GORE EXCLUDER AAA Endoprosthesis PLC141000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00733132618637), received between Jul 11, 2018 and Feb 24, 2026 — classified as 3 deaths, 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED TO TREAT THE ABDOMINAL AND THORACIC AORTA. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT DEVELOPED PARAPLEGIA AND UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN BELIEVES POOR MANAGEMENT OF THE PATIENT¿S HYPOTENSION AND A MAP IN THE 60¿S FOR A FEW HOURS PRECEDING THE PARAPLEGIA WERE CONTRIBUTORY FACTORS AND NOT DEVICE RELATED BUT A NEUROLOGICAL DEFICIT.

  Patient problems: Paraplegia

  MAUDE report 24434255 ↗
• InjuryFeb 21, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. A GORE® MOLDING & OCCLUSION BALLOON WAS USED FOR BALLOONING. AFTER DEPLOYMENT OF A PLC141000 DEVICE, THE PHYSICIAN BALLOONED THE ILIAC ARTERY. WHILE THE PHYSICIAN WAS BALLOONING, SOMETHING IN THE ILIAC APPEARED TO POP ON THE FLUORO, AND ABOUT 5 SECONDS LATER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN TOOK AN ANGIO, AND SAW THAT THE ILIAC HAD RUPTURED WITH EXTRAVASATION. THE PHYSICIAN RELINED THE ILIAC ARTERY WITH TWO PLC121400 DEVICES. THE RUPTURE WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE, AND WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2026. REPORTEDLY, THE ILIAC ARTERY WAS STENOTIC AND CALCIFIED PRIOR TO THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24409096 ↗
• InjuryDec 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE ON DECEMBER 8 FROM A NOTIFICATION RELATED TO THE TGR STUDY AND THE IMEDIDATA DATABASE: ON (B)(6) 2025, 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 AND GORE® EXCLUDER® AAA ENDOPROSTHESES. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. A CTA PERFORMED ON (B)(6) 2025, REVEALED COMPRESSION OF THE RIGHT ILIAC STENT. THE PHYSICIAN PLANS TO REPAIR THE STENT ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878064 ↗
• MalfunctionDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 63MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 23MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM WAS REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE, PROCEDURE, OR WITHDRAWAL OF THE DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). REVIEW BY GORE IMAGING SERVICES (GIS) REPORTS A TYPE II ENDOLEAK ORIGINATING FROM FIVE LUMBAR ARTERIES (LUMBAR DOMINANT), THE IMA IS NOT PATENT. GIS ADDITIONALLY REPORTS GORE DEVICE COMPRESSION/INFOLDING. REVIEW OF THE CTA BY THE SITE REPORTS A TYPE II ENDOLEAK, THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA IS REPORTED TO MEASURE 58MM AND REPORTS/CONFIRMS COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795273 ↗
• DeathNov 6, 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 23493307 ↗
• DeathNov 6, 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 23493131 ↗
• InjuryNov 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, A PATIENT WAS TREATED IN AN AORTO-UNI-ILIAC (AUI) PROCEDURE FOR A DEGENERATIVE JUXTARENAL ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, INCLUDING TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES. AFTER THE PATIENT WAS CLOSED, BUT BEFORE THE PATIENT EXTUBATED, THE PATIENT LOST NEURO-MONITORING SIGNALS DUE TO SPINAL CORD ISCHEMIA. THE PATIENT WAS CONVERTED TO OPEN REPAIR TO PERFORM AN EMERGENT FEMORAL-FEMORAL BYPASS TO REPERFUSE THE SPINAL CORD VIA THE RIGHT INTERNAL ILIAC. FOLLOWING THE FEM-FEM BYPASS, NEUROMONITORING SIGNALS WERE REGAINED. REPORTEDLY, THE RIGHT COMMON ILIAC ARTERY WAS CHRONICALLY OCCLUDED PRIOR TO THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE SPINAL CORD ISCHEMIA WAS PRESUMABLY DUE TO AORTIC COVERAGE. NOTE THAT ALTHOUGH AN AUI WAS BEING PERFORMED, THE PHYSICIAN WAS NOT INTENDING TO PERFORM A FEM-FEM BYPASS UNTIL AFTER THE SPINAL CORD ISCHEMIA OCCURRED.

