjuryFeb 20, 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, IT WAS REPORTED THAT THE PATIENT HAD ACUTE KIDNEY INJURY. THE STUDY DATABASE STATES IT IS PROCEDURE RELATED. THE PATIENT WAS TREATED WITH MEDICATION, AND IT RESOLVED ON (B)(6) 2025.

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

  MAUDE report 24401740 ↗
• InjuryJan 9, 2026Malposition of Device

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM AND A 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. THE PROCEDURE REQUIRED THAT A CTAG TAPERED STENT GRAFT BE PLACED TO LAND THE TAMBE COMPONENT INSIDE OF. DURING THE CASE, IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO WIRE CANNULATE THE CELIAC ARTERY DUE TO THE TORTUOSITY OF THE PATIENT¿S ANATOMY. AFTER AN EXTENSIVE AMOUNT OF TIME, IT WAS DECIDED TO INSTANT WIRE THE SMA, RIGHT RENAL, AND LEFT RENAL. THE CELIAC PORTAL WAS EXTENDED WITH A VBX AND A 14 MM AMPLATZ PLUG WAS PLACED INSIDE OF THE VBX STENT. ADDITIONALLY, IT WAS BELIEVED DURING THE CASE, THAT POSSIBLY DUE TO POOR IMAGING AND VISUALIZATION OF THE CELIAC ARTERY THAT THE CTAG MAY HAVE BEEN COVERING THE ORIGIN. THE PATIENT TOLERATED THE PROCEDURE AND WAS R

  Patient problems: Obstruction/Occlusion

  MAUDE report 24024450 ↗
• InjuryDec 19, 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, A PATIENT WAS TREATED FOR AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), INCLUDING 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES (PLC). REPORTEDLY, THE PHYSICIAN HAD PREVIOUSLY TRIED OPEN REPAIR AND WAS REINTERVENING BECAUSE THE AORTA WAS REJECTING THE OPEN REPAIR. ON (B)(6) 2025, A REINTERVENTION TOOK PLACE. A PSEUDOANEURYSM HAD DEVELOPED AT THE PROXIMAL END OF THE TAMBE DEVICE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER WAS PLACED PROXIMAL TO THE TAMBE. IMAGES ARE AVAILABLE. REPORTEDLY, THE PHYSICIAN ATTRIBUTES THE PSEUDOANEURYSM THE INTERACTION BETWEEN THE DEVICES AND THE PATIENT'S CONNECTIVE TISSUE DISORDER.

  Patient problems: Pseudoaneurysm

  MAUDE report 23857924 ↗
• InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS THE CEREBRAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ischemia; Movement Disorder; Paresis

  MAUDE report 23775071 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6), 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PROCEDURE WAS A TECHNICAL SUCCESS. REPORTEDLY, SEVERAL HOURS POST PROCEDURE, THE PATIENT DEVELOPED LOWER EXTREMITY PARALYSIS. THE PHYSICIAN REINTERVENED AND PUT IN A SPINAL DRAIN. THE PARALYSIS IS ONGOING.

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

  MAUDE report 23618808 ↗
• InjurySep 15, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT UPON SCHEDULED REINTERVENTION SURGERY ON (B)(6) 2025, THE PHYSICIAN ANGIOGRAPHICALLY INTERROGATED THE STENT BRANCHES, ESPECIALLY THE LEFT RENAL BRANCH, AND COULD NOT PRODUCE AN ENDOLEAK. PHYSICIAN CONCLUDED THAT THE LEAK EVIDENCED ON THE PREVIOUS CT SCAN, WAS MOST LIKELY READ INCORRECTLY AS A TYPE 3, AND IS ACTUALLY A TYPE 2 LEAK. PHYSICIAN INDICATED THAT HE WOULD CONTINUE TO MONITOR THIS PATIENT AND THE LEAK DILIGENTLY.

