GORE EXCLUDER Iliac Branch Endoprosthesis CEB231410ARecalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00733132635306), received between Oct 25, 2018 and Sep 30, 2026 — classified as 5 deaths, 106 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  The following information was reported to Gore:On (b)(6) 2026, this patient underwent an endovascular treatment for pararenal abdominal aortic aneurysm using GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE).GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), and GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) were concomitantly implanted.After deploying the second VBX device in the right renal artery, it migrated proximally during ballooning and dislodged from the renal artery to the aneurysmal sac. Therefore, two more VBX devices were implanted to bridge the TAMBE portal to the right renal artery.During the initial procedure, a type II Endo leak and dissection of a branch vessel of the right renal artery were found. They were left for monitoring.After the procedure, it was reported that treatment for the type II Endo leak was performed (details unknown).

  Patient problems: Clinical Endoleak

  MAUDE report 50942709 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE CONCOMITANTLY IMPLANTED. ADDITIONALLY, PRIOR TO THIS PROCEDURE, THE PATIENT HAD RECEIVED FIRST STAGE IMPLANTATION WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ON (B)(6) 2026. ALL THE PLANNED DEVICES WERE IMPLANTED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT DEVELOPED SPINAL CORD ISCHEMIA WITHIN 1 DAY. CEREBROSPINAL DRAINAGE WAS INITIATED, AND THE PATIENT WAS UNDER OBSERVATION AT THE TIME OF THIS REPORTING.

  Patient problems: Ischemia

  MAUDE report 25543089 ↗
• MalfunctionJun 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 22MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 19.3MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY MEASURED 40MM AND THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY MEASURED 22MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM WAS REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE, PROCEDURE, OR WITHDRAWAL OF THE DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2026. ON (B)(6) 2026, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND THE SITE REPORTS THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 21MM, THE MAXIMUM DIAMETER OF THE RCIA MEASURED 43MM, AND THE MAXIMUM DIAMETER OF THE LCIA

  Patient problems: Clinical Endoleak

  MAUDE report 25538237 ↗
• 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 25449438 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTOILIAC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIA)WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 56MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 25.4MM. THE MAXIMUM DIAMETER OF THE RICA AND LCIA WERE NOT PROVIDED. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6), 2025. ON (B)(6), 2025, THE PATIENT UNDERWENT FOLLOW-UP CTA AND WAS REPORTED TO HAVE A TYPE II ENDOLEAK INVOLVING THE INFERIOR MESENTERIC ARTERY (IMA) AND LUMBAR ARTERIES. THERE IS NO LOSS OF PATENCY TO A GORE® DEVICE AND NO DEVICE INTEGRITY EVENTS REPORTED. THIS EVENT IS NOTED TO BE ON GOING AND NO TREATMENT WAS PROVID

  Patient problems: Clinical Endoleak

  MAUDE report 25446774 ↗
• MalfunctionMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ADDITIONALLY, IT WAS REPORTED ADJUNCTIVE PROCEDURES PERFORMED DURING INDEX PROCEDURE INCLUDED: COIL EMBOLIZATION OF AN INTERNAL/EXTERNAL ILIAC ARTERY (SIDE NOT IDENTIFIED). THE PATIENT TOLERATED THE PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 64MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 28MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 47MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 36MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322321 ↗
• MalfunctionMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ADDITIONALLY, IT WAS REPORTED ADJUNCTIVE PROCEDURES PERFORMED DURING INDEX PROCEDURE INCLUDED: COIL EMBOLIZATION OF AN INTERNAL/EXTERNAL ILIAC ARTERY (SIDE NOT IDENTIFIED). THE PATIENT TOLERATED THE PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 64MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 28MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 47MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 36MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322140 ↗
• InjuryMay 23, 2026Material Deformation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ILIAC ARTERY ANEURYSMS USING A NON-GORE STENT GRAFT (ENDURANT) AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. FOLLOWING DEPLOYMENT OF A NON-GORE MAIN TRUNK, AN ILIAC BRANCH COMPONENT (IBC) WAS PLACED IN THE RIGHT COMMON ILIAC, AND AN INTERNAL ILIAN COMPONENT (IIC) WAS PLACED IN THE RIGHT INTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, COMPRESSION OF THE IIC AND OCCLUSION OF THE RIGHT INTERNAL ILIAC WERE OBSERVED. REINTERVENTION WAS PERFORMED, AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED AT THE STENOTIC SEGMENT OF THE RIGHT EXTERNAL ILIAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 25263905 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH), GORE® TRI LUMEN CATHETER (TLC), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE CONCOMITANTLY USED FOR THE PROCEDURE. APPROXIMATELY 2-3 HOURS AFTER COMPLETION OF THE PROCEDURE, THE PATIENT COMPLAINED OF NUMBNESS IN BOTH LEGS, AND A SPINAL DRAINAGE CATHETER WAS PLACED. AS THE SYMPTOMS IMPROVED, THE DRAINAGE CATHETER WAS REMOVED. HOWEVER, WEAKNESS OF BOTH LOWER LIMBS DEVELOPED THEREAFTER, AND DECREASED MUSCLE STRENGTH WAS CONFIRMED AT THE TIME OF THIS REPORTING. IN ADDITION, BLOOD PRESSURE WAS ACTIVELY ELEVATED TO PREVENT WORSENING OF PARALYSIS, RESULTING IN CEREBRAL HEMORRHAGE; HOWEVER, THE PATIENT REMAINED ASYMPTOMATIC. THE REPORTING PHYSICIAN CONSIDERED THAT THE PARAPLEGIA DEVELOPED DUE TO BILATERAL LOWER LIMB ISCHEMIA CAUSED BY INSERTION OF 22 FR DSF SHEATH ON BOTH SIDES.

