GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT361414Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00733132651078), received between Feb 23, 2022 and Aug 6, 2026 — classified as 4 deaths, 37 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration” (11 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  The following notifications were received by Gore Imaging Services (GIS):On (b)(6), 2025, this patient underwent endovascular treatment for an Aortoiliac aneurysm (AAA) and bilateral common iliac artery aneurysms (BCIAA) and was implanted with GORE® EXCLUDER® AAA ENDOPROSTHESIS devices and GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) devices. 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), 2025. On (b)(6), 2025, the patient underwent follow-up CTA. The site reports the maximum diameter of the abdominal aorta measures 49mm, the maximum diameter of the (RCIA) measures 25mm, and the maximum diameter of the (LCIA) was not provided. The site reports no endoleak, adverse events or device deficiencies and no loss of patency of the aorto-iliac device. Gore Imaging Services (GIS) review of the CTA reports device compression / infolding of the EXCLUDER Conformable AAA Endoprosthes

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166089 ↗
• InjuryApr 26, 2026Material Deformation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A NON-GORE STENT GRAFT (AFX® ENDOVASCULAR AAA SYSTEM). THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DUE TO A SUSPECTED TYPE III ENDOLEAK IN THE PREVIOUSLY IMPLANTED NON-GORE STENT GRAFT. TO PREVENT INTERFERENCE WITH THE INTERNAL FRAMEWORK OF THE PRE-EXISTING STENT GRAFT, BALLOON EXPANSION WAS PERFORMED, AFTER WHICH A 16FR SHEATH WAS INSERTED AND ADVANCED SMOOTHLY WITHOUT RESISTANCE. THE TRUNK IPSILATERAL LEG WAS THEN DEPLOYED JUST BELOW THE RENAL ARTERIES; HOWEVER, THE CONTRALATERAL GATE APPEARED TO BE INSUFFICIENTLY OPENED. ALTHOUGH CANNULATION WAS ATTEMPTED, THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND APPROXIMATELY HALFWAY THROUGH THE GATE. THE IPSILATERAL LEG WAS DEPLOYED FIRST, AND FOLLOWING BALLOON DILATION, CANNULATION VIA AN OVER-THE-TOP APPROACH FROM THE IPSILATERAL LIMB WAS ATTEMPTED; HOWEVER, THE WIRE COULD NOT BE ADVANCED THROUGH THE GATE. A PIGTAIL CATHETER WAS INSERTED THROUGH THE IPSILATERAL LIMB, AND ANGIOGRAPHY DEMONSTRATED NO CONTRAST FLOW

