GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT321414Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00733132651061), received between Oct 14, 2021 and Sep 28, 2026 — classified as 2 deaths, 46 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 65 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6) 2025, the patient underwent an endovascular treatment for an abdominal aortic aneurysm using GORE® EXCLUDER® Conformable AAA Endoprosthesis and GORE® EXCLUDER®AAA Endoprosthesis devices. The patient was on dialysis. Therefore, the Trunk-Ipsilateral Leg Component was deployed distal to the superior mesenteric artery (SMA). No Endo leak was observed on completion angiography, and the procedure was completed. On an unknown date, during postoperative follow-up imaging, enlargement of the aneurysm sac was observed. A proximal Type I Endo leak and/or Type II Endo leaks were suspected. On (b)(6) 2026, reintervention was performed to address the suspected proximal type I Endo leak. Intraoperative angiography did not demonstrate a definitive proximal Type I Endo leak; however, an additional stent graft was deployed at the proximal side as a preventive measure. Angiography confirmed a Type II Endo leak originating from lumbar arteries. No treatment was performed for the Type II Endo leak, and the procedure was completed.

  Patient problems: Aneurysm expansion

  MAUDE report 50911130 ↗
• InjuryJul 27, 2026Device Endoleak

  The following was reported:On (b)(6) 2026, the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm.The patient was treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprostheses. The GORE® devices were successfully implanted. The patient was discharged on (b)(6) 2026.On (b)(6), 2026, the patient underwent a CTA.GIS noted that the patient had a Type II Endoleak.The clinical site reported that the patient had a Type IA Endoleak.The physician stated that a reintervention procedure is scheduled for (b)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 50046115 ↗
• InjuryJun 9, 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 AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER DEPLOYMENT OF THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT, ANGIOGRAPHY FOR REPOSITIONING REVEALED OCCLUSION OF THE LEFT RENAL ARTERY. THE LEFT RENAL ARTERY WAS SELECTIVELY CATHETERIZED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS PLACED FOLLOWING DEPLOYMENT OF ALL THE PLANNED DEVICES. ADEQUATE BLOOD FLOW IN THE LEFT RENAL ARTERY WAS CONFIRMED. THE PROCEDURE WAS CONCLUDED WITHOUT ANY OTHER PROBLEMS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE LEFT RENAL ARTERY WAS VISUALIZED ON THE INITIAL ANGIOGRAPHY; HOWEVER, IT WAS FOUND TO BE OCCLUDED ON ANGIOGRAPHY AFTER DEPLOYMENT OF THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG. IN ADDITION TO PRE-EXISTING STENOSIS OF THE LEFT RENAL ARTERY, THE AORTIC NECK WAS HIGHLY SHAGGY, AND IT IS CONSIDERED THAT PLAQUE SHIFT OR THROMBUS DISLODGEMENT DURING DEPLOYMENT MAY HAVE CAUSED THE OCCLUSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25439508 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLACED ON THE LEFT SIDE. COMPLETION ANGIOGRAPHY FOLLOWING STENT GRAFT DEPLOYMENT REVEALED A TYPE II ENDOLEAK, BUT NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE ANEURYSM DIAMETER WAS APPROXIMATELY 67 MM. ON AN UNKNOWN DATE, POSTOPERATIVE FOLLOW-UP IMAGING DEMONSTRATED ENLARGEMENT OF THE ANEURYSM SAC. ON (B)(6) 2026 (EXACT DATE UNKNOWN), COMPUTED TOMOGRAPHY (CT) SHOWED THAT THE ANEURYSM DIAMETER HAD INCREASED TO 77 MM. DELAYED-PHASE CT IMAGING CONFIRMED A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY. THE FINDINGS SUGGESTED ANEURYSM SAC ENLARGEMENT ASSOCIATED WITH THE TYPE II ENDOLEAK. HOWEVER, A LINEAR CONTRAST ENHANCEMENT EXTENDING FROM THE RIGHT LEG OF THE STENT GRAFT WAS ALSO OBSERVED, AND THE POSSIBILITY OF A TYPE IIIB ENDOLEAK COULD NOT BE RULED OUT. ON (B)(6) 2026, REINTERVENTION WAS PERFORMED. INTRAOPERATIVE ANGIOGRAPHY IDENTIFIED A TYPE II ENDOLEAK

