GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281418Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00733132622559), received between Sep 11, 2018 and Jan 8, 2026 — classified as 1 death, 28 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (4 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Device Endoleak

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281418). ON (B)(6) 2025, THE PATIENT RECEIVED MEDICAL IMAGING, AS THE PATIENT WAS HAVING BACK PAIN AND LOW HEMOGLOBIN (HGB). REPORTEDLY, THE MEDICAL IMAGING REVEALED A POTENTIAL TYPE 1A ENDOLEAK ON THE RLT281418. IT IS REPORTED THE CAUSE OF THE TYPE 1A ENDOLEAK IS UNKNOWN AND IT IS UNKNOWN IF THE ENDOLEAK LED TO ANEURYSM ENLARGEMENT. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE POTENTIAL TYPE 1A ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER, PLA280300). IT WAS REPORTED THAT THE TYPE 1A ENDOLEAK WAS NOT VISIBLE ON THE AORTOGRAM, HOWEVER, THE PHYSICIAN ELECTED TO STILL IMPLANT AN AORTIC EXTENDER. REPORTEDLY, IT IS UNKNOWN IF THE TYPE 1A ENDOLEAK WAS RESOLVED AS IT COULD NOT BE SEEN ON THE AORTOGRAM DURING THE REINTERVENTION PROCEDURE. THE PATIENT TOLERATED THIS PROCEDURE. ON AN UNKNOWN DATE AFTER THE REINTERVENTION PROCEDURE, THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY (IR) TO TREAT A TYPE 2 ENDOLEAK. IT IS UNKNOWN WHAT WAS DONE TO TREAT THE TYPE 2 ENDOLEAK. REPOR

  Patient problems: Anemia; Clinical Endoleak; Pain; Ruptured Aneurysm

  MAUDE report 24004479 ↗
• MalfunctionDec 15, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PLUS A LEFT ILIAC BRANCH TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3). REPORTEDLY, ONCE ALL PROCEDURAL ILIAC BRANCH STEPS WERE COMPLETED ON THE LEFT COMMON ILIAC AND HYPOGASTRIC ARTERIES THEN THE EXCLUDER C3 TRUNK WAS DEPLOYED AND THE CONTRALATERAL GATE WAS PROPERLY CANULATED. THE IPSILATERAL LEG OF THE EXCLUDER C3 IS DEPLOYED WITH A STEADY AND CONSTANT MOTION OF THE GRAY HUB COMPLETING A TOTAL EXIT OF THE RETAINING SUTURE WITH NO RESISTANCE BUT THE DISTAL PORTION OF THE IPSILATERAL LEG WAS NOT FULLY OPEN (ABOUT 1.5CM) AND SEEMS TO BE CONSTRAINED. THE DOCTOR IS ASKED TO NOT KEEP REMOVING THE DELIVERY CATHETER BECAUSE IN HIS FIRST ATTEMPT ON DOING SO, THE WHOLE DEVICE IS VISIBLY DISPLACED FROM ITS DESIRED PROXIMAL LANDING POSITION. AFTER CHECKING THE DEPLOYMENT LINE ACCESS HATCH AND NOTICING THAT ALL FIBERS WERE ENTIRELY REMOVED AND DETACHED CORRECTLY FROM THE HUB; 2 OPTIONS WERE CONSIDERED TO CONTINUE WITH THE PROCEDURE, THE FIRST ONE WAS CONVERTING TO OPEN SURGERY BUT DUE TO THE PATIENT HEALTH CONDITIONS THIS OPTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810813 ↗
• InjuryNov 19, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2016 THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT). ON AN UNKNOWN DATE, THE PATIENT RECEIVED A CAT SCAN REVEALING A TYPE 1A ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE TYPE 1A ENDOLEAK. THE ENDOLEAK WAS TREATED WITH A TERUMO MODIFIED GRAFT AND A 27 MM GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC) TO RELINE THE EXISTING GRAFTS DOWN TO THE TRUNK OF THE EXISTING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE CAUSE OF THE TYPE 1A ENDOLEAK IS UNKNOWN, AND THE ENDOLEAK DID LEAD TO ANEURYSM ENLARGEMENT, HOWEVER, GROWTH AMOUNT IS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23598057 ↗
• InjuryNov 16, 2025Material Invagination; Device Endoleak; Material Invagination; Device Endoleak

