GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231414Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00733132622375), received between Aug 29, 2018 and Sep 10, 2025 — classified as 4 deaths, 24 injuries, 1 malfunction.

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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS USED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2025. PROCEDURE WENT VERY SMOOTHLY, WITH EXCELLENT FINAL ANGIOGRAPHY, AND NO CONCERNS. PATIENT PRESENTED AT HOSPITAL IN EARLY ON (B)(6) 2025 WITH PAIN IN RIGHT FOOT. CT PERFORMED ON (B)(6) 2025 SHOWED A COMPLETE LIMB OCCLUSION ON RIGHT SIDE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE SURGEON PERFORMED FEM-FEM CROSSOVER, AND ALSO RE-BALLOONED WHOLE GRAFT AND LEFT SIDE, THE FLOW WAS RESTORED. THE SURGEON AND GORE REPRESENTATIVE RE-REVIEWED THE CASE AND IMAGES ON (B)(6) 2025. THE ORIGINAL PATHOLOGY WAS NOT A TYPICAL ABDOMINAL AORTIC ANEURYSM, BUT RATHER MORE OF AN ANOMALOUS PENETRATING AORTIC ULCER-TYPE LESION IN THE ABDOMINAL AORTA WITH SOME CALCIFICATION. IN HINDSIGHT, IT WAS REPORTED THAT IT LOOKED A LITTLE NARROW BUT THERE WERE NO CONCERNS AT THE TIME OF THE PROCEDURE. FOLLOWING IMPLANT, THE FINAL ANGIOGRAM LOOKED GREAT AND SHOWED GOOD FLOW DOWN BOTH LIMBS. THE SURGEON REPORTEDLY HAS NO CONCERNS REGARDING THE DEVICE AT ALL AND DOES NOT THINK THE DEVICE IS AT FAULT IN ANY WAY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23014472 ↗
• InjuryJul 17, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 55 MM IN DIAMETER. ON (B)(6) 2021, A TYPE II ENDOLEAK WITH SAC ENLARGEMENT WAS DIAGNOSED. MEASURING 66 MM COMPARED TO 48 MM ON (B)(6) 2020. ON (B)(6) 2021 COIL EMBOLIZATION WAS PERFORMED. IT ALSO WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT HAD DISCONTINUED THE STUDY AS HE HAD EXPIRED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22529223 ↗
• DeathApr 22, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT AND 2 PLCS) IN ZONE 5. PRIOR TO THE PROCEDURE, THE PHYSICIAN ADDRESSED THE PATIENT'S LEFT RENAL ARTERY THAT WAS ALREADY OCCLUDED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WAS DEPLOYED INTO THE RENAL PORTAL THAT WAS FOLLOWED BY AN AMPLATZER PLUG. DURING THE PROCEDURE, THERE WAS NOT AN ADEQUATE LANDING ZONE IN THE PATIENT¿S CELIAC ARTERY. THERE WAS A SHORT BRANCH FROM THE LEFT GASTRIC ARTERY THAT BRANCHED OFF THE SPLENIC ARTERY. TO ACHIEVE A SEAL INTO THE CELIAC ARTERY, THE PHYSICIAN PLUGGED THE SPLENIC ARTERY AND COILED THE LEFT GASTRIC ARTERY. A VBX DEVICE WAS THEN IMPLANTED INTO THE PATIENT¿S HEPATIC ARTERY. ADDITIONAL VBX DEVICES WERE IMPLANTED IN THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY WITH NO ISSUES. ON (B)(6) I-CAST STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY (RRA) DUE TO EXISTING HIGH-GRADE STENOSIS. DURING THE PROCEDURE, TWO VBX DEVICES WERE DEPLOYED WITHIN THE RRA. AS REPORTED, PROCEDURE WENT SMOOTHLY AND THE PATI

