GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231214Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132622337), received between Dec 21, 2018 and Nov 14, 2023 — classified as 1 death, 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND CONTRALATERAL LEG. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT ADDITIONAL SURGERY TO TREAT A TYPE II ENDOLEAK. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO TAKE NO FURTHER ACTION TO TREAT THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18131198 ↗
• InjuryApr 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION WAS UNAVAILABLE.

  Patient problems: Aneurysm expansion

  MAUDE report 16792520 ↗
• InjuryMay 19, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2022 THE PATIENT WAS ADMITTED FOR EVAR (AAA). AS REPORTED THE DEVICE WAS INSERTED IN THE STANDARD FASHION, MARKED THE RENAL ARTERIES, DEPLOYED THE GRAFT, CANNULATED, BROUGHT THE GRAFT DOWN INTO POSITION UNDER THE RENAL ARTERIES. IT WAS NOTED THAT THE RENAL ARTERIES MAY HAVE BEEN PARTIALLY COVERED. THE RENAL ARTERIES SEEMED TO BE ABOUT EQUAL IN POSITION BUT ON CT THE RIGHT RENAL WAS LOWER. THE SURGEON ELECTED TO CANNULATE THE RENAL ARTERIES AND PLACED NON-GORE STENTS (VISI-PRO) IN ORDER TO ENSURE FLOW AND TO PREVENT ANY MIGRATION OF THE RLT231214 GRAFT PROXIMALLY FOLLOWING THE PROCEDURE. FOLLOWING THIS THE RENAL ARTERIES WERE CONFIRMED TO BE PATENT, THERE WERE NO OBSERVED LEAKS AND ALL STENTS APPEARED TO BE IN GOOD POSITIONS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14438733 ↗
• InjuryApr 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICE WAS FULLY DEPLOYED, AND A BALLOON WAS USED TO HELP SEAT THE GRAFT. IN DOING SO, THE AORTA RUPTURED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED TO COVER THE RUPTURED AREA. BECAUSE OF THE LOCATION OF THE RUPTURE, THE RIGHT RENAL WAS COVERED BY THE EXCLUDER. THE PATIENT TOLERATED THE PROCEDURE. THE AORTA WAS HEAVILY CALCIFIED IN THE AREA OF THE IMPLANT, AND IT IS BELIEVED THE PHYSICIAN OVERINFLATED THE BALLOON, CAUSING THE RUPTURE.

  Patient problems: Rupture

  MAUDE report 11694878 ↗
• DeathFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM WITH SHORT DISTANCE CLAUDICATION OF BOTH LOWER EXTREMITIES AND BILATERAL ILIAC ARTERY OCCLUSIONS; WITH COMPLETE OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY (RCIA) AND LEFT COMMON ILIAC ARTERY (LCIA). POST DISSECTION OF THE BILATERAL CIA¿S A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS ADVANCED AND DEPLOYED WITHIN THE RCIA AND EXTENDED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DOWN TO THE REIA AND INFLATED TO 12MMHG. A 16 FR SHEATH WAS THEN ADVANCED THROUGH THE RIGHT ILIAC VIABAHN® SYSTEM AND A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT FEATURING C3® DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED JUST DISTAL TO THE RENAL ARTERIES. A SECOND TRUNK IPSILATERAL LEG COMPONENT OF THE SAME SIZE WAS THEN ADVANCED AND DEPLOYED TO OVERLAP THE FIRST ONE. ANGIOPLASTY OF THE ENTIRE SYSTEM WAS PERFORMED ALL THE WAY DOWN TO THE COMMON AND EXTERNAL ILIAC¿S. COMPLETION ANGIOGRAPHY DEMONSTRATED NO ENDOLEAK AND A WIDELY PATENT GRAFT SYSTEM AND A FEMORAL TO FEMORAL ARTERY BYPASS WAS PERFORMED. AN ANGIOGRAPH WAS PERFORMED AND SHOWED TWO AREAS O