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2025, A PATIENT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES FOR ABDOMINAL AND ILIAC ANEURYSM. SIGNIFICANT THROMBUS WAS MEASURED IN THE PROXIMAL AORTIC NECK (7 MM AND 50% OF THE VESSEL CIRCUMFERENCE IN THE INTENDED SEAL ZONE). THE ANEURYSM IN THE LEFT COMMON ILIAC ARTERY ALSO HAD SIGNIFICANT THROMBUS WITH MINIMAL TRUE LUMEN AND NARROW INTERNAL ILIAC ARTERY (WHICH LEAD TO THE DECISION TO OVERSTENT/EMBOLIZE THE INTERNAL ILIAC ARTERY). A FOLLOW-UP CT ON (B)(6) 2025 SHOWED A COLLAPSE/INFOLDING OF THE PROXIMAL PART OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL COMPONENT RLT281448), LEADING TO A TYPE 1A ENDOLEAK. THE CT ALSO SHOWED THAT BOTH THE LEFT (PLC121000) AND THE RIGHT (PLC231400) CONTRALATERAL LEG COMPONENTS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE THROMBOSED. ON AN UNKNOWN DATE, A REINTERVENTION WAS PERFORMED ON THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RIGHT CONTRALATERAL LEG DEVICE (PLC231400)) INVOLVING THROMBECTOMY, AS WELL AS DILATION OF THE PROXIMAL NECK FOR THE RLT281448. REPORTEDLY, A FULL PROXIMAL EXPANSION OF THE RLT281448 WAS NOT ACHIEVABLE. A NEW CONTROL CT ON (B)(6) 2025 STILL SHOWED A PROXIMA

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 23565430 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE IMPLANTED DEVICE MIGRATED DISTALLY. ROOT CAUSE OF MIGRATION IS UNKNOWN. A FUTURE REINTERVENTION IS BEING PLANNED.

  Patient problems: Aneurysm

  MAUDE report 21654369 ↗
• InjuryNov 5, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, FOLLOW-UP CT IMAGING WAS PERFORMED. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE TRUNK-IPSILATERAL LEG COMPONENT. THE PHYSICIAN REPORTED THE ENDOLEAK TO THE GORE REPRESENTATIVE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE ENDOLEAK. A PLA280300 GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT WAS SUCCESSFULLY IMPLANTED. THE ENDOLEAK WAS DEEMED RESOLVED, AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 20612502 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS BEING TREATED USING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR AN INFRARENAL AORTIC ANEURYSM. AFTER DEPLOYMENT OF THE TRUNK, WHILE REMOVING THE DEPLOYMENT SYSTEM, THE OLIVE TIP CAME OFF OF THE END OF THE CATHETER, INSIDE OF THE SHEATH. THIS WAS NOT NOTICED IMMEDIATELY - IT WAS ONLY NOTICE WHEN A BALLOON WAS ADVANCED AND BEGAN PUSHING THE OLIVE TIP THROUGH THE SHEATH. THE OLIVE TIP WAS SNARED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049668 ↗
• InjuryJun 24, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AT THE TIME OF THE INITIAL PROCEDURE, THE PATIENT HAD THROMBUS IN THE AORTIC NECK NEAR THE PROXIMAL LANDING ZONE. BECAUSE THERE WAS THROMBUS, PHYSICIAN AT THE TIME ELECTED NOT TO BALLOON IN THE AREA OF THE AORTIC NECK AND PHYSICIAN BELIEVES BECAUSE THEY DID NOT BALLOON THE AORTIC NECK THAT'S WHY THE DEVICES SLIPPED (8CM) INTO THE ANEURYSM SAC (GROWTH SIZE GREATER THAN 5MM) AND HAD TYPE 1A ENDOLEAK ON THE TRUNK IPSILATERAL LEG. THE AORTIC NECK ALSO GREW IN DIAMETER AS THE NECK WAS DILATED. ON (B)(