GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261412Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00733132622443), received between Sep 19, 2018 and Sep 28, 2026 — classified as 7 deaths, 47 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Failure to Seal

  Patient problems: Clinical Endoleak

  MAUDE report 50918116 ↗
• InjuryAug 7, 2026Malposition of Device; Migration

  It was reported to Gore that, on (b)(6) 2026, a GORE® EXCLUDER® AAA Endoprosthesis was used for an endovascular aneurysm repair (EVAR). During preparation for introduction of the iliac component on the ipsilateral side, the 18 Fr GORE® DrySeal Flex Introducer Sheath was re-advanced and encountered some resistance. The clinician pushed the sheath past the resistance, causing proximal migration of the GORE® EXCLUDER® AAA Endoprosthesis trunk, resulting in coverage of the renal arteries. A chimney procedure was subsequently performed without complications and blood flow to both renal arteries was maintained. The patient tolerated the procedure.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 50170368 ↗
• MalfunctionFeb 10, 2026Material Invagination; Difficult to Advance; Activation Failure

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2026, A PATIENT WAS IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY WAS INTRODUCED SUCCESSFULLY FROM THE LEFT SIDE VIA A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH FOLLOWED BY THE FIRST DEPLOYMENT STEP. THE ANGIOGRAPHIC IMAGES SHOW THAT THE OPENING OF THE CONTRALATERAL LIMB WAS TYPICAL, BUT WITH A NARROWING/DENTING AT THE PROXIMAL PART OF THE FLOW DIVIDER. THERE ARE NO ANATOMICAL CONSTRAINTS RECOGNIZED. THE CONTRA GATE WAS CANNULATED, BUT THE GUIDEWIRE COULD NOT BE ADVANCED TOWARDS PROXIMAL; DUE TO THE NARROWING AT THE LEVEL OF THE FLOW DIVIDER. MULTIPLE ATTEMPTS WERE MADE USING DIFFERENT GUIDEWIRES AND CATHETERS. EVENTUALLY, A SMALL OPENING COULD BE CREATED, ALLOWING THE GUIDEWIRE TO BE ADVANCED UPWARD. A 12 F SHEATH COULD BE INSERTED. THE IMPLANTATION WAS THEN COMPLETED WITHOUT FURTHER ISSUES, AND THE PATIENT IS IN GOOD CONDITION. THE NARROWING WAS NO LONGER PRESENT AT THE END OF THE PROCEDURE. THE CONTRALATERAL LEG COMPONENT OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IS NOT AFFECTED BY THIS NARROWING PRE-CANNULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307783 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PHYSICIAN WAS GOING TO DO AN EXPLORATORY ANGIOGRAM TO TREAT AN UNKNOWN ENDOLEAK (EITHER PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK). UPON CONFIRMATION, THE PHYSICIAN WILL TREAT DURING PROCEDURE. THERE IS REPORTEDLY ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN).

  Patient problems: Clinical Endoleak

  MAUDE report 23856251 ↗
• InjuryJun 30, 2025Activation Failure; Activation Failure

