GORE EXCLUDER AAA Endoprosthesis PLC231000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00733132618576), received between Aug 16, 2018 and Mar 18, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (3 reports).

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Material Puncture/Hole

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC231000-CONTRALATERAL COMPONENT). REPORTEDLY, ON AN UNKNOWN DATE IN (B)(6), A ROUTINE POST-OP CTA IMAGING WAS PERFORMED, IN WHICH AN UNSPECIFIED ENDOLEAK, POSSIBLY A TYPE 2 WAS OBSERVED. ON (B)(6) 2026, THE PATIENT HAD AN ANGIOGRAM WHICH REVEALED A HOLE IN THE PLC231000 GRAFT AND AN ASSOCIATED TYPE 3 ENDOLEAK DUE TO THE HOLE. NO TYPE 2 ENDOLEAK WAS OBSERVED. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THE TYPE 3 ENDOLEAK. THE CAUSE OF THE HOLE IN THE DEVICE IS UNKNOWN. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO RELINE THE PLC231000 GRAFT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG (PLC231000). NO FURTHER PATIENT INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628315 ↗
• InjuryNov 13, 2025Migration; Migration

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A 10 CM SYMPTOMATIC ABDOMINAL ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC231200 AND PLC231000) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA260005). THE PLC231200 WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, THEN EXTENDED WITH THE PLC231000 FOR ADDITIONAL COVERAGE, AND THEN THE CXA260005 WAS IMPLANTED DISTAL TO THE PLC231000 AS ADDITIONAL COVERAGE. IN ADDITION TO THESE THREE DEVICES IN THE LEFT COMMON ILIAC ARTERY, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND TWO OTHER GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRALATERAL LEGS) IN THE RIGHT COMMON ILIAC ARTERY. ON THE FINAL ANGIOGRAM FOR THE INITIAL PROCEDURE, THERE WAS A TYPE 2 ENDOLEAK REPORTED WHICH THE PHYSICIAN PLANNED TO MONITOR. THIS TYPE 2 ENDOLEAK WAS CAUSED BY COLLATERALIZATION FEEDING THE ANEURYSM SAC. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THIS TYPE 2 ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION AS THE PLC231200, PLC231000, AND CXA260005 HAD MIGRATED PROXIMALLY AS ONE UNIT INTO THE LEFT COMMON ILIAC ARTERY, CAUSING A TYPE 1B ENDOLEAK.

  Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm

  MAUDE report 23547252 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTO ILIAC ANEURYSM A DISSECTION FROM THE ABDOMINAL AORTA TO THE RIGHT COMMON FEMORAL ARTERY AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® LLIAC BRANCH ENDOPROSTHESIS (IBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE (IBE SIDE) AND ANEURYSM ENLARGEMENT TO 10CM. A GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO SEAL AND EXTEND. THE ENDOLEAK WAS RESOLVED. DURING THE PROCEDURE, THOUGH NO ENDOLEAK WAS SEEN, THE PHYSICIAN DECIDED TO REINFORCE THE OVERLAP ZONE OF THE BRIDGING COMPONENT AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO RELINE THIS AREA. THE PATIENT TOLERATED THE PROCEDURE WITH GREAT RESULTS.

  Patient problems: Clinical Endoleak

  MAUDE report 23451708 ↗
• InjuryMar 15, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND UNILATERAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AN RLT311413 TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S AORTA, A CEB231410A ILIAC BRANCH COMPONENT AND HGB161407A INTERNAL ILIAC COMPONENT WERE IMPLANTED IN THE PATIENT'S LEFT ILIAC ARTERY, AND A PLC271000 CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGING COMPONENT. A PLC231000 CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE IPSILATERAL LIMB. IMAGING EVALUATION SUGGESTS THAT THE PATIENT'S AORTIC NECK IS APPROXIMATELY 70 DEGREES. ON (B)(6) 2024, POST-IMPLANTATION NON-CONTRAST CT REVEALED THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT APPEARED TO BE COMPRESSED AT THE ANGULATED PORTION OF THE AORTA. ON (B)(6) 2025, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PRESENTED WITH LEG PAIN. EVALUATION OF POST-IMPLANTATION CTA IMAGING, DATED ON (B)(6) 2025, REVEALED THAT THE AORTA HAD DISSECTED AND THAT THE ENTIRE DEVICE SYSTEM HAD THROMBOSED AND OCCLUDED. THE DISSECTION REPORTEDLY EXTENDED PROXIMAL TO THE PATIENT'S DESCE

