GORE EXCLUDER AAA Endoprosthesis PLC271200Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00733132618545), received between Jun 22, 2018 and Apr 14, 2026 — classified as 1 death, 49 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (15 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Device Endoleak

  ON (B)(6), THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24876309 ↗
• MalfunctionDec 19, 2025Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC271200) WAS INTENDED TO BE USED FOR AN ANEURYSM RUPTURE REPAIR. DURING THE EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) IMPLANTATION PROCEDURE THE SURGEON WANTED TO DEPLOY THE BRIDGING COMPONENT PLC271200, BUT THE DEPLOYMENT LINE BROKE WHEN THE DEPLOYMENT STARTED. LUCKILY, THE PLC271200 DID NOT DEPLOY PARTIALLY INTO THE PATIENT SO THE CATHETER WAS REMOVED AND REPLACED BY ANOTHER. THE PATIENT TOLERATED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849475 ↗
• InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (2 CONTRALATERAL COMPONENTS), GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT) TO TREAT AN ANEURYSM. ON (B)(6) 2025, A GRAFT INFECTION WAS OBSERVED, AND PATIENT UNDERWENT EXPLANT SURGERY IN WHICH ALL THE DEVICES WERE EXPLANTED. IT ALSO UNKNOWN WHICH DEVICE HAD AN INFECTION. IT WAS ALSO REPORTED PATIENT HAS NO KNOWN HISTORY OF PREVIOUS INFECTIONS, AND IT IS UNKNOWN WHAT CAUSED THE INFECTION. NO FURTHER PATIENT INFORMATION IS AVAILABLE, AND DEVICES WERE DISCARDED. THE FIELD SALES ASSOCIATE WAS NOTIFIED ABOUT THIS EXPLANT SURGERY ON (B)(6) 2025. CODE 1001-E: -UNKNOWN-USED TO CAPTURE INFECTION WITH UNKNOWN CAUSE.

  Patient problems: Medical device site infection

  MAUDE report 23498179 ↗
• MalfunctionOct 15, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A CONTRALATERAL LEG ENDOPROSTHESIS, THE DEPLOYMENT LINE WAS PULLED BUT THE DEVICE DID NOT DEPLOY. THE PHYSICIAN RETRACTED THE DEVICE THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH 15FR AND REMOVED BOTH THE UNDEPLOYED DEVICE AND SHEATH FROM THE PATIENT. A NEW SHEATH AND A NEW DEVICE WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THERE WAS NO ANATOMIC CONSTRAINTS OR ANATOMY ANOMALIES. THERE WERE NO ISSUES ADVANCING THE DEVICE.

  Patient problems: Aneurysm

  MAUDE report 23293876 ↗
• InjurySep 19, 2025Migration; Device Endoleak; Migration; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, A PATIENT WAS TREATED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. ON (B)(6) 2025, A CT SCAN SHOWED A TYPE 1B ENDOLEAK. REPORTEDLY, THE RIGHT COMMON ILIAC HAD ENLARGED, AND THE CONTRALATERAL LEG HAD MIGRATED PROXIMALLY INTO THE ANEURYSM SAC. A REINTERVENTION IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Clinical Endoleak

  MAUDE report 23100418 ↗
• DeathJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN 2014, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2019, PATIENT UNDERWENT AN UNKNOWN REINTERVENTION UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND AN AORTIC EXTENDER), AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT AND ILIAC BRANCH COMPONENT). ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION ENDOVASCULAR PROCEDURE ON A PRIOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT A TYPE 1A AND 1B ENDOLEAKS UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS (THREE CONTRALATERAL LEGS AND AORTIC EXTENDER), AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER). REPORTEDLY, PHYSICIAN WAS NOT ABLE TO GET CONTRAST SCANS DUE TO PATIENT'S POOR RENAL FUNCTION, WHICH WAS DUE TO PATIENT CONDITION. THE TYPE 1B ENDOLEAK WAS ON THE TRUNK IPSILATERAL LEG FROM 2014 AND THE TYPE 1B ENDOLEAKS WAS ON THE CONTRALATERAL LEG IMPLANTED IN 2019. DESPITE USING MULTIPLE CONTRALATERAL LEGS AND CONFIRMABLE AORTIC EXTENDER