  Patient problems: Ischemia

  MAUDE report 23454997 ↗
• InjuryAug 28, 2025Device Stenosis; Device Stenosis

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE CLINICAL STUDY DATABASE: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE®EXCLUDER®AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS NOTED TO HAVE A POST-IMPLANT CT IMAGING SHOWING SIGNIFICANT COMPRESSION OF THE LEFT ILIAC GRAFT (GORE®EXCLUDER®AAA ENDOPROSTHESIS CONTRALATERAL LEG). THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE, ANGIOPLASTY OF THE COMPRESSED LIMB TO PREVENT ACUTE OCCLUSION. A BALLOON ANGIOPLASTY WAS PERFORMED WITH PERIPHERAL STENT GRAFT PLACEMENT. A SIDE BRANCH (REDUCED PROFILE VBX) WAS PLACED. TREATMENT WAS PERFORMED BEFORE OCCLUSION TO PREVENT EVENTUAL LOSS OF PATENCY. THE PATIENT TOLERATED THE REINTERVENTION.

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

  MAUDE report 22912918 ↗
• InjuryMar 17, 2025Deformation Due to Compressive Stress; Device Stenosis; Deformation Due to Compressive Stress; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, A FOLLOW-UP CT WAS TAKEN SHOWING COMPRESSION ON THE LEFT CONTRALATERAL LIMB, DISTAL TO THE GATE, NEAR THE DISTAL BIFURCATION. ON (B)(6) 2025, THE PHYSICIAN CONTACTED A GORE REP ABOUT PERFORMING A REINTERVENTION. ON (B)(6) 2025, THE PHYSICIAN IMPLANTED TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. REPORTEDLY, THERE WAS GOOD RESULT WITH IMPROVED FLOW TO BOTH LIMBS. THE PHYSICIAN IS UNSURE ABOUT THE CAUSE OF THE COMPRESSION, BUT THE AORTA WAS A NORMAL DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624847 ↗
• InjuryMar 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE ANEURYSM SIZE AT THE TIME OF THE PROCEDURE IS UNAVAILABLE. AN RLT261414 TRUNK-IPSILATERAL LEG COMPONENT AND PLC201200 CONTRALATERAL LEG COMPONENT WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED DUE TO ANEURYSM ENLARGEMENT WITH NO APPARENT ENDOLEAK. NO GORE REPRESENTATIVE WAS PRESENT AT THE CASE. A PLC121400 CONTRALATERAL LEG COMPONENT, PLC141000 CONTRALATERAL LEG COMPONENT, AND PLA280300 AORTIC EXTENDER COMPONENT WERE USED TO TREAT THE ANEURYSM ENLARGEMENT. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION AGAIN FOR CONTINUED ANEURYSM ENLARGEMENT WITH NO APPARENT ENDOLEAK. THE ANEURYSM MEASURED APPROXIMATELY 6.5 TO 7.0 CM AND THE GORE REPRESENTATIVE WAS MADE AWARE OF THE ONGOING ENLARGEMENT AT THIS TIME. AN ADDITIONAL PLC121400, PLC141000, AND PLA280300 WERE USED TO RELINE THE PREVIOUSLY IMPLANTED DEVICES. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 21499582 ↗
• InjuryMay 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THERE WERE NO REPORTED ISSUES WITH DEVICE PLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A LEFT EXTERNAL ILIAC ARTERY RUPTURE. THE RUPTURE REPORTEDLY OCCURRED DIRECTLY ADJACENT TO THE DISTAL END OF THE IMPLANTED PLC141000 CONTRALATERAL LEG COMPONENT. THE PHYSICIAN SUSPECTED THAT DEVICE OVERSIZING DURING THE INDEX PROCEDURE OR POTENTIALLY THE DEVICE LANDING IN TORTUOUS ANATOMY MAY HAVE CAUSED OR CONTRIBUTED TO THE EXTERNAL ILIAC RUPTURE. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE LEFT SIDE DISTALLY. TREATMENT WAS REPORTED AS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 19371381 ↗
• InjuryDec 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2023, AFTER A FALL. A CT WAS PERFORMED AND A DISTAL TYPE I ENDOLEAK WAS OBSERVED ON THE CONTRALATERAL LEG COMPONENT PLACED ON THE PATIENT'S LEFT SIDE. IT IS REPORTEDLY SUSPECTED THAT LACK OF DISTAL SEAL ZONE IN THE PATIENT'S LEFT COMMON ILIAC ARTERY CONTRIBUTED TO THE ENDOLEAK EVENT. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS USED TO EXTEND THE LEFT SIDE. THE REINTERVENTION WAS DEEMED SUCCESSFUL. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18279734 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2022, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE, AND TWO CONTRALATERAL LEGS). REPORTEDLY, THE NECK OF THE AORTA BECAME ANEURYSMAL (ANEURYSM GROWING BUT SIZE UNKNOWN) WITH A CLEAR TYPE 1A ENDOLEAK ON THE STENT GRAFT TRUNK IPSILATERAL LEG CONFORMABLE THAT WAS SEEN ON ANGIO (DATE UNKNOWN) DUE TO DISEASE PROGRESSION. ON (B)(6), 2023, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE GORE DEVICES AND PHYSICIAN DID AN OPEN SURGICAL REPAIR. PATIENT IS DOING OKAY.