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21613793 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2023, A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, IMAGES REVEALED LACK OF DEVICE APPOSITION (IPSILATERAL LIMB SIDE OF PATIENT) DUE TO DISEASE PROGRESSION. A REINTERVENTION IS BEING PLANNED.

  Patient problems: Clinical Endoleak

  MAUDE report 20517953 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LATER THIS SAME DAY (B)(6) 2024) THE PHYSICIAN RE-INTERVENED ON THE PATIENT. IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE BLOOD FLOW IN HIS LEFT LEG AND HE WAS BROUGHT BACK TO THE OPERATING ROOM. A FEMORAL TO FEMORAL BYPASS, AND EBOLECTOMY WAS PERFORMED ON THE LEFT SIDE; AND BI-LATERAL FASCIOTOMIES FROM THE KNEE DOWN ON WERE PERFORMED ON BOTH LEGS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 18937407 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT ILIAC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND AN UNKNOWN SIZE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WHICH WAS IMPLANTED IN THE INTERNAL ILIAC ARTERY. ON 2/13/2024, FSA CALLED AND NOTIFIED PHYSICIAN REPORTED PATIENT HAS A POSSIBLE UNSPECIFIED LEAK WITH A POSSIBLE REINTERVENTION. FURTHER INFORMATION TO BE PROVIDED. ON 2/14/2024, IT WAS REPORTED THERE WAS A TYPE II ENDOELEAK, SUSPECTED TYPE 1 ENDOLEAK, AND POSSIBLE TYPE 3 COMPONENT DISCONNECTION. PLANS FOR REINTERVENTION SURGERY WILL BE SCHEDULED FOR (B)(6) 2024. ON 3/5/2024, IT WAS REPORTED PATIENT UNDERWENT REINTERVENTION SURGERY ON (B)(6) 2024 TO TREAT THESE ENDOLEAKS. FSA ALSO REPORTS AN AORTIC EXTENDER WAS PLACED PROXIMALLY, BUT THE THERE WAS A LEAK IN THE IBE GATE. REPORTEDLY, DURING THE PROCEDURE ANGIOGRAPHY WAS PERFORMED AND A BRISK TYPE III JUNCTIONAL LEAK WAS NOTED AT THE VBX STENT GRAFT. IT APPEARED THE VBX STENT GRAFT HAD RECOILED (REDUCED IN DIAMETER) OVER TIME. PHYSICIAN BALLOONED IT WITH A 12 OR 14 BALLOON, AND THE L

  Patient problems: Clinical Endoleak

  MAUDE report 18856456 ↗
• InjuryApr 19, 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, 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 WENT TO ANOTHER FACILITY (UNIVERSITY OF COLORADO HEALTH SCIENCE CENTER) APPROXIMATELY A WEEK AFTER THE PRIMARY PROCEDURE ((B)(6) 2023 WILL BE USED FOR DATE OF EVENT) FOR AN EVALUATION. IT WAS DETERMINED THE PATIENT HAD A PARTIALLY OCCLUDED LIMB/DEVICE ON THE LEFT SIDE. DUE TO AN ADVERSE REACTION TO HEPARIN, THE PATIENT WAS AT RISK FOR BRAIN BLEED, SO NO INTERVENTION HAS BEEN DONE. THE PATIENT IS BEING EVALUATED FOR TOLERANCE OF HEPARIN AND WILL EITHER RECEIVE A STENT TO OPEN LEFT LIMB, OR A SURGICAL FEM-FEM WILL BE DONE. THIS EVENT IS ONGOING AND NO LONGER UNDER CARE OF IMPLANTING PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE DUE TO THE PATIENT SWITCHING FACILITIES AND PHYSICIAN.

