GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT261412Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00733132651030), received between Jun 13, 2021 and Aug 25, 2026 — classified as 3 deaths, 73 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (19 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 87 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Malposition of Device; Material Deformation

  The following information was reported to Gore:On (b)(6) 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm using a GORE® EXCLUDER® Conformable AAA Endoprosthesis device.When guidewire insertion into the contralateral gate of the trunk-ipsilateral leg was attempted, it was difficult. The left leg of the trunk-ipsilateral leg near the flow divider was found to be compressed.The physician attempted to apply tension to the pull-through guidewire to press the device against the vessel at the compressed area; however, the guidewire could not advance through the compressed area.Then the physician removed the clear knob and deployed the ipsilateral leg, and attempted to access the contralateral gate from the proximal side; however, the guidewire still could not advance. Also, a 0.014-inch guidewire was used to gain access, but it also could not advance. The physician attempted ballooning of the ipsilateral leg and used a micro guidewire from distal; however, all attempts failed to advance the guidewire into the contralateral gate.The physician decided to abandon the procedure considering the fluoroscopy time and radiation dose.The procedure was compl

  Patient problems: Obstruction/Occlusion

  MAUDE report 50424279 ↗
• InjuryJul 30, 2026Material Deformation

  The following information was reported to Gore:On (b)(6)2026, a patient underwent an endovascular procedure to treat abdominal aortic and iliac artery aneurysms using a GORE® EXCLUDER® Conformable AAA Endoprosthesis device, GORE® EXCLUDER® AAA Endoprosthesis System devices, and GORE® EXCLUDER® Iliac Branch Endoprosthesis devices.On (b)(6)2026, a follow-up angiography revealed that the left leg of the trunk-ipsilateral component near the flow splitter area was compressed. A stent was deployed inside the left leg of the trunk-ipsilateral component. The compression was resolved.The patient tolerated the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50078063 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. END OF PROCEDURE IMAGES REVEALED TECHNICAL SUCCESS AND FLOW TO BOTH RENAL ARTERIES. IT WAS REPORTED THAT ON A LATER DATE IN (B)(6) 2026 (EXACT DATE IS UNKNOWN) THE PATIENT PRESENTED EMERGENTLY TO A DIFFERENT HOSPITAL AND WAS PLACED ON HEMODIALYSIS FOR KIDNEY FAILURE. THE IMPLANTING PHYSICIAN WAS MADE AWARE AND RE-REVIEWED THE IMPLANT IMAGES FROM IMPLANT PROCEDURE AND STATED THAT A DIFFERENT VIEW SHOWS POSSIBLE ENCROACHMENT (PARTIAL COVERAGE) FROM THE CXT OF THE LEFT RENAL ARTERY. THE EVENT IS ONGOING. REPORTEDLY, THE PATIENT DID NOT ATTEND ANY OF HIS POST IMPLANT FOLLOW UP IMAGING DATES. THE PATIENT HAS NOT CONTACTED THE IMPLANTING PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Renal Impairment

  MAUDE report 25155428 ↗
• MalfunctionApr 28, 2026Material Invagination

  ON (B)(6) 2025, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF BI-LATERAL COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® 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 34MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 22MM, THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC ARTERY MEASURED 29MM, THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY MEASURED 30MM. 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) 2026, GORE IMAGING SCIENCES (GIS) POST REVIEW OF FOLLOW-UP IMAGING PERFORMED ON (B)(6) 2025 REPORTS AN INDETERMINATE ENDOLEAK WITH COMPRESSION/INFOLDING OF THE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG. ADDITIONALLY, IMAGING DETERMINED THE MA

  Patient problems: Clinical Endoleak

  MAUDE report 25021981 ↗
• InjuryApr 27, 2026Material Deformation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES. AT A POINT 10 MM DISTAL TO THE RENAL ARTERIES, A TRUNK IPSILATERAL LEG (CXT261412) WAS DEPLOYED, AND CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED. HOWEVER, DUE TO THE LARGE ANEURYSM DIAMETER, CANNULATION PROVED DIFFICULT DESPITE MULTIPLE CATHETER EXCHANGES. THE PLAN WAS THEREFORE CHANGED TO AN OVER-THE-TOP CANNULATION APPROACH, AND THE IPSILATERAL LIMB OF THE TRUNK IPSILATERAL LEG WAS DEPLOYED FIRST. SUBSEQUENTLY, BALLOON DILATATION WAS PERFORMED AT EACH SEGMENT; DURING THIS PROCESS, BALLOONING OF THE IPSILATERAL LIMB CAUSED COMPRESSION AROUND THE BIFURCATION AREA. CANNULATION USING A MICRO-GUIDEWIRE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. COMPRESSION AND OCCLUSION OF THE CONTRALATERAL GATE WERE THEN CONFIRMED. PREOPERATIVELY, OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY HAD BEEN IDENTIFIED, AND COLLATERAL CIRCULATION TO THE RIGHT DISTAL VESSELS WAS CONSIDERED WELL DEVELOPED; THEREFORE, THE PROCEDURE WAS CONVERTED TO AN AUI (AORTO-UNI-ILIAC). A CONTRALATERAL LE