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21883810 ↗
• MalfunctionNov 13, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT ON (B)(6), 2024, A PATIENT WAS TO BE IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER DEVICE) DURING ENDOVASCULAR SURGERY TO TREAT ABDOMINAL ARTERY ANEURYSM. THE EXCLUDER DEVICE WAS ADVANCED TO TARGET LESION. AFTER THE PHYSICIAN PULLED OUT THE FIRST DEPLOYMENT LINE COMPLETELY, THE TRUNK WASN'T EXPANDED UNDER DSA. THEN THE PHYSICIAN REMOVED BACKUP DEPLOYMENT MECHANISM. IT WAS FOUND THAT FIRST DEPLOYMENT LINE WAS COMPLETELY REMOVED, AND THE EXCLUDER DEVICE STILL CONSTRAINED WITHOUT ANY EXPANSION. THEN THE DEVICE WAS REMOVED OUT OF PATIENT. ANOTHER RLT261412 WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679784 ↗
• DeathOct 29, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, THE PATIENT PRESENTED BACK TO THE ED WITH ABDOMINAL PAIN. BLOOD WORK SHOWED AN ELEVATED WHITE COUNT. ADDITIONALLY, CT IMAGING OF THE PATIENT'S ABDOMEN WAS PERFORMED WHICH SHOWED A PROXIMAL TYPE I AND BILATERAL DISTAL TYPE I ENDOLEAKS. THE PHYSICIAN REPORTED THAT THE ENDOLEAKS WERE SUSPECTED TO BE DUE TO INFLAMMATION IN THE AORTA. A PLA230300 GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT AND TWO GORE® EXCLUDER® AAA ILIAC EXTENDER COMPONENTS (PLL161207 AND PLL161407) WERE IMPLANTED TO RESEAL THE ANEURYSM AND STABILIZE THE PATIENT WHO WAS REPORTEDLY TOO UNSTABLE TO UNDERGO DEVICE EXPLANT AT THAT TIME. ON (B)(6) 2024, THE PATIENT WAS TAKEN TO THE OR AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE SYSTEM WAS EXPLANTED DUE TO SYSTEMIC INFECTION. THE SOURCE OF THE INFECTION WAS UNKNOWN. IT IS UNKNOWN IF THE PATIENT HAD AN ACTIVE INFECTION AT THE TIME OF DEVICE IMPLANT TO TREAT THE PRE-EXISTING RUPTURED AAA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPIRED ON AN UNKNOWN DATE AFTER THE PROCEDURE.

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 20554398 ↗
• InjuryOct 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR A LARGE ANEURYSM AROUND THE ILIAC ARTERY USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THIS PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY (RIIA) WAS COILED. ON (B)(6) 2024, A REINTERVENTION OCCURRED BECAUSE THE LIMB PULLED OUT OF THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN EXTENDED DISTALLY WITH ANOTHER EXCLUDER AND A VBX DEVICE. ON (B)(6) 2024, CONTRAST WAS SEEN ON THE CT IMAGE PROXIMALLY, INDICATED A SUSPECTED TYPE I ENDOLEAK. ANOTHER REINTERVENTION OCCURRED, AND AN AORTIC EXTENDER WAS PLACED PROXIMALLY. IT WAS NOTED THAT THE COIL HAD NOT FULLY SEALED. A REINTERVENTION IS PLANNED TO LIGATE THE RIIA.

  Patient problems: Clinical Endoleak

  MAUDE report 20489139 ↗
• InjuryJun 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, IMAGING FOLLOW-UP REVEALED THERE WAS A TYPE II ENDOLEAK. ON (B)(6) 2024 (GORE ASSOCIATE WAS NOT PRESENT), PATIENT UNDERWENT REINTERVENTION SURGERY, AND THE IMA WAS COILED. ANOTHER FOLLOW-UP SCAN (UNKNOWN DATE), REVEALED THERE WAS A PERSISTENT TYPE II ENDOLEAK FROM THE LUMBAR ARTERIES. ON (B)(6) 2024, AN ANGIOGRAM WAS PERFORMED. COIL EMBOLIZATION OF THE TWO LUMBAR ARTERIES WAS PERFORMED BY ADDITIONAL COILING OF THE AAA SAC. NO TYPE 1B OR ISSUE WAS OBSERVED ON THE PLC181200 CONTRALATERAL LEG COMPONENT, BUT ACCESS WAS GAINED INTO THE AAA SAC, AND RIGHT COMMON ILIAC ARTERY LIMB WAS EXTENDED TO MAXIMIZE THE SEAL ZONE AS A PRECAUTIONARY MEASURE. PATIENT TOLERATED THE PROCEDURE. NO IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19638910 ↗
• InjuryOct 30, 2023Partial Blockage; Partial Blockage