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25212095 ↗
• InjuryMar 12, 2026Device Endoleak

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT281412 AND CXT321414) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLL161207, PLC181200, AND PLC201000). A PARTIAL DEPLOYMENT OCCURRED WITH THE PLC181200 DURING THE INITIAL PROCEDURE, WHICH LED TO THE LEADING END OF THE CATHETER BREAKING AND REMAINING IN THE PATIENT (REFERENCE (B)(4). ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT A TYPE 1A ENDOLEAK ON THE CXT321414. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA320005) WAS IMPLANTED TO TREAT THE ENDOLEAK. REPORTEDLY, THE ENDOLEAK WAS NOT RESOLVED FOLLOWING THIS REINTERVENTION AND IT IS UNKNOWN IF THERE WAS ANEURYSM GROWTH ASSOCIATED WITH THE ENDOLEAK. THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE ON MARCH 11, 2026, THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN EXPLANT OF ALL FIVE DEVICES IMPLANTED IN THE INITIAL PROCEDURE DUE TO A PERSISTENT TYPE 1A ENDOLEAK. THE PATIENT WAS REPAIRED DURING THE EXPLANT PROCEDURE AND TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24581569 ↗
• InjuryJan 14, 2026Adverse 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, AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, A DISTAL TYPE I ENDOLEAK WAS OBSERVED IN THE RIGHT LIMB; HOWEVER, IT WAS MANAGED WITH OBSERVATION ONLY. ON (B)(6) 2025, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A LARGE AMOUNT OF THROMBUS IN THE LEFT LIMB. NO OCCLUSION WAS IDENTIFIED. ON (B)(6) 2025, THE LIMB PULSE BECAME NON-PALPABLE, AND CT IMAGING CONFIRMED THROMBOTIC OCCLUSION OF THE LEFT LIMB. ON (B)(6) 2025, TO TREAT THE THROMBOTIC OCCLUSION, THROMBECTOMY AND BARE METAL STENT PLACEMENT WERE PERFORMED. ATTENDING PHYSICIAN¿S OPINION. THE EVENT WAS ATTRIBUTED TO ANATOMICAL FACTORS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24077316 ↗
• InjuryJan 6, 2026Malposition of Device

  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 DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. THE PROXIMAL END WAS POSITIONED JUST BELOW THE LEFT RENAL ARTERY, AND THE TRUNK IPSILATERAL LEG WAS DEPLOYED. AFTER REMOVAL OF THE TRANSPARENT KNOB, THE MAIN TRUNK MIGRATED PROXIMALLY, RESULTING IN COVERAGE OF THE DISTAL BRANCH OF THE TWO LEFT RENAL ARTERIES. TO PERFORM PTRA (PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY), THE PHYSICIAN ATTEMPTED TO DELIVER A BARE-METAL STENT (EXPRESS VASCULAR SD) USING AN 18FR SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE INSERTION VIA THE LEFT FEMORAL ARTERY. THE ACCESS SITE WAS THEN SWITCHED TO THE LEFT BRACHIAL APPROACH. SUBSEQUENTLY, AN ADDITIONAL BARE-METAL STENT WAS IMPLANTED IN THE DISTAL LEFT RENAL ARTERY. THE PHYSICIAN¿S COMMENT: ¿IT MAY HAVE BEEN PUSHED IN DURING REMOVAL OF THE TRANSPARENT KNOB.¿