  Patient problems: Obstruction/Occlusion

  MAUDE report 24993923 ↗
• MalfunctionApr 9, 2026Difficult or Delayed Activation

  ON (B)(6), 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT361414). REPORTEDLY DURING THE PROCEDURE, THE CONSTRAINING LOOP ON THE DEVICE WOULD NOT RELEASE. WHEN THE PHYSICIAN DISENGAGED THE CONSTRAINING MECHANISM BY SLIDING THE RED SAFETY LOCK BACK WHILE ROTATING THE TRANSPARENT KNOB, THE TOP OF THE DEVICE CONSTRAINED UNIFORMLY WHEN THE KNOB WAS PULLED. THE CAUSE OF THIS EVENT IS UNKNOWN. THE PHYSICIAN THEN WENT INTO THE BACKUP HATCH, AND LINE 2 (LOCK PIN) AND LINE 3 (CONSTRAINING LOOP LINE) WERE REMOVED SUCCESSFULLY. WHEN THE PHYSICIAN BEGAN TO PULL LINE 4 (SECONDARY CONSTRAINING SLEEVE DEPLOYMENT LINE), THE TOP STENT ROW OF THE DEVICE WAS STILL CONSTRAINED AND WOULD NOT RELEASE SO THE PHYSICIAN STOPPED PULLING. SUBSEQUENTLY, THE PHYSICIAN INSERTED A MOLDING AND OCCLUSION BALLOON TO THE PROXIMAL END OF THE CXT DEVICE, THEN INFLATED IT AND SIMULTANEOUSLY PULLED AND REMOVED LINE 4 SUCCESSFULLY. THE REMOVAL OF LINE 4 RELEASED THE PROXIMAL CONSTRAINING OF THE CXT WITHOUT INCIDENT AND DEPLOYED THE CXT TRUNK TO FULL DIAMETER. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITHOUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830803 ↗
• InjuryApr 9, 2026Patient-Device Incompatibility; Detachment of Device or Device Component; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2026, FOLLOW-UP CT IMAGING REVEALED DISTAL MIGRATION OF THE TRUNK IPSILATERAL LEG, AS WELL AS THE PRESENCE OF A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2026, FOLLOW-UP CT IMAGING DEMONSTRATED ENLARGEMENT OF THE ANEURYSM SAC. THE IMAGES INDICATED THAT ONLY THE GREATER-CURVATURE¿SIDE ANCHORS REMAINED IN PLACE, WITH THE GRAFT BODY APPEARING TO HAVE COLLAPSED DOWNWARD. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED, AND TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24824792 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  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. POSTOPERATIVE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) REVEALED A TYPE II ENDOLEAK ORIGINATING FROM LUMBAR ARTERIES AND A DISTAL TYPE I ENDOLEAK AT THE LEFT DISTAL SIDE. ON (B)(6) 2026, AS TREATMENT FOR THE TYPE II ENDOLEAK, COIL EMBOLIZATION OF THE RIGHT LUMBAR ARTERY WAS PERFORMED. ON (B)(6) 2026, FOR THE DISTAL TYPE I ENDOLEAK, COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED, FOLLOWED BY THE PLACEMENT OF AN ADDITIONAL STENT GRAFT EXTENDING TO THE LEFT EXTERNAL ILIAC ARTERY. COIL EMBOLIZATION OF THE LEFT LUMBAR ARTERY WAS ALSO PERFORMED. ALTHOUGH THE TYPE II ENDOLEAK PERSISTED, IT WAS DECIDED TO BE MONITORED. PHYSICIAN¿S COMMENT: THE LENGTH OF THE COMMON ILIAC ARTERY WAS ORIGINALLY APPROXIMATELY 2 CM, WHICH DID NOT ALLOW ADEQUATE SEALING ZONE OF THE LEG DEVICE TO THE BIFURCATION OF THE INTERNAL AND EXTERNAL ILIAC ARTERIES. CONSEQUENTLY, THE DEVICE MIGRATION MAY HAVE OCCURRED DURING POSTOPERATIVE FOLLOW-UP.