  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® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE MAIN BODY, THE CONTRA GATE IMMEDIATELY WAS "CRUSHED". IT DID NOT FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO REPOSITION THE DEVICE TO RESOLVE THE ISSUE, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN FULLY DEPLOYED THE DEVICE TO 100 PERCENT AND DEPLOYED THE MAIN BODY, AND ATTEMPTED TO COME UP AND OVER THE FLOW DIVIDER, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN THEN IMPLANTED 2 CONTRALATERAL LIMBS AND EXTENDED DOWN TO THE RIGHT COMMON AND CONVERTED TO AN AUI. THE AUI WAS UNPLANNED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22361143 ↗
• DeathApr 3, 2025Migration or Expulsion of Device; Malposition of Device; Migration; Migration or Expulsion of Device; Malposition of Device; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ENSUING INITIAL DEPLOYMENT OF THE GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT261412, THE PHYSICIAN REPOSITIONED THE DEVICE, DISENGANGED THE CONSTRAINING MECHANISM AND REMOVED THE TRANSPARENT KNOB FROM THE CATHETER HANDLE, WHICH REMOVED THE CONSTRAINING LOOP FROM THE DEVICE. IMMEDIATELY THEREAFTER, THE DEVICE COMPONENT WAS REPORTED TO HAVE JUMPED AND MIGRATED PROXIMALLY FOR A LENGTH OF MORE THAN 20 MM. AS IT WAS NOT POSSIBLE TO CORRECT THE POSITION OF THE DEVICE COMPONENT BY ENDOVASCULAR MEANS, THE PHYSICIAN DECIDED TO PERFORM OPEN SURGERY TO REMOVE THE DEVICE. HOWEVER, THE PATIENT EXPERIENCED SUBSTANTIAL BLOOD LOSS DURING THE SURGERY, RESULTING IN HYPOXIC BRAIN DAMAGE. FOLLOWING THE PATIENT¿S WILL, HIS FAMILY AS A HEALTH CARE PROXY DECIDED TO NO LONGER EXTEND HIS LIFE. THE PATIENT EXPIRED A FEW DAYS POST PROCEDURE ON AN UNKNOWN DATE IN THE INTENSIVE CARE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21767035 ↗
• InjuryMar 20, 2025Device Dislodged or Dislocated; Device Endoleak; Device Dislodged or Dislocated; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WITH AN EXTREME TORTUOUS COMMON ILIAC ARTERY WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (BOTH THE ILIAC BRANCH COMPONENT AND THE INTERNAL ILIAC COMPONENT) WAS PLACED SUCCESSFULLY. THE MAIN BODY (GORE® EXCLUDER® AAA ENDOPROSTHESIS - (B)(6)) WAS PLACED, THE CONTRALATERAL LEG CANNULATED, AND TWO BRIDGE LIMBS WERE PLACED. THESE TWO BRIDGE LIMBS (GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT CONTRALATERAL LEG COMPONENTS) WERE REPORTEDLY NECESSARY DUE TO THE ANGULATION AND DIFFICULTY INTERPRETING THE NEEDED LENGTH. THE IPSILATERAL SIDE OF THE MAIN BODY WAS ALSO EXTENDED WITH A FLARED LIMB. WHEN BALLOONING IT WAS CLEAR THAT THE BRIDGE LIMB WAS DISCONNECTED FROM THE MAIN BODY (NO MIGRATION OF THE MAIN BODY). THERE WAS NO WIRE THROUGH THE LIMB, THEREFORE IMPOSSIBLE TO CANNULATE THE CONTRALATERAL LEG OF THE MAIN BODY. THE PHYSICIANS DECIDED TO CONVERT THE PATIENT TO OPEN AND MAKE A HAND MADE END-TO-END ANASTOMOSIS FROM THE BRIDGE AND THE CONTRALATERAL LEG, THIS SO THEY DIDN¿T HAVE TO EXPLANT ALL THE DEVICES. THE PROXIMAL PART OF THE BR

  Patient problems: Clinical Endoleak

  MAUDE report 21650348 ↗
• InjuryMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. ON (B)(6) 2025, IT WAS DISCOVERED THAT THE RIGHT COMMON ILIAC OF THE PATIENT HAD DILATED. ON (B)(6) 2025, THE PHYSICIAN REINTERVENED EXTENDING WITH A CONTRALATERAL LEG DEVICE.

  Patient problems: Aneurysm expansion

  MAUDE report 21606687 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH THE IMPLANTED GRAFT PARTIALLY THROMBOSED IN BOTH ILIAC ARTERY LIMBS AND THE MAIN BODY OF THE GRAFT HAD COLLAPSED DUE TO ANGULATION OF THE AORTA. ON (B)(6) 2025, A REINTERVENTION OF 24-HOUR LYSIS WAS INITIATED, RESULTING IN THE RESTORATION OF BLOOD FLOW TO THE PARTIALLY THROMBOSED AREA. ON (B)(6) 2025, AFTER LYSIS COMPLETED, A SUPRA RENAL FIXATION CUFF WAS IMPLANTED PROXIMAL TO THE IMPLANTED GRAFT. AN ADDITIONAL GRAFT WAS IMPLANTED DISTALLY TO EXTEND THE LIMB ON THE LEFT SIDE. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Thromboembolism