  Patient problems: Obstruction/Occlusion

  MAUDE report 23986210 ↗
• InjuryJan 5, 2026Migration

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR ANEURYSM TREATMENT USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS PLACED IN ZONE 9. POST-OPERATIVE CT IMAGING (EXACT DATE UNKNOWN) LATER IDENTIFIED PROXIMAL GRAFT MIGRATION (DISTANCE UNKNOWN), WHICH RESULTED IN COVERAGE OF THE RIGHT RENAL ARTERY. THE PATIENT SUBSEQUENTLY REQUIRED A BYPASS PROCEDURE, THOUGH THE DATE OF THIS INTERVENTION WAS NOT REPORTED. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD A SHORT, CONICAL NECK THAT TAPERED TO APPROXIMATELY 7MM BEFORE WIDENING AGAIN. THE PHYSICIAN INDICATED THAT OVERSIZING WAS NECESSARY TO ACHIEVE DISTAL SEAL. THE PATIENT'S ANATOMY WAS NOT IDEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965861 ↗
• MalfunctionDec 18, 2025Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, AFTER THE GRAFT WAS DEPLOYED (THERE WAS NO REPORTED DIFFICULTY DEPLOYING THE GRAFT), PHYSICIAN WAS REMOVING THE DELIVERY CATHETER, IT GOT CAUGHT ON SOMETHING. PHYSICIAN IS UNSURE, IF THERE WAS GORE SHEATH INTERACTION OR IF IT WAS DUE TO PATIENT'S TORTUOUS ANATOMY AND THEY USED EXTRA FORCE TO PULL THE CATHETER OUT AND WITH THAT IT SEPARATED THE HYPO TUBE AND THE BLUE DELIVERY CATHETER. THEY WERE ABLE TO SNARE THE TIP OF THE OF THE EXCLUDER AND THE DELIVERY CATHETER THEN PULL IT BACK OUT OF THE BODY. NO HARM WAS DONE TO THE PATIENT AND DEVICE WAS DEPLOYED CORRECTLY, FIELD SALES ASSOCIATE WAS NOT PRESENT FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841753 ↗
• MalfunctionNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THERE WAS DEVICE FAILURE WITH THE PLASTIC SHEATH BREAKING OFF INSIDE PATIENT. ON NOVEMBER 03, 2025, ADDITIONAL INFORMATION RECEIVED: PHYSICIAN NOTICE A SMALL PIECE OF THE NOSE CONE WAS MISSING WHEN HE REMOVED THE DELIVERY SYSTEM POST EVAR PROCEDURE (NO RESISTANCE FELT). CASE WAS SUCCESSFULLY COMPLETED AND THEY COULD NOT VISUALIZE THE PIECE UNDER IMAGING. THEY ARE NOT SURE IF THE PIECE WAS MISSING BEFORE IT WENT INTO PATIENT. PATIENT IS DOING WELL WITH NO ISSUES REPORTED. 1600-E:-CATHETER EVENTS - OTHER/UNKNOWN IS USED TO CAPTURE THE MISSING NOSE CONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639787 ↗
• InjuryNov 12, 2025Entrapment of Device; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Entrapment of Device; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN EVAR PROCEDURE UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (CXT) DEVICE. REPORTEDLY, DURING THE PROCEDURE THE PHYSICIAN ROTATED THE MAIN BODY TO FACILITATE CANNULATION OF THE CONTRALATERAL GATE. THE ROTATIONS REPORTEDLY CAUSED THE IPSILATERAL BRANCH TO FAIL TO OPEN COMPLETELY. THIS COULD HAVE BEEN DUE TO THE PHYSICIAN ROTATING THE DEVICE BY 180 DEGREES SEVERAL TIMES OR ROTATING TOO HARD. THIS EVENT WAS NOT INITIALLY DETECTED DUE TO POOR IMAGE QUALITY ON THE FLUOROSCOPY UNIT. FOLLOWING THE ROTATIONS, THE CONTRALATERAL GATE WAS SUCCESSFULLY CANNULATED AND A CONTRALATERAL LIMB WAS DEPLOYED SUCCESSFULLY. SUBSEQUENTLY, THE IPSILATERAL BRANCH OF THE CXT WAS DEPLOYED. THE DISTAL PORTION OF THE IPSILATERAL BRANCH, JUST ABOVE THE INTERNAL ILIAC, OPENED COMPLETELY, BUT THE PORTION OF THE IPSILATERAL BRANCH THAT GOT TWISTED DID NOT OPEN COMPLETELY. REPORTEDLY, WHILE ATTEMPTING TO REMOVE THE DELIVERY CATHETER FROM THE DEPLOYED CXT, THE OLIVE TIP (STILL ATTACHED TO THE DELIVERY CATHETER) BECAME STUCK AND COULD NOT BE REMOVED AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO AN OPEN SURGER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535106 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION IN A SURGICAL AORTIC VALVE (TAV IN SAV). DURING THE PROCEDURE, AN ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK AND SUSPICION OF A DISTAL TYPE I ENDOLEAK; THEREFORE, ADDITIONAL STENT GRAFTS WERE PLACED IN EACH SITE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23483337 ↗
• DeathNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT WAS CONVERTED TO OPEN AND EXPLANT OF ALL THE DEVICES WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT'S AORTA WAS SEVERELY INFECTED WITH AREAS OF HARD INFECTION AND OTHER AREAS FULL OF CLEAR PUSS WHICH WAS SUCKED OUT AND REMOVED. THE PHYSICIAN WONDERED WHETHER OR NOT THE PATIENT HAD A PRE-EXISTING INFECTION. HE DID NOT KNOW AS THE INDEX PROCEDURE WAS PERFORMED BY ANOTHER PHYSICIAN AT A DIFFERENT HOSPITAL. POST EXPLANT OF ALL DEVICES DURING CLOSING, WHEN THE PHYSICIAN REMOVED THE CLAMP ON THE SUPER CELIAC, THE PATIENT'S BLOOD PRESSURE TANKED AND THE PATIENT CODED. CPR WAS PERFORMED BUT THEY WERE NOT ABLE TO GET THE PATIENT BACK, HE EXPIRED DURING CLOSING. ACTUAL CAUSE OF DEATH WAS NOT KNOWN.