  Patient problems: Clinical Endoleak

  MAUDE report 24761169 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS AND GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WELL. IN MID-(B)(6) 2026, DURING FOLLOW-UP, DISTAL MIGRATION OF THE TRUNK IPSILATERAL LEG WAS OBSERVED. IN ADDITION, A PROXIMAL TYPE I ENDOLEAK AND ENLARGEMENT OF THE ANEURYSM DIAMETER WERE CONFIRMED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED, AND TWO ADDITIONAL STENT GRAFTS WERE PLACED PROXIMALLY. THE ENDOLEAK DISAPPEARED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24480055 ↗
• InjuryDec 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE ON DECEMBER 8, 2025, FROM THE IMEDIDATA DATABASE: ON (B)(6) 2024, THIS 77-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC 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 DEPLOYED. ON (B)(6) 2024, THE PATIENT DEVELOPED A TYPE II ENDOLEAK. ON (B)(6) 2025, A CT REVEALED THAT THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA WAS 70 MM. ON (B)(6) 2025, A DUPLEX ULTRASOUND CONFIRMED THE TYPE II ENDOLEAK. ON (B)(6) 2025, A CT REVEALED THAT THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA WAS 75 MM. ON (B)(6) 2025, A CTA REVEALED THAT THE TYPE II ENDILEAK AND THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA WAS 75 MM. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. COIL EMBOLIZATION WAS PERFORMED, AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23874103 ↗
• MalfunctionDec 10, 2025Malposition of Device; Activation Failure; Malposition of Device; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON WEDNESDAY, (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) DEVICE. WHEN DEPLOYING THE DEVICE, THE PROXIMAL END OF THE DEVICE FAILED TO OPEN FULLY AT A NARROWING IN THE INFRARENAL NECK, LEAVING A LARGE BIRD-BEAKING. THE PHYSICIAN TRIED RECONSTRAINING THE DEVICE THREE TIMES AND MOVING IT UP. ON THE 4TH ATTEMPT TO RECONSTRAIN, THE EXCC WOULD NOT REOPEN BACK UP. THE PHYSICIAN HAD TO OPEN THE HATCH AND PULL THE NUMBER 2 WIRE TO GET THE DEVICE TO OPEN BACK UP. AFTER OPENING THE CONSTRAINING LOOP, THE DEVICE MIGRATED DISTALLY, REQUIRING THE PHYSICIAN TO IMPLANT TWO 36MM AORTIC EXTENDER DEVICES PROXIMALLY. AT THE COMPLETION OF THE CASE, SEAL WAS ACHIEVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773859 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESES AND GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR STENT GRAFTS WERE IMPLANTED: ONE TRUNK IPSILATERAL LEG, ONE AORTIC EXTENDER AND TWO CONTRALATERAL LEGS. ON (B)(6) 2025, DUE TO ENLARGEMENT OF THE ANEURYSM, A REINTERVENTION WAS PERFORMED USING THE GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ONE STENT GRAFT WAS ADDITIONALLY DEPLOYED IN EACH OF THE BILATERAL RENAL ARTERIES, FOLLOWED BY DEPLOYMENT OF THE CTAG JUST DISTAL TO THE SUPERIOR MESENTERIC ARTERY. REPORTEDLY, THERE WAS BLEEDING FROM THE DELIVERY HANDLE AFTER INSERTION OF THE CTAG, AND THE PHYSICIAN HAD TO COMPLETE THE DEPLOYMENT IMMEDIATELY. NO BLOOD TRANSFUSION WAS ADMINISTERED. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: ¿THE DIAMETER OF THE PROXIMAL NECK EXCEEDED 32 MM, AND I WAS EXPECTING ADDITIONAL STENT GRAFT PLACEMENT IF THE ANEURYSM CONTINUES TO GROW.¿

  Patient problems: Aneurysm expansion

  MAUDE report 23652635 ↗
• MalfunctionNov 19, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ON (B)(6) 2025, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. DURING DEPLOYMENT OF THE GORE® EXCLUDER® TRUNK-IPSILATERAL ENDOPROTHESIS IT WAS REPORTED THAT THE PROXIMAL END OF THE DEVICE DID NOT DEPLOY PROPERLY. A CODA BALLOON WAS ADVANCED UP THE CONTRALATERAL LIMB AND INFLATED AND THE PROXIMAL PORTION THEN RELEASED AND FULLY DEPLOYED AND SEALED. AS THE TREATMENT WAS FOR A RUPTURE, THE SITE REPORTS THE PATIENT¿S BLOOD LOSS WAS 550ML AND THE PATIENT DID REQUIRE TRANSFUSION. THERE WAS NO ADVERSE EVENT TO THE PATIENT AND THE DEVICE WAS LANDED AS INTENDED. THE PATIENT TOLERATED THE PROCEDURE BUT REQUIRED PROLONGED HOSPITALIZATION. ON (B)(6), 2025, THE SITE REPORTS THE PATIENT SUFFERED AN ADVERSE EVENT (AE) OF ACUTE BLOOD LOSS ANEMIA (PATHOLOGY: RELATED TO DISEASE PROGRESSION). THE PATIENT RECEIVED ADDITIONAL MEDICATION/PHARMACOLOGICAL TREATMENT THIS DATE FOR AND WAS TREATED WITH ¿FLUIDS, BLOOD PRODUCTS, VASOPRESSORS, VOLUME REPLACEMENT. 2 UNITS PRBCS, 2 UNITS PLATELETS¿. THIS AE WAS REPORTED TO HAVE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2025. ON (B)(6) 2025, THE SI