  MAUDE report 21351517 ↗
• MalfunctionJan 14, 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE TRUNK IPSILATERAL LEG C3 DEVICE WAS FULLY DEPLOYED INCLUDING THE IPSILATERAL SIDE AND UPON TRYING TO REMOVE THE DELIVERY CATHETER FROM THE PATIENT, IT WAS NOTICED THAT EXCLUDER GRAFT WAS FOLDING IN TOWARDS THE NOSE CONE AND THE DEVICE WAS MIGRATING WITH THE MAIN BODY CATHETER. PHYSICIAN ATTEMPTED TO TAKE THE NOSE CONE HIGHER AND THE WHOLE DEVICE MOVED PROXIMALLY (2-3CM) AND COVERED THE RENAL ARTERIES MOMENTARILY. PHYSICIAN THEN TRIED TO BRING THE NOSE CONE DISTALLY AND THE GRAFT MIGRATED BACK WITH IT BELOW THE RENAL ARTERIES WITH NO SERIOUS INJURY OF RENAL COMPLICATIONS. AFTER WHICH, PHYSICIAN CANNULATED THE CONTRALATERAL SIDE AND BALLOONED THE PROXIMAL NECK. HOWEVER, THEY WERE STILL UNABLE TO RETRIEVE MAIN BODY WITHOUT THE GRAFT COMING WITH IT. PHYSICIAN INFLATED A BALLOON WHILST TRYING TO PULL BACK THE CATHETER AND WERE UNABLE TO MOVE THE CATHETER OUT WITHOUT MOVING THE GRAFT. THEY CHECKED THE HATCH ON THE HANDLE AFTER DEPLOYMENT WAS COMPLETED TO MAKE SURE ALL THE LINES WERE DEPLOYED AND ALL OF THEM WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152410 ↗
• InjuryJan 10, 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) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A BILATERAL ILIAC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2024, THE PATIENT WAS BROUGHT IN TO THE HOSPITAL AS THE PROXIMAL NECK OF THE TRUNK IPSILATERAL LEG WAS COMPROMISED OR CRUSHED AS THE LEFT RENAL ARTERY HAD BECOME ANEURYSMAL AND ANEURYSM SAC CONTINUED TO GROW (SIZE UNKNOWN) WHICH PUT PRESSURE ON THE GRAFT AND PATIENT CLOTTED BILATERALLY. BLOOD FLOW WAS COMPROMISED WITH PARTIAL OCCLUSION. PHYSICIAN USED A PENUMBRA DEVICE TO SUCK THE CLOTS OUT THEN REALIGNED THE PROXIMAL END WITH AORTIC CUFF AND TWO 27X10 CONTRALATERAL LEGS. PHYSICIAN ALSO IMPLANTED A 7X9 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) IN THE LEFT AND 6X19 VBX IN THE RIGHT RENAL ARTERY. BOTH RENAL ARTERIES ARE OPEN AND HAVE EFFICIENT BLOOD FLOW. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 21125407 ↗
• InjuryNov 4, 2024Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR BILATERAL IBE PROCEDURE TO TREAT AN ABDOMINAL AORTIC AND BILATERAL COMMON ILIAC ANEURYSMS UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON (B)(6) 2024, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED OF THE EVENT THAT A PATIENT HAD ARRIVED IN THE EMERGENCY ROOM AFTER MIDNIGHT WITH ABDOMINAL PAIN. CTA SCANS WERE REVIEWED THAT OBSERVED THE PROXIMAL END OF THE MAIN BODY EXCLUDER STENT GRAFT (TRUNK IPSILATERAL LEG C3) HAD COLLAPSED ON ITSELF AND THE ENTIRE GRAFT HAD THROMBOSED. THERE WAS BLOOD FLOW JUST OUTSIDE THE LIMBS AS THE BLOOD FLOW RECONSTITUTED AT THE END OF BOTH INTERNAL AND EXTERNAL LIMBS OF THE TRUNK IPSILATERAL GRAFT. PHYSICIAN PLACED 6FR SHEATHS IN BOTH THE GROINS AND INSERTED BILATERAL EKOS CATHETERS FOR 24 HOURS. ON THE SAME DAY, IN THE MORNING, THE ANGIOGRAM WAS COMPLETED SHOWING THE PROXIMAL END OF THE GRAFT HAD OPENED UP AGAIN AND THERE WAS NO PRESENCE OF THE THROMBUS THROUGHOUT THE ENTIRE GRAFT WITH ALL INTERNAL AND EXTERNAL LIMBS ALSO OPEN. THE EKOS CATHETERS WERE CONTINUED AND HAD EFFICIENT BLOOD FLOW THROUGHOUT THE GRAFT OF MAIN

  Patient problems: Abdominal Pain; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 20599019 ↗
• MalfunctionJun 10, 2024Unintended Movement; Unintended Movement