  Patient problems: Clinical Endoleak

  MAUDE report 22668266 ↗
• InjuryMar 31, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES TO TREAT AN ISOLATED ILIAC ANEURYSM. THE PROCEDURE WAS PERFORMED BY DR. (B)(6). THE CASE WAS SUCCESSFUL WITH NO ISSUES NOTED. ON (B)(6) 2025, A FOLLOW UP CT SHOWED PATENT GRAFTS. ON MARCH 15, 2025, THE GORE FIELD SALE ASSOCIATE (FSA) RECEIVED A CALL FROM DR. (B)(6) TO COME ASSIST IN THE REVISION OF THIS CASE AS THE TRUNK OF THE MAIN BODY HAD COLLAPSED ON ITSELF AND WAS OCCLUDING THE REST OF THE GRAFTS. REPORTEDLY, ALL LIMBS WERE OCCLUDED COMPLETELY BUT THE PATIENT WAS GETTING RETROGRADE FLOW FROM THE INTERNAL ARTERIES. REPORTEDLY, THE RLT WAS THE ONLY GRAFT COMPRESSED. THE PATIENT PRESENTED TO HOSPITAL WITH CLAUDICATION SYMPTOMS. THE GRAFT WAS SUCCESSFULLY RE-CANNULIZED AND THE TRUNK OF THE MAINBODY OPENED UP DURING THE PROCESS OF ADVANCING THE WIRES UP INTO THE AORTA. DR. (B)(6) EXTENDED PROXIMALLY WITH KISSING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (10X79) FROM BELOW TO FLOW DIVIDER TO ABOVE THE ORIGINAL RLT GRAFT. THE INITIAL EVAR HAD BEEN INTENTIONALLY DEPLOYED LOWER THAN THE MAIN RENAL ARTERIES TO MAINTAIN FLOW TO A

  Patient problems: Movement Disorder; Reduced Blood Flow

  MAUDE report 21735322 ↗
• InjuryMar 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A COMPLICATED ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT. TWO IBE ILIAC BRANCH COMPONENTS AND TWO IBE INTERNAL ILIAC COMPONENTS WERE IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A GRAFT INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 21728362 ↗
• 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 - RLT261412) 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