  Patient problems: Paralysis

  MAUDE report 25198230 ↗
• InjuryMay 8, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE VIA A TGR STUDY ALERT NOTIFICATION ON APRIL 27, 2026: ON (B)(6), 2025, THE PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ALL DEVICES WERE SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS DISCHARGED ON (B)(6), 2025. FOLLOW-UP CTA IMAGING ON (B)(6), 2026 EACH REVEALED A TYPE II ENDOLEAK. BASED ON THESE FINDINGS, THE PHYSICIAN HAS ELECTED TO PLAN A REINTERVENTION IN (B)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 25124611 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND AN ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES (A TRUNK IPSILATERAL LEG ENDOPROSTHESIS, AN AORTIC EXTENDER ENDOPROSTHESIS, AND TWO CONTRALATERAL LEG ENDOPROSTHESIS DEVICES) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES (AN ILIAC BRANCH COMPONENT AND TWO INTERNAL ILIAC COMPONENT DEVICES). THE GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE IMPLANTED USING GORE® DRYSEAL FLEX INTRODUCER SHEATH DEVICES AND A GORE® MOLDING & OCCLUSION BALLOON CATHETER. IT WAS NOTED THAT THE AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO COVER THE LUMBAR ARTERY AND THE INFERIOR MESENTERIC ARTERY BEFORE THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF A HEADACHE. AND THE PATIENT FELL WHILE WALKING AND HIT HIS HEAD. THREE DAYS AFTER THE PROCEDURE, MRI CONFIRMED A CEREBRAL INFARCTION. THE FALL APPEARS TO HAVE BEEN RELATED TO VISUAL FIELD CONSTRICTION SECONDARY TO THE CEREBRAL INFARCTION. IT I

  Patient problems: Ischemia Stroke

  MAUDE report 25121116 ↗
• InjuryApr 21, 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, INCLUDING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). ACCESS WAS GAINED THROUGH THE RIGHT SIDE USING A GORE® DRYSEAL FLEX SHEATH (DSF). 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 (B)(6), 2026 WAS DISCHARGED INTO REHAB. REPORTEDLY, THE PARAPLEGIA IS NOW RESOLVED.

  Patient problems: Ischemia

  MAUDE report 24944611 ↗
• 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 (B)(6) 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 (B)(6) 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 THIS TIM

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24900925 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: THIS PATIENT UNDERWENT STAGED ENDOVASCULAR PROCEDURES FOR THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). ON (B)(6), 2026, THE FIRST STAGE PROCEDURE WAS PERFORMED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC). TWO CTAG ACS WERE IMPLANTED IN THE DESCENDING AORTA. ON (B)(6), 2026, THE SECOND STAGE PROCEDURE WAS PERFORMED. THE TAMBE DEVICE WAS IMPLANTED. GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE CONCOMITANTLY IMPLANTED AS WELL. ON AN UNKNOWN DATE, STENT GRAFT INFECTION WAS FOUND. ALTHOUGH THE EXACT DATE WAS UNKNOWN, REPORTEDLY THE INFECTION OCCURRED SOME TIME (NOT IMMEDIATELY) AFTER THE SECOND STAGE PROCEDURE. THE EXTENT OF THE INFECTION WAS UNKNOWN, AND IT WAS ALSO UNCLEAR WHICH DEVICES WERE AFFECTED. TREATMENT WITH ANTIBIOTICS WAS STARTED. THE PATIENT OUTCOME WAS UNKNOWN. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: IT IS UNCLEAR WHETHER THE INFECTION OCCURRED DURING THE PROCEDURE ORE POSTOPERATIVELY (IN THE ICU, ETC.), BU