  Patient problems: Aneurysm

  MAUDE report 16773345 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9-INFRARENAL ANEURYSM PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. LATER THAT EVENING, PATIENT HAD UNCONTROLLED BLEEDING IN THE LEG, SUSPECTED TO BE FROM THE STENT GRAFT CONTRALATERAL LEG, ACCESS SITE WAS BLEEDING (BLOOD LOSS UNKNOWN), AND A SHEATH WAS USED AND UNDERWENT AN EMERGENCY ENDOVASCULAR REPAIR WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT THE BLEEDING. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN DID NOT THINK THE BLEEDING WAS DEVICE RELATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16185651 ↗
• InjuryDec 21, 2022Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTING WITH ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, THE TRAINEE VASCULAR SURGEON INADVERTENTLY COVERED BOTH RENAL ARTERIES WHEN MANIPULATING THE IPSILATERAL LEG AND EXTENSION. THE GRAFTS WERE IMMEDIATELY EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 16024603 ↗
• InjuryJul 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED: LEFT SIDE RLT281416 AND PLC231000, CONTRALATERAL RIGHT SIDE PLC231400. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT UNDERWENT EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY, WITH RELINING OF THE LEFT LEG UNTIL THE EXTERNAL ILIAC ARTERY ON (B)(6) 2022. THE REASON FOR THE REINTERVENTION IS A TYPE 1B ENDOLEAK WITH CONNECTING ANEURYSM DISTAL TO THE IMPLANT. AN ADDITIONAL GORE DEVICE WAS USED FOR THE EXTENSION OF THE PRIMARY GRAFT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 15128157 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® LLIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK ASSOCIATED WITH A 23 CONTRALATERAL LEG COMPONENT USED TO EXTEND COVERAGE ON THE LEFT SIDE DUE TO ELONGATION OF THE INTERNAL ILIAC ARTERY AND A FULL OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY. TWO ADDITIONAL CONTRALATERAL LEG COMPONENTS WERE PLACED DISTALLY ON THE LEFT SIDE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12081722 ↗
• MalfunctionApr 28, 2021Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IN (B)(6) 2019 THE PATIENT WAS TREATED WITH NON-GORE DEVICES FOR AN ABDOMINAL AORTO-BIILIAC ANEURYSM WHICH EXTENDED INTO THE RIGHT ILIAC ARTERY. THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN INCREASE OF THE ANEURYSMAL SAC BECAUSE OF A TYPE 2 ENDOLEAK. THEY PERFORMED AN ENDOVASCULAR REINTERVENTION AND TREATED THE ENDOLEAK WITH AN EMBOLIZATION OF THE ANEURYSMAL SAC AND WITH AN EXTENSION OF THE PREVIOUSLY IMPLANTED STENT GRAFTS INTO THE LEFT ILIAC ARTERY WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC231000). THEY REPORTED, THAT WHEN THEY TRIED TO DEPLOY THE PLC231000 THE DEPLOYMENT LINE HAS BROKEN WITHIN THE FIRST 3 CENTIMETERS OF OPENING. NO EXCESSIVE TRACTION WAS USED. IT WAS STATED, THAT THE DEPLOYMENT LINE GOT CAUGHT ON THE DEVICES IMPLANTED PREVIOUSLY (1700-E:-IMPLANTABLE DEVICE EVENTS PRE DEPLOYMENT - OTHER/UNKNOWN), BECAUSE ON IMAGES THEY RECOGNIZED, THAT THE PREVIOUSLY IMPLANTED DEVICE WAS MOVING WHEN PULLING THE DEPLOYMENT LINE. REPORTEDLY, THE PLC231000 DID NOT START TO DEPLOY WITHIN THE PATIENT. IT WAS THEREFORE POSSIBLE TO WITHDRAW IT WITHOUT CONSEQUENCES FOR THE PATIENT. THEY USED ANOTHER PLC231000 TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737881 ↗
• InjuryJan 15, 2021Patient-Device Incompatibility

