GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231412Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00733132622368), received between Aug 28, 2018 and Jun 9, 2026 — classified as 4 deaths, 51 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Migration” (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 62 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED AFTER THE IMPLANT PROCEDURE; THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS AND THAT PROGRESSED INTO LOWER EXTREMITY PARALYSIS. THERE WAS NO INTERVENTION, THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT. REPORTEDLY A SPINAL DRAIN WAS PLACED PRE-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 25448276 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2026, POST PROCEDURE IMAGES REVEALED TWO DISTAL ENDOLEAKS AND A TYPE III ENDOLEAK. THERE WAS A REINTERVENTION.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25237010 ↗
• MalfunctionMar 2, 2026Malposition of Device; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER DEPLOYING THE DEVICE, AN ANGIO WAS TAKEN, AND IT WAS DETERMINED THAT THE DEVICE HAD COVERED THE RENAL ARTERIES. THE EXCLUDER WAS RECONSTRAINED AND PULLED DOWN UNTIL IT WAS ONLY COVERING THE RENALS BY ABOUT 5MM. HOWEVER, AT THAT POINT, WHEN PULLING ON THE CATHETER, THE LEADING OLIVE WOULD MOVE WITHOUT THE DEVICE MOVING ANYMORE. SINCE THE DEVICE APPEARED TO BE DETACHED FROM THE CATHETER, DEPLOYMENT WAS COMPLETED. THE PHYSICIAN REPORTS NO IMPACT TO THE PATIENT. THE CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491443 ↗
• MalfunctionFeb 20, 2026Break

  THE ENTIRE DEPLOYMENT LINE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401471 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PROCEDURE WAS A TECHNICAL SUCCESS. REPORTEDLY, SEVERAL HOURS POST PROCEDURE, THE PATIENT DEVELOPED LOWER EXTREMITY PARALYSIS. THE PHYSICIAN REINTERVENED AND PUT IN A SPINAL DRAIN. THE PARALYSIS IS ONGOING.

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

  MAUDE report 23618894 ↗
• InjuryAug 28, 2025Adverse 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. FOLLOW UP IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) WITH A POSSIBLE TYPE III ENDOLEAK. REINTERVENTION ON (B)(6) 2025, THERE WAS NO TYPE III ENDOLEAK, THERE WAS A TYPE II ENDOLEAK. THE PHYSICIAN COILED THE FEEDING ARTERY AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 22913104 ↗
• InjuryJul 17, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE FROM IMEDIDATA DATABASE: IT WAS REPORTED TO GORE THAT ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 69 MM IN DIAMETER. ON (B)(6) 2020 A TYPE II ENDOLEAK WITH SAC ENLARGEMENT WAS DIAGNOSED MEASURING 84 MM COMPARED TO 70 MM ON (B)(6) 2019. ON (B)(6) 2021 GLUE EMBOLIZATION WAS PERFORMED. IT ALSO WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD DISCONTINUED THE STUDY AS HE HAD EXPIRED.

  Patient problems: Clinical Endoleak

  MAUDE report 22529309 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. POST OPERATIVELY THIS SAME DAY APPROXIMATELY 2 HOURS LATER; THE PATIENT WOKE UP WITH NO FEELING/MOVEMENT OF THE LEGS. A SPINAL DRAIN WAS PLACED AND SOMETIME LATER THAT NIGHT, THE PATIENT REPORTED FEELING IN THE LEGS, BUT NO MOVEMENT. THE PHYSICIAN PLANS TO DISCHARGE THE PATIENT TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT WITH THERAPY.

  Patient problems: Paraplegia

  MAUDE report 22350761 ↗
• DeathApr 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED ON (B)(6) 2025 DURING AN ENDOVASCULAR PROCEDURE ON A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM ASSOCIATED WITH A RIGHT COMMON ILIAC ANEURYSM. DURING THE PROCEDURE THE FINAL ANGIOGRAPHY SHOWED A PERFECT RESULT WITH NO DELAY OF THE CONTRAST PRODUCT AND GOOD ARTERIAL PULSES ON BOTH AXES. 9 DAYS POST-IMPLANT, ON (B)(6) 2025, THE PATIENT WAS ADMITTED IN EMERGENCY FOR ACUTE ISCHEMIA. THE CT SCAN SHOWS THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAS COMPLETELY COLLAPSED AND THE CONTRAST PASSING OUTSIDE THE ENDOPROSTHESIS. THE PATIENT UNDERWENT A SURGERY FOR AN AXILLARY BIFEMORAL BYPASS. THE PATIENT PAST AWAY 2 DAYS LATER FROM ISCHEMIA SYNDROMES.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21751148 ↗
• InjuryMar 31, 2025Material Invagination; Obstruction of Flow; Activation, Positioning or Separation Problem; Patient Device Interaction Problem; Material Invagination; Obstruction of Flow; Activation, Positioning or Separation Problem; Patient Device Interaction Problem