  Patient problems: Obstruction/Occlusion

  MAUDE report 25010657 ↗
• InjuryApr 20, 2026Complete Blockage

  ON (B)(6) 2023, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF A INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 7CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, FOLLOW-UP ULTRASOUND DETERMINED RIGHT LIMB DEVICE OCCLUSION WITH NO VISUALIZED ENDOLEAK. ON (B)(6) 2026, REVIEW OF THE PATIENT¿S FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, SHOWED A DECREASE IN DIAMETER OF THE AAA AND AN OCCLUSION OF THE RIGHT ILIAC ARTERY DEVICE. ON (B)(6) 2026, THE PATIENT UNDERWENT EXPLANT OF ALL GORE DEVICES AND PLACEMENT OF A DACRON GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24931617 ↗
• MalfunctionApr 20, 2026Fluid/Blood Leak; Material Integrity Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (18FR) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING PREPARATION FOR STENT GRAFT INSERTION, SEPARATION OF THE METAL STYLET AND OLIVE TIP WAS NOTED. THE OLIVE TIP WAS FOUND TO BE SLIGHTLY MORE SEPARATED THAN NORMAL. THE COMPONENTS WERE MANUALLY REPOSITIONED, AND THE OLIVE TIP APPEARED INTACT AND IN NORMAL ALIGNMENT. THE DEVICE WAS THEN INSERTED INTO THE DRYSEAL SHEATH. SHORTLY THEREAFTER, BLOOD WAS OBSERVED GUSHING FROM THE SHEATH, INDICATING LOSS OF HEMOSTASIS AND POSSIBLE PUNCTURE OF THE SHEATH BLADDER WITH THE DEVICE WITHDRAWN. THERE WAS ALSO CONCERN THAT A POSTERIOR NITINOL WIRE FROM THE STENT GRAFT HAD BECOME EXPOSED OR DISPLACED, LIKELY DURING MANIPULATION. THE NITINOL WIRE IS BELIEVED TO HAVE PUNCTURED THE DRYSEAL SHEATH BLADDER, CONTRIBUTING TO LOSS OF HEMOSTASIS. DURING THE INITIAL INSPECTION OF THE GRAFT PACKAGING SUGGESTED THE GRAFT APPEARED SLANTED TO ONE SIDE, ALTHOUGH NO DEPLOYMENT ISSUES WERE IDENTIFIED. IT WAS SUSPECTED THAT THE STYLET MAY HAVE BEEN BENT DURING DEVICE MANIPULA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24927382 ↗
• InjuryApr 14, 2026Device Endoleak

  ON (B)(6), THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24876305 ↗
• DeathApr 13, 2026Material Deformation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ILIAC ARTERY ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES; AFTER DEPLOYMENT OF THE TRUNK IPSILATERAL LEG, CANNULATION OF THE CONTRALATERAL LIMB WAS ATTEMPTED BUT FAILED. INADEQUATE DEPLOYMENT OF THE CONTRALATERAL GATE (COLLAPSE DUE TO AORTIC ANGULATION) WAS OBSERVED. THE PHYSICIAN ATTEMPTED TO ROTATE THE DEVICE USING THE CONSTRAINING SYSTEM TO ADJUST THE ORIENTATION OF THE GATE; HOWEVER, THE GATE BECAME FURTHER COLLAPSED AND COULD NOT BE CANNULATED. CONSEQUENTLY, A PULL THROUGH WAS CREATED VIA THE RIGHT BRACHIAL APPROACH. DURING CREATION OF THE PULL THROUGH, THE GUIDEWIRE BECAME ENTANGLED SEVERAL TIMES, AND IT TOOK APPROXIMATELY 30 MINUTES TO COMPLETE. SUBSEQUENTLY, THE CATHETER WAS ADVANCED TOWARD THE CONTRALATERAL GATE, BUT THIS WAS UNSUCCESSFUL, AND THE PHYSICIAN DEPLOYED THE IPSILATERAL LIMB FIRST. THE PULL THROUGH WIRE HAD BECOME ENTANGLED WITH THE IPSILATERAL LIMB; HOWEVER, AFTER REMOVAL OF THE WIRE AND RELEASE OF THE PULL THROUGH, CANNULATION WAS SUCCESSFULLY ACHIEVED. DEPLOYMENT OF ALL STENT GRAFT COMPONENTS, INCLUD