  Patient problems: Aneurysm expansion

  MAUDE report 17861914 ↗
• InjurySep 13, 2023Adverse 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) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PATIENT ADMITTED EMERGENTLY ON (B)(6) 2023, WITH A RUPTURED ANEURYSM. PATIENT HAD A HISTORY OF A KNOWN TYPE II ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN) AND A DISTAL TYPE I ENDOLEAK. PHYSICIAN STATED PROGRESSION OF ANEURYSMAL DISEASE CAUSED THE LOSS OF THE PROXIMAL SEAL OF IMPLANTED DEVICE. THE PHYSICIAN REINTERVENED AND RELINED THE IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PHYSICIAN DID NOT FEEL THE PATIENT WOULD TOLERATE AN EXPLANT AND CONVERSION PROCEDURE AND CHOSE TO INTENTIONALLY COVER THE LEFT RENAL ARTERY TO HAVE ADEQUATE SEAL ZONE. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17738854 ↗
• MalfunctionMay 3, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2023 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, FOLLOW-UP TODAY SHOWED AN OCCLUSION OF THE CONTRALATERAL LIMB (PLC141000/26538035) IN THE PATIENT¿S LEFT COMMON ILIAC ARTERY. THE PATIENT UNDERWENT REINTERVENTION AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE IMPLANTED IN THE DISTAL AORTA AND POPPED THE COLLAPSED LIMB BACK OPEN. THE PATIENT TOLERATED THE PROCEDURE AND GOOD FLOW AND PULSES WERE ACHIEVED. THE CAUSE OF THE COLLAPSE/OCCLUSION IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE A 3 CM SEGMENT OF OF THE PATIENT'S NORMAL DISTAL AORTA THAT MEASURED 15 MM. THE RIGHT LIMB WAS A 14.5 MM WITH AN 18 MM FLARED LIMB EXTENSION. IN RETROSPECT, KISSING BALLOONS SHOULD HAVE BEEN USED TO POST DILATE THE DEVICES. THE SURGEON BALLOONED THE LEFT LIMB FIRST WITH THE MOB THEN SWITCHED TO THE RIGHT SIDE AND BALLOONED IT CRUSHING THE LEFT LIMB. THE RIGHT SIDE LIKELY ALSO HAD MORE RADIAL FORCE BECAUSE THERE WERE TWO LIMBS VERSE ONE ON THE LEFT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16865397 ↗
• InjuryApr 20, 2023Adverse 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) 2022, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2023, FOLLOW UP IMAGES REVEALED THERE WERE TWO CONTAINED RUPTURED ANEURYSMS PRESENT ON THE PROXIMAL AND DISTAL UNTREATED EDGE OF THE IMPLANTED DEVICES. PROXIMAL EDGE OF THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESES AND DISTAL EDGE OF THE GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES (LEFT SIDE). ON (B)(6) 2023, THE PHYSICIAN PERFORMED AN EMERGENT REINTERVENTION AND IMPLANTED A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES. THE PATIENT TOLERATED THE REINTERVENTION. THE ROOT CAUSE FOR THESE TWO CONTAINED RUPTURED ANEURYSMS IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 16777406 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) AND GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN THE AAA1701 TAMBE STUDY. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT IMAGES DATED (B)(6) 2021, REVEALED A DISSECTION OF LEFT EXTERNAL ARTERY.