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, AN ABDOMINAL AORTIC ANEURYSM WAS BEING TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING DEPLOYMENT, THE GRAFT DID NOT FULLY DEPLOY. A BALLOON WAS ADVANCED. WHILE ADVANCING, THE DEVICE CONTINUED TO SLOWLY EXPAND, BUT DID NOT REACH FULL DIAMETER. THEN THE DEVICE WAS SUCCESSFULLY BALLOONED TO FULL DIAMETER. AFTER BALLOONING, THE PHYSICIAN ATTEMPTED TO REMOVE THE CONSTRAINING MECHANISM. HOWEVER, THE CLEAR HANDLE WOULD NOT DISENGAGE. EACH TIME THE HANDLE WAS PULLED BACK, THE PROXIMAL END OF THE RIGHT SIDE OF THE GRAFT WOULD BE PULLED DOWN. ANOTHER BALLOON WAS ADVANCED INTO THE GRAFT. WHEN THE BALLOON WAS INFLATED, THE HANDLE WAS PULLED AGAIN. ALTHOUGH THERE WAS RESISTANCE, THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED WITH NO MIGRATION OF THE DEVICE. THE PATIENT HAD NO ADVERSE EVENTS RELATED TO EITHER DEVICE EVENT. IT WAS REPORTED THAT THE FINAL PLACEMENT OF THE DEVICE WAS EXCELLENT. CODE 1900-E WAS USED FOR THE DIFFICULTY REMOVING THE CONSTRAINING MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495846 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  IT WAS REPORTED TO GORE (THOUGHT A GEPROMED LEVEL 1 MACROSCOPIC ANALYSIS FOR EXPLANTED GRAFTS 24-041) THAT A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS IMPLANTED ON (B)(6) 2018, IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, AFTER ABOUT 6 YEARS AND 1 MONTH, THE ENDOPROSTHESIS WAS EXPLANTED DUE TO TYPE II ENDOLEAK WITH ENLARGEMENT OF THE ANEURYSM SAC.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19379593 ↗
• MalfunctionMay 15, 2024Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3). REPORTEDLY, DURING DEPLOYMENT OF THE SECOND STAGE, THERE WAS A DEPLOYMENT FAILURE. THE STENT GRAFT WENT IN SMOOTH WITH THE FIRST STAGE OF DEPLOYMENT BEING DEPLOYED ACCURATELY. WHEN THE PHYSICIAN WENT TO REMOVE THE LOCK PIN AND RECONSTRAINING MECHANISMS, THE LOCKPIN DID NOT DISENGAGE FROM THE OLIVE TIP AND WHEN THE PHYSICIAN PULLED ON THE GREY HANDLE, THE GRAFT WOULD RECONSTRAIN BUT THE WHOLE GRAFT WOULD COME DOWN. PHYSICIAN THEN PROCEEDED TO OPEN THE EMERGENCY HATCH TO ACCESS THE DIFFERENT DEPLOYMENT LINES, PHYSICIAN CLAMPED ON THE LOCKPIN LINE AND CUT DISTAL TO THE CLAMP BUT WHEN PHYSICIAN WENT TO PULL THE LOCKPIN LINE THERE WAS NOT ENOUGH GRIP AND THE LINE JUST BROKE AND IT HAPPENED FEW TIMES. SINCE THERE WAS NO LONGER ANY WIRE TO GRAB, THE SURGEON DEPLOYED THE IPSILATERAL LIMB AND USED A SCALPEL TO ACCESS THE LOCKPIN LINE THROUGH THE BLUE DELIVERY CATHETER SYSTEM BY CUTTING IT OPEN AND FINDING THE LOCKPIN LINE THERE. THIS WAS SUCCESSFUL AND PHYSICIAN WAS ABLE TO REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326359 ↗
• DeathApr 14, 2024Collapse; Collapse

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES IN THE ABDOMINAL AORTA. IT WAS REPORTED THAT, ON AN UNKNOWN DATE, ONE MONTH FOLLOW-UP CT IMAGING WAS PERFORMED AND THERE WERE NO REPORTED ISSUES. ON MARCH 15, 2024, IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BLOOD PRESSURE IN THE 200S. THE PROXIMAL PORTION OF THE TRUNK HAD REPORTEDLY COLLAPSED AND WAS THROMBOSED. THE CAUSE OF THE COLLAPSED GRAFT WAS UNKNOWN, AND IT WAS UNKNOWN WHETHER THE COLLAPSED TRUNK HAD CAUSED THE HIGH BLOOD PRESSURES OR VICE VERSA. ON THE SAME DAY THE PATIENT UNDERWENT EMERGENT REINTERVENTION TO EXPLANT THE TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENTS. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE CONTRALATERAL LIMBS OR IMPLANTED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). THE IBE DEVICES REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT, AT SOME POINT DURING POST-OP DAY ONE, THE PATIENT EXPIRED FROM AN INTRACRANIAL BLEED. IT WAS UNKNOWN WHETHER THE COLLAPSED GRAFT AND HIGH BLOOD PRESSURES HAD CAUSED/CONTRIBUTED TO THE INTRACRANIAL BLEED, BUT IT