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS, A GORE® ILIAC BRANCH COMPONENT, AND A GORE® INTERNAL ILIAC COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, IT WAS DETERMINED THAT THE IPSILATERAL LEG OF THE EXCLUDER MAIN BODY WAS COMPRESSED, COMPETING FOR SPACE IN A NARROW AORTA. THE PHYSICIAN PERFORMED A THROMBECTOMY WITH AN EMBOLECTOMY CATHETER, AND WAS ABLE TO REESTABLISH THE FLOW. THE PATIENT WAS PUT ON HEPARIN, AND THEN THE LIMB WAS RELINED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO GIVE ADDITIONAL RADIAL FORCE TO COMPETE EQUALLY WITH THE CONTRA SIDE. THE FLOW WAS RESTORED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 18030578 ↗
• DeathJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND DID NOT PRESENT WITH ANY ENDOLEAKS. THAT EVENING, THE PATIENT WAS CONVERTED TO OPEN SURGERY DUE TO GRADUALLY DECREASING BLOOD PRESSURE. REPORTEDLY THE DEVICES HAVE BEEN EXPLANTED AND THE LESION WAS SURGICALLY REPAIRED WITH A BIFURCATED PROSTHESIS (NOT FURTHER SPECIFIED). DURING THE PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARREST 3 TIMES. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT BUT DIED LATER IN THE NIGHT DUE TO BLOOD LOSS UNDER THE PERITONEUM AND SUCCESSIVE CARDIAC ARRESTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 17323780 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION. IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK HAD DEGENERATED AND THE ANEURYSM SAC HAD ENLARGED (AMOUNT UNKNOWN). REPORTEDLY, THERE WAS NO EVIDENCE OF A TYPE I ENDOLEAK. A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT (CXA) WAS USED TO EXTEND THE PREVIOUSLY IMPLANTED TRUNK-IPSILATERAL LEG COMPONENT PROXIMALLY. THE PATIENT'S INFERIOR MESENTERIC ARTERY WAS EMBOLIZED AND THE CXA DEVICE WAS IMPLANTED. THERE WERE NO ISSUES OBSERVED AT THE CLOSE OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 17262936 ↗
• 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 16777317 ↗
• InjuryDec 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, CT IMAGING DETECTED ANEURYSM GROWTH OF 2 CM (FROM A 5 CM BASELINE TAKEN IN 2015). IT IS THOUGHT THAT A TYPE IB AND TYPE II ENDOLEAK WERE CONTRIBUTING TO ANEURYSM GROWTH. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED AND TYPE IB AND TYPE II ENDOLEAKS WERE CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16061880 ↗
• DeathNov 4, 2022Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SOME DIFFICULTIES TO DO A CANNULATION. DURING THE CANNULATION, THE PATIENT BECAME UNSTABLE AND SUBSEQUENTLY DIED. THE CASE WAS DISCUSSED WITH THE PHYSICIAN. THE PHYSICIAN IS NOT INTERESTED IN A DEVICE INVESTIGATION, AND BELIEVES THE DEATH IS ATTRIBUTED TO THE PATIENTS PATHOLOGY/ DISEASE AND NOT DUE TO THE DEVICE. THE CAUSE OF DEATH WAS RUPTURED ANEURYSM. NO MORE INFORMATION IS GOING TO BE PROVIDED BY THE PATIENT'S FAMILY WISH.