  Patient problems: Cardiogenic Shock; Hypovolemic Shock

  MAUDE report 11382114 ↗
• InjuryDec 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY IDENTIFIED A TYPE IA ENDOLEAK, AND A TYPE IB ENDOLEAK ON THE RIGHT (CONTRALATERAL) SIDE. THE CAUSE OF THE ENDOLEAKS IS NOT KNOWN, BUT IT WAS SUSPECTED THAT CALCIFICATION IN THE INFRARENAL NECK AND ILIAC ARTERIES MAY HAVE BEEN A CONTRIBUTING FACTOR. THE ANEURYSM SAC MEASURED 4.5CM X 5.1CM ON THIS DATE. ON (B)(6) 2020, A FOLLOW-UP EXAMINATION REPORTEDLY CONFIRMED THE TYPE IA AND IB ENDOLEAKS. THE ANEURYSM SAC MEASURED 5.6CM X 5.2CM ON THIS DATE. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY TO TREAT THE TYPE IA ENDOLEAK. THE PHYSICIAN ALSO COIL-EMBOLIZED THE RIGHT HYPOGASTRIC ARTERY, AND THEN IMPLANTED AN ILIAC EXTENDER COMPONENT DISTALLY TO TREAT THE TYPE IB ENDOLEAK. BOTH ENDOLEAKS WERE RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 11087960 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Activation Failure; Patient-Device Incompatibility; Activation Failure

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY A PROXIMAL AND DISTAL ABDOMINAL AORTIC ANEURYSM WERE PRESENT WITH A NARROW SPACE BETWEEN THE TWO ANEURYSMS. IT WAS REPORTED THAT A TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED ON THE PATIENT'S RIGHT SIDE AND DEPLOYED WITH THE CONTRALATERAL LEG GATE LOCATED IN THE NARROW PORTION OF THE AORTA BETWEEN THE TWO ANEURYSMS. REPORTEDLY, DUE TO THE PATIENT'S ANATOMY, THE CONTRALATERAL LEG GATE WAS CRUSHED UPON DEPLOYMENT OF THE PROXIMAL TRUNK. THE INABILITY OF THE CONTRALATERAL LEG GATE TO OPEN WAS REPORTEDLY SOLELY DUE TO PATIENT ANATOMY. AN ADDITIONAL TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED AND DEPLOYED WITHIN THE INITIAL TRUNK-IPSILATERAL LEG COMPONENT. AN AORTO-UNI-ILIAC PROCEDURE AND RIGHT TO LEFT FEMORAL TO FEMORAL BYPASS WERE PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10697673 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A TYPE II ENDOLEAK. GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ADDITIONAL DEVICE WAS UNABLE TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10589995 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, COMPUTED TOMOGRAPHY IMAGES (DATE IS NOT KNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE WAS ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN REINTERVENED ON (B)(6) 2019, AND IMPLANTED A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9462165 ↗
• InjuryNov 5, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A "SIGNIFICANT CHUNK OF THROMBUS" THAT WAS ATTACHED TO THE DISTAL AORTA NEAR THE AORTIC BIFURCATION. THE THROMBUS WAS SHOWERING INTO THE PATIENTS LEGS. THE PHYSICIAN PLANNED TO TRAP THE THROMBUS AGAINST THE DISTAL AORTA USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED WITH THE IPSILATERAL LEG ON THE RIGHT SIDE, AND THE CONTRALATERAL LEG COMPONENT ON THE LEFT SIDE. AN ILIAC EXTENDER COMPONENT WAS ALSO IMPLANTED ON THE RIGHT SIDE. LATER ON THE SAME DAY, THE PHYSICIAN REPORTED THAT THE IPSILATERAL SIDE OF THE TRUNK-IPSILATERAL COMPONENT AND THE ILIAC EXTENDER COMPONENT HAD BECOME OCCLUDED. IT IS BELIEVED THAT THE THROMBUS IN THE DISTAL AORTA WAS PUSHING AGAINST THE IPSILATERAL LEG AND BLOOD FLOW WAS HINDERED FROM GOING DOWN THE IPSILATERAL SIDE, THUS CONTRIBUTING TO THE OCCLUSION. ON (B)(6) 2019, BOTH GORE DEVICES WERE EXPLANTED. AN AORTO-UNI-ILIAC BYPASS WAS PERFORMED ON THE PATIENT¿S RIGHT SIDE, AND AN AORTO-FEMORAL BYPASS WAS COMPLETED ON THE PATIENT¿S LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE. NO OTHER INFORMATION WAS GIVEN, AND