  ON (B)(6) 2006, THIS PATIENT UNDERWENT OPEN SURGERY AND WAS IMPLANTED WITH A PROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2016, AN ADDITIONAL ENDOVASCULAR TREATMENT WITH GORE® EXCLUDER® AAA ENDOPROSTHESES WAS PERFORMED AFTER FOLLOW-UP IMAGING ON AN UNKNOWN DATE HAD IDENTIFIED SUTURE RELATED DISTAL ANASTOMOTIC ANEURYSMS. ON THAT DAY, THE PATIENT WAS REPORTEDLY IMPLANTED WITH A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT231412, AND WITH TWO GORE® EXCLUDER® CONTRALATERAL LEG COMPONENTS, PLC231000 AND PLC27100. ON (B)(6) 2020, FOLLOW-UP IMAGING REVEALED AN ANEURYSM OF THE LEFT COMMON ILIAC ARTERY MEASURING 46 MM IN DIAMETER DUE TO DISEASE PROGRESSION DISTAL TO THE CONTRALATERAL LEG COMPONENT PLC231000. IT WAS ALSO NOTED THAT THE COMPONENT NOW SHOWED A TYPE 1B ENDOLEAK THAT REPORTEDLY WAS BELIEVED TO HAVE BEEN CAUSED BY THE DEVELOPING ANEURYSM. THE COMMON ILIAC ARTERY ON THE RIGHT APPEARED TO BE EXPANDED BUT SHOWED NO ANEURYSM REQUIRING TREATMENT. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED TO TREAT THE ANEURYSM ON THE LEFT TOGETHER WITH THE ENDOLEAK AND THE PLC231000 ENDOPROSTHESIS WAS EXTENDED WITH A GORE® EXCLUDER® ILIAC BRANCH COMPONENT CEB231410. ADDITIONA

  Patient problems: Aneurysm

  MAUDE report 11180871 ↗
• InjuryJun 29, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON FOLLOW UP IMAGING PEFORMED ON (B)(6) 2020, A TYPE III ENDOLEAK WAS DISCOVERED. THE PHYSICIAN PLANS TO DO A REINTERVENTION TO TREAT THE ENDOLEAK. THE PHYSICIAN BELIEVES THE CAUSE OF THE EVENT WAS INSUFFICIENT OVERLAP BETWEEN THE TWO BRIDGE DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10206754 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A RIGHT ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS NOTED THAT THERE WAS DISSECTION OF THE PATIENT'S LEFT ILIAC ARTERY. IT WAS REPORTED THAT THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG AND CONTRALATERAL LEG COMPONENTS WERE ADVANCED AND DEPLOYED WITH NO REPORTED ISSUES. REPORTEDLY, A GORE® MOLDING & OCCLUSION BALLOON (MOB) CATHETER WAS USED TO BALLOON THE CONTRALATERAL LEG COMPONENT, LOCATED ON THE PATIENT'S LEFT SIDE. UPON INFLATION OF THE MOB CATHETER, THE PATIENT'S LEFT ILIAC ARTERY WAS RUPTURED. THE PHYSICIAN AND CLINICAL SPECIALIST REPORTED THAT ILIAC ARTERY RUPTURE WAS DUE TO OVER BALLOONING. REPORTEDLY THERE WAS NO ISSUE WITH EITHER THE GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT, OR THE MOB CATHETER. THE PATIENT ADVERSE EVENT OCCURRED SOLELY DUE TO OVER BALLOONING. THE PHYSICIAN CONVERTED TO AN OPEN PROCEDURE. THE CONTRALATERAL LEG COMPONENT WAS REMOVED. THE TRUNK-IPSILATERAL LEG COMPONENT REMAINED IN THE PATIENT. THE PATIENT'S LEFT ILIAC ARTERY WAS CLAMPED AND SUTURED, AND A RIGHT FEMORAL TO LEFT FEMORAL ARTERY BYPASS WAS PERFORMED. THE MOB CATHETER WAS DISCARDED AT THE FACILITY. TH