  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) AT (B)(6) HOSPITAL. THE CASE WAS SUCCESSFUL WITH NO ISSUES NOTED. ON (B)(6), 2025, A FOLLOW UP CT SHOWED PATENT GRAFTS. ON (B)(6) 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 M

  Patient problems: Movement Disorder; Reduced Blood Flow; Vascular Dissection

  MAUDE report 21735166 ↗
• InjuryNov 4, 2024Device Difficult to Maintain; Device Difficult to Maintain

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR THE ABDOMINAL AORTIC ANEURYSM, COMMON ILIAC ANEURYSM AND HYPOGASTRIC ANEURYSM PROCEDURE WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND BILATERAL (IBE) GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON AN UNKNOWN DATE, PATIENT HAD A ONE MONTH FOLLOW UP, WHICH SHOWED COMPLETELY PATENT VESSELS AND GRAFTS WERE WELL IMPOSED. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COLD LEGS. CT SCAN WAS DONE THAT SHOWED THE PATIENT'S MAIN BODY TRUNK IPSILATERAL LEG C3 HAD INFOLDED. PHYSICIAN DID AN EMERGENT OPEN SURGICAL REPAIR BY EXPLANTING THE TRUNK IPSILATERAL LEG C3 ALONG WITH THE CONTRALATERAL LEG. PHYSICIAN THEN SURGICALLY SEWED THE DACRON FABRIC GRAFT TO THE BILATERAL IBES. BOTH THE IBES AND THE HYPOGASTRIC GRAFTS REMAIN IMPLANTED. THE CONTRALATERAL LEG THAT WAS USED AS BRIDGING PIECE WAS REMOVED BUT THE 2ND BRIDGING PIECE THAT WAS AN ENDURANT MEDTRONIC GRAFT ALSO REMAINED IMPLANTED AND SEWED TO THE DACRON GRAFT. ON OCTOBER 07, 2024, THE FIELD SALES ASSOCIATE WAS INFORMED OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598658 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 37MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. THE PATIENT WAS ALSO REPORTED TO BE EXPERIENCING HYPOTENSION AND WAS ADMINISTERED DOPAMINES AND IV FLUIDS. ON (B)(6) 2014, THE PATIENT WAS REPORTED TO BE DIAGNOSED WITH ACUTE ON CHRONIC ANEMIA AND WAS TRANSFUSED WITH 2 UNITS PRBC'S. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT REQUIRED IN-PATIENT HOSPITALIZATION FOR TREATMENT OF A LEFT GROIN WOULD INFECTION AND RECEIVED IV ANTIBIOTICS. ADDITIONALLY, THE PATIENT RECEIVED WOUND CARE AND UNDERWENT INCISION AND DRAINAGE OF THE AREA. THE CAUSE OF THE GROIN INFECTION WAS UNKNOWN BUT REPORTED TO BE NOT RELATED TO THE DEVICES. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 33MM. ON (B)(6) 2018, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO HEPATOPLULMONARY SYNDROME WITH CIRRHOSIS. THERE WAS NO DEFICIENCY OF THE DEVICES REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 20057524 ↗
• MalfunctionAug 21, 2024Activation Problem; Activation Problem