  Patient problems: Embolism/Embolus; Ischemia; Multiple Organ Dysfunction Syndrome; Thrombosis/Thrombus

  MAUDE report 24867397 ↗
• InjuryApr 7, 2026Improper or Incorrect Procedure or Method; Device Endoleak

  ON (B)(6 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, ON (B)(6) 2026, AT THE PATIENT'S 30-DAY POST-OP CTA, IT WAS DISCOVERED THAT THERE WAS A TYPE 3 ENDOLEAK (COMPONENT DISCONNECTION) BETWEEN THE CXT261412 AND PLC231400. THE CAUSE OF THE ENDOLEAK IS DUE TO THE PLC231400 MIGRATING 2.5 CM DISTALLY AND SITTING AT THE OPENING OF THE CXT261412 GATE, AS THE DEVICES WERE NOT IMPLANTED WITH A 3 CM OVERLAP. IT WAS REPORTED THAT THE DEVICES WERE ONLY OVERLAPPED BY 2.5 CM DURING THE INITIAL PROCEDURE DUE TO A TECHNICAL ERROR. THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE ON MARCH 26, 2026, THAT THE PHYSICIAN WAS PLANNING TO REINTERVENE. THERE WAS NO ANEURYSM ENLARGEMENT DUE TO THE ENDOLEAK. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE ENDOLEAK. ANOTHER PLC231400 WAS IMPLANTED AND ADEQUATE DEVICE OVERLAP WAS ENSURED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24800307 ↗
• InjuryApr 3, 2026Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FOLLOW-UP CTA REVEALED THE LEFT RENAL ARTERY OBSTRUCTION DUE TO A SUSPECTED PROXIMAL MIGRATION OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. A BARE STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT, DURING THE INITIAL PROCEDURE, THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS HAD BEEN IMPLANTED BELOW THE LEFT RENAL ARTERY AND THAT THERE HAD BEEN NO ISSUE WITH BLOOD FLOW IN THE LEFT RENAL ARTERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24772877 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK-IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. AFTER ALL DEVICES HAD BEEN IMPLANTED, TOUCH-UP DILATATION OF THE STENT GRAFTS WAS PERFORMED WITH A NON-GORE BALLOON CATHETER. ANGIOGRAPHY REVEALED A DISSECTION AT THE PROXIMAL NECK. THIS DISSECTION OCCURRED DURING TOUCH-UP OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WITH THE NON-GORE BALLOON. TO COVER THE DISSECTION, AORTIC EXTENDER ENDOPROSTHESIS DEVICES WERE IMPLANTED. ANGIOGRAPHY CONFIRMED NO LEAK OR FLOW INTO THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE TOUCH-UP BALLOONING WAS TOO AGGRESSIVE.

  Patient problems: Vascular Dissection

  MAUDE report 24725797 ↗
• MalfunctionMar 24, 2026Fracture

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT261412). IT WAS REPORTED DURING THE PROCEDURE, AFTER THE STENT GRAFT WAS DEPLOYED, UPON REMOVING THE DELIVERY CATHETER OF CXT261412, THE NOSE CONE BROKE OFF FROM THE DELIVERY CATHETER. PHYSICIAN WAS ABLE TO EASILY REMOVE THE SHEATH AND DELIVERY CATHETER, AND NO APPARENT DAMAGE WAS NOTED ON THE SHEATH. A NEW SHEATH WAS INSERTED, AND PHYSICIAN BALLOONED THE BROKEN NOSE CONE INTO THE SHEATH, AND SUCCESSFULLY REMOVED BOTH THE SHEATH AND THE NOSE CONE. THE CAUSE OF THIS BREAKAGE IS UNKNOWN, AS NO RESISTANCE WAS NOTED UPON REMOVAL. NO PATIENT ADVERSE EVENTS OCCURRED DUE TO THIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680573 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. ON (B)(6) 2025, THE PATIENT HAD A TYPE II ENDOLEAK. THIS ADVERSE EVENT REQUIRED HOSPITALIZATION AND TREATMENT WITH A REINTERVENTION. ON (B)(6) 2026, THE PATIENT UNDERWENT EMBOLIZATION WITH COILS.