  Patient problems: Aneurysm; Ruptured Aneurysm

  MAUDE report 15740142 ↗
• InjuryMay 5, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2022 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022 IT WAS REPORTED THAT THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS THROMBOSED AND OCCLUDED. IT WAS REPORTED THAT THE IPSILATERAL LIMB WAS COMPRESSED DUE TO THE PATIENT'S ANATOMY. ON THE SAME DAY A REINTERVENTION WAS PERFORMED. A THROMBECTOMY WAS PERFORMED USING AN EDWARDS FOGARTY® CATHETER AND BOTH SIDES WERE THEN RELINED USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES IN A KISSING STENT TECHNIQUE. THERE WERE NO REPORTED ISSUES WITH THE CONTRALATERAL LEG COMPONENT PRIOR TO RELINING. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 14292827 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT WAS IMPLANTED WITH THE FOLLOWING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR ENDOVASCULAR ANEURYSM REPAIR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. RLT231414 (GORE LOT/SN: (B)(4)), TRUNK IPSILATERAL LEG ENDOPROSTHESIS. PLC141200 (GORE LOT/SN: (B)(4)) CONTRALATERAL LEG ENDOPROSTHESIS. AS REPORTED BY THE PHYSICIAN FOR HISTORY OF THE PRESENTED ILLNESS, THE POST-PROCEDURE ULTRASOUND SURVEILLANCE SUGGESTED CONTINUED RESIDUAL ANEURYSM SAC EXPANSION AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SUGGESTED AN ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THERE WAS AN ATTEMPTED ENDOLEAK REPAIR BY INTERVENTIONAL RADIOLOGY CONDUCTED IN (B)(6) OF 2022 FROM WHICH IT WAS SUGGESTED A TYPE I OR TYPE III ENDOLEAK WAS PRESENT. THE ANEURYSM SAC REMAINED ASYMPTOMATIC. ON (B)(6) 2022 THE TYPE III ENDOLEAK WAS CONFIRMED BETWEEN THE OVERLAP OF THE GORE® EXCLUDER® AAA TRUNK IPSILATERAL C3 AND CONTRALATERAL LEG ENDOPROSTHESES . AS REPORTED, IT IS UNKNOWN IF THE CAUSE OF THE ENDOLEAK IS DUE TO INCORRECT PLACEMENT OF THE CONTRALATERAL LIMB RESULTING IN INSUFFICIENT OVERLAP, OR DUE TO ENDOPROSTHESIS MIGRATION. ON (B)(6) 2022 REINTERVENTION WAS CONDUCTED. THE PROCEDURE CONSISTED OF RELINING THE

  Patient problems: Aneurysm

  MAUDE report 13967450 ↗
• InjuryMar 1, 2022Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN PSEUDOANEURYSM THAT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, THE PATIENT PRESENTED WITH ARTERIAL THROMBOSIS OF THE STENT GRAFT. ON (B)(6) 2021, THE THROMBOSIS WAS TREATED WITH AN EVAR RELINING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13636880 ↗
• InjuryJan 31, 2022Obstruction of Flow; Device Damaged by Another Device; Obstruction of Flow; 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. HE ALSO IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON THE LEFT SIDE, BUT IT 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 PLC DEVICES THAT HAD BEEN IMPLANTED. THE LIMBS WERE CROSSED, SO THAT IN ADDITION TO THE FACT THAT THE VESSEL WAS HEAVILY CALCIFIED AND OF SMALL DIAMETER, IT RESULTED IN PRESSURE THAT CAUSED THE LIMB TO COLLAPSE. A THROMBECTOMY WAS PERFORMED, AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO REOPEN THE LIMB. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13392404 ↗
• InjuryOct 15, 2020Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT ON (B)(6) 2020, DEVICE INFECTION OF THE IMPLANTED ENDOPROSTHESES WAS IDENTIFIED. THE PHYSICIAN STATED THE PATIENT HAD RECENT GASTROENTERITIS CAUSED BY CAMPYLOBACTER FETUS. THE SAME GERMEN WAS FOUND IN THE ENDOGRAFT AND THE BLOOD CULTURE. ON (B)(6) 2020, THE DEVICES WERE EXPLANTED AND A BYPASS USING PERICARDIAL BOVINE PATHS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2020.