  Patient problems: Abdominal Pain; High Blood Pressure/ Hypertension; Intracranial Hemorrhage; Thrombosis/Thrombus

  MAUDE report 19103032 ↗
• MalfunctionApr 12, 2024Insufficient Device Problem Information; Activation Failure; Activation Problem; Insufficient Device Problem Information; Activation Failure; Activation Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AT THE 1ST STAGE DEPLOYMENT OF THE EXCLUDER AT THE PROXIMAL NECK, THE LIVE FLUOROSCOPY SHOWED THAT THE DEVICE WAS NOT FULLY OPEN (APPROX 80%, NOT FULLY OPPOSED TO VESSEL WALL AND OVERSIZED 26MM GRAFT FOR 23 SIZE VESSEL DUE TO CALCIUM). THE GRAFT MOVED DISTALLY AFTER CANNULATION PIGTAIL RUN AS THE PATIENT AORTIC NECK WAS ANGULATED. IT WAS REPORTED THAT THE DEVICE WAS RECONSTRAINED AND RE-POSITIONED PROXIMALLY. ATTEMPT TO REOPEN FAILED; BLACK NUT WOULD NOT MOVE COMPLETELY TO LT (ABOUT 80%). THE PHYSICIAN SAID IT WAS PHYSICALLY STOPPING TO FULLY OPEN. REMOVED CONSTRAINING MECHANISM AT THIS POINT AND GRAFT OPENED TO ABOUT 90%. FINISHED DEPLOYING IPSILATERAL LIMB OF THE MAIN BODY AND THEN USED RELIANT BALLOON TO FULLY OPEN TRUNK OF MAIN BODY. REPORTEDLY, THE DEVICE WAS FULLY EXPANDED AFTER RELEASING CONSTRAINING MECHANISM AND FINISHING DISTAL LIMB. THE PHYSICIAN THEN BALLOONED TRUNK OF GRAFT TO ACHIEVE COMPLETE WALL APPOSITION. THE PHYSICIAN BELIEVES THAT IT WAS A FAULTY DELIVERY SYSTEM, AIDED BY PROOF OF BLACK NUT NOT BEING

  Patient problems: Calcium Deposits/Calcification; Failure of Implant

  MAUDE report 19102445 ↗
• DeathDec 18, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  ON (B)(6) 2014, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 79.1MM IN DIAMETER AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6), 2014, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 78.9MM. ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT REINTERVENTION FOR AN OCCLUDED GORE TRUNK IPSILATERAL LEG ON (B)(6) THE RIGHT SIDE; AND AN OCCLUSION OF THE GORE® EXCLUDER® ILIAC EXTENDER COMPONENT IMPLANTED WITHIN THE DISTAL LEFT EXTERNAL ILIAC ARTERY (B)(6). A ULTRASOUND GUIDED RIGHT COMMON FEMORAL ACCESS FOR INITIATION OF CATHETER DIRECTED THOMBOLYTICS WAS ADMINISTERED. THE PATIENT TOLERATED THE PROCEDURE AND WAS RELEASED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2023 FOLLOW-UP CTA WAS PERFORMED AND REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 59MM. ADDITIONALLY, THE PATIENT WAS REPORTED TO HAVE AN INTRAABDOMINAL AND RETROPERITONEL HEMORRHAGE/AORTIC RUPTURE AND UNDERWENT PLACEMENT OF AN AORTOBIFEMORAL BYPASS GRAFT, A BILATERAL RE-DO FEMORAL ARTERY E