  Patient problems: Clinical Endoleak

  MAUDE report 24529163 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9-10 ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2026, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 50MM, WITH A MAXIMUM PROXIMAL LANDING ZONE DIAMETER OF 22MM. EMERGENT ADJUNCTIVE PROCEDURES WERE DUE TO ENLARGING, POSSIBLY SYMPTOMATIC AAA WITH MURAL THROMBUS. THE ISCHEMIC EVENT OCCURRED POST IMPLANT AND LED TO THE ADJUNCTIVE PROCEDURES. THE PATIENT EXPERIENCED LOWER RIGHT EXTREMITY ISCHEMIA POST IMPLANT AND AN ENDARTERECTOMY AND A RIGHT EXTERNAL ILIAC TO PROFUNDA FEMORAL ARTERY BYPASS WERE PERFORMED. THE PATIENT¿S BI-FEMORAL ARTERY ACCESS VESSELS WERE REPORTED TO HAVE A DIAMETER OF 6MM. THE MAXIMUM DIAMETER OF THE LEFT COMMON ILIAC MEASURED 14MM AND WITH THE RIGHT MEASURING 12MM. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS; NO REPORTED COMPLICATIONS OR DEVICE DEFICIENCIES AND WAS DISCHARGED TO (HOME- WITH HOME HEALTH SERVICES) ON (B)(6) 2026.

  Patient problems: Ischemia

  MAUDE report 24315960 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® MOLDING & OCCLUSION BALLOON CATHETER AND GORE® DRYSEAL FLEX INTRODUCER SHEATH DEVICES. ON THE SAME DAY, THE PATIENT DEVELOPED CHOLESTEROL CRYSTAL EMBOLIZATION WHICH WAS RELATED TO TREATMENT/PROCEDURE. THE FOLLOWING MEDICATIONS WERE ADMINISTERED FOR ITS MANAGEMENT: ACETAMINOPHEN ON (B)(6) 2025; MIROGABALIN BESILATE ON (B)(6) 2025; AND TRAMADOL HYDROCHLORIDE ON (B)(6) 2025. THIS ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELAE ON SEPTEMBER 12, 2025.

  Patient problems: Embolism/Embolus

  MAUDE report 24186191 ↗
• InjuryJan 7, 2026Migration; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK-IPSILATERAL CONFORMABLE), AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS). A RECENT CTA (DATE UNKNOWN) DEMONSTRATED ANEURYSM SAC GROWTH FROM 54MM ON (B)(6) 2024, TO 65MM ON (B)(6) 2025. THE SOURCE OF THE ENDOLEAK WAS UNCLEAR, AND AN ANGIOGRAM WAS RECOMMENDED. ON (B)(6) 2025, AN ANGIOGRAM REVEALED A TYPE 1A ENDOLEAK WITH APPROXIMATELY 6MM OF PROXIMAL MIGRATION OF THE TRUNK-IPSILATERAL CONFORMABLE. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE) WAS DEPLOYED TO EXTEND THE PROXIMAL SEAL TO THE RENAL ARTERIES, SUCCESSFULLY RESOLVING THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23990981 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT SHOWED UP AT (B)(6) VA AND WAS SEEN BY A PHYSICIAN WHO DETERMINED THE ANEURYSM SACK AND THE GRAFTS ARE INFECTED. THE PHYSICIAN PLANS TO EXPLANT THE DEVICES HOWEVER THIS PROCEDURE HAS NOT YET BEEN SCHEDULED, AS THE PATIENT WANTS TO WAIT.