  Patient problems: Clinical Endoleak

  MAUDE report 21650380 ↗
• InjuryJan 16, 2025Migration; Device Endoleak; Migration; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER ENDOPROSTHESIS IN ZONE 9 THAT HAD EXPANSION OF THE LEFT COMMON ILIAC. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT AT THE TIME OF THE (B)(6) 2022 PROCEDURE, A 27MM PLC WAS USED BUT LANDED 2 CM SHORT OF THE HYPOGASTRIC ARTERY AND ENDED UP PULLING BACK INTO THE ANEURYSM OVERTIME. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION TO A PRIOR ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL AND CONTRALATERAL LEG) IN ZONE 10. IT WAS REPORTED THAT ANOTHER 27MM PLC WAS USED ALONG WITH TWO AORTIC CUFFS THAT ENDED UP SEALING THE COMMON ILIAC TYPE LB LEAK. THERE WERE NO FILMS AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21165143 ↗
• InjuryOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK ON THE RIGHT COMMON ILIAC ARTERY. THE RIGHT SIDE WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH COMPONENT, GORE® EXCLUDER® CONTRALTERAL LEG ENDOPROSTHESES AND VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 20562588 ↗
• InjuryOct 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ALTHOUGH THE PHYSICIAN WANTED TO USE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), DUE TO THE TORTUOUS ANATOMY THEY DECIDED AGAINST, AND USED A FLARED LIMB INSTEAD, KNOWING THAT THEY MIGHT HAVE TO DO A REINTERVENTION LATER. ON SEPTEMBER 16, 2024, AT A ROUTINE FOLLOW-UP, A TYPE 1B ENDOLEAK WAS DISCOVERED. ON SEPTEMBER 23, 2024, A REINTERVENTION OCCURRED. THE LIMB WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY, AND THE LEFT INTERNAL ILIAC ARTERY WAS COILED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20481341 ↗
• InjuryJun 7, 2024Malposition of Device; Device Endoleak; Malposition of Device; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415, PLC271200, AND PLC231000) AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231410 AND HGB161407) WAS IMPLANTED ON (B)(6) 2024 IN ORDER TO TREAT A PATIENT WITH AN AORTIC ANEURYSM. THE MAIN TRUNK OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415) WAS EXTENDED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC271200) ON ONE SIDE WHICH CONTINUED TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE OTHER SIDE OF THE MAIN TRUNK OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415) WAS EXTENDED WITH THE OTHER GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC231000). THE PROCEDURE WENT WELL. ON A UNKNOWN DATE A FEW DAYS LATER, THE FOLLOW-UP CT SCAN SHOWED A COMPONENT DISCONNECTION BETWEEN THE RLT311415 AND THE PLC271200. THE PATIENT DID NOT SHOW ANY SYMPTOMS. A NEW ENDOVASCULAR REPAIR WAS PERFORMED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WHICH WAS PLACED BETWEEN THE RLT311415 AND THE PLC271200. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481905 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD AN EXTREMELY ANGULATED AORTIC NECK. WHILE DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS THE DEVICE MIGRATED APPROXIMATELY 5MM BELOW THE LEFT RENAL ARTERY (LOWEST RENAL ARTERY). THIS RESULTED IN A PROXIMAL TYPE I ENDOLEAK. TWO ADDITIONAL AORTIC EXTENDER ENDOPROSTHESIS WERE IMPLANTED, THE PROXIMAL TYPE I ENDOLEAK REMAINED. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO REPAIR THE UNRESOLVED ENDOLEAK FROM THE PROCEDURE ON (B)(6) 2024. THE PHYSICIAN PLANNED A PHYSICIAN MODIFIED ENDOGRAFT (PMEG) PROCEDURE. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT321414/28256561) WAS MODIFIED FOR THE PROCEDURE. THERE WERE PORTALS MADE TO THE GRAFT FOR THE RENAL ARTERIES. TWO FENESTRATIONS WERE CREATED, ONE FOR THE SUPERIOR MESENTERIC ARTERY AND ONE FOR THE CELIAC ARTERY. THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS IMPLANTED PROXIMAL TO THE CELIAC ARTERY. THE PHYSICIAN WAS UNABLE TO CANNULATE THE CELIAC ARTERY, THE BARE FENES