  Patient problems: Bacterial Infection

  MAUDE report 10683391 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. THE PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 64MM. FROM (B)(6) 2016 TO (B)(6) 2018 THE FOLLOW UP ANGIOGRAPHY DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 61MM TO 57MM. ON (B)(6) 2019 A CTA REVEALED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/ LESION WAS 63MM. ON AN UNKNOWN DATE, A TYPE II ENDOLEAK WAS FOUND. REPORTEDLY, ON (B)(6) 2020, THE PATIENT UNDERWENT THE EMBOLIZATION PROCEDURE TO TREAT THE TYPE II ENDOLEAK AND THE ANEURYSM ENLARGEMENT. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10569243 ↗
• InjuryAug 13, 2020Partial Blockage; Use of Device Problem; Partial Blockage; Use of Device Problem

  ON AN UNKNOWN DATE, REPORTEDLY MORE THAN 10 YEARS PRIOR TO 2020, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A DACRON GRAFT. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A DISRUPTION IN THE DISTAL ANASTOMOSIS AT THE AORTIC BIFURCATION OF THE DACRON GRAFT USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. LEFT FEMORAL ACCESS WAS OBTAINED BY CUTDOWN AND A PLANNED ENDARTERECTOMY WAS CARRIED OUT. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WAS ADVANCED THROUGH A 16FR SHEATH. AFTER THE DEVICE REACHED THE LEVEL OF THE RENAL ARTERIES, THE SHEATH WAS WITHDRAWN FROM THE RENAL ARTERY LEVEL. THE DEVICE WAS MOVED UP AND DOWN, BUT NOT LATERALLY. THE PROXIMAL END OF THE DEVICE WAS DEPLOYED IN THE NATIVE AORTA, 1-2CM ABOVE THE DACRON TUBE GRAFT. HOWEVER, IT APPEARED THAT THE CONTRALATERAL GATE HAD NOT OPENED. THE DEVICE WAS RECONSTRAINED, MANEUVERED AND RE-DEPLOYED, BUT CONTRALATERAL GATE WAS STILL CLOSED. THE REMAINDER OF THE DEVICE WAS DEPLOYED BUT NO CHANGE WAS NOTED IN THE STATUS OF THE GATE. A .014" WIRE WAS THEN ADVANCED IN AN UP AND OVER TECHNIQUE. THIS WIRE WAS SNARED ALLOWING FOR A .035

  Patient problems: Occlusion

  MAUDE report 10405565 ↗
• InjuryJan 27, 2020Collapse; Material Invagination; Patient-Device Incompatibility; Collapse; Material Invagination; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A 4.7CM RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. A SMALL DISTAL AORTIC ANEURYSM WAS ALSO REPORTEDLY PRESENT, BUT TREATMENT WAS FOCUSED ON THE ILIAC ARTERY ANEURYSM. THE GORE® EXCLUDER® ILIAC BRANCH DEVICES WERE PLACED ON THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT, UPON COMPLETION OF THE PROCEDURE, THE TRUNK-IPSILATERAL LEG COMPONENT IN THE PATIENT'S INFRARENAL ABDOMINAL AORTA DID NOT HAVE FULL CIRCUMFERENTIAL WALL APPOSITION PROXIMALLY (A BIRD BEAK WAS PRESENT) DUE TO ANGULATION OF THE PATIENT'S AORTA. THE ANGLE OF THE PATIENT'S AORTA IS REPORTEDLY UNAVAILABLE. ON (B)(6) 2020 THE PATIENT PRESENTED WITH BILATERAL LEG PAIN. ONE HOUR AFTER THE PATIENT PRESENTED WITH THE REPORTED LEG PAIN, A CT WAS PERFORMED. IT WAS REPORTED THAT THE PROXIMAL MAIN BODY OF THE TRUNK-IPSILATERAL LEG COMPONENT HAD COLLAPSED AND WAS THROMBOSED. COMPRESSION WAS PRESENT ON THE TRUNK MAIN BODY OF THE DEVICE. REPORTEDLY IT IS UNKNOWN IF ANY BLOOD FLOW WAS PRESENT THROUGH THE DEVICE. NO THROMBUS OR OCCLUSION WAS REPORTEDLY PRESENT IN THE CONTRALATERAL LEG COMPONENT,