  Patient problems: Medical device site infection

  MAUDE report 23785006 ↗
• InjuryDec 9, 2025Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS), GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2025, THE PATIENT WAS URGENTLY TRANSPORTED TO THE HOSPITAL. CT REVEALED A TYPE A DISSECTION (OUTSIDE THE TREATMENT AREA OF THE EXCLUDER DEVICES), COLLAPSE OF THE PROXIMAL PORTION OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS, AND ALMOST COMPLETE LOSS OF BLOOD FLOW TO THE LOWER LIMBS. ON THE SAME DAY, THE PATIENT UNDERWENT ARTIFICIAL GRAFT REPLACEMENT. THE PHYSICIAN STATED THAT AN ULTRASOUND TAKEN AT DISCHARGE REVEALED NO ENDOLEAKS AND NO FINDINGS SUGGESTIVE OF TYPE A DISSECTION. THE PHYSICIAN ALSO STATED THAT THE TYPE A DISSECTION WAS OBSERVED APPROXIMATELY 2 WEEKS AFTER DISCHARGE, SO IT MIGHT HAVE NEWLY DEVELOPED AFTER DISCHARGE, AND THE PROXIMAL PORTION OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS MIGHT HAVE COLLAPSED BECAUSE A FALSE LUMEN COMPRESSED IT.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 23753394 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. NO PRE-PROCEDURE VESSEL DIAMETERS WERE PROVIDED. 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) 2024. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP COLOR DUPLEX ULTRASOUND WAS PERFORMED AND DETERMINED A TYPE II ENDOLEAK, THE MAXIMUM AORTIC DIAMETER WAS REPORTED TO MEASURE 21.2MM. THE EVENT IS ONGOING. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION AND COIL EMBOLIZATION WAS PERFORMED, THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN IF THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2025, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED. REVIEW BY GORE IMAGING SERVICES (GIS) REPORTS A TYPE II ENDOLEAK ORIGINATING FROM FOUR LUMBAR ARTERIES MESENTERY DOMINANT (IMA/LUMBAR) DOMINANT, T

  Patient problems: Clinical Endoleak

  MAUDE report 23751675 ↗
• InjuryDec 4, 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, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS HOSPITALIZED TO UNDERGO CORONARY ARTERY BYPASS GRAFTING (CABG). A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN OCCLUSION EXTENDING FROM THE PROXIMAL PORTION OF THE CONTRALATERAL LIMB OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS TO THE LEFT COMMON FEMORAL ARTERY. THE INTERNAL ILIAC ARTERY WAS ALSO OCCLUDED. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT THE OCCLUSION. THROMBECTOMY USING FOGARTY CATHETERS WAS ATTEMPTED. BECAUSE COMPLETE REMOVAL OF THROMBUS WAS NOT ACHIEVED, AN ADDITIONAL STENT GRAFT WAS PLACED AS AN INNER LINING. FURTHERMORE, DUE TO VESSEL ANGULATION NEAR THE FLOW DIVIDER OF THE ILIAC BRANCH COMPONENT (IBE), A BARE-METAL STENT WAS ADDITIONALLY DEPLOYED. BLOOD FLOW IMPROVED BUT FLOW DISTAL TO THE COMMON FEMORAL ARTERY REMAINED REDUCED. THE PROCEDURE WAS CONCLUDED WITH A PLAN FOR FOLLOW-UP OBSERVATION. NO TREATMENT W

  Patient problems: Obstruction/Occlusion

  MAUDE report 23724089 ↗
• MalfunctionDec 4, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AFTER PRIMARY DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS BELOW THE LEFT RENAL ARTERY, CONTRALATERAL GATE CANNULATION WAS PERFORMED. WHEN ATTEMPTING SECONDARY DEPLOYMENT OF THE TRUNK DEVICE USING STANDARD TECHNIQUE, RESISTANCE WAS ENCOUNTERED. THE TRANSPARENT KNOB COULD NOT BE REMOVED AND NOT BE PULLED FURTHER AT A POSITION APPROXIMATELY 10 CM WITHDRAWN. THE PROXIMAL END OF THE TRUNK DEVICE SEEMED CONSTRAINED. THE LINE CENTERED IN THE TRANSPARENT KNOB WAS REMOVED USING FORCEPS. THE PROXIMAL END OF THE TRUNK DEVICE REMAINED CONSTRAINED. THE ACCESS HATCH WAS OPENED, AND LINE 2 (LOCK PIN) WAS REMOVED, AND THEN LINE 3 (CONSTRAINING LOOP) WAS PULLED, BUT THE LINE 3 (CONSTRAINING LOOP) WAS BROKEN DURING THE PROCESS. SUBSEQUENTLY, THE IPSILATERAL LEG OF THE TRUNK WAS FULLY DEPLOYED USING STANDARD MANEUVER, AND THE DELIVERY CATHETER WAS SUCCESSFULLY REMOVED; HOWEVER, THE BROKEN CONSTRAINING LOOP WAS CAUGHT ON THE LEFT SIDE OF THE PROXIMAL END OF THE TRUNK DEVICE. ATTEMPTS TO REMOVE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723930 ↗
• InjuryDec 2, 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, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) WAS USED AS AN ACCESSORY. DUE TO SEVERE ANGULATION OF THE PROXIMAL NECK, THE SHEATH WAS INSERTED USING A PULL-THROUGH WIRE TECHNIQUE. AFTER DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS JUST BELOW THE LEFT RENAL ARTERY, LEGS WERE PLACED BOTH ON THE RIGHT AND LEFT SIDES. SUBSEQUENTLY, BALLOON TOUCH-UP BY MOB WAS PERFORMED FROM THE PROXIMAL END TO THE DISTAL SEGMENT. ANGIOGRAPHY REVEALED AN ANTEGRADE DISSECTION NEAR THE PROXIMAL NECK OF THE TRUNK DEVICE. AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDED PROXIMALLY TO EXTEND THE PROXIMAL NECK BY APPROXIMATELY 1 CM. BALLOON TOUCH-UP WAS NOT PERFORMED, AND FOLLOW-UP ANGIOGRAPHY CONFIRMED RESOLUTION OF THE ANTEGRADE DISSECTION AT THE PROXIMAL NECK. HOWEVER, SUBSEQUENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A RETROGRADE DISSECTION EXTENDING TO THE THORACIC ARCH. IT WAS CONFIRMED THAT THE DISSECTION DID NOT REACH THE ASCENDING AORTA, AND THE PATIENT