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

  MAUDE report 19378317 ↗
• InjuryNov 3, 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) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR A ZONE 9 ANEURYSM WITH AN ANEURYSMAL LEFT COMMON ILIAC ARTERY TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THE PHYSICIAN USED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (CXT BIFURCATED DEVICE) WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) ON THE LEFT SIDE. UPON COMPLETION OF THE PROCEDURE THERE WAS NO ENDOLEAK VISIBLE. ON (B)(6) 2023, UPON FOLLOW UP CT (COMPUTED TOMOGRAPHY DATE UNKNOWN) THE PHYSICIAN INFORMED THE FSA THAT THERE WAS A TYPE 3 ENDOLEAK (COMPONENT DISCONNECTION). THE FSA REPORTED THAT THE ¿27MM LIMB ON THE LEFT SIDE PULLED OUT OF THE IBE DEVICE¿. ON (B)(6) 2023, THE PHYSICIAN REINTERVENED AND IMPLANTED AN ADDITIONAL DEVICE TO BRIDGE THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. THE ROOT CAUSE OF THE ENDOLEAK IS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 18066967 ↗
• InjuryAug 28, 2023Adverse 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. A PLC271200 CONTRALATERAL LEG COMPONENT WAS USED IN THE PATIENT'S SHORT, DILATED LEFT COMMON ILIAC ARTERY (LCIA). ON OR ABOUT (B)(6), 2023, AN ENDOLEAK WAS OBSERVED ON FOLLOW-UP CTA IMAGING. IT WAS SUSPECTED THAT THERE WAS EITHER A DISTAL TYPE I ENDOLEAK PRESENT ON THE PATIENT'S LEFT SIDE OR A TYPE II ENDOLEAK FROM THE PATIENT'S INFERIOR MESENTERIC ARTERY (IMA). ON (B)(6), 2023, AN ANGIOGRAM WAS PERFORMED WHICH DID NOT SHOW A DISTAL TYPE I ENDOLEAK. HOWEVER, IT WAS REPORTED THAT THE PATIENT'S LCIA APPEARED TO BE DEGENERATING AT THE DISTAL EDGE OF THE IMPLANTED LIMB. THE PHYSICIAN ELECTED TO PLACE A CEB231210A GORE® EXCLUDER® ILIAC BRANCH COMPONENT (IBC) INTO THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT, FOLLOWED BY TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (8LX59 & 11X59) WHICH WERE USED TO EXTEND FROM THE IBC GATE DISTALLY INTO THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. FINALLY, A PLC271000 CONTRALATERAL LEG COMPONENT WAS USED TO TREAT THE DISEASED AREA DISTALLY. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION. SUCCE

  Patient problems: Aneurysm

  MAUDE report 17636888 ↗
• InjuryAug 28, 2023Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED TO GORE THAT, ON (B)(6) 2023, THE PATIENT PRESENTED WITH AN AORTIC ABDOMINAL ANEURYSM HAS BEEN TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (CEB231010 DEVICES). REPORTEDLY THE ANATOMY WAS TORTUOUS, BUT A GOOD DIAMETER WAS GIVEN, NO CALCIFICATION WAS REPORTED. STIFF GUIDE WIRES WERE USED DURING THE PROCEDURE. IT WAS STATED THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200 DEVICE), USED AS THE BRIDGING STENT BETWEEN THE AORTIC MAIN BODY AND THE LEFT CEB231010 DEVICE, LANDED AS INTENDED AND GOOD OVERLAP WAS ACHIEVED BOTH, PROXIMALLY AND DISTALLY. REPORTEDLY, THE DISTAL END OF THE PLC271200 DEVICE TENDED TO PULL UP DURING FINAL BALLOONING. AFTER THE STIFF GUIDE WIRES WERE TAKEN OUT FOR FINAL IMAGING, THE ANATOMY RELAXED TO ITS ORIGINAL POSITION AND THE PLC271200 DEVICE MOVED AN ADDITIONAL 10 TO 15 MM OUT OF THE CEB231010 DEVICE. BECAUSE THERE WAS STILL A SMALL OVERLAP OF THE DEVICES, THEY RELIGNED THE OVERLAP REGION WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AORTIC EXTENDER ENDOPROSTHESIS (CXA280005E DEVICE). REPORTEDLY A SMALL ENDOLEAK WAS

  Patient problems: Clinical Endoleak

  MAUDE report 17631116 ↗
• InjuryAug 28, 2023Patient-Device Incompatibility; Unintended Movement; Migration; Patient-Device Incompatibility; Unintended Movement; Migration