  Patient problems: Rupture

  MAUDE report 23596160 ↗
• DeathNov 6, 2025Insufficient Device Problem Information; Device Endoleak; Insufficient Device Problem Information; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS TRUNK (CXT) AND 3 GORE®EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. BECAUSE OF THE SHORT PROXIMAL AORTIC NECK, THE PHYSICIAN ELECTED TO PROCEED WITH AN OFF-LABEL CHIMNEY TECHNIQUE TO PRESERVE THE SMA AND RIGHT RENAL ARTERY. INTRAOPERATIVELY, A SMALL TYPE 1A ENDOLEAK WAS OBSERVED. THE PHYSICIAN WAS SATISFIED WITH THE FINAL ANGIOGRAPH, AND INDICATED THE PATIENT WAS STABLE. ON (B)(6) 2025, THE PATIENT LOST FEMORAL PULSE. ON FOLLOW-UP CT SCAN, THE PHYSICIAN SAW THE TYPE 1A ENDOLEAK CONTINUING AND DISCUSSED A REINTERVENTION. ON (B)(6) 2025, THE PATIENT PASSED. THE CAUSE OF DEATH IS UNKNOWN. REPORTEDLY, THE PHYSICIAN BELIEVED THAT THE LOSS OF FEMORAL PULSE WAS DUE TO A CLOT IN THE RIGHT FEMORAL ARTERY.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 23490425 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (2 CONTRALATERAL COMPONENTS), GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT) TO TREAT AN ANEURYSM. ON (B)(6) 2025, A GRAFT INFECTION WAS OBSERVED, AND PATIENT UNDERWENT EXPLANT SURGERY IN WHICH ALL THE DEVICES WERE EXPLANTED. IT ALSO UNKNOWN WHICH DEVICE HAD AN INFECTION. IT WAS ALSO REPORTED PATIENT HAS NO KNOWN HISTORY OF PREVIOUS INFECTIONS, AND IT IS UNKNOWN WHAT CAUSED THE INFECTION. NO FURTHER PATIENT INFORMATION IS AVAILABLE, AND DEVICES WERE DISCARDED. THE FIELD SALES ASSOCIATE WAS NOTIFIED ABOUT THIS EXPLANT SURGERY ON (B)(6) 2025. CODE 1001-E: -UNKNOWN-USED TO CAPTURE INFECTION WITH UNKNOWN CAUSE.

  Patient problems: Medical device site infection

  MAUDE report 23452335 ↗
• MalfunctionOct 20, 2025Material Invagination; Material Invagination

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND AORTIC EXTENDER). REPORTEDLY, THE TRUNK IPSILATERAL LEG (CXT) WAS DEPLOYED HIGH INTENTIONALLY DURING THE FIRST STAGE OF DEPLOYMENT. DURING THE SECOND STAGE OF DEPLOYMENT, THE CXT DEVICE WAS CONSTRAINED AND MOVED DOWN BELOW THE RENAL ARTERIES WHERE THE CXT INFOLDED ON ONE SIDE. DEPLOYMENT WAS COMPLETED ON THE CXT DEVICE. REPORTEDLY, THE CAUSE OF THE CXT DEVICE INFOLDING COULD HAVE BEEN RELATED TO THE LOCKPIN GETTING CAUGHT ON ONE SIDE OF THE DEVICE. THERE WERE NO ENDOLEAKS, ADVERSE EVENTS, OR OTHER COMPLICATIONS AS A RESULT OF THE INFOLDING. DUE TO AESTHETIC REASONS AND LONG-TERM CONCERNS, THE PHYSICIAN DECIDED TO EXTEND THE CXT DEVICE WITH A PROXIMAL EXTENSION USING AN AORTIC EXTENDER (CXA). FOLLOWING DEPLOYMENT OF THE CXA DEVICE, BALLOONING WAS COMPLETED AND FINAL IMAGING SHOWED GOOD RESULTS. FINAL POSITIONING OF THE DEVICES WERE GOOD, AS THE PHYSICIAN DEPLOYED WHERE THEY WANTED TO LAND. REPORTEDLY, PATIENT ANATOMY WAS NOT A CONCERN OR CAUSE OF THE DEVICE INFOLDING, AS THERE WAS NO TORTUOSITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337232 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL COMPONENT) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (4 CONTRALATERAL LEG COMPONENTS). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON (B)(6) 2025, THE PATIENT PRESENTED WITH LEG PARALYSIS. THE PATIENT WAS TREATED WITH VASOPRESSOR MEDICATION TO INCREASE BLOOD FLOW. IT WAS ALSO REPORTED THERE WAS NO SPINAL CORD ISCHEMIA, AND NEUROLOGIST BELIEVES FULL LEG FUNCTION WILL RETURN. THE CAUSE OF PARALYSIS IS UNKNOWN. THERE WERE NO ISSUES NOTED DURING THE INITIAL IMPLANT PROCEDURE. NO FURTHER PATIENT OR CASE INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 23069790 ↗
• InjurySep 9, 2025Migration; Migration