  Patient problems: Perforation of Vessels

  MAUDE report 10121547 ↗
• InjuryMar 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON AN UNKNOWN DATE IN (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN AORTIC ANEURYSM IN THE RIGHT INTERNAL ILIAC. THE PATIENT REPORTED EMERGENTLY ON (B)(6) 2019, WITH A CONTAINED ILIAC RUPTURE. THE RUPTURE WAS CAUSED BY A DISCONNECT BETWEEN THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND ONE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES. A PLC271400 WAS USED TO RELINE THE AREA OF THE DISCONNECT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9812187 ↗
• InjuryDec 5, 2019Malposition of Device; Malposition of Device

  ON (B)(6), 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. WHEN DEPLOYING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT, IT WAS DETECTED THAT THE LEFT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED. REPORTEDLY, AN INTERNAL ILIAC ARTERY OSTIUM WAS VISUALIZED WITH CONTRAST AND MARKED. THE LENGTH WAS MEASURED WITH A PIGTAIL CATHETER. A CORRECT DEVICE WAS SELECTED AND DEPLOYED. THE PHYSICIAN WAS NOT CERTAIN HOW THIS HAPPENED, HOWEVER, HE WAS NOT CONCERNED ABOUT THIS OUTCOME. REPORTEDLY, THERE WAS NOTHING IN PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WAS EXTENDED INTO EXTERNAL ILIAC ARTERY TO SECURE SUFFICIENT PURCHASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE RIGHT INTERNAL ILIAC ARTERY PRESERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 9419713 ↗
• InjuryOct 8, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PREOP STUDY ON (B)(6) 2019. AN ANEURYSM OF THE LEFT ILIAC WAS NOTED, AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED. AT AN UNKNOWN TIME AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH RIGHT SIDE LEG PAIN AND CLAUDICATION. A POSTOP STUDY ON (B)(6) 2019 INDICATED A RESTRICTED LUMEN AT THE FLOW DIVIDER ON THE IPSILATERAL LIMB. REINTERVENTION IS SCHEDULED AT THE END OF (B)(6) 2019.

  Patient problems: Claudication; Pain; Thrombus

  MAUDE report 9167579 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES, AND TREATMENT OF BI-LATERAL ILIAC ANEURYSMS TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT AN ENDOLEAK (UNKNOWN TYPE AND UNKNOWN FROM WHICH DEVICE) WAS REPORTED ON COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2019. THE PHYSICIAN CLAIMED EITHER A TYPE III ENDOLEAK BETWEEN THE IBE BRIDGE COMPONENTS (CEB231210A/16550024 AND PLC231000/13731351 OR PLC231000/17275880) DUE TO INSUFFICIENT OVERLAP OF THE DEVICES IN THE ORIGINAL PROCEDURE OR POSSIBLY A TYPE II ENDOLEAK. THE PHYSICIAN REINTERVENED ON (B)(6) 2016, AND RELINED THE AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS AND CONTRALATERAL LEG ENDOPROSTHESIS WITH AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS, DUE TO THE ILIAC ARTERY ANEURYSM GROWING (AMOUNT OF GROWTH IS UNKNOWN). THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH FOR A POSSIBLE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8680849 ↗
• InjuryMar 22, 2019Material Separation; Material Separation

  ON FEBRUARY 17, 2019, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED A TYPE III ENDOLEAK INVOLVING A DISCONNECTION BETWEEN THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC231000 AND THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT CEB231410.