  IT WAS REPORTED TO GORE THAT, ON (B)(6) 2023, THE PATIENT PRESENTED WITH AN AORTIC ABDOMINAL ANEURYSM HAS BEEN TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (CEB231010 DEVICES). REPORTEDLY THE ANATOMY WAS TORTUOUS, BUT A GOOD DIAMETER WAS GIVEN, NO CALCIFICATION WAS REPORTED. STIFF GUIDE WIRES WERE USED DURING THE PROCEDURE. IT WAS STATED THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200 DEVICE), USED AS THE BRIDGING STENT BETWEEN THE AORTIC MAIN BODY AND THE LEFT CEB231010 DEVICE, LANDED AS INTENDED AND GOOD OVERLAP WAS ACHIEVED BOTH, PROXIMALLY AND DISTALLY. REPORTEDLY, THE DISTAL END OF THE PLC271200 DEVICE TENDED TO PULL UP DURING FINAL BALLOONING. AFTER THE STIFF GUIDE WIRES WERE TAKEN OUT FOR FINAL IMAGING, THE ANATOMY RELAXED TO ITS ORIGINAL POSITION AND THE PLC271200 DEVICE MOVED AN ADDITIONAL 10 TO 15 MM OUT OF THE CEB231010 DEVICE. BECAUSE THERE WAS STILL A SMALL OVERLAP OF THE DEVICES, THEY RELIGNED THE OVERLAP REGION WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AORTIC EXTENDER ENDOPROSTHESIS (CXA280005E DEVICE). REPORTEDLY A SMALL ENDOLEAK TYPE

  Patient problems: Clinical Endoleak

  MAUDE report 17630419 ↗
• InjuryAug 2, 2023Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  IT WAS REPORTED TO GORE, THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN THE RIGHT COMMON ILIAC ARTERY. IT WAS STATED THAT THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT, CEB231410 DEVICE) AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT, HGB161407 DEVICE) WERE IMPLANTED WITHOUT ANY PROBLEMS IN THE RIGHT COMMON ILIAC ARTERY VIA A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1633 SHEATH) PLACED IN THE RIGHT AND A DSF1245 SHEATH IN THE LEFT COMMON ILIAC ARTERY. THEN THE DSF1245 SHEATH WAS REPLACED WITH A DSF1833 SHEATH TO SUCCESSFULLY IMPLANT A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (CXT241412E DEVICE). THEN A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS, PCL271200 DEVICE) WAS USED AS A BRIDGING DEVICE. IT WAS ADVANCED THROUGH THE DSF1633 SHEATH TO THE RIGHT COMMON ILIAC ARTERY. REPORTEDLY VERY LITTLE PUSH WAS NEEDED TO LAND EXACTLY AT THE BIFURCATION OF THE CEB231410 DEVICE. IT WAS REPORTED THAT THEY STARTED TO

  Patient problems: Foreign Body Embolism; No Clinical Signs, Symptoms or Conditions; Reduced Blood Flow

  MAUDE report 17443670 ↗
• InjuryJul 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 - RLT311413) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS -PLC271200 AND PLC201200). REPORTEDLY, ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 9 INFRARENAL TO TREAT A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC WHERE THE CONTRALATERAL LEG (PLC271200) LIMB WAS PLACED AS THERE WAS ANEURYSM GROWTH AND MEASURED AS 33MM AROUND THE 27MM BELL BOTTOM, THUS, THE PLANNED REINTERVENTION WAS TO COIL EMBOLIZE AND COVER THE RIGHT HYPOGASTRIC ARTERY AND THEN EXTENDED DISTALLY WITH A CONTRALATERAL LEG (PLC141400). ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17419974 ↗
• InjuryJun 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT OF AN ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS HIGHLY CALCIFIED WITH LITTLE FLOW. A CEB231010 ILIAC BRANCH COMPONENT WAS PLACED ON THE PATIENT'S RIGHT SIDE, AND AN INTERNAL ILIAC COMPONENT WAS PLACED IN AN ATTEMPT TO PRESERVE THE INTERNAL ILIAC ARTERY WITH THE KNOWLEDGE THAT THE ARTERY MAY REQUIRE BYPASS. THE INTERNAL ILIAC COMPONENT WAS SUCCESSFULLY PLACED, BUT DUE TO THE CALCIFICATION THE DEVICE WAS UNABLE TO STAY PATENT. THEREFORE, A 27MMX12CM CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGING PIECE BETWEEN THE CEB AND THE TRUNK-IPSILATERAL LEG COMPONENT, AND THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY COVERED USING A 12MMX14CM CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE PATIENT'S RIGHT ILIAC ARTERY WAS PATENT POST OP. THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT A FOLLOW-UP CT WAS PERFORMED ON (B)(6) 2023. ON MAY 16, 2023, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM. IT WAS REPORTED THAT THE PATIENT'S RIGHT LEG WAS ISCHEMIC, AND THE DEVICES IN THE PATIENT'S R