  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® CONFORMABLE AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT¿S VASCULAR CONDITION WAS POOR. ON (B)(6) 2025, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE MAIN BODY HAD MIGRATED AND BECOME DISLODGED FROM THE AORTIC NECK. AN OPEN SURGICAL GRAFT REPLACEMENT IS PLANNED. ATTENDING PHYSICIAN¿S OPINION: THE DEVICE WAS ORIGINALLY PLACED IN A VESSEL WITH A LARGE DIAMETER, AND THE NECK DIAMETER HAD EXPANDED FROM APPROXIMATELY 32 MM PREOPERATIVELY TO ABOUT 39 MM. SINCE EXTENSION WITH A CUFF IS NOT FEASIBLE, AN OPEN SURGICAL GRAFT REPLACEMENT IS SCHEDULED WITHIN THE NEXT FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000587 ↗
• InjuryAug 4, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT361414). ON AN UNKNOWN DATE AN ENDOLEAK WAS OBSERVED. THE TYPE OF ENDOLEAK AT THE TIME WAS UNKNOWN. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS ENDOLEAK. A TYPE 1A ENDOLEAK WAS OBSERVED, AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER-CXA360005) WAS IMPLANTED TO TREAT THIS ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22710541 ↗
• InjuryAug 1, 2025Positioning Failure; Obstruction of Flow; Malposition of Device; Positioning Failure; Obstruction of Flow; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AT MOUNT NITTANY USING GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS SYSTEM (EXCC), WITH GORE®EXCLUDER®AAA ENDOPROSTHESIS LEGS. THE CXT361414 L/S#: (B)(6) WAS PLACED SUCCESSFULLY THROUGH RIGHT FEMORAL ACCESS. AFTER PARTIAL DEPLOYMENT OF THE EXCC, THE PHYSICIAN HAD DIFFICULTY CANNULATING THE CONTRALATERAL GATE. HE DECIDED TO FULLY DEPLOY THE MAIN DEVICE AND THEN SNARE THE WIRE FROM THE LEFT SIDE BY COMING UP AND OVER THE AORTIC BIFURCATION FROM THE RIGHT SIDE. AFTER DEPLOYING THE MAIN DEVICE COMPLETELY AND WHILE PASSING THE WIRE FROM THE LEFT, THE PHYSICIAN APPEARED TO CANNULATE THE CONTRALATERAL GATE AND CONFIRMED ACCESS BY SPINNING THE PIGTAIL CATHETER IN THE PROXIMAL PORTION OF THE CXT. THEREFORE, THE PHYSICIAN BELIEVED THE SNARE TECHNIQUE (UP AND OVER) WAS NO LONGER NECESSARY. THE CONTRALATERAL LIMB (PLC121200 L/S#: (B)(6) WAS PLACED ON THE LEFT SIDE. AFTER DEPLOYMENT OF THE CONTRALATERAL LIMB THE IPSILATERAL LIMB EXTENSION (PLC121000 L/S#: (B)(6) WAS PLACED ON THE RIGHT SIDE, EXTENDING THE CXT. THE COMPLETION ANGIOGRAM LOOKED GOOD BUT REDUCED FLOW WAS NOTED. AFTER SEVERAL A