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 9 INFRARENAL ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. UPON PROXIMAL DEPLOYMENT OF THE EXCLUDER DEVICE (STENT GRAFT TRUNK IPSILATERAL LEG C3), PHYSICIAN TURNED THE KNOB 90 DEGREES COUNTER-CLOCKWISE WISE, PULLED THE DEPLOYMENT KNOB, AND THE DEPLOYMENT STRING CAME OUT, HOWEVER THE GRAFT WOULD NOT DEPLOY. THERE WERE NO ISSUES WITH THE PULLING OF THE DEPLOYMENT LINE. PHYSICIAN MOVED THE GRAFT AROUND A BIT TO MAKE SURE THERE WAS NO CALCIUM, AND NOTHING DEPLOYED. THE PROXIMAL END (TOP PORTION) FEATHERED OPEN JUST A FEW MILLIMETERS, NOT EVEN 20% DEPLOYMENT. PHYSICIAN TRIED TO RECAPTURE THE GRAFT BY ADVANCING THE 16FR SHEATH, BUT COULD NOT GET IT PASSED JUST DISTAL TO THE GATE. PHYSICIAN THEN TRIED PULLING THE GRAFT INTO THE SHEATH, AND PHYSICIAN COULD STILL NOT GET PASSED THAT POINT. PHYSICIAN THEN ATTEMPTED TO CONTINUE DEPLOYMENT AS GRAFT COULD NOT GET PASSED THE SHEATH. PHYSICIAN DEPLOYED THE CONSTRAINING MECHANISM AND NOTHING HAPPENED. THEN PHYSICIAN DEPLOYED THE IPSILATERAL LEG COMPONENT, AND IT DEPLOYED. SO NOW THERE WAS AN OPEN IPSILATERAL-LIMB, BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011401 ↗
• InjuryAug 13, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON APRIL 22, 2015, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED WITH COMPUTED TOMOGRAPHY (CTA) WAS 51 MM. ON (B)(6) 2020, THE PATIENT PRESENTED AS AN EMERGENCY REFERRAL DUE TO ANEURYSM EXPANSION AND WAS DIAGNOSED WITH A COVERED RUPTURED ANEURYSM DUE TO A TYPE IA ENDOLEAK. AT THE TIME OF INTAKE, THE ANEURYSM MEASURED 71 X 58 MM (UP FROM 59 X 51 MM AS MEASURED DURING A PREVIOUS FOLLOW UP). THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 67 MM. BOTH OF THE ABOVE MEASUREMENTS WERE DONE USING CTA. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR ON THE SAME DAY.

  Patient problems: Ruptured Aneurysm

  MAUDE report 19973022 ↗
• MalfunctionAug 13, 2024Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT COMMON ILIAC ANEURYSM (IBE) WITH SMALL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3). REPORTEDLY, THE PHYSICIAN HAD AN ISSUE WITH THE RECONSTRAINING LINE. THE DEVICE WAS DEPLOYED WITH NO ISSUES, IT WAS RECONSTRAINED ONCE TO BRING THE GRAFT DOWN SLIGHTLY AND UNCONSTRAINED WITHOUT INCIDENT. AFTER CANNULATION THE SURGEON ATTEMPTED TO REMOVE THE CLEAR HANDLE AND AFTER COMING BACK APPROXIMATELY 3 INCHES, RESISTANCE WAS FELT AND THE SURGEON STOPPED PULLING. THE LOCK PIN LINE WAS PULLED ON AND REMOVED BUT THE RECONSTRAINING LINE WAS NOT PULLING OUT. AS THE SURGEON WAS ABLE TO ACCESS THE IPSILATERAL LINE FROM THE HANDLE THIS WAS DEPLOYED AND THE WHOLE DEPLOYMENT CATHETER WAS ATTEMPTED TO BE REMOVED. RESISTANCE WAS STILL FELT ON THE CONSTRAINING LINE AND AT THIS POINT THE LINE BROKE OFF OF THE CLEAR HANDLE AND THE WHOLE DELIVERY SYSTEM CAME OUT LEAVING THE RECONSTRAINING LINE IN PLACE. THE SURGEON INFLATED AN AORTIC BALLOON IN THE MAIN BODY GRAFT AND ATTEMPTED TO PULL ON THE RECONTRAINING LINE BUT WAS UNSUCCESSFUL IN REMOVING IT. THE DECISI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971244 ↗
• InjuryJul 8, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. ON (B)(6) 2024, THE PHYSICIAN CONTACTED THE FSA AND REPORTED THAT THE PATIENT HAD A COMPRESSED IPSILATERAL LIMB IN THE GATE OF A BIFURCATED GRAFT. THE PATIENT HAD AN IBE AND HAD A NORMAL AORTA, SO THE LIMB IS COMPRESSED IN ~19MM LUMEN OF THE AORTA. THE PHYSICIAN BELIEVES THAT THE PATIENT'S NORMAL BUT SMALL AORTA CAUSED THE ISSUE. THE INITIAL PLAN FOR REINTERVENTION WAS SCHEDULED FOR (B)(6) 2024, HOWEVER THE PROCEDURE WAS NOT PERFORMED AS OF YET. THE PROCEDURE WILL BE PERFORMED AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696464 ↗
• InjuryJun 13, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Device Endoleak; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Endoleak