  Patient problems: Aneurysm

  MAUDE report 15551058 ↗
• InjuryAug 4, 2022Device Damaged by Another Device; Device Damaged by Another Device

  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 TRUNK IPSILATERAL LEG ON THE RIGHT SIDEK AND A CONTRALATERAL LEG ON THE LEFT SIDE. THE RIGHT SIDE DEVICE WAS ABOUT 1 CM SHORT OF THE LIA, SO HE IMPLANTED A SECOND GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REACH TO THE LIA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN OBSTRUCTION ON THE LEFT SIDE OF THE MAIN BODY. IT WAS FOUND THAT THE LEFT LIMB HAD COLLAPSED FROM THE FLOW DIVIDER ON DOWN. THE PHYSICIAN BELIEVES THIS WAS DUE TO THE TWO DEVICES THAT HAD BEEN IMPLANTED ON THE RIGHT SIDE. THEY CREATED A RADIAL FORCE THAT COLLAPSED/COMPRESSED THE DEVICE ON THE LEFT SIDE. THE LIMBS WERE CROSSED, IN ADDITION TO THE FACT THAT THE VESSEL WAS HEAVILY CALCIFIED AND OF SMALL DIAMETER, THE COMPRESSION WAS NOTED TO BE AT THE DISTAL WAIST OF THE AORTA, THE FLOW DIVIDER WAS PATENT, INDICATING THE TRUNK DEVICE WAS NOT INVOLVED. THE COLLAPSE OF THE DEVICE ON THE LEFT SIDE RESULTED IN THE FORMATION OF A THROMBUS. A THROMBECTOMY WAS PERFORMED, AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE IMPLANTED TO R