  Patient problems: Occlusion

  MAUDE report 9278593 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP IMAGES (DATE AND MODALITY IS UNKNOWN), AT THE DISTAL BIFURCATION GOING INTO THE IPSILATERAL LIMB (RLT231214/20489416) HAD THROMBOSED. THE AREA WAS STILL PATENT. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND PERFORMED A THROMBECTOMY AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8871176 ↗
• InjuryJul 10, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE AORTIC NECK WAS DESCRIBED AS HIGHLY ANGULATED, APPROXIMATELY 60 DEGREES. PERCUTANEOUS RIGHT FEMORAL ACCESS WAS OBTAINED. THE TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED. THE FIRST STAGE OF DEPLOYMENT WAS COMPLETED, SEATING THE DEVICE JUST BELOW THE LOWEST RENAL ARTERY. THE CANNULATION OF THE CONTRALATERAL GATE WAS ACCOMPLISHED. A CONFIRMATION ANGIO RUN WAS COMPLETED. IT WAS NOTED THE TRUNK-IPSILATERAL LEG HAD MIGRATED APPROXIMATELY 1CM. THE DEVICE WAS RECONSTRAINED AND POSITIONED, THEN DEPLOYED. UPON ANOTHER FLUORO RUN, IT WAS DISCOVERED THE IPSILATERAL-LEG ON THE RIGHT SIDE HAD COVERED HYPOGASTRIC ARTERY. ADDITIONALLY, THE TRUNK-IPSILATERAL-LEG COMPONENT SLIPPED AGAIN, DISTALLY. SO A MEDTRONIC CUFF WAS ADVANCED AND DEPLOYED TO EXTEND TREATMENT TO THE LOWEST RENAL. THE PATIENT TOLERATED PROCEDURE AND DID WELL IN FOLLOW-UP.

  Patient problems: Occlusion

  MAUDE report 8776357 ↗
• InjuryFeb 28, 2019Partial Blockage; Patient-Device Incompatibility; Partial Blockage; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE IT WAS NOTED THAT THE AORTIC DIAMETER AT THE LEVEL OF THE TRUNK-IPSILATERAL LEG COMPONENT FLOW DIVIDER WAS, "13MM-14MM." REPORTEDLY, IT WAS SUSPECTED THAT POST-DEPLOYMENT BALLOONING OF THE CONTRALATERAL GATE MAY HAVE CAUSED THE IPSILATERAL LIMB TO PARTIALLY COLLAPSE. IT WAS REPORTED THAT, ON (B)(6) 2019, THROMBUS WAS NOTED IN THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT BELOW THE DEVICE FLOW DIVIDER. IT WAS ALSO REPORTED THAT THE CONTRALATERAL LEG COMPONENT LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY, WAS OCCLUDED. IT WAS REPORTED THAT, ON (B)(6) 2019, A THROMBECTOMY WAS PERFORMED, AND THE PHYSICIAN DEPLOYED TWO BARE METAL STENTS WITHIN THE TRUNK-IPSILATERAL LEG AND CONTRALATERAL LEG COMPONENTS, CREATING A NEW FLOW DIVIDER. THE PROCEDURE WAS CONCLUDED AND NO FURTHER ISSUES WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 8380262 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH SPINAL CORD ISCHEMIA AND COULD NOT MOVE HER LEGS. NO SPINAL DRAIN WAS PLACED DURING THE PROCEDURE. NO ARTERIES WERE UNINTENTIONALLY COVERED. THE CAUSE OF PARALYSIS IS UNKNOWN. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH.

  Patient problems: Aneurysm

  MAUDE report 8192107 ↗

Recalls under the same FDA submission

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

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