  Patient problems: Reduced Blood Flow

  MAUDE report 22688502 ↗
• InjuryJul 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK DEVICE, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE. ON AN UNKNOWN DATE IN (B)(6) 2024 OR (B)(6) 2025, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL FOR EXPLANTATION OF THE DEVICES AND OPEN RECONSTRUCTION DUE TO GRAFT INFECTION. THE PATIENT HAD SEVERAL RETURN TRIPS TO WASH OUT ABSCESSES, AND IN (B)(6) 2025 HE RECEIVED A TRACHEOTOMY. THE PATIENT REMAINS IN CRITICAL CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 22494438 ↗
• MalfunctionJul 3, 2025Break; Break

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® CONFORMABLE ENDOPROSTHESIS. IT WAS REPORTED THAT THE CONSTRAINING LOOP BROKE FROM THE TRANSPARENT KNOB. AT THIS POINT USING THE BACK UP MECHANISM WAS NO LONGER AN OPTION. THE PHYSICIAN PROCEEDED WITH THE SURGERY BY DEPLOYING THE SECOND STAGE OF THE DEVICE AND SUCCESSFULLY REMOVING THE CATHETER FROM THE BODY. THE CONSTRAINING LOOP LINE WAS REMOVED ALONG WITH THE CATHETER. THE DEVICE WAS ABLE TO BE FULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394854 ↗
• InjuryJul 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 EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ALTHOUGH NO ENDOLEAK WAS OBSERVED, A PROXIMAL EXTENSION WAS PLANNED TO PREVENT POTENTIAL FUTURE OCCURRENCE OF A TYPE I ENDOLEAK. ON (B)(6), 2025, THE PATIENT UNDERWENT REINTERVENTION TO REINFORCE PROXIMAL SEALING. AN ADDITIONAL STENT GRAFT WAS DEPLOYED AT THE PROXIMAL END OF THE PREVIOUSLY PLACED DEVICE. PHYSICIAN¿S COMMENT: NO ENDOLEAK WAS OBSERVED, BUT THE EXTENSION WAS PERFORMED TO SECURE A LONGER SEALING ZONE.

  Patient problems: Insufficient Information

  MAUDE report 22379870 ↗
• InjuryJul 1, 2025Migration; Migration

  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, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER RETURNING TO THE INTENSIVE CARE UNIT, A DECLINE IN RENAL FUNCTION WAS NOTED. ON (B)(6) 2025, ANGIOGRAPHY TO EVALUATE BLOOD FLOW TO THE RENAL ARTERIES AND PERCUTANEOUS RENAL ARTERY ANGIOPLASTY WERE PERFORMED. THE LEFT RENAL ARTERY WAS SUSPECTED TO HAVE EMBOLISM DUE TO PLAQUE SHIFT. THE RIGHT RENAL ARTERY WAS DETERMINED TO BE COVERED DUE TO STENT GRAFT MIGRATION. IN AN ATTEMPT TO RESTORE BLOOD FLOW TO THE RIGHT RENAL ARTERY, A GUIDING CATHETER WAS ADVANCED NEAR THE ARTERY AND A GUIDEWIRE WAS INSERTED, WHICH RESULTED IN ARTERIAL DISSECTION. CONSEQUENTLY, THE RIGHT RENAL ARTERY BECAME COMPLETELY OCCLUDED, AND BLOOD FLOW RESTORATION WAS DEEMED UNFEASIBLE, LEADING TO TERMINATION OF THE PROCEDURE. ALTHOUGH THE RIGHT RENAL ARTERY WAS OCCLUDED, COLLATERAL CIRCULATION WAS CONFIRMED TO MAINTAIN A CERTAIN LEVEL OF BLOOD FLOW. CONTINUOUS HEMODIAFILTRATION WAS INITIATED, AND THE PATIENT WAS PLACED UNDER OBSERVATION. (B)(6) 2025: A MILD CEREBRAL INFARCTIO