  Patient problems: Occlusion; Pain; Thrombus

  MAUDE report 9633885 ↗
• InjuryNov 11, 2019Complete Blockage; Deformation Due to Compressive Stress; Complete Blockage; Deformation Due to Compressive Stress

  IT WAS INITIALLY REPORTED THAT, DURING THE INTERVENTION ON (B)(6) 2019, AN AORTOILIAC BYPASS WAS PERFORMED ON THE PATIENT'S RIGHT SIDE WHEREBY THE BYPASS GRAFT WAS ATTACHED PROXIMAL TO THE ILIAC BRANCH COMPONENT (IBC) IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY, AND REATTACHED DISTAL TO THE IBC DEVICE IN THE PATIENT'S RIGHT FEMORAL ARTERY. ADDITIONAL CLARIFICATION WAS RECEIVED ON (B)(6) 2019 THAT, DURING THE INTERVENTION ON (B)(6) 2019, AS THE THROMBECTOMY ON THE PATIENT'S RIGHT SIDE WAS SUCCESSFUL, THE BIFURCATED BYPASS GRAFT WAS ATTACHED TO THE IBC ON THE PATIENT'S RIGHT SIDE AS WAS PREVIOUSLY PLANNED. THERE WAS NO DISTAL BYPASS ON THE PATIENT'S RIGHT SIDE. DUE TO THE FAILED THROMBECTOMY ON THE PATIENT'S LEFT SIDE, THE JUMP GRAFT WAS PLACED AS A BYPASS AROUND THE ILIAC BRANCH ENDOPROSTHESES. DISTAL BYPASS WAS ONLY PERFORMED ON THE PATIENT'S LEFT SIDE.

  Patient problems: Occlusion; Pain; Paresis; Thrombus

  MAUDE report 9307545 ↗
• InjuryOct 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, THE PATIENT PRESENTED WITH A 55 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. A FOLLOW-UP CTA, DATED (B)(6) 2016, SHOWED THE ANEURYSM TO BE 56.7 MM. THE ANEURYSM SIZE APPEARED TO BE STABLE UNTIL (B)(6) 2017. ON (B)(6) 2018, A TYPE II ENDOLEAK OF UNSPECIFIED ORIGIN WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH GLUE EMBOLIZATION. THE ANEURYSM MEASURED 66 MM BY CTA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9259715 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A PENETRATING AORTIC ULCER USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. NO COMPLICATIONS OR ISSUES DURING PROCEDURE WERE REPORTED, HOWEVER, AFTER THE PROCEDURE THE PATIENT PRESENTED WITH CHEST PAIN AND COMPUTED TOMOGRAPHY (CT) WAS ORDERED WHICH REVEALED A TYPE B DISSECTION IN THE DESCENDING AORTA DISTAL TO THE INFRARENAL GRAFT. THE DISSECTION WAS NOT PREVIOUSLY NOTED ON CT SCAN OR ANGIOGRAPHIC IMAGES. NO ADDITIONAL INTERVENTIONS HAVE BEEN PLANNED AND IT IS NOT KNOWN WHAT CAUSED THE POST PROCEDURE DISSECTION. THE PATIENT IS BEING TREATED WITH BLOOD PRESSURE MEDICATIONS AND IS BEING MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 9011125 ↗
• InjuryMay 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 THE PATIENT HAD FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE THE PATIENT HAD A CT SCAN AND IT WAS NOTED BY THE PHYSICIAN THE PROXIMAL END OF THE RLT231414 HAD COLLAPSED. ON (B)(6) 2019, ALL FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE BEING EXPLANTED AND THE SURGERY WAS CONVERTED TO OPEN REPAIR. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8597634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

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