  ON (B)(6) 2016, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 120MM. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP IMAGING FROM (B)(6) 2016 TO (B)(6) 2019 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 97.7MM TO 109MM. ON (B)(6) 2019, THE ANEURYSM ENLARGEMENT FROM THE ENDOLEAK WAS NOTICED. ON (B)(6) 2020, AN EXPLANT PROCEDURE WAS PERFORMED. ADDITIONALLY, THE ADDITIONAL PROCEDURE WAS DONE USING A DACRON TUBE AORTIC GRAFT. ACCORDING TO THE SITE, THE EVENT WAS RELATED TO THE AORTIC DEVICE OR THE PROCEDURE. THE SITE MENTIONED THAT THE DECISION WAS MADE TO EXPLANT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND REPAIR THE AORTA WITH DACRON GRAFT. REPORTEDLY, MURAL THROMBUS WAS REMOVED FROM THE SAC. LUMBAR VESSELS LOCATED AS A SOURCE OF ENDOLEAK WERE OVER SEWN. THE FOLLOW UP IMAGING FROM JANUARY 22, 2021 TO JANUARY 20, 2023 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 93MM TO 70MM.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19534208 ↗
• InjuryApr 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PRIOR ENDOVASCULAR REPAIR WITH A MEDTRONIC AFIX GRAFT AND A VELA CUFF. GORE® EXCLUDER®AAA ENDOPROSTHESIS WERE IMPLANTED TO TREAT A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE MEDTRONIC DEVICES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER MEASURED 52MM. ON AN UNKNOWN DATE ESTIMATED TO BE ON OR ABOUT (B)(6) 2023, THE PATIENT WAS DETERMINED TO HAVE A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIIA) AND A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE PROXIMAL GRAFTS. ON (B)(6) 2024, THE PATIENT UNDERWENT ADDITIONAL ENDOVASCULAR OF A SUSPECTED PROXIMAL TYPE AND TREATMENT OF THE RCIAA, TWO GORE® EXCLUDER® AORTIC EXTENDERS WERE IMPLANTED PROXIMALLY AND THE RCIAA WAS COIL EMBOLIZED AND EXTENDED DISTALLY WITH A GORE® EXCLUDER® ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE WITH NO ENDOLEAK CONFIRMED, AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024 IN STABLE CONDITION.

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

  MAUDE report 19102270 ↗
• MalfunctionMar 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON DECEMBER 13, 2023, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, BLOOD LEAKED FROM THE HANDLE. THE PHYSICIAN REPORTED THAT THEY HAD TO DEPLOY THE DEVICE MORE HASTILY BECAUSE OF THE HANDLE LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928801 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2015. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 57MM. ON (B)(6) 2015, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 43MM. ALSO, A TYPE II ENDOLEAK WAS NOTICED. THE PHYSICIAN MONITORED THE PATIENT. FROM (B)(6) 2018 TO (B)(6) 2020 THE FOLLOW UP SCANS SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 47MM TO 51MM. ON AN UNKNOWN DATE IN (B)(6) 2021, THE PATIENT UNDERWENT A LEFT POSTERIOR LUMBAR VESSELS EMBOLIZATION PROCEDURE. FROM (B)(6) 2022 TO (B)(6) 2022 THE FOLLOW UP SCANS SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 59MM TO 62MM. REPORTEDLY, IN (B)(6) 2022, A TYPE II ENDOLEAK RECURRED. ON (B)(6) 2023, A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED TO CHECK THE LOCATION OF THE TYPE II ENDOLEAK. ON (B)(6) 2024, THE PATIENT UNDERWENT ILIOLUMBAR ARTERY EMBOLIZATION PROCEDURE. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18682379 ↗
• InjuryDec 21, 2023Partial Blockage; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Device Endoleak; Partial Blockage; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Device Endoleak