  Patient problems: No Code Available

  MAUDE report 8443032 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY UNKNOWN) REVEALED A DISTAL TYPE I ENDOLEAK NOTED FROM THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2018, THERE WAS A REINTERVENTION. REPORTEDLY THE END OF THE DEVICE/LIMB WAS NOTED TO BE PULLED BACK INTO THE ANEURYSM SAC. THE LEFT HYPOGASTRIC ARTERY WAS COILED. THE LIMB WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC121400/18759233 DEVICE. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8261436 ↗
• InjuryNov 13, 2018Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). ON (B)(6) 2018, A TYPE III ENDOLEAK ORIGINATING FROM THE OVERLAP BETWEEN A CONTRALATERAL LEG ENDOPROSTHESIS (PLC231000) AND AN ILIAC BRANCH COMPONENT (CEB231410) WAS IDENTIFIED. IT WAS STATED THAT THE CAUSE FOR THE ENDOLEAK WAS INSUFFICIENT OVERLAP BETWEEN THE TWO DEVICES. ADDITIONALLY IT WAS REPORTED THAT THE DIAMETER OF THE COMMON ILIAC ARTERY WAS >23MM. THE USED PLC IN THE COMMON ILIAC ARTERY IS RECOMMENDED TO BE USED IN A VESSEL DIAMETER OF 18.5 TO 21.5MM. ON (B)(6) 2018, BOTH DEVICES WERE SUCCESSFULLY RELINED WITH THE IMPLANTATION OF AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS AND IT WAS REPORTED THAT THE ENDOLEAK WAS SOLVED.

  Patient problems: No Code Available

  MAUDE report 8063628 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSM WITH A LEFT ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESES, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. REPORTEDLY THE PATIENT HAD VERY TORTUOUS ANATOMY. IT WAS REPORTED THAT AFTER THE FINAL ANGIOGRAM, THERE WAS SLUGGISH FLOW ON THE LEFT SIDE AND DIMINISHED PULSES (1000-E:-OTHER - EXPLAINED IN FILE). THE PHYSICIAN DECIDED TO PERFORM A CUT DOWN AND ENDARTERECTOMY. THERE WAS A DISSECTED FLAP BUT THE LEFT FEMORAL ARTERY WAS PATENT. THE NEXT DAY AN ANGIOGRAM REVEALED ONE OF THE DEVICES HAD COMPRESSED, BUT IT IS UNKNOWN WHICH ONE (PLC231000/18198471, CEB231210A/18065349, AND HGB161007A/18007068). ON (B)(6) 2018, THE PHYSICIAN REINTERVENED AND ATTEMPTED TO USE A PTA BALLOON TO OPEN ALL THREE DEVICES BY INFLATING AND DRAGGING THE INFLATED BALLOON UP AND DOWN ALL THREE DEVICES. THE PATIENT¿S BLOOD PRESSURE BECAME UNSTABLE AND THE PHYSICIAN PERFORMED AN OPEN PROCEDURE, A FEM-TO-FEM BYPASS. THE PULSES TO THE FOOT WERE BETTER AND THE PATIENT TOLERATE THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7854099 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN AORTIC ABDOMINAL ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK ON THE PLC231000 WITH ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. IT WAS REPORTED THE ENDOLEAK WAS CAUSED BY DISEASE PROGRESSION (DILATATION) CAUSING A LOSS OF SEAL. ON THE SAME DAY, THE RIGHT EXTERNAL ILIAC ARTERY WAS COILED EMBOLIZED AND A DEVICE WAS IMPLANTED TO EXTEND FROM THE PLC231000 TO TREAT THE ENDOLEAK. FINAL IMAGING IDENTIFIED THAT THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7789718 ↗

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