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15169419 ↗
• InjuryJun 13, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT UNDERWENT TREATMENT OF A 58MM ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. ON (B)(6) 2018, IMAGES REVEALED THERE WAS A KINK IN THE DEVICE. A REINTERVENTION WAS PERFORMED AND A STENT GRAFT WITH EXPANDABLE BALLOON WAS IMPLANTED. THE KINK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14674735 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022 THE FIELD SALES ASSOCIATE WAS INFORMED THAT THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY HAD DILATED. REPORTEDLY THERE WAS NO ANEURYSM PRESENT IN THE PATIENT'S RIGHT ILIAC ARTERY, BUT THE NATIVE VESSEL HAD DILATED AND EXPANDED. THE PHYSICIAN STATED THAT THE ISSUE WAS NOT SUSPECTED TO BE DEVICE RELATED, BUT IT WAS SUSPECTED THAT A TYPE II ENDOLEAK MAY BE PRESENT. PRESENCE OF AN ENDOLEAK WAS NOT CONFIRMED. A REINTERVENTION WAS PERFORMED ON (B)(6) 2022 TO EXTEND THE CONTRALATERAL LEG COMPONENT IN THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. REPORTEDLY AN ADDITIONAL PLC121000 CONTRALATERAL LEG COMPONENT WAS SUCCESSFULLY IMPLANTED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14599013 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® AFTER MARKET DEVICES, AS WELL AS THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH FEMORAL COMPARTMENT SYNDROME (UNKNOWN IF IT WAS ON THE LEFT OR RIGHT SIDE). THE PHYSICIAN REINTERVENED AND PERFORMED A FASCIOTOMY. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 14575797 ↗
• InjuryMay 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. THE MAIN TRUNK DEVICE WAS EXTENDED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESES. DURING THE PROCEDURE, THE TRUNK DEVICE LANDED 5 MM BELOW THE LEFT RENAL ARTERY. THE PHYSICIAN DECLINED TO RECONSTRAIN AND REPOSITION DUE TO THE PATIENT'S POOR KIDNEY CONDITION. THE RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY OVERSTENTED. AT THE CONCLUSION OF THE PROCEDURE, IMAGING REPORTEDLY SHOWED DISTAL MIGRATION OF 15 MM AND OVERSTENTING OF THE LEFT INTERNAL ILIAC ARTERY. THE PHYSICIAN IS TAKING A WAIT AND SEE APPROACH AND IS CURRENTLY MONITORING THE PATIENT FOR POTENTIAL COMPLICATIONS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14460470 ↗
• InjuryMar 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY WHEREIN THE PHYSICIAN IDENTIFIED A TYPE 1B ENDOLEAK WAS PRESENT IN THE RIGHT COMMON ILIAC ARTERY (RCIA) AND DECIDED TO TREAT IT. THE PHYSICIAN DECIDED TO COIL EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY (RIIA) AND EXTEND THE ORIGINAL DEVICE IN THE RIGHT COMMON ILIAC ARTERY (RCIA). A CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND COVERAGE DOWN TO THE RIGHT EXTERNAL ILIAC ARTERY WITH INTENTIONAL COVERAGE OF THE RIIA. THE DISTAL ENDOLEAK WAS NOTED TO HAVE BEEN DUE TO DISEASE PROGRESSION DISTAL TO THE ORIGINAL DEVICE. THE ENDOLEAK RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 13742890 ↗
• InjuryFeb 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT WAS SEEN FOR A FOLLOWUP EXAM. THE PATIENT REPORTED NEW ONSET LEFT LEG PAIN AND BUTTOCK CLAUDICATION. IT WAS DETERMINED THAT THE ISSUES WERE DUE TO THE LEFT ILIAC LIMB BEING COMPRESSED DUE TO A TIGHT DISTAL AORTA. THE PHYSICIAN IMPLANTED A COVERED STENT ON (B)(6) 2022. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 13471278 ↗
• InjuryMar 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ARTERIAL OCCLUSIVE DISEASE USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT A GORE® EXCLUDER® ILIAC BRANCH COMPONENT (IBC) WAS PLACED IN THE PATIENT'S AORTA, A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS PLACED IN THE PATIENT'S RIGHT ILIAC ARTERY, AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT AND GORE® EXCLUDER® AAA ILIAC EXTENDER COMPONENT WERE PLACED IN THE PATIENT'S LEFT ILIAC ARTERY. IT WAS ALSO REPORTED THAT THERE WAS NOT ENOUGH ROOM IN THE PATIENT'S AORTA FOR THE IBC DEVICE. ON AN UNKNOWN DATE, DEVICE OCCLUSION WITH NO DISTAL BLOOD FLOW WAS REPORTED THROUGH THE DEVICES LOCATED IN THE PATIENT'S LEFT ILIAC ARTERY. THE GORE REPRESENTATIVE WAS MADE AWARE OF THE ISSUE ON FEBRUARY 22, 2021. IT WAS REPORTEDLY SUSPECTED THAT THE DEVICE OCCLUSION MAY HAVE BEEN RELATED TO THERE NOT BEING ENOUGH ROOM IN THE PATIENT'S AORTA FOR THE IBC DEVICE. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. IT WAS REPORTED THAT THE CONTRALATERAL LEG COMPONENT IN THE PATIENT'S RIGHT LIMB WAS REINFORCED USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. A FEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547708 ↗

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