  Patient problems: Clinical Endoleak

  MAUDE report 23059726 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE TO TREAT A JUXTARENAL SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. REPORTEDLY, THE ON-LABEL TAMBE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS AND PATIENT WOKE UP FORM ANESTHETIC WITHOUT ISSUE. HOWEVER, LATER IN THE AFTERNOON, PHYSICIAN INFORMED THE FIELD SALES ASSOCIATE THAT THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN POST-OP WITH CONCERNS ABOUT VISCERAL VESSEL DISSECTION. PHYSICIAN PERFORMED AN URGENT CTA, WHICH SHOWED ALL BRANCH VESSELS PATENT WITH NO ISSUE. PATIENT THEN COMPLAINED OF PAINFUL FEET AND NUMBNESS AND PARALYSIS. BLOOD PRESSURE INCREASED AND SPINAL DRAIN INSERTED WITHIN 30 MINUTES. POTENTIAL CAUSE IS SPINAL CORD ISCHEMIA BUT SINCE THE SPINAL DRAIN INSERTION, THE PATIENT'S FEELING AND SENSATION IN HIS FEET HAS RETURNED BUT NO MOVEMENT. PATIENT IS CURRENTLY UNDER OBSERVATION.

  Patient problems: Ischemia Stroke; Paralysis

  MAUDE report 22838047 ↗
• DeathJul 17, 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 AND FOR A ZONE 4 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON JUNE 28, 2025, THE ATTENDING PHYSICIAN REPORTED THE PATIENT'S UNEXPECTED PASSING. THE STATED CAUSE OF DEATH WAS CEREBRAL HERNIATION. NOTABLY, THE PATIENT HAD A SPINAL DRAIN PLACED PRIOR TO THE PROCEDURE AND REMAINED STABLE THROUGH THE NIGHT OF (B)(6). ON THE MORNING OF (B)(6), ADDITIONAL CEREBROSPINAL FLUID WAS DRAINED, FOLLOWING WHICH THE PATIENT BECAME ACUTELY UNSTABLE AND SUBSEQUENTLY EXPIRED. HERNIATION OF THE SPINE WAS ALSO REPORTED. A GORE REPRESENTATIVE INVOLVED IN PROCEDURAL SUPPORT NOTED INTRAOPERATIVE LOSS OF PERFUSION TO THE RIGHT HYPOGASTRIC ARTERY, LIKELY CAUSED BY PLAQUE DISPLACEMENT ("SNOW PLOWING") AT THE VESSEL¿S ORIGI

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

  MAUDE report 22537839 ↗
• InjuryJun 30, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE ON JUNE 3, 2025 FROM THE IMMEDIATE STUDY DATABASE: ON (B)(6), 2025, A 72-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL ANEURYSM TYPE IV WITH NO ILIAC INVOLVEMENT. THE PATIENT ALSO HAD A STENOSES RIGHT RENAL ARTERY AND AN OCCLUDED LEFT RENAL ARTERY. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AORTIC COMPONENT, THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES, AND FOUR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. ON (B)(6) , 2025, THE PATIENT WAS NOTED TO HAVE A TYPE 1A ENDOLEAK ON THE TAMBE DEVICE. A REINTERVENTION WAS SCHEDULED FOR (B)(6) 2025, BUT THE PATIENT CANCELLED.