  Patient problems: Pyogenic Infection

  MAUDE report 23472016 ↗
• InjurySep 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) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, DISTAL MOVEMENT OCCURRED, BUT THE POSITION WAS CORRECTED USING THE CONSTRAINING SYSTEM. ON AN UNKNOWN DATE, ALTHOUGH NO DEFINITIVE ENDOLEAK WAS IDENTIFIED, ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION AS A PREVENTIVE MEASURE AGAINST A POTENTIAL ENDOLEAK. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS PLACED EXTENDING INTO THE RIGHT EXTERNAL ILIAC ARTERY.

  Patient problems: Aneurysm expansion

  MAUDE report 22960777 ↗
• InjuryAug 29, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). AFTER DEPLOYMENT OF ALL THE PLANNED DEVICES, AN INTRAOPERATIVE ANGIOGRAPHY SHOWED THAT THE LEFT RENAL ARTERY WAS UNINTENTIONALLY PARTIALLY (ABOUT 80%) COVERED BY THE TRUNK-IPSILATERAL LEG. AN ADDITIONAL BARE-METAL STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: VISUALIZATION FOR THE RENAL ARTERIES MIGHT NOT HAVE BEEN PERFECT. OR, THE STENT GRAFT POSITIONING MIGHT HAVE BEEN ALTERED ON BALLOONING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22920853 ↗
• InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING DEPLOYMENT OF THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, MOVEMENT TO DISTAL SIDE OCCURRED. REPOSITIONING WAS PERFORMED USING THE CONSTRAINING SYSTEM. ON COMPLETION ANGIOGRAPHY, FINDINGS SUGGESTIVE OF A PROXIMAL TYPE I ENDOLEAK WERE OBSERVED. BALLOON DILATION WAS ATTEMPTED, BUT NO IMPROVEMENT WAS NOTED. DUE TO POOR VASCULAR CONDITION AT THE AORTIC NECK, NO FURTHER TREATMENT WAS PERFORMED. ON AN UNKNOWN DATE, DURING FOLLOW-UP, A PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK WAS SUSPECTED. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE ENDOLEAKS. FOR THE PROXIMAL TYPE I ENDOLEAK, COIL EMBOLIZATION WAS PERFORMED OUTSIDE THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. EMBOLIZATION WAS ALSO PERFORMED TO TREAT TYPE II ENDOLEAKS ORIGINATING FROM THE LUMBAR ARTERY AND THE LEFT INTERNAL ILIAC ARTERY. ADDITIONALLY, TO REPAIR A RIGHT INTERNAL ILIAC ARTERY ANEURYSM (OUTSIDE THE TREATMENT