  Patient problems: Vascular Dissection

  MAUDE report 23700666 ↗
• InjuryOct 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, AS WELL AS DURING TOUCH-UP, SOME DISTAL MOVEMENT OCCURRED; HOWEVER, THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. ON AN UNKNOWN DATE, DURING HOSPITALIZATION, GRADUAL ENLARGEMENT OF THE ANEURYSM DIAMETER WAS OBSERVED. COMPUTED TOMOGRAPHY IMAGING SUGGESTED A STRONG LIKELIHOOD OF TYPE II ENDOLEAK. ON (B)(6) 2025, AS THE PATIENT¿S CONDITION STABILIZED, REPLACEMENT WITH A Y-SHAPED SURGICAL GRAFT WAS PLANNED. UPON LAPAROTOMY, SEVERAL TYPE II ENDOLEAKS WERE IDENTIFIED, BUT NO OTHER ISSUES WERE NOTED, AND THE REPLACEMENT PROCEDURE WAS NOT PERFORMED. BECAUSE THE PROXIMAL SEAL ZONE WAS JUDGED TO BE RELATIVELY SHORT, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY. ATTENDING PHYSICIAN¿S OPINION: ALTHOUGH A CLEAR PROXIMAL TYPE I ENDOLEAK WAS NOT EVIDENT, THE SEAL LENGTH WAS SOMEWHAT SHORT, SO AN ADDITIONAL STENT GRAFT WAS PLACED. FURTHERMORE, THE ANEURYSM WALL WAS FOUND TO BE

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23320598 ↗
• InjuryAug 27, 2025Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER INSERTING A BARE-METAL STENT INTO THE LEFT RENAL ARTERY, THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS PUSHED UP AND DEPLOYED JUST BELOW THE RIGHT RENAL ARTERY. DURING DEPLOYMENT, THE DEVICE MIGRATED DISTALLY AND WAS PLACED IN A CONFIGURATION WITH APPROXIMATELY 90 DEGREES OF ANGULATION CENTERED AROUND THE FLOW DIVIDER. FURTHER PUSHING UP ALONG THE GREATER CURVATURE RESULTED IN SHORTENING OF THE CONTRALATERAL LIMB OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. WHILE ATTEMPTING CANNULATION OF THE CONTRALATERAL GATE, THE PREVIOUSLY INSERTED BARE-METAL STENT IN THE LEFT RENAL ARTERY DISLODGED. ALTHOUGH THE PUSHING UP WAS RELAXED, THE SHAPE OF THE CONTRALATERAL LIMB DID NOT IMPROVE. MULTIPLE ATTEMPTS WERE MADE TO CANNULATE THE GATE, BUT ALL WERE UNSUCCESSFUL, AND THE PROCEDURE WAS CONVERTED TO AN AUI (AORTO-UNI-ILIAC). THE STENT GRAFTS WERE DEPLOYED WITHIN THE TRUNK PORTION OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS TO BLOCK BLOOD FLOW TO THE

  Patient problems: Insufficient Information

  MAUDE report 22901746 ↗