  Patient problems: Clinical Endoleak

  MAUDE report 22359272 ↗
• InjuryJun 27, 2025Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Device Endoleak; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. IT WAS NOTED THAT THE PATIENT'S LEFT RENAL ARTERY WAS COIL EMBOLIZED AS PLANNED DUE TO PREEXISTING OCCLUSION, AND NO GORE DEVICES WERE IMPLANTED IN THE LEFT RENAL ARTERY. ON FINAL COMPLETION ANGIOGRAPHY, A TYPE III GENERAL ENDOLEAK WAS OBSERVED FROM THE LEFT RENAL ARTERY PORTAL WHERE THE AMPLATZ PLUGS WERE UTILIZED AS PLANNED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE III ENDOLEAK. CANNULATION OF THE LEFT RENAL PORTAL WAS ATTEMPTED BUT WAS UNSUCCESSFUL AFTER NUMEROUS ATTEMPTS. THE PROCEDURE WAS TERMINATED AND THE ENDOLEAK IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 22349543 ↗
• DeathJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A TAMBE PROCEDURE TO TREAT THORACIC AND INFRARENAL ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. REPORTEDLY, ALL DEVICES WERE IMPLANTED SUCCESSFULLY AND PATIENT WAS DOING WELL POST PROCEDURE AS THE FINAL ANGIO RUN SHOWED EVERYTHING LOOKED GOOD. ON (B)(6) 2025, FIVE DAYS POST PROCEDURE, PATIENT PASSED AWAY. SOMETIME PRIOR TO THIS, PATIENT WAS IN ICU AS SHE HAD HYPOTENSION AS PATIENT'S BLOOD PRESSURE DROPPED, X-RAY WAS DONE, WHICH WAS ABNORMAL THEN A CT SCAN WAS DONE WHICH SHOWED A TYPE B DISSECTION AND PATIENT HAD GOTTEN BETTER BUT THEN QUICKLY CODED AND PASSED AWAY. ON (B)(6) 2025, THE PHYSICIAN NOTIFIED FIELD SALES ASSOCIATE OF PATIENT'S PASSING AND REPORTED PER THE INITIAL AUTOPSY REPORTS WHICH ARE UNREMARKABLE BUT THERE IS A TYPE B DISSECTION PROXIMAL TO THE TAMBE DEVICE. THIS DISSECTION WAS NOT PRESENT WHEN THEY DID THE FINAL ANGIO RUN DURING THE ORIGINAL PROCEDURE. IT COULD BE A PROCEDURAL ISSUE BUT EXACT CAUSE OF DEATH IS UNKNOWN AND A MORE COMPREHENSIVE AUTOPSY IS BEING CONDUCTED TO ASCERTAIN THE EXACT CAUSE OF DEATH.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 22345279 ↗
• DeathJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN ZONE 5 WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. IT WAS REPORTED PRIOR TO THE PROCEDURE; THE PATIENT'S LEFT RENAL ARTERY WAS ALREADY OCCLUDED. DURING THE PROCEDURE, THERE WAS A DISTAL PERFORATION IN THE RIGHT RENAL DUE TO A 0.035" ROSEN GUIDEWIRE. THE PERFORATION WAS RESOLVED BY PLACEMENT OF A NON-GORE CORONARY COVERED STENT. THE PHYSICIAN HAD RIGHT SIDED ACCESS DUE TO THE LEFT SUBCLAVIAN BEING STENOTIC AND ALREADY HAVING AN UNKNOWN STENT IN PLACE FROM A PREVIOUS SURGERY. THE PHYSICIAN IMPLANTED ALL DEVICES WITHOUT ANY ISSUES. TWO VBX DEVICES WERE IMPLANTED IN THE SMA, THREE VBX DEVICES WERE IMPLANTED IN THE RIGHT RENAL, AND TWO VBX DEVICES WERE IMPLANTED IN THE CELIAC. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A STROKE AND EXPIRED. THE PHYSICIAN STATED DISPLACEMENT OF ATHEROMA (PLAQUE) IN THE ARCH, M

  Patient problems: Ischemia Stroke

  MAUDE report 22175615 ↗
• DeathMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN ANASTOMOTIC AORTIC ANEURYSM IN ZONE 5 USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE PATIENT HAD TWO PREVIOUS OPEN ANEURYSM REPAIRS, OPEN ARCH AND THORACOABDOMINAL. THERE WAS DEGENERATION OF THE NATIVE AORTA AT THE ANASTOMOSIS SITE. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WENT INTO SPONTANEOUS PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND EXPIRED. THE PHYSICIAN IS NOT ATTRIBUTING THE DEATH TO THE GORE DEVICE BUT STATED THE PEA ARREST MAY HAVE BEEN BROUGHT ON FROM THE ANESTHESIA.

  Patient problems: Aneurysm

  MAUDE report 22015001 ↗
• InjuryMar 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT IN THE AAA24-01 TAMBE POST APPROVAL STUDY USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM FOR TREATMENT OF A DESCENDING THORACOABDOMINAL AORTIC ANEURYSM. AN ATAA43120160A TAMBE AORTIC COMPONENT AND A CEB231410A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WERE IMPLANTED IN THE PATIENT'S AORTA. ON (B)(6) 2025, SPINAL CORD ISCHEMIA WAS OBSERVED. A SPINAL DRAIN WAS PLACED FOR TREATMENT. THE PATIENT WAS DISCHARGED FROM THE FACILITY TO INPATIENT REHAB ON (B)(6) 2025.