  Patient problems: Unspecified Infection

  MAUDE report 24838005 ↗
• InjuryMar 30, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER, TRUNK IPSILATERAL LEG C3, TWO CONTRALATERAL LEGS, TWO ILIAC EXTENDERS) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (TWO ILIAC BRANCH COMPONENTS (IBE) AND TWO INTERNAL ILIAC COMPONENTS). ON (B)(6) 2026, PATIENT UNDERWENT A BILATERAL IBE REINTERVENTION PROCEDURE FOR THE TYPE 3 ENDOLEAK WITH AN ANEURYSM GROWTH (SIZE UNKNOWN) FROM THE LAST FOLLOW-UP PATIENT HAD (DATE UNKNOWN). FIELD SALES ASSOCIATE (FSA) NOTED THAT THE INFERIOR MESENTERIC ARTERY (IMA) WAS EMBOLIZED, AFTER WHICH, PHYSICIANS EXPLAINED TO FSA THAT THE PATIENT PREVIOUSLY UNDERWENT A REINTERVENTION FOR TYPE 2 ENDOLEAK AT APPROXIMATELY 1 TO 1.5-YEARS POST-OP EVAR INITIAL PROCEDURE. THE PHYSICIANS STATED THAT THE 1-YEAR POST EVAR REPAIR WAS DONE BY COIL EMBOLIZING A LARGE INFERIOR MESENTERIC ARTERY TO STOP ANEURYSM GROWTH FROM A TYPE 2 ENDOLEAK. THE PATIENT WAS THEN LOST IN FOLLOW-UPS UNTIL RECENTLY WHEN THE IMAGING SCANS REVEALED THAT THE PATIENT'S BRIDGE LIMBS INTO BOTH IBE DEVICES HAVE PULLED OUT CAUSING A TYPE 3 ENDOLEAK. THE BRIDGE LIMBS

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24718813 ↗
• 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 24591174 ↗
• InjuryMar 13, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR COMMON ILIAC ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) SYSTEM, WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS MAIN BODY AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. ON (B)(6) 2026, A REINTERVENTION OCCURRED BECAUSE THE IBE DEVICE WAS OCCLUDED, IN THE RIGHT EXTERNAL ILIAC ARTERY, AROUND THE LEVEL OF THE FLOW DIVIDER. THE PHYSICIAN EXPLANTED THE EXCC, IBE, AND CONTRALATERAL LIMB, AND PERFORMED AN OPEN REPAIR OF THE ABDOMINAL AORTA AND RIGHT COMMON ILIAC. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DID NOT GIVE AN OPINION AS TO THE CAUSE OF THE OCCLUSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24589727 ↗
• InjuryFeb 24, 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 24434410 ↗
• InjuryFeb 6, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE 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 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS BEING USED IN THE ILIAC ARTERIES. THE PHYSICIAN INTENTIONALLY DID NOT IMPLANT DEVICES IN THE HGB, SO THAT BLOOD WOULD CONTINUE TO PERFUSE THE ANEURYSM SAC AND PROVIDE BLOOD TO THE SPINAL CORD. THE PATIENT TOLERATED THE PROCEDURE. ON 1 MONTH FOLLOW-UP IMAGING, THE ANEURYSM SAC MEASURED 64MM. ON 6MONTH FOLLOW-UP IMAGING, THE ANEURYSM SAC MEASURED 66MM. ON FOLLOW-UP IMAGING (B)(6) 2025, THE ANEURYSM SAC MEASURED 71MM. NO TREATMENT IS LISTED; BUT THE PHYSICIAN INTENDS TO PERFORM AN ANGIO IN (B)(6) 2026 TO SEE WHAT COULD BE DONE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24283410 ↗
• InjuryJan 21, 2026Malposition of Device