  ON (B)(6) 2023, A PATIENT WAS PRESENTED WITH AN AORTOILIAC RUPTURED ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT WAS IN A BAD CONDITION DUE TO THE ANEURYSM RUPTURE. IT WAS REPORTED THAT THE PATIENT HAD AN ANGULATED AORTIC NECK AND A LARGE AORTOILIAC ANEURYSM. REPORTEDLY, DURING THE PROCEDURE, BOTH ILIAC ARTERIES WERE COIL EMBOLIZED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE TWO HOURS FOLLOWING THE PROCEDURE. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR. THE PHYSICIAN OBSERVED THAT THE TRUNK IPSILATERAL LEG MIGRATED DISTALLY OUT OF THE PROXIMAL NECK FOR SEVERAL CMS. THE PHYSICIAN DID AN OPEN RECONSTRUCTION. THE PATIENT SUBSEQUENTLY DIED TO OPEN CONVERSION AND BLOOD LOSS COMPLICATIONS. IT IS UNKNOWN IF THE DEATH WAS DUE TO THE RUPTURED ANEURYSM. ALSO, IT IS UNKNOWN IF THE DEVICE MIGRATION WAS DUE TO THE RUPTURED ANEURYSM.

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

  MAUDE report 18378981 ↗
• InjurySep 8, 2023No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER WAS 51.2MM. FROM (B)(6) 2016 TO (B)(6) 29, 2022 THE MAXIMUM AORTIC DIAMETER INCREASED FROM 55MM TO 66MM. REPORTEDLY, ON (B)(6) 2023, AN ENLARGEMENT OF THE JUXTARENAL ABDOMINAL AORTIC ANEURYSM WAS DETERMINED, AND THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE USING AN AORTIC ENDOGRAFT. THE PROBLEM WAS SOLVED. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PROGRESSION OF ANEURYSM DISEASE CAUSED THE ANEURYSM ENLARGEMENT. THERE WAS NOTHING IN PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE PHYSICIAN CONFIRMED THAT IT WAS AN ANEURYSM WITHOUT ENDOLEAKS. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: Aneurysm

  MAUDE report 17716562 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER WAS 52MM. FROM (B)(6) 2015 TO (B)(6) 2017 THE MAXIMUM AORTIC DIAMETER DECREASED FROM 49.8MM TO 45MM. ON (B)(6) 2018, THE MAXIMUM AORTIC DIAMETER WAS 49MM AND LATER, DECREASED IN SIZE TO 45MM ON (B)(6) 2021. REPORTEDLY, ON (B)(6) 2023, A DISTAL TYPE I ENDOLEAK WAS DETERMINED. ACCORDING TO THE SITE, THE EVENT WAS NOT DEVICE OR PROCEDURE RELATED. IT WAS REPORTED THAT THE TREATMENT WAS PLANNED BY THE PHYSICIAN, HOWEVER, THE DATE WAS NOT DECIDED YET. THE PHYSICIAN IS MONITORING THE PATIENT.

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

  MAUDE report 17579127 ↗
• InjuryMay 16, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® DEVICE PAIRED WITH THE GORE® C3® DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS POSITIONED BELOW THE RENAL ARTERIES AFTER BEING REPOSITIONED TWICE. THE POSITION WAS CONFIRMED VIA INTRAPROCEDURAL ANGIOGRAPHY. FINAL ANGIOGRAPHY SHOWED THAT THE RENAL ARTERIES (RA) WERE COVERED AND THE SUPERIOR MESENTERIC ARTERY (SMA) WAS PARTIALLY COVERED. RA AND SMA WERE STENTED USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES IN A CHIMNEY TECHNIQUE. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP IMAGING PERFORMED ON (B)(6) 2023, SHOWED THAT THE AFFECTED ARTERIES WERE PATENT. NO REINTERVENTION IS PLANNED.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 16938809 ↗
• InjuryMay 4, 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) 2013, 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 LEG ISCHEMIA. IMAGES REVEALED THE IPSILATERAL LEG OF THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESES HAD COMPRESSED, AND THROMBUS WAS PRESENT. THIS CAUSED PARTIAL OCCLUSION AND ISCHEMIA IN THE LEG. THE PHYSICIAN REINTERVENED AND PERFORMED A FEM-FEM BYPASS. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16873273 ↗

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