  Patient problems: Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17122261 ↗
• InjuryMay 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2018, THE PATIENT WAS TREATED FOR AN UNKNOWN ISSUE. 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) 2023, A TYPE IB ENDOLEAK WAS DETECTED. THE PHYSICIAN PLANS TO DO A REINTERVENTION. REVISION WAS DONE ON MOVE MEDICAL CASE (B)(4). THE ENDOLEAK WAS BALLOONED, AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16877462 ↗
• MalfunctionMay 1, 2023Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. AFTER DEPLOYING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM, THE PHYSICIAN ATTEMPTED TO IMPLANT A GORE® EXCLUDER® AAA ENDOPROSTHESIS AS THE CONTRA LEG. WHILE ATTEMPTING TO ADVANCE THE DELIVERY CATHETER THROUGH THE GATE, THE CATHETER KEPT GETTING CAUGHT ON THE GATE. THE ILIAC WAS NOTED TO BE TORTUOUS, WHICH MADE ADVANCING THE CONTRA DEVICE DIFFICULT. FINALLY, THE PHYSICIAN DECIDED TO REMOVE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND TRY AGAIN WITH ANOTHER DEVICE. HOWEVER, WHEN ATTEMPTING TO PULL IT BACK, THE STENT GOT CAUGHT ON THE SHEATH. DURING THE ATTEMPT, THE OLIVE BROKE LOOSE, REMAINING ATTACHED TO THE DEVICE ONLY BY THE DEPLOYMENT LINE. THE PHYSICIAN WAS FORCED TO CUT DOWN AND REMOVE THE DEVICE AND SHEATH. IT WAS NOTED AT THE TIME THAT THE PROXIMAL PART OF THE DEVICE HAD BEEN DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844492 ↗
• InjuryMar 20, 2023Material Invagination; Material Invagination

  ON (B)(6) 2023, THIS PATIENT UNDERWENT TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND A UNILATERAL COMMON ILIAC ARTERY ANEURYSM (CIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT REINTERVENTION ON (B)(6) 2023 DUE TO INFOLDING OF THE TRUNK IPSILATERAL LEG COMPONENT AND THE PROXIMAL BRIDGE GRAFT (PLC271200) TO THE ILIAC BRANCH COMPONENT. IT WAS REPORTED THAT AN AXILLO-BIFEMORAL BYPASS WAS PERFORMED. NO EXPLANT OF ANY OF THE DEVICES WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE. A CAUSE OF THE INFOLDING WAS NOT PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 16578066 ↗
• MalfunctionMar 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A ZONE 2 DISSECTION OF THE AORTA. AFTER CANNULATION AND NEAR DEPLOYMENT OF A BRIDGE TO A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS BROKE OFF OF THE CATHETER. THE PHYSICIAN WAS UNABLE TO GET THE DEVICE BACK ON THE SHEATH, AND AFTER MULTIPLE ATTEMPTS TO SNARE IT, THE DECISION WAS MADE TO LEAVE THE DEVICE UNDEPLOYED AND CONTINUE THE CASE WITH ANOTHER DEVICE. THE SECOND DEVICE WAS DEPLOYED TO BRIDGE, AND THE FIRST DEVICE WAS PINNED BEHIND IT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478808 ↗

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