  Patient problems: Clinical Endoleak

  MAUDE report 22746898 ↗
• MalfunctionJul 30, 2025Defective Component; Defective Component

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO COMPLETE STAGE 1 OF DEPLOYMENT, THE PHYSICIAN ROTATED THE WHITE HANDLE AND PULLED (FIRST STAGE OF DEPLOYMENT) THE HANDLE; THERE WAS A GOOD AMOUNT OF STRING THAT CAME WITH IT, BUT THE GRAFT DID NOT DEPLOY AT ALL. WE REMOVED THE FULLY CONSTRAINED DEVICE THROUGH THE SHEATH AND IMPLANTED ANOTHER DEVICE IN IT¿S PLACE TO CONCLUDE THE PROCEDURE. THE DEVICE WAS INSPECTED ON THE BACK TABLE AND CONFIRMED THE DEPLOYMENT LINE (STRING) TORE NEAR THE GRAFT. THE DEVICE WAS NOT DEPLOYED AND NOTHING WAS EXPLANTED. IT WAS WITHDRAWN FROM THE PATIENT AND ANOTHER DEVICE WAS USED WITHOUT ISSUE TO CONCLUDE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667500 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC AND ILIAC ARTERY ANEURYSM FROM DISSECTION AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES IN THE INFRARENAL ABDOMINAL AORTA, A GORE® EXCLUDER®AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE IN THE LEFT COMMON ILIAC ARTERY, AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES IN THE RIGHT COMMON ILIAC ARTERY. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 56MM, WITH A PROXIMAL LANDING ZONE DIAMETER OF 25MM. ADDITIONALLY, THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND COVERED; AND THE RIGHT RENAL ARTERY WAS STENTED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A TYPE II ENDOLEAK AND WAS EXPERIENCING RIGHT SIDE LOWER BACK PAIN/BUTTOCK CLAUDICATION; AND WAS DETERMINED TO HAVE A TYPE II ENDOLEAK. NO TREATMENT WAS REQUIRED, HOWEVER IN PATIENT HOSPITALIZATION WAS UTILIZED; THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 22289711 ↗
• InjuryMay 16, 2025Device Dislodged or Dislocated; Device Endoleak; Device Dislodged or Dislocated; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE TGR23-02AA TOGETHER AORTIC REGISTRY: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER®¿CONFORMABLE AAA ENDOPROSTHESIS (EXCC) TRUNK-IPSILATERAL LEG COMPONENT IN THE INFRARENAL ABDOMINAL AORTA AND A GORE®¿EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT IN THE RIGHT COMMON ILIAC ARTERY. THE DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON (B)(6) 2024, A TYPE III ENDOLEAK AND CONTAINED ANEURYSM RUPTURE WERE OBSERVED. ON (B)(6) 2024, A TYPE IV ENDOLEAK WAS ALSO REPORTED. ON THE SAME DATE, A REINTERVENTION WAS PERFORMED WHEREBY THE DEVICE SYSTEM WAS RELINED USING A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT AND BILATERAL ILIAC LIMBS. THE ANEURYSM RUPTURE WAS NOTED AS RESOLVED ON (B)(6) 2024. THE TYPE IV ENDOLEAK WAS NOTED AS RESOLVED ON (B)(6) 2024.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22040712 ↗
• InjuryMay 16, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE TGR23-02AA TOGETHER AORTIC REGISTRY: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) TRUNK-IPSILATERAL LEG COMPONENT IN THE INFRARENAL ABDOMINAL AORTA. THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA WAS 96MM. THE DEVICE WAS SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON (B)(6) 2024, A TYPE II ENDOLEAK WAS OBSERVED, EMBOLIZED, AND WAS NOTED TO BE RESOLVED. ON THE SAME DATE, THE TYPE II ENDOLEAK WAS OBSERVED AGAIN. ON (B)(6) 2024, COIL EMBOLIZATION OF MULTIPLE ILIOLUMBAR BRANCHES AND THE INFERIOR MESENTERIC ARTERY WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. THE ADVERSE EVENT WAS NOTED AS RESOLVED ON (B)(6) 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 22040660 ↗
• InjuryMay 16, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE TGR23-02AA TOGETHER AORTIC REGISTRY: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS (EXCC) TRUNK-IPSILATERAL LEG COMPONENT IN THE INFRARENAL ABDOMINAL AORTA. THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA WAS 96MM. THE DEVICE WAS SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON (B)(6) 2024, A TYPE II ENDOLEAK WAS OBSERVED. ON (B)(6) 2024, AN EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. THE ENDOLEAK WAS NOTED TO BE RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 22040370 ↗
• InjuryMay 15, 2025Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: A PATIENT WAS TREATED ON (B)(6) 2022, FOR AN EMERGENT RUPTURE USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC), CXT321414. ON (B)(6) 2025, THE PATIENT PRESENTED EMERGENTLY WITH AN AORTIC RUPTURE IN THE TREATED AREA. ON CT SCAN, THE EXCC WAS SITTING DOWN NEAR THE BIFURCATION, HAVING MIGRATED ABOUT 6CM. THE PHYSICIAN REINTERVENED, USING 7 GORE DEVICE TO RELINE THE GRAFT. DUE TO THE RUPTURE, THE PATIENT REQUIRED AN INTRAOPERATIVE TRANSFUSION - 2 UNITS OF RED, AND 2 FFP. REPORTEDLY, THE PROXIMAL END OF THE DEVICE HAD SEAL IN 2022, BUT THE AORTIC NECK HAD DILATED TO 32CM. THE CONTRALATERAL LEGS HAD NOT MOVED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22027172 ↗
• InjuryApr 23, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND THE LEFT INTERNAL ILIAC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER DEPLOYING THE TRUNK IPSILATERAL LEG, THE BALLOON WAS INFLATED INSIDE THE PROXIMAL END. THIS EXTENDED THE DEVICE DEPLOYED IN A SLIGHTLY BENT STATE, RESULTING IN THE COVERAGE OF THE RIGHT RENAL ARTERY. ALTHOUGH A DECREASE IN BLOOD FLOW WAS OBSERVED VIA ANGIOGRAPHY, THE BLOOD FLOW IN THE RIGHT RENAL ARTERY WAS MAINTAINED. DUE TO THE DIFFICULTY IN CANNULATION, NO FURTHER TREATMENT WAS PERFORMED, AND THE PATIENT WAS PLACED UNDER OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿IT WAS A CHALLENGING CASE AS THE PATIENT HAD A RUPTURED ANEURYSM, AND DUE TO THE POOR SHAPE OF THE PROXIMAL NECK.¿