  Patient problems: Rupture

  MAUDE report 18346303 ↗
• InjuryDec 7, 2023Patient-Device Incompatibility; Device Endoleak; Patient-Device Incompatibility; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED BY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS 50 MM ON (B)(6) 2016 THE MAXIMUM DIAMETER OF AORTIC ANEURYSM AS MEASURED BY CTA WAS 71 MM (B)(6) 2022. ON (B)(6) 2022, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK. ON (B)(6) 2023, THE IMPLANTED DEVICES WERE EXPLANTED AND THE PATIENT WAS TREATED WITH AORTO-BI-ILIAC BYPASS SURGERY.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18281722 ↗
• InjuryNov 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6), 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 55 MM VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). ON (B)(6), 2017, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 53 MM VIA CTA. ON (B)(6), 2018, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK AND WAS TREATED WITH ANGIO-EMBOLIZATION OF A LUMBAR ARTERY WITH ONYX¿ LIQUID EMBOLIC SYSTEM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18242258 ↗
• InjuryNov 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND TWO CONTRALATERAL LEGS). REPORTEDLY, SINCE THE ORIGINAL IMPLANTS, THE PATIENT HAS EXPERIENCED CONTINUED ANEURYSM SAC GROWTH ON THE FOLLOW UP CTA SCANS (UNKNOWN DATE). ON AN UNKNOWN DATE, A REINTERVENTION WAS PERFORMED TO ATTEMPT TO EMBOLIZE THE ANEURYSM SAC BUT SAC STILL CONTINUED TO GROW (ANEURYSM SIZE 7CM). THERE IS POSSIBLE TYPE 2 ENDOLEAK VISIBLE ON SCANS BUT NO CLEAR TYPE 2 WHEN THEY OPENED UP THE SAC AND PHYSICIAN THOUGHT THAT THE CONTINUED ANEURYSM GROWTH MIGHT BE FROM A TYPE 1A ENDOLEAK (UNKNOWN ON WHAT DEVICE) BUT IT WAS NOT VISIBLE ON THE SCANS. ON (B)(6) 2023, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT THE GROWING ANEURYSM SAC AS PHYSICIAN DECIDED TO EXPLANT THE EXCLUDER DEVICES AND DID A SURGICAL REPAIR WITH A DACRON GRAFT. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18068338 ↗
• InjuryOct 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY, TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS LIMBS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS BRANCH COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH AN OCCLUDED AORTA. THE PHYSICIAN INTERVENED TO RESOLVE THE ISSUE, BUT THE PATIENT PASSED AWAY. AT THIS TIME, THERE IS NO INFORMATION ON WHEN THE OCCLUSION OCCURRED, WHEN THE PATIENT WAS TREATED, WHAT INTERVENTION WAS PERFORMED, THE CAUSE OF DEATH AND THE TIME OF DEATH.

  Patient problems: Reduced Blood Flow

  MAUDE report 18040186 ↗
• InjuryAug 17, 2023Complete Blockage; Patient-Device Incompatibility; Complete Blockage; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, THE CONTRALATERAL LEG WAS UNINTENTIONALLY DEPLOYED HIGHER THAN THE LONG MARKER AT THE FLOW DIVIDER BY APPROXIMATELY .5 CM. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN DECIDED NOT TO IMPLANT A MATCHING LIMB ON THE IPSILATERAL LEG. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH OCCLUSION OF THE TRUNK IPSILATERAL LEG. AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED AND FLOW WAS RESTORED. THE PATIENT TOLERATED THE PROCEDURE. PATIENT IMAGING IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 17563366 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT HAD AORTIC DISSECTION THOUGHT TO HAVE BEEN CREATED DURING THE EVAR PROCEDURE ON (B)(6) 2023. THE DISSECTION IS REPORTED BEGIN RIGHT AT THE RENAL ARTERY AND EXTEND PROXIMALLY TO THE LEFT SUBCLAVIAN ARTERY (LSA). ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION AND A COOK ZENITH DISSECTION ENDOVASCULAR STENT WAS PLACED FOLLOWED BY A PALMAZ STENT. THE REINTERVENTION WAS SUCCESSFUL AND THE PATIENT IS STABLE.

  Patient problems: Aneurysm

  MAUDE report 17208770 ↗
• InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 86MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ADDITIONALLY, AN AORTIC BRANCH VESSEL PROCEDURE WAS DONE, AND THE RIGHT INTERNAL ILIAC ARTERY (RIIA) WAS EMBOLIZED AND AN AMPLATZER PLUG WAS PLACED WITHIN THE RIIA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 82MM. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 116MM AND A TYPE II ENDOLEAK. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED TO TREAT THE TYPE II ENDOLEAK.

  Patient problems: Aneurysm expansion

  MAUDE report 16855880 ↗

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