  Patient problems: Ischemia

  MAUDE report 21714015 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE RIGHT RENAL ARTERY WAS CANNULATED AND STENTED, THEN THE LEFT RENAL ARTERY, THEN THE SUPERIOR MESENTERIC ARTERY (SMA) AND LAST THE CELIAC ARTERY. THE PROCEDURE FOR THE TAMBE TOOK APPROXIMATELY THREE HOURS. UPON THE FINAL COMPLETION ANGIOGRAM, IT WAS NOTED THAT THE RENAL ARTERIES DID NOT HAVE FLOW. THE PHYSICIAN CANNULATED THE RENAL ARTERIES AND DISCOVERED BOTH RENAL ARTERIES HAD THROMBUS PRESENT. THE PHYSICIAN PREFORMED A THROMBECTOMY WITH PENUMBRA WHERE SHE REESTABLISHED FLOW. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO VISUALIZE THE RENAL ARTERIES TO MAKE SURE THE STENTS WHERE NOT CRUSHED. EVERYTHING LOOKED APPROPRIATE VIA IVUS. DURING THIS TIME, THE PHYSICIAN DISCOVERED THAT ANESTHESIA HAD BEEN STRUGGLING KEEPING THE ACTIVATED CLOTTING TIME (ACT) THERAPEUTIC. WITH ACT¿S BEING BELOW 200. THE PATIENT WAS SWITCHED OVER TO ARGATROBAN, AT THAT POINT THE PATIENT¿S ACT WENT TO THERAPEUTIC LEVELS. THE PATIENT¿S LABS WERE SENT IN TO DETERMINE IF THE PATIENT HAD HEPARIN-INDUCED THROMBOC

  Patient problems: Coagulation Disorder

  MAUDE report 21684245 ↗
• DeathAug 20, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 ABDOMINAL AORTIC ANEURYSM. THE PATIENT¿S IS REPORTED TO HAVE A PRE-EXISTING AAA S/P Y-GRAFT WHICH WAS IMPLANTED IN 2004. PRESENTLY, THE PHYSICIAN REPORTS THE ANEURYSM HAS DILATED TO 4.65CM WITH DILATION OF THE SUPRARENAL ARTERY MEASURING 5CM AND AN AREA AT THE RENAL ARTERIES THAT BLOSSOMS OUT TO APPROXIMATELY 9CM. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® ABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). IT WAS REPORTED THAT ALL PROXIMAL AND BRANCH DEVICES HAD BEEN SUCCESSFULLY DEPLOYED AS INTENDED WITH TECHNICAL SUCCESS (WITH EXCEPTION OF THE FINAL BRANCH DEVICE WHICH WAS ADVANCED BUT NOT YET DEPLOYED). IT WAS REPORTED THAT UPON DEPLOYMENT OF THE DISTAL END OF THE TAMBE AORTIC COMPONENT, THE VBX¿S DEPLOYED IN THE RIGHT RENAL ARTERY BECAME DISLODGED FROM THE RIGHT RENAL ARTERY PORTAL OF THE AORTIC COMPONENT A

  Patient problems: Aneurysm expansion

  MAUDE report 20006246 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT DURING THE PROCEDURE A ROSEN WIRE (BOSTON SCIENTIFIC PRODUCT) WAS BEING USED IN THE LEFT RENAL ARTERY, DURING THIS ATTEMPT THE WIRE PERFORATED THE LEFT RENAL ARTERY. THE PHYSICIAN CHOSE TO COIL EMBOLIZE THE LEFT RENAL ARTERY. THE PHYSICIAN COULD NOT CANNULATE THE CELIAC ARTERY AFTER MULTIPLE ATTEMPTS (WIRE BEING USED IS UNKNOWN). THE PHYSICIAN CHOSE NOT TO IMPLANT A GORE® VIABAHN® DEVICE, THE PORTAL REMAINED OPEN, AND THE CELIAC ARTERY WAS STILL GETTING PROFUSION. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 19832000 ↗
• InjuryJul 2, 2024Off-Label Use; Off-Label Use

  REPORTEDLY, THE PHYSICIAN MADE FENESTRATIONS IN THE DEVICE BECAUSE THERE WAS AN ADDITIONAL ACCESSORY RENAL THAT HE WANTED TO REACH.

  Patient problems: Vascular Dissection

  MAUDE report 19655724 ↗