  Patient problems: Obstruction/Occlusion

  MAUDE report 21891381 ↗
• DeathApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 9 ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT321414, PLL161207, PLL161007, AND PLC121000). DURING THE PROCEDURE, ALL DEVICES WERE IMPLANTED WITH NO ISSUES. SOON AFTER THE PATIENT'S BLOOD PRESSURE SEEMED TO DROP, BILATERAL ILIAC RUPTURE WAS OBSERVED, AND PATIENT EXPIRED. IT WAS ALSO REPORTED PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. PHYSICIAN ALSO REPORTED PATIENT HAD A VERY THIN ARTERY. NO FURTHER PATIENT OR CASE INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 21875040 ↗
• InjuryApr 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND THE LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. TOTAL 4 STENT GRAFTS (1X TRUNK IPSILATERAL LEG, 3X CONTRALATERAL LEGS) WERE IMPLANTED. ON (B)(6) 2025, A FOLLOW-UP CT SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. A TYPE I ENDOLEAK WAS OBSERVED ON THE PROXIMAL SIDE OF THE MAIN TRUNK VIA ANGIOGRAPHY. AN ADDITIONAL STENT GRAFT WAS IMPLANTED ON THE PROXIMAL SIDE AS A TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE PROXIMAL NECK WAS SEVERELY BENT, AND THE VASCULAR CONDITION WAS POOR.¿

  Patient problems: Clinical Endoleak

  MAUDE report 21863162 ↗