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Renal Impairment

  MAUDE report 22379364 ↗
• MalfunctionMay 9, 2025Break; Break

  ON (B)(6) 2025, DURING AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF A ZONE 9 INFRARENAL AORTIC ANEURYSM POST DEPLOYMENT OF A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. WHEN WITHDRAWING THE DEVICE DELIVERY CATHETER FROM THE PATIENT, IT WAS REPORTED THAT THE LEADING OLIVE BECAME DETACHED FROM THE DELIVERY CATHETER. IT IS BELIEVED THE DEVICE DELIVERY CATHETER MAY HAVE GOTTEN HUNG UP ON THE VALVE OF THE SHEATH, CAUSING IT TO BREAK OFF INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENT TO THE PATIENT AND GOOD RESULTS. THE DEVICE DELIVERY CATHETER WILL BE RETURNED TO GORE FOR EVALUATION. THERE HAD BEEN NO ISSUES DURING DEPLOYMENT WITH ADVANCEMENT OF THE DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996183 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A ¿SHORT¿ AORTIC NECK. IT WAS REPORTED THAT ALL DEVICES WERE IMPLANTED BUT THERE WAS NOT A GOOD SEAL AT THE PROXIMAL AORTIC NECK, DUE TO AORTIC NECK ANATOMY. THE PHYSICIAN CHOSE TO EXPLANT THE IMPLANTED DEVICES AND CONVERTED TO AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21767686 ↗
• DeathMar 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM RUPTURE UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA IN ZONE 9. IT WAS REPORTED THAT THE PATIENT PRESENTED SYMPTOMATIC OF A RUPTURED ANEURYSM. HIS LEFT RENAL WAS INTENTIONALLY COVERED BECAUSE THE ANEURYSM EXTENDED TO THE LEFT RENAL. ALSO, TWO PLCS WERE PLACED IN THE PATIENT. A FINAL ANGIOGRAM WAS PERFORMED THAT SHOWED NO EVIDENCE OF ENDOLEAK AND THE CONTAINMENT OF THE ANEURYSM SAC. THE RIGHT RENAL WAS FUNCTIONAL WITH NO ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2025, THE PATIENT'S RENAL FUNCTION DECLINED. THE PHYSICIAN PERFORMED AN OPEN RENAL REVASCULARIZATION WITH ENDOSCOPIC INTERVENTION. THE PHYSICIAN ALSO PERFORMED A LAPAROTOMY. AT SOME POINT DURING THESE PROCEDURES, AN AORTIC EXTENDER AND NON GORE BARE METAL STENT WAS PLACED IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON MARCH 10, THE FSA WAS IN COMMUNICATION WITH THE PHYSICIAN. THE PHYSICIAN STATED THE PATIENT EXPIRED. THE EXACT EXPIRATION DATE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21734765 ↗
• InjuryFeb 12, 2025Migration; Migration

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (CXT361414/(B)(6)). IT WAS REPORTED THAT AT THE BEGINNING OF THE CASE WE WERE ENCROACHING ON THE RENAL ARTERY HOWEVER POST DEPLOYMENT, FINAL ANGIOGRAPHY SHOWED IT LOOKED GOOD ALSO (ENCROACHING BUT NO COVERAGE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT THE PATIENT PRESENTED TO THE HOSPITAL WITH RIGHT SIDED PAIN. THEY DID A POST-OPERATIVE SCAN WHICH SHOWED THE DEVICE IS COMPLETELY COVERING AND OCCLUDING THE RIGHT RENAL ARTERY. THE PATIENT ALSO REPORTED THAT TWO DAYS POST-OP HE SLIPPED ON THE ICE, LANDING HARD AND FULLY OUTSTRETCHED ON HIS RIGHT SIDE. THE PHYSICIAN IS CONVINCED THAT THE FALL CAUSED THE DEVICE TO MIGRATE UP (AMOUNT UNKNOWN) AND COVER THE RENAL ARTERY. THE PATIENT IS STILL HOSPITALIZED AND EXPERIENCING PAIN ON THE RIGHT SIDE. THE PHYSICIAN WILL MONITOR THE PATIENT, NO REINTERVENTION IS PLANNED.

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

  MAUDE report 21364990 ↗