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT RE-INTERVENTION FOR A DISCONNECT/OCCLUSION OF THE IBE DEVICES IN THE RIGHT INTERNAL ILIAC ARTERY (RIIA) FROM THE CEB IN THE RIGHT COMMON ILIAC ARTERY. WE PUT A LIMB EXTENSION INTO THE RIGHT EXTERNAL ILIAC ARTERY AND BYPASSED OVER THE FLOW DIVIDER OF THE IBE DEVICE, INTENTIONALLY COVERING THE RIIA AND LEAVING ONLY FLOW VIA THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24132620 ↗
• InjuryDec 16, 2025Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL ANEURYSM IV USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. ALSO, WERE IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED, THE PATIENT HAD A SPINAL CORD ISCHEMIA WITH FLACCID PARALYSIS OF THE LOWER EXTREMITY. THE PATIENT HAD MINOR MOTOR DEFICIT, ABLE TO WALK WITH ASSISTANCE OR INDEPENDENTLY (IMPLIES THE ABILITY TO MOVE AGAINST GRAVITY). REPORTEDLY, NO DEVICE OR VESSEL OCCLUSION WAS NOTICED. ON (B)(6) 2025, THE PATIENT HAD A RECUSE MANEUVERS TREATMENT- LUMBAR DRAINAGE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE SPINAL CORD ISCHEMIA WAS A DISTAL THORACIC AORTIC STENT AS PART OF THE PROCEDURE. THE CAUSE OF PARALYSIS OF THE LOWER EXTREMITY AND THE PATIENT MINOR MOTOR DEFICIT WAS LIKELY THE TEVAR PROCEDURE. ON (B)(6) 2025, THE PATIENT DISCHARGED HOME. THE PATIENT WAS DIAGNOSED TO HAVE GI BLEED AND PANCREATIC MASS BUT DECLINED TO BE FURTHER EVALUATED.

  Patient problems: Ischemia; Movement Disorder; Paralysis

  MAUDE report 23820790 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON NOVEMBER 24, 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 62-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® BRANCH ENDOPROSTHESIS DEVICES. THERE WAS SUCCESSFUL ACCESS, DELIVERY AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT HAD INTRAOPERATIVE BLEEDING RELATED TO TREATMENT/PROCEDURE. THIS LED TO TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23814346 ↗
• InjuryDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILZING TAMBE THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE SAME DAY, UPON WAKING FROM THE SURGERY, PATIENT'S LEGS WERE PARALYZED. A RESCUE SPINAL DRAIN WAS PLACED RIGHT AFTER THE PROCEDURE UPON THE PATIENT WAKING UP. IT WAS ALSO REPORTED PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS PARALYSIS, AS THERE WERE NO ISSUES DURING THE PROCEDURE. NO FURTHER PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 23791216 ↗
• InjuryNov 19, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231410A). ON (B)(6) 2025, THE PATIENT RECEIVED A FOLLOW-UP CAT SCAN IN WHICH A TYPE 1B ENDOLEAK WAS DETECTED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181000). REPORTEDLY, THE CAUSE OF THE ENDOLEAK WAS VESSEL SIZE AND TORTUOSITY AND IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23597964 ↗
• InjuryNov 19, 2025Adverse 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) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE USED DEVICES OTHER THAN TAMBE ARE LISTED BELOW: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS: 6 COMPONENTS IN TOTAL, GORE® EXCLUDER® AAA ENDOPROSTHESIS: ONE CONTRALATERAL LEG, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE): ONE ILIAC BRANCH COMPONENT, GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), GORE® TRI LUMEN CATHETER, GORE® MOLDING & OCCLUSION BALLOON CATHETER. DURING THE PROCEDURE, INSERTION OF A 22FR DSF VIA THE LEFT FEMORAL ARTERY WAS ATTEMPTED BUT WAS DIFFICULT TO ADVANCE DUE TO CALCIFICATION. THE SHEATH WAS EXCHANGED FOR A 16FR DSF, BUT SIMILAR RESISTANCE WAS ENCOUNTERED. AFTER GUIDEWIRE EXCHANGE, BOTH 16FR AND 22FR DFSS WERE ADVANCED WITH RESISTANCE BUT SUCCESSFULLY INSERTED. WHILE POSITIONING THE AORTIC COMPONENT, WIRE WRAP OCCURRED AND WAS RESOLVED BY ROTATING THE GUIDEWIRE 360 DEGREES. THE AORTIC COMPONENT WAS DEPLOYED WITHOUT ISSUE. CANNULATION OF THE LEFT RENAL ARTERY WAS CHALLENGING, BUT AFTER GUIDEWIRE EXCHANGE, THE BRANCH COMPONENT

  Patient problems: Embolism/Embolus; Renal Impairment

  MAUDE report 23591246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis