GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT231412Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00733132651016), received between Jun 16, 2021 and Sep 28, 2026 — classified as 3 deaths, 60 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (13 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 82 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Patient-Device Incompatibility

  The following publication was reviewed: Title: Treatment of Patients with Severely Angulated Proximal Aortic Necks Using the GORE EXCLUDER Conformable AAA Endoprosthesis.Source: The 56th Annual Meeting of the Japanese Society for Cardiovascular Surgery, O61-6.It was reported the outcomes of four patients with severely angulated proximal aortic necks of 90 degrees or greater who underwent endovascular aneurysm repair at the one institution between April 2023 and July 2025. The GORE EXCLUDER Conformable AAA Endoprosthesis was used in all patients.¿Case 2¿A 75-year-old man with a medical history of cerebral infarction, myocardial infarction treated with percutaneous coronary intervention, rectal cancer surgery, and emphysema. The patient underwent EVAR because the abdominal aortic aneurysm measured more than 50 mm in diameter and showed progressive enlargement. The proximal aortic neck angle was 97 degrees, and the neck length was 25 mm.The main device was angulated to conform to the infrarenal aortic angulation and was subsequently deployed. Intraoperative angiography showed no abnormal findings.A Type II endoleak was identified postoperatively. Transcatheter arterial embolization wa

  Patient problems: Clinical Endoleak

  MAUDE report 50911106 ↗
• InjuryAug 12, 2026Device Endoleak

  The following was reported to Gore:On (b)(6) 2025 the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm. The patient was treated with a GORE® EXCLUDER® Conformable Endoprosthesis, and GORE® EXCLUDER® AAA Endoprosthesis. The GORE® devices were successfully implanted.On (b)(6) 2026 the patient underwent a reintervention procedure to treat a Type 1A endoleak. Endoanchors were placed to resolve the endoleak.

  Patient problems: Clinical Endoleak

  MAUDE report 50222447 ↗
• InjuryJun 19, 2026Patient-Device Incompatibility; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS HAD MIGRATED DISTALLY, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2026, A REINTERVENTION WAS PERFORMED. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTA EXTENDER) WAS IMPLANTED PROXIMALLY. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. THE MIGRATION MIGHT HAVE BEEN AVOIDED IF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS HAD BEEN DEPLOYED IN BETTER CONFORMITY WITH THE PATIENT¿S ANATOMY. THE PATIENT¿S PROXIMAL NECK WAS REPORTED TO BE ANGULATED.

  Patient problems: Clinical Endoleak

  MAUDE report 25557710 ↗
• MalfunctionJun 11, 2026Material Deformation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE IN (B)(6) 2026, AT THE ONE-MONTH FOLLOW-UP EXAMINATION, COMPRESSION OF THE IPSILATERAL LEG OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS OBSERVED AT THE ANGULATED PORTION BELOW THE PROXIMAL NECK. THE ABI WAS REPORTED TO BE LESS THAN 1.0. THE PATIENT WAS ASYMPTOMATIC. REINTERVENTION WITH IMPLANTATION OF A BARE STENT IN THE STENOTIC AREA IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467229 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2026, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED SLIGHT ANEURYSM SAC ENLARGEMENT WITH A PERSISTENT TYPE II ENDOLEAK RELATED TO THE L3/L4 LUMBAR ARTERIES. ON (B)(6), 2026, THE PATIENT UNDERWENT REINTERVENTION FOR THE TYPE II ENDOLEAK AND ENDOANCHORS WERE PLACED. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25446962 ↗
• InjuryApr 28, 2026Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC AND ILIAC ARTERY ANEURYSMS USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. A TOTAL OF 6 STENT GRAFTS WERE IMPLANTED. A RESIDUAL TYPE II ENDOLEAK WAS SUSPECTED AT THE FINAL ANGIOGRAPHY; HOWEVER, THE PROCEDURE WAS COMPLETED WITH FOLLOW-UP OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE WELL. ON AN UNKNOWN DATE, AS PERSISTENCE OF A TYPE II ENDOLEAK WAS IDENTIFIED, COIL EMBOLIZATION OF THE LEVEL 4 LUMBER ARTERIES WAS PERFORMED. ON (B)(6) 2025, FOLLOW-UP CT DEMONSTRATED ENLARGEMENT OF THE ANEURYSM SAC. CONTRAST ENHANCEMENT WAS OBSERVED NEAR THE BIFURCATION OF THE TRUNK IPSILATERAL LEG. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THE ENDOLEAK WAS ASSESSED AS MOST LIKELY A TYPE II ORIGINATING FROM FLOW VIA THE LEVEL 3 LUMBAR ARTERIES. THREE ADDITIONAL STENT GRAFTS WERE IMPLANTED, AND DISAPPEARANCE OF THE ENDOLEAK WAS CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25011821 ↗
• InjuryFeb 26, 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 ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS ALSO USED. DURING THE PROCEDURE, AN ANGIOGRAPHY SHOWED A SUSPECTED TYPE IA ENDOLEAK OR LOCALIZED DISSECTION AROUND THE AORTIC NECK FOLLOWING SUCCESSFUL DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG AND BALLOONING. AN ADDITIONAL AORTIC EXTENDER WAS DEPLOYED, BUT THAT FINDING REMAINED THOUGH IT BECAME MINOR. CONSIDERING A POSSIBILITY OF DISSECTION, NO ADDITIONAL BALLOONING WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PATIENT¿S AORTIC NECK CONDITION WAS POOR AND IT WAS CONSIDERED THAT LOCALIZED AORTIC DISSECTION OCCURRED DURING THE INITIAL BALLOONING. GIVEN THE DEVICE POSITIONING AND THE FACT THAT THE CONTRAST EFFECT DID NOT REACH THE ANEURYSM SAC, IT WAS PROBABLY NOT A TYPE IA ENDOLEAK.

  Patient problems: Vascular Dissection

  MAUDE report 24453191 ↗
• InjuryFeb 17, 2026Structural Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND GORE® EXCLUDER® AAA ENDOPROSTHESES (THREE PLCS). ON AN UNKNOWN LATER DATE, THE PATIENT RECEIVED IMAGING AND THE PHYSICIAN BELIEVED THE PLC LIMBS LOOKED "TENSED" AND NEEDED TO BE RE-BALLOONED. REPORTEDLY, IT IS UNKNOWN IF THE PHYSICIAN THOUGHT THE DEVICES WERE COMPRESSED FROM THE INITIAL IMPLANT; HOWEVER, THE PHYSICIAN BELIEVED THEY NEEDED TO BE EXPANDED MORE BY BALLOONING. IT WAS REPORTED THE PATIENT HAD A TIGHT AORTIC BIFURCATION AND CALCIUM AROUND THE AREA OF THE DEVICES. THE PHYSICIAN INFORMED THE GORE FIELD SALES ASSOCIATE ON (B)(6), 2026 THAT A REINTERVENTION WAS PLANNED FOR THE PATIENT TO RE-BALLOON THE LIMBS. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHERE THE PHYSICIAN BALLOONED THE LIMBS BILATERALLY AT THE DISTAL AORTIC BIFURCATION. IT IS UNKNOWN WHICH SPECIFIC PLC DEVICES WERE BALLOONED. THERE ARE NO CLINICAL IMAGES AVAILABLE. THE PATIENT HAD NO CLINICAL SEQUELAE AND THERE WERE NO OTHER ADVERSE EVENTS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364793 ↗
• MalfunctionFeb 13, 2026Material Separation

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT). REPORTEDLY, THE RADIOPAQUE MARKER RING ON THE CONTRALATERAL GATE HOLE OF THE CXT CAME LOOSE ON HALF OF THE RING, OBSERVED AFTER THE FIRST STAGE OF DEPLOYMENT. THE PHYSICIAN BELIEVES THE LOOSE SECTION OF THE RING WAS TACKED AGAINST THE WALL OF THE CXT CONTRALATERAL GATE FOLLOWING IMPLANT OF A CONTRALATERAL LEG COMPONENT (PLC). THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332448 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, A CONTRAST-ENHANCED CT SCAN SHOWED ANEURYSM ENLARGEMENT AND SUSPECTED TYPE II AND TYPE IB ENDOLEAKS; THEREFORE, AN ADDITIONAL PROCEDURE WAS INDICATED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. AN ANGIOGRAPHY SHOWED A TYPE II ENDOLEAK ORIGINATING FROM THE ILIOLUMBAR ARTERY AND A TYPE IB ENDOLEAK ON THE LEFT SIDE. BILATERAL ILIOLUMBAR ARTERY EMBOLIZATION WAS PERFORMED, AND AN ADDITIONAL CONTRALATERAL LEG WAS PLACED ON THE LEFT SIDE. THE ENDOLEAKS DISAPPEARED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24206871 ↗
• MalfunctionJan 21, 2026Malposition of Device; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE). REPORTEDLY, THE 1ST STAGE OF TRUNK IPSILATERAL LEG CONFORMABLE DEPLOYED FINE, CANNULATED THE GATE, AND AT THE 2ND STAGE, THE CONSTRAINING SLEEVE WOULD NOT RELEASE. PHYSICIAN TRIED PULLING ON THE HANDLE A FEW TIMES AND WHEN PULLING, FELT RESISTANCE AS IF IT WAS STUCK, AND WHOLE GRAFT MOVED A LITTLE BIT DOWN (LESS THAN 5MM) BUT THE GRAFT WAS STILL AT THE IDEAL LOCATION PHYSICIAN WANTED TO DEPLOY AT. PHYSICIAN THEN OPENED THE BACKUP DEPLOYMENT HATCH, AND REMOVED DEPLOYMENT LINES 2, 3, AND 5 BUT WAS UNABLE TO REMOVE DEPLOYMENT LINE 4 AS IT WAS STUCK. PHYSICIAN DID NOT CUT THROUGH THE CATHETER BUT DID END UP CUTTING LINE 4 INSIDE THE HATCH AND AT NO POINT DID THE DEPLOYMENT LINE BREAK. PHYSICIAN THEN TRIED TO BALLOON THE PROXIMAL END OF THE GRAFT BUT THAT DID NOT HELP IN RELEASING THE SUTURE LINE AND UNSURE IF BALLOONING OPENED THE GRAFT FULLY. PHYSICIAN THEN MOVED TO DEPLOY IPSILATERAL LIMB WITH THE 5TH LINE AND THE 2ND CONSTRAINING SLEEVE (LINE 4) WAS LEFT INSIDE THE PATIENT AS EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129662 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Advance

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT231412) AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (GDSF1533). REPORTEDLY, AFTER DEPLOYING THE CXT231412 AND REMOVING THE DELIVERY SYSTEM, IT WAS NOTICED THE LEADING END OF THE DELIVERY CATHETER AND OLIVE TIP DISLODGED FROM THE DELIVERY SYSTEM. IT WAS REPORTED THE OLIVE TIP LIKELY GOT CAUGHT ON THE END OF THE SHEATH AND WAS FORCEFULLY TUGGED OFF. THE PHYSICIAN REMOVED THE SHEATH WITH PLANS TO SWITCH TO A LARGER SHEATH FOR A SNARE, AND THE OLIVE TIP AND REST OF THE DELIVERY CATHETER WERE AT THE END OF THE SHEATH AND WERE SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THE CXT231412 WAS DIFFICULT TO INSERT AND REMOVE; HOWEVER, THE REASON IS UNKNOWN AS A 15FR SHEATH WAS USED AND THAT IS THE RECOMMENDED SHEATH SIZE. IT WAS REPORTED THERE WAS PATIENT TORTUOSITY. IT WAS ALSO REPORTED THE DEVICE WAS PREPPED PROPERLY AND NOT ADVANCED OUTSIDE THE SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944300 ↗
• MalfunctionDec 8, 2025Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED TO GORE ON NOVEMBER 13, 2025 FROM THE IMAGING DATABASE AND THE IMEDIDATA DATABASE: ON (B)(6) 2025, THIS 81-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 SUCCESSFULLY DEPLOYED. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA FOLLOW-UP. IT WAS NOTED THAT THERE WAS COMPRESSION/INFOLDING OF THE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG. NO ADDITIONAL INFORMATION, INCLUDING REINTERVENTION, WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752359 ↗
• InjuryNov 23, 2025Patient Device Interaction Problem; Device Endoleak; Patient Device Interaction Problem; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND A GORE®EXCLUDER®AAA ENDOPROSTHESIS DEVICE IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES. THE GORE® DEVICES WERE SUCCESSFULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED HOME ON (B)(6) 2025. PRE- TREATMENT CTA ON (B)(6) 2025 SHOWED THAT THE MAXIMUM DIAMETER OF A RIGHT COMMON ILIAC ARTERY WAS 55MM. MINIMUM DIAMETER OF A RIGHT COMMON ILIAC ARTERY WAS 23 MM. ON (B)(6) 2025, GORE FOLLOW UP IMAGING REVEALED A TYPE II ENDOLEAK FROM LUMBAR ARTERIES. ADDITIONALLY, AN ENDOLEAK INDETERMINATE TYPE WAS NOTED. ON (B)(6) 2025, GORE FOLLOW UP IMAGING REVEALED A TYPE II ENDOLEAK FROM LUMBAR ARTERIES. NO OTHER ADVERSE EVENTS HAVE BEEN NOTICED. THE SITE CONFIRMED GORE IMAGING FINDINGS AND THE PHYSICIAN STATED THAT THEY ARE PREPARING TO FIX THE ENDOLEAKS (TYPE II AND INDETERMINATE) MOST LIKELY IN DECEMBER. ADDITIONALLY, ACCORDING TO THE SITE, THE ANEURYSM ENLARGED FROM (B)(6) FROM 52MM TO 56MM. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23627902 ↗
• MalfunctionOct 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE FIRST DEPLOYMENT LINE WAS PULLED THE DEVICE (PROXIMAL END) LOOKED TO BE CONSTRAINED AT 70%. THE PHYSICIAN ATTEMPTED TO RECONSTRAIN AND RELEASE, POSITIONING CONFIRMED, THAT DID NOT UNCONSTRAIN THE DEVICE. THE PHYSICIAN BALLOONED THE AREA, THE DEVICE FULLY OPENED. THERE WERE NO FURTHER ISSUES, AND THE POSITIONING OF THE DEVICE WAS GOOD. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THERE WERE NO ANATOMICAL CONSTRAINTS, NO TORTUOSITY, AND NO ISSUES ADVANCING THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS DESTROYED AT THE HOSPITAL.

  Patient problems: Aneurysm

  MAUDE report 23357064 ↗
• InjuryOct 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  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. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED, AND FINE ADJUSTMENTS WERE MADE USING THE CONSTRAINING SYSTEM, DURING WHICH INVAGINATION OF THE CONTRALATERAL GATE OCCURRED. THE INVAGINATION OF THE GATE WAS REPORTED TO BE DUE TO THE PATIENT¿S ANATOMICAL CONFIGURATION. AFTER CANNULATION OF THE CONTRALATERAL GATE, IT EXPANDED WITHOUT ISSUE. DURING THE PROCEDURE, A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY WAS OBSERVED AND MANAGED WITH OBSERVATION. ON (B)(6) 2025, ANEURYSM RUPTURE WAS CONFIRMED. THE STENT GRAFTS WERE EXPLANTED, AND REPLACEMENT WITH A Y-SHAPED PROSTHETIC GRAFT WAS CARRIED OUT. ATTENDING PHYSICIAN¿S COMMENT: IT IS POSSIBLE THAT THE PROXIMAL END OF THE NECK WAS SLIGHTLY OVERSIZED, CAUSING WRINKLING AND LEADING TO A PROXIMAL TYPE I ENDOLEAK, WHICH RESULTED IN RUPTURE. DURING THE INITIAL IMPLANTATION, ONLY A TYPE II ENDOLEAK WAS OBSERVED.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 23286784 ↗
• MalfunctionSep 15, 2025Fracture; Fracture

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, TO TREAT AN ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1633 SERIAL# IS UNKNOWN). IT WAS REPORTED DURING THE PROCEDURE, AFTER THE GRAFT WAS SUCCESSFULLY DEPLOYED, UPON REMOVING THE DELIVERY CATHETER OF THE CONFORMABLE DEVICE, THE PHYSICIAN COULD NOT REMOVE IT THROUGH THE TIP OF THE DSF1633 DRYSEAL SHEATH. THE NOSE CONE OF THE DELIVERY CATHETER COULD NOT PASS THROUGH THE SHEATH. THE PHYSICIAN ATTEMPTED TO USE SOME EXTRA FORCE, BUT THE DELIVERY CATHETER STILL COULD NOT BE REMOVED. IT WAS ALSO REPORTED, PHYSICIAN DECIDED TO REMOVE BOTH THE CONFORMABLE DEVICE AND THE SHEATH ALL AT ONCE, PULLING BOTH OUT AT THE SAME TIME, WITH THE NOSE CONE PORTION REMAINING OUTSIDE OF THE SHEATH. UPON REMOVAL OF THE CONFORMABLE DELIVERY CATHETER, A PORTION OF THE CATHETER APPEARED MISSING. THE PHYSICIAN THEN CUT THE VALVE PORTION OF THE SHEATH OFF IN AN ATTEMPT TO FIND THIS MISSING PIECE INSIDE THE SHEATH. NO FRAGMENT WAS FOUND IN THE SHEATH. A POST ANGIOGRAM WAS PERFORMED, AND NO FRAGMENT WAS SEEN INSIDE THE PATIENT. NO FURTHER ISSUES WERE NOTED, AND THE PATIENT TOLERATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059782 ↗
• InjurySep 11, 2025Material Deformation; Material Deformation

  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. AFTER DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED; HOWEVER, CANNULATION BECAME DIFFICULT AFTER PASSING THROUGH THE GATE. THE IPSILATERAL SIDE WAS DEPLOYED FIRST, AND THE CONTRALATERAL LEG ENDOPROSTHESIS WAS EXTENDED TO THE RIGHT EXTERNAL ILIAC ARTERY. MULTIPLE CANNULATION ATTEMPTS TO THE CONTRALATERAL GATE WERE MADE USING MICRO GUIDEWIRES AND CATHETERS FROM BOTH THE LEFT AND RIGHT DISTAL ACCESS ROUTES, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. IT WAS DECIDED TO CONVERT TO AUI PROCEDURE. THE LEFT COMMON ILIAC ARTERY WAS EMBOLIZED USING PLUGS AND COILS, AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED FROM THE PROXIMAL NECK WITHIN THE TRUNK DEVICE TO THE RIGHT/IPSILATERAL LEG. AFTER F-F BYPASS WAS PERFORMED, THE PROCEDURE WAS COMPLETED. IT WAS SUSPECTED THAT TWIST OR KINK OF THE TRUNK DEVICE NEAR THE BIFURCATION OF THE MAIN BODY BECAUSE THE WIRE COULD NOT PASS ABOVE THE LONG MARKER. IT WAS ALSO SUSPECTE

  Patient problems: Insufficient Information

  MAUDE report 23034253 ↗
• MalfunctionSep 9, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  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. REPORTEDLY, THE PATIENT¿S COMMON ILIAC ARTERIES SHOWED ANEURYSMAL CHANGES. DURING DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, THE LONG MARKER WAS UNINTENTIONALLY PLACED AT THE LEVEL OF THE RENAL ARTERIES, REQUIRING REPOSITIONING USING THE CONSTRAINING SYSTEM. DURING THIS PROCESS, THE CONTRALATERAL GATE BECAME CAUGHT WITHIN THE ANEURYSM SAC AND WAS COMPRESSED. THE DELIVERY CATHETER WAS OPERATED FOR ADJUSTMENT, AND THE PROXIMAL PORTION WAS REDEPLOYED, BUT FULL EXPANSION WAS NOT ACHIEVED. CANNULATION OF THE CONTRALATERAL GATE WAS THEN PERFORMED WHILE THE DELIVERY CATHETER WAS HELD WITH FORCEPS. AFTER DEPLOYMENT OF ALL STENT GRAFT COMPONENTS, TOUCH-UP OF THE RIGHT LIMB WAS PERFORMED USING A NON-GORE BALLOON IN THE RIGHT COMMON ILIAC ARTERY, DURING WHICH A RUPTURE WAS OBSERVED. TO REPAIR THE INJURY, TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED. PHYSICIAN'S COMMENT: EXCESSIVE PRESSURE WAS APPLIED DURING THE TOUCH-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012444 ↗
• MalfunctionAug 22, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (CXT). THE CXT WAS ADVANCED TO THE INTENDED LOCATION AND PRIMARY DEPLOYMENT WAS PERFORMED. THE PHYSICIAN CHOSE TO MOVE THE DEVICE A LITTLE MORE PROXIMAL SO THE DEVICE WAS CONSTRAINED AND REPOSITION PROXIMALLY. ONCE IT WAS POSITIONED WHERE HE WANTED WE PROCEEDED TO 2ND STAGE DEPLOYMENT. STAGE 2 WAS ATTEMPTED AND THE RED TAB WAS MOVED BACK, BUT THE CLEAR HANDLE JUST SPUN AND WOULDN'T RELEASE. AFTER APPLYING MORE PRESSURE THE HANDLE WAS ABLE TO BE SEPARATED AND THE DEVICE DEPLOYED TO 100 PERCENT. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879980 ↗
• InjuryAug 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, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® MOLDING & OCCLUSION BALLOON (MOB). AFTER DEPLOYMENT OF ALL STENT GRAFTS, THE PROXIMAL NECK OF THE AORTA WAS FURTHER COMPRESSED USING THE MOB TO REINFORCE FIXATION. DURING THIS PROCEDURE, AN AORTIC RUPTURE WAS CONFIRMED. TO REPAIR THE RUPTURE, AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED FROM BELOW THE LEFT RENAL ARTERY, BUT HEMOSTASIS COULD NOT BE ACHIEVED. ADDITIONAL STENT GRAFTS WERE PLACED USING THE CHIMNEY TECHNIQUE FROM BELOW THE RIGHT RENAL ARTERY AND INTO THE LEFT RENAL ARTERY, RESULTING IN SUCCESSFUL HEMOSTASIS. ATTENDING PHYSICIAN¿S COMMENT: THE RUPTURE WAS LIKELY CAUSED BY OVEREXPANSION DURING BALLOON COMPRESSION.

  Patient problems: Perforation of Vessels

  MAUDE report 22844298 ↗
• InjuryAug 8, 2025Malposition of Device; Malposition of Device

  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. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED IN ALIGNMENT WITH THE LEFT RENAL ARTERY, BUT IT WAS INITIALLY POSITIONED SLIGHTLY DISTAL. THEREFORE, REPOSITIONING WAS PERFORMED, AND THE GRAFT WAS REDEPLOYED JUST BELOW THE RENAL ARTERIES. IN THE FINAL ANGIOGRAPHY, RENAL ARTERY COVERAGE WAS SUSPECTED; HOWEVER, SINCE BLOOD FLOW TO THE RENAL ARTERIES WAS CONFIRMED, NO ADDITIONAL INTERVENTION WAS UNDERTAKEN. ON (B)(6) 2025, THE PATIENT DEVELOPED ANURIA, RAISING SUSPICION OF RENAL ARTERY COVERAGE. A COMPUTED TOMOGRAPHY SCAN CONFIRMED BILATERAL RENAL ARTERY COVERAGE. REINTERVENTION WAS ATTEMPTED TO PLACE STENTS IN BOTH RENAL ARTERIES, BUT CANNULATION WAS UNSUCCESSFUL, AND STENT PLACEMENT WAS ABANDONED. THE PATIENT IS SCHEDULED TO UNDERGO DIALYSIS. IT WAS REPORTED THAT PROXIMAL MOVEMENT OCCURRED DURING THE PLACEMENT OF THE CONTRALATERAL LEG.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22746859 ↗
• InjuryJul 31, 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 AN EMERGENCY ENDOVASCULAR TREATMENT FOR AN IMPENDING RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED BELOW THE RIGHT RENAL ARTERY, BUT THE DEVICE MOVED DISTALLY ABOUT 5 MM DUE TO NECK ANGULATION. THERE WAS NO ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. TREATMENT OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WAS PLANNED AS A STAGED PROCEDURE. ON AN UNKNOWN DATE, POSTOPERATIVE FOLLOW-UP EXAMINATION SHOWED THE ANEURYSM ENLARGEMENT. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. ALTHOUGH NO OBVIOUS ENDOLEAKS WERE IDENTIFIED, AN ADDITIONAL STENT GRAFT WAS IMPLANTED IN THE PROXIMAL SIDE TO ADDRESS A SUSPECTED PROXIMAL TYPE I ENDOLEAK. FOR A SUSPECTED TYPE II ENDOLEAK VIA THE ILIOLUMBAR ARTERY, EMBOLIZATION OF THE LUMBAR ARTERY WAS PERFORMED. AS PART OF THE STAGED TREATMENT FOR THE LEFT COMMON ILIAC ARTERY ANEURYSM, THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY.

  Patient problems: Aneurysm expansion

  MAUDE report 22683629 ↗
• InjuryJul 25, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THE ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AFTER CONTRALATERAL CANNULATION, RESISTANCE WAS ENCOUNTERED WHEN ELEVATING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. FOLLOWING DEPLOYMENT OF THE CONTRALATERAL LIMB, IT WAS CONFIRMED THAT THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS HAD UNINTENTIONALLY COVERED APPROXIMATELY 80% OF THE RIGHT RENAL ARTERY. A STENT WAS PLACED IN THE RIGHT RENAL ARTERY. <PHYSICIAN¿S COMMENT> RESISTANCE WAS ENCOUNTERED WHEN ELEVATING THE SHEATH AFTER CONTRALATERAL CANNULATION. IT IS SUSPECTED THAT THE MAIN BODY MAY HAVE BEEN UNINTENTIONALLY LIFTED ALONG WITH THE SHEATH DUE TO THE APPLICATION OF EXCESSIVE FORCE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22613754 ↗
• InjuryJul 14, 2025Entrapment of Device; Device Handling Problem; Entrapment of Device; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT PRESENTED TO EMERGENCY ROOM FOR AN EMERGENT ANEURYSM RUPTURE IN AN ENDOVASCULAR PROCEDURE UTILIZING A 15FR GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THE 15FR SHEATH WAS USED FOR THE IPSILATERAL SIDE IN ORDER TO PLACE THE 23MM TRUNK IPSILATERAL LEG CONFORMABLE. THE GRAFT WAS DEPLOYED FULLY, HOWEVER, WHEN TRYING TO REMOVE THE CATHETER, THE OLIVE TIP BROKE OFF AS IT CAUGHT ON THE SHEATH. FORTUNATELY, PHYSICIAN WAS ABLE TO SNARE THE OLIVE TIP BACK INTO THE SHEATH WITH NO HARM TO PATIENT (NO PIECE LEFT INSIDE) AND REPLACED THE SHEATH WITH A 16FR SHEATH TO CONTINUE THE PROCEDURE. THE PATIENT'S ILIACS WERE NOTED TO BE TORTUOUS AND AT END OF PROCEDURE, THERE WAS A TYPE 1A ENDOLEAK WHICH PHYSICIAN ATTEMPTED TO FIX BY ADDING AN AORTIC EXTENDER BUT IT DID NOT FIX THE PROBLEM. AT THIS POINT, PHYSICIAN TRIED TO PLACE ENDO ANCHORS INTO THE GRAFT, HOWEVER, PHYSICIAN WAS ONLY ABLE TO PLACE ONE ENDOANCHOR WHEN PATIENT'S PRESSURES STARTED TO WORSEN AND THEY HAD TO OPEN THE PATIENT'S ABDOMEN. AFTER THEY SUCTIONED OUT THE PATIENT¿S BELLY, THEY WENT BACK IN AND TRIED TO PLACE THE O

  Patient problems: Ruptured Aneurysm

  MAUDE report 22492990 ↗