GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351414Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00733132618477), received between Jun 29, 2018 and Jul 8, 2025 — classified as 3 deaths, 61 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Migration” (9 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 73 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT AORTOGRAM SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 56.9MM. THE FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT FROM (B)(6) 2015 TO (B)(6) 2018 THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 55MM TO 66MM. IT WAS REPORTED THAT THE ANEURYSM ENLARGEMENT WAS DETERMINED ON IMAGING DURING THE HOSPITALIZATION FOR HEMATURIA DUE TO SUBSEQUENT DIAGNOSIS OF BLADDER CANCER. REPORTEDLY, NO TREATMENT WAS PERFORMED TO FIX THE ANEURYSM ENLARGEMENT.

  Patient problems: Aneurysm expansion

  MAUDE report 22442830 ↗
• InjuryMay 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION FOR ANEURYSM RUPTURE AND A TYPE 1A ENDOLEAK UTILIZING THREE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE). REPORTEDLY, PATIENT HAS A HISTORY OF TYPE 2 ENDOLEAK WITH PRIOR COILING DONE (DATE UNKNOWN). THE TYPE 1A ENDOLEAK WAS RESOLVED AFTER IMPLANTING THREE AORTIC EXTENDER CONFORMABLE, WHICH LED TO THE LEFT RENAL ARTERY BEING COVERED AS PART OF THE PLANNED PROCEDURE. THE PROXIMAL NECK DID NOT HAVE MUCH ROOM TO EXTEND FROM THE TRUNK IPSILATERAL LEG. PATIENT TOLERATED PROCEDURE, NO ENDOLEAK SEEN AT END OF CASE. ON (B)(6) 2025, FIELD SALES ASSOCIATES PROVIDED THAT PATIENT STATUS ON RENAL FUNCTION AS RESULT OF PLANNED COVERAGE OF LEFT RENAL ARTERY REMAINS UNKNOWN.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22073953 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT TREATMENT OF ABDOMINAL AORTIC ANEURYSM RUPTURE WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT351414/ (B)(6) ). ON AN UNKNOWN DATE, A PROXIMAL TYPE I ENDOLEAK WAS DISCOVERED. ON (B)(6) 2017, THE PATIENT UNDERWENT A PLANNED REINTERVENTION AND TWO GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS (PLA360400/ (B)(6), PLA360400/ (B)(6) ) WERE IMPLANTED PROXIMALLY TO EXTEND COVERAGE. IT IS UNKNOWN IF THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2019, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 78.2MM. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REPORTS A PROXIMAL TYPE I ENDOLEAK NOT RELATED TO THE DEVICE OR PROCEDURE. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 147.0MM, THE PATIENT WAS SCHEDULED FOR A PROCEDURE AT A FUTURE DATE HOWEVER IT WAS CANCELLED BY THE PATIENT WHO EXPRESSED NO ADDITIONAL PROCEDURES WERE WANTED. ON (B)(6) 2024, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH A RUPTURED ANEURYSM AND THE FAMILY OPTED FOR COMFORT CARE ONLY. THE PATIENT EXPIRED IN THE ER. THE PATIENT'S DEATH IS REPORTED TO NOT BE DEVICE RELATED.

  Patient problems: Rupture

  MAUDE report 21646700 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM (RLT351414/(B)(6). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK. A SNORKEL/CHIMNEY PROCEDURE WAS PERFORMED WITH PLACEMENT OF A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS (CXA360005/(B)(6) AND A GORE® STENT GRAFT VIABAHN® BX 2.0 (BXB065902A/(B)(6) WHICH WAS EXTENDED WITHIN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 21316064 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2024, FOLLOW UP VISIT REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE IS ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN). A FUTURE REINTERVENTION IS BEING PLANNED; NO DATE PLANNED AS OF YET. THE ROOT CAUSE IS DISEASE PROGRESSION.

  Patient problems: Clinical Endoleak

  MAUDE report 20517810 ↗
• InjurySep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6)2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 65MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 64MM. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO HAVE AN ENLARGING ABDOMINAL AORTIC ANEURYSM WITH A TYPE II ENDOLEAK. THE PHYSICIAN RECOMMENDED TREATMENT HOWEVER THE PATIENT HAS POSTPONED ANY ENDOLEAK REPAIR. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 97MM.

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

  MAUDE report 20297619 ↗
• MalfunctionSep 11, 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. REPORTEDLY, THE TRUNK IPSILATERAL LEG C3 DEVICE WAS INSERTED AND FIRST STAGE OF DEPLOYMENT WAS DONE WITH THE STRING COMING OUT AS NORMAL BUT THE DEVICE REMAINED CONSTRAINED, DID NOT OPEN UP. SECOND STAGE OF DEPLOYMENT WAS PULLED WITH SAME RESULT OF STRING COMING OUT AND STILL DEVICE REMAINING CONSTRAINED. THIRD STAGE OF DEPLOYMENT HAD SIMILAR ISSUE BUT IT OPENED A LITTLE BIT TOWARDS THE DISTAL END OF THE IPSILATERAL LIMB (TRAILING END OF THE GRAFT). ALL THREE STAGES OF DEPLOYMENT HAD THE DEPLOYMENT LINES COME OFF FULLY WITH THE HANDLE OFF AS WELL. IT WAS ALSO CHECKED IN THE BACKUP HATCH AND DEPLOYMENT LINE WAS FULLY REMOVED THERE AS WELL. PHYSICIAN THEN PULLED THE DELIVERY SYSTEM OUT AT WHICH POINT, THE DEVICE MANAGED TO BE FULLY OPENED UP BY PULLING THE OLIVE TIP THROUGH THE DEVICE. PROCEDURE WENT WELL WITH NO OTHER ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189477 ↗
• MalfunctionSep 2, 2024Device Slipped; Patient-Device Incompatibility; Migration; Device Slipped; Patient-Device Incompatibility; Migration

  ON (B)(6) 2014 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM OF 51 MM IN DIAMETER AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ADDITIONAL INFORMATION RECEIVED STATED THAT BETWEEN MARCH 21, 2014 AND MAY 17, 2019, FOLLOW-UP CTA IMAGES SHOWED THE DEVICE HAD MIGRATED DISTALLY RELATIVE TO THE LEFT RENAL ARTERY FROM INITIALLY 3 TO 30 MM. REPORTEDLY, AN ENDOLEAK DID NOT DEVELOP. ON MAY 31, 2019, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THE ABDOMINAL ANEURYSM HAD DECREASED TO 49 MM IN DIAMETER. ON (B)(6) 2020, THE PATIENT WAS REPORTEDLY DIAGNOSED WITH MEGA AORTA SYNDROME AND AN AORTIC GROWTH OF MORE THAN 9 CM WAS FOUND. ON THE SAME DAY, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR WITH A CUSTOMIZED, NON-GORE THORACIC DEVICE. REPORTEDLY, THIS WAS UNRELATED TO THE PREVIOUS ABDOMINAL AORTIC ANEURYSM REPAIR. ON JUNE 26, 2020, FOLLOW-UP CTA REVEALED THAT THE ABDOMINAL ANEURYSM STILL MEASURED 49 MM IN DIAMETER.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20122307 ↗
• InjuryAug 21, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2016 , A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM AS MEASURED BY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS 52.5 MM. ON (B)(6) 2018, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM AS MEASURED BY CTA WAS 54.2 MM. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK BEING FED BY THE INFERIOR MESENTERIC ARTERY (IMA). ON (B)(6) 2018, THE PATIENT WAS TREATED WITH EMBOLIZATION OF THE IMA. ON (B)(6) 2023, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM AS MEASURED BY CTA WAS 73 MM. THE CAUSE OF THE CONTINUED ANEURYSM GROWTH IS UNKNOWN. NO REINTERVENTION HAS BEEN REPORTED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20010654 ↗
• InjuryApr 23, 2024Migration; Migration

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION TO TREAT MIGRATION DISTAL MIGRATION OF 13CM THE (DISTAL TO THE LOWEST RENAL ARTERY) OF THE PROXIMAL TRUNK. THE PHYSICIAN¿S INTENDED TREATMENT PLAN WAS TO RE-LINE THE C3 TRUNK WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES, HOWEVER WIRE ACCESS THROUGH THE ORIGINALLY IMPLANTED C3 GRAFT WAS UNABLE TO BE ACHIEVED. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE TO RELINE AND SCHEDULE EXPLANT OF THE DEVICES. TORTUOSITY OF THE PATIENT¿S ILIAC ARTERIES WAS REPORTED TO HAVE CONTRIBUTED TO THE INABILITY TO GAIN WIRE ACCESS THROUGH THE ORIGINALLY IMPLANTED C3 TRUNK DEVICE. THE PATIENT TOLERATED THE PROCEDURE. A DATE FOR EXPLANT HAS NOT YET BEEN SCHEDULED. THE CXT DEVICE WAS NOT PART OF THIS PROCEDURE, IT HAD NOT BEEN PREPPED OR REMOVED FROM IT¿S PACKAGING.

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

  MAUDE report 19169394 ↗
• InjuryMar 29, 2024Device Endoleak; Device Endoleak

  ON MARCH 17, 2015, IT WAS REPORTED THAT A PATIENT PRESENTED WITH A COMMON ILIAC ANEURYSM ON THE RIGHT SIDE (MEASURED 33 MM) WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PXL161007). IT WAS REPORTED TO GORE THAT AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC121000) WAS IMPLANTED ON (B)(6) 2018 DUE TO A TYPE III ENDOLEAK IN THE RIGHT ILIAC BRANCH. NO ANEURYSM GROWTH HAS BEEN OBSERVED AT DATE OF ONSET (MEASURED 32 MM ON (B)(6) 2018).

  Patient problems: Clinical Endoleak

  MAUDE report 19006801 ↗
• InjuryMar 25, 2024Microbial Contamination of Device; Device Endoleak; Microbial Contamination of Device; Device Endoleak

  IT WAS REPORTED THAT ON SEPTEMBER 25, 2019, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. SIX WEEKS POST OPERATIVELY, THE PATIENT PRESENTED WITH SKIN LESIONS. COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED SUCCESSFUL EXCLUSION OF THE AORTIC ANEURYSM AND NO ENDOLEAKS. ON (B)(6) 2020, CT IMAGING SHOWED AN INCREASE OF ANEURYSM DIAMETER. NO MEASUREMENT GIVEN. IN (B)(6) 2021, MAXIMUM ANEURYSM DIAMETER INCREASED TO 7 CM. AN ENDOLEAK WAS VISIBLE POSTERIOMEDIAL ASPECT OF THE ILIAC LIMB. IT WAS DECIDED THAT THE PATIENT WAS PRESENTING WITH A TYPE II ENDOLEAK. IN (B)(6) 2021, THE PATIENT WAS SUCCESSFULLY TREATED WITH ONYX EMBOLIC MATERIAL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18968132 ↗
• MalfunctionJan 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-9 INFRARENAL ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, FSA REPORTS THERE WAS SOME BLOOD LEAKING THROUGH THE TUOHY BORST VALVE. THE LEAKAGE DID NOT RESULT IN BLOOD LOSS THAT REQUIRES TRANSFUSION. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. DEPLOYMENT WAS RUSHED DUE TO THIS LEAKAGE. THE DEVICE WAS SUCCESSFULLY DEPLOYED WITH NO FURTHER ISSUES. NO PATIENT HARM WAS OBSERVED. THE DELIVERY CATHETER WAS DISCARDED. IMAGES ARE NOT AVAILABLE. NO FURTHER PATIENT INFORMATION IS AVAILABLE. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515195 ↗
• InjuryDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). THE CTAG-AC WAS THE MOST PROXIMAL DEVICE AND WAS DEPLOYED JUST DISTAL TO THE LOWEST RENAL ARTERY WITH THE EXCLUDER TRUNK HAVING BEEN DEPLOYED WITHIN THE CTAG-AC DUE TO THE SIZE OF THE PATIENT AORTA AND THE SIZE OF THE ANEURYSM (7CM). POST DEPLOYMENT OF ALL DEVICES AND ANGIOPLASTY OF ALL THE DEVICES A SMALL PROXIMAL TYPE I ENDOLEAK WAS NOTED. A SECOND BALLOON INFLATION WITH A GORE® TRI-LOBE BALLOON CATHETER (BCL2645/26440564) ENSUED WITH THE TRI-LOBE BALLOON CATHETER UPON WHICH THE PROXIMAL AORTA WAS NOTICED TO HAVE RUPTURE . THE PATIENT WAS CONVERTED TO OPEN WHEREIN ALL THE DEVICES WERE EXPLANTED AND A DACRON GRAFT WAS SEWN INTO THE AORTA. THE PATIENT TOLERATED THE PROCEDURE. THE RUPTURE IS BELIEVED TO HAVE BEEN DUE TO OVERINFLATION OF THE BALLOON DURING ANGIOPLASTY.

  Patient problems: Fluid Discharge

  MAUDE report 18274869 ↗
• InjuryNov 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PLC201000) . ON (B)(6) 2022, PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO ANEURYSM ENLARGEMENT NOTED ON PLC201000 SIDE (AMOUNT UNKNOWN), ATTRIBUTED TO DISEASE PROGRESSION. NO ENDOLEAK WAS NOTED. PHYSICIAN EXTENDED DISTALLY. A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL COMPONENT WAS IMPLANTED. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO ANEURYSM ENLARGEMENT (LESS THAN 0.5CM) ON THE RIGHT SIDE ((RLT351414), ATTRIBUTED TO DISEASE PROGRESSION. NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO PLACE A LIMB EXTENSION USING A CONTRALATERAL LEG TO EXTEND THE SEAL ZONE SEVERAL CENTIMETERS ALL THE WAY TO THE ORIGIN OF THE RIGHT HYPOGASTRIC ARTERY. THIS EXTENSION WAS COMPLETED USING THE FOLLOWING DEVICE: PLC201000 L/S#: (B)(6). PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 18222102 ↗
• InjuryNov 8, 2023Insufficient Flow or Under Infusion; Positioning Problem; Insufficient Flow or Under Infusion; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR ZONE 8 RENALS PROCEDURE TO TREAT AN ANEURYSM RUPTURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414, PLC231200, PLC231000, PLC 141400 AND PLC21000). REPORTEDLY, DURING THE EMERGENT PROCEDURE THE PHYSICIAN HAD ALREADY DEPLOYED THE TRUNK IPSILATERAL LEG C3 BY THE TIME THE FIELD SALES ASSOCIATE (FSA) ARRIVED AND THERE WAS DIFFICULTLY CANNULATING THE CONTRALATERAL LEG BUT THEY WERE ABLE TO SUCCESSFULLY CANNULATE AND DEPLOY THE DEVICE AFTER ROTATING THE GRAFT WITHOUT FURTHER ISSUES. PHYSICIAN STATED THAT HE PURPOSELY COVERED THE RENAL ARTERIES WITH TRUNK IPSILATERAL LEG C3 IN ORDER TO HAVE A PROPER SEAL AND STOP THE AORTIC RUPTURE BLEEDING AND ALL DEVICES DEPLOYED WITHOUT ANY ISSUES. PATIENT TOLERATED THE PROCEDURE BUT PATIENT CONDITION WAS NOT GOOD AND PATIENT STATUS AT THIS TIME IS UNKNOWN AND FURTHER INFORMATION IS BEING SOUGHT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 24, 2024: PATIENT IS DOING OKAY AFTER THE PROCEDURE AND PER THE LATEST CT SCANS, THE ANEURYSM RUPTURE IS CONTAINED BUT THERE ARE KIDNEY ISSUES DUE TO BOTH THE RENAL ARTERIES COVERAGE AS THERE IS PARTIAL BLOOD

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow; Renal Impairment

  MAUDE report 18097023 ↗
• InjuryOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RUPTURED ANEURYSM DUE TO A DISTAL TYPE I ENDOLEAK FROM THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT. THE PATIENT UNDERWENT REINTERVENTION AND TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS WERE PLACED PROXIMALLY DESPITE NO EVIDENCE OF ENDOLEAK. FOR TREATMENT OF THE DISTAL TYPE I ENDOLEAK FROM THE RIGHT ILIAC ARTERY (RIA); THE RIGHT INTERNAL ILIAC ARTERY (RIIA) WAS COIL EMBOLIZED AND A CONTRALATERAL LEG COMPONENT WAS PLACED PROXIMAL WITH ANOTHER CONTRALATERAL LEG COMPONENT WAS PLACED DISTALLY IN THE RCIA. LASTLY, A GORE® EXCLUDER® ILIAC EXTENDER WAS PLACED ACROSS THE COILED VESSEL, AND EXTENDED INTO THE REIA. THE PHYSICIAN REPORTED NO LEAK SEEN ON THE LEFT ILIAC SIDE BUT PLANS TO FOLLOW UP WITH THE PATIENT AND DISCUSS OPTIONS TO TREAT THE DILATING LEFT COMMON ILIAC ARTERY IN THE FUTURE. THE PHYSICIAN ATTRIBUTED THIS ISSUE TO OVERALL ARTERIAL DILATION DUE TO DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923793 ↗
• InjurySep 28, 2023Migration; Migration

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT, ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PATIENT'S AORTIC NECK HAD GROWN AND THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED DISTALLY (DISTANCE UNKNOWN). ON (B)(6), A REINTERVENTION WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, A GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT, AND A GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENT WERE USED TO ACHIEVE PROXIMAL SEAL. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840445 ↗
• InjurySep 7, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK. THE ENDOLEAK WAS REPORTEDLY BEING FED BY THE RIGHT LUMBAR AND INFERIOR MESENTERIC ARTERIES. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS OBSERVED TO BE 51 MM VIA COMPUTED TOMOGRAPHY IMAGING (CTA). ON (B)(6) 2023, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM HAD EXPANDED TO 82 MM VIA CTA. THE IMPLANTED DEVICES WERE EXPLANTED ON (B)(6) 2023 AND THE PATIENT WAS TREATED WITH AN AORTO-BILIAC BYPASS.

  Patient problems: Aneurysm; Aneurysm expansion; Clinical Endoleak

  MAUDE report 17697449 ↗
• InjuryJul 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM REPAIR UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT TRUNK IPSILATERAL LEG C3, STENT GRAFT CONTRALATERAL LEG, AND STENT GRAFT ILIAC EXTENDER). A WEEK BEFORE PRESENTING TO EMERGENCY ROOM (DATE UNKNOWN), THE PATIENT PRESENTED FOR LEFT FLANK PAIN. PATIENT HAD CT SCAN AT THE TIME WHICH DEMONSTRATED A LARGE TYPE 1A ENDOLEAK (GROWTH SIZE UNKNOWN). PATIENT WAS SCHEDULE TO SEE THE PHYSICIAN THE SAME DAY AND BE SCHEDULED FOR URGENT OPEN ANEURYSM REPAIR BUT PATIENT NEVER ARRIVED FOR THE CLINIC VISIT. ON (B)(6) 2023, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) FOR A URGENT FOLLOW-UP AND ADMISSION AFTER RECURRENT CHEST PAIN FOR THE LAST 3 DAYS RADIATING DOWN THE LEFT ARM. PATIENT WAS ON ASPIRIN AND NITROGLYCERIN AND HAS TENDERNESS OVER THE PALPABLE ANEURYSM SAC AND POTENTIAL ASYMPTOMATIC ANEURYSM. ITS BEEN PERSISTENT BUT NOT WORSENING OVER THE PAST 2 WEEKS AND AN OPEN REPAIR WILL BE NEEDED TO TREAT THE TYPE 1A ENDOLEAK OF AORTIC GRAFT AND ALONG WITH CARDIAC WORK-UP DONE IN ER FOR CHEST PAIN AND SURGERY PLANNED WITHIN 1-2 DAYS. ON (B)(6) 2023, TH

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17404454 ↗
• InjuryJul 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND ON GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE PATIENT RECEIVED A CT SCAN RELATED TO A KIDNEY FUNCTION ISSUE. AT THAT TIME, IT WAS SEEN THAT THE MAIN BODY DEVICE HAD MIGRATED INTO THE ANEURYSM SAC, CAUSING A TYPE IA ENDOLEAK. THE PHYSICIAN EXTENDED PROXIMALLY WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS, WHICH SEALED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17333673 ↗
• DeathJul 13, 2023Positioning Failure; Positioning Failure

  ON (B)(6) 2023, IT WAS REPORTED THAT DURING AN ALIF (ANTERIOR LUMBAR INTERBODY FUSION) ORTHOPEDIC PROCEDURE THE PATIENT¿S INFERIOR VENA CAVA (IVC) AND THE ILIAC VEINS WERE TORN BY THE INTERVERTEBRAL FUSION CAGE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS RLT351414 WAS ADVANCED WITHIN THE IVC AND DEPLOYED. WHEN TRYING TO CANNULATE THE CONTRALATERAL GATE; WHENEVER THE PHYSICIAN WOULD ADVANCE THE WIRE IT WOULD EITHER GET CAUGHT UP IN SOME OBSTRUCTION OR IT WOULD LEAVE THE VESSEL AND JUST GO OUT INTO THE ABDOMEN. WHEN ATTEMPTING TO SNARE THE WIRE THE DEVICE WAS PUSHED UP INTO THE CHEST AND HAD TO BE SURGICALLY REMOVED. NO ADDITIONAL ENDOVASCULAR TREATMENT WAS CONSIDERED GOING FORWARD AND THE ENDOVASCULAR PORTION OF THE PROCEDURE WAS CONCLUDED. THE PHYSICIAN LATER THIS DATE REPORTED THAT THE PATIENT HAD EXPIRED INTRAPROCEDURAL WHEN HIS HEART STOPPED DUE TO THE DAMAGE TO THE AORTIC WALL, THE IVC AND SURROUNDING AREA, AND BLOOD LOSS OF 15 UNITS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17322116 ↗
• InjuryJun 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM HAD MIGRATED DISTALLY DUE TO DILATATION. PLANS WERE MADE TO REINTERVENE ON (B)(6) 2023, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(S) (VBX DEVICE) WERE INTENDED AS SNORKEL DEVICES DURING TREATMENT OF AN AORTIC ANEURYSM. THE VBXS WERE TO BE IMPLANTED AS PART OF A PROCEDURE TO EXTEND PROXIMALLY WITH A COOK DEVICE. ONE VBX DEVICE WAS STATIONED IN THE MESENTERIC ARTERY INSIDE THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) AND ANOTHER VBX DEVICE WAS STATIONED IN THE RENAL ARTERY INSIDE THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) AND WERE BEING STAGED FOR DEPLOYMENT. HOWEVER, WHILE ADVANCING A COOK THORACIC DEVICE THE ANEURYSM WAS DISSECTED AND THE BLOOD PRESSURE DROPPED. THE PHYSICIANS WERE UNABLE TO GET THE BLEEDING UNDER CONTROL AND THE PATIENT EXPIRED. THERE WAS NO ALLEGATION AGAINST THE GORE DEVICE IN RELATION TO THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059113 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE, THAT THE PATIENT PRESENTED WITH A COMMON ILIAC ARTERY ANEURYSM WAS SUCCESSFULLY TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON (B)(6) 2022. IT WAS STATED THAT AT THE FINAL ANGIOGRAPHY NO SIGN OF A PROXIMAL TYPE 1A ENDOLEAK WAS DETECTED WHEREAS A TYPE 2 ENDOLEAK WAS DETECTED DUE TO THE PRESENCE OF SEVERAL LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY WHICH PERFUSED THE ANEURYSM SAC. THE PATIENT WAS FOLLOWED-UP WITHIN THE FOLLOWING MONTHS AND THE CT SCAN STILL REVEALED A SAC PERFUSION. ON (B)(6) 2023 THE PATIENT WAS ADMITTED TO EMERGENCY CARE TO TO ABDOMINAL PAIN AND A CT SCAN WAS PERFORMED. IT WAS STATED THAT A SAC ENLARGEMENT FROM 7CM (PREIMPLANT) TO 9CM HAS BEEN DETECTED. REPORTEDLY A SURGICAL CONVERSION WAS CONDUCTED AND THE DEVICE WAS EXPLANTED SHOWING A CONTAINED RUPTURE OF THE AORTIC ANEURYSM. THE PATIENT FOLLOWED UP IN INTENSIVE CARE.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 16922750 ↗
• InjuryMay 9, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2018, THE PATIENT UNDERWENT AN EVAR PROCEDURE WITH BILATERAL IBE PLACEMENT WITH LARGE ANEURYSMS IN THE ABDOMINAL AORTA AND BOTH COMMON ILIAC ARTERIES MEASURING UP TO 14CM IN MAX DIAMETER. THE SACS BEGIN TO SHRINK AFTER THE PROCEDURE. ON (B)(6), 2023, THE CTA SCANS SHOWED THE SACS WERE FOUND TO BE INCREASING IN SIZE AGAIN. THE AAA WAS MEASURING 80MM DIAMETER, THE RIGHT COMMON ILIAC SAC ANEURYSM WAS 92MM DIAMETER AND LEFT COMMON ILIAC SAC ANEURYSM WAS 125MM DIAMETER AND THIS COMPARES TO THE BASELINE BACK IN 2018 BEFORE THE PATIENT HAD THE ORIGINAL GRAFT IMPLANTED AT 71MM FOR AAA, 82MM RIGHT COMMON ILIAC ANEURYSM, AND 105MM FOR LEFT COMMON ILIAC ANEURYSM. THE PROXIMAL NECK HAD DEVELOPED MODERATE ANGULATION WITH REMODELING OF THE AORTA WHICH WAS FELT TO BE THE CAUSE OF THE MAIN BODY DEVICE TO MIGRATE DISTALLY BY 1-2 CM AND CREATE A BIRD BEAK APPEARANCE. NO OBVIOUS ENDOLEAK WAS SEEN, BUT IT WAS THOUGHT THERE MAY BE A TYPE 1A ENDOLEAK DUE TO THIS CHANGE. ON (B)(6) 2023, THE PATIENT WAS BROUGHT BACK AND TWO 36MM EXCLUDER CONFORMABLE AORTIC CUFF DEVICES WERE USED TO SUCCESSFULLY EXTEND PROXIMALLY FROM THE ORIGINAL GRAFT DEVICE TO THE LEVEL OF

  Patient problems: Aneurysm expansion

  MAUDE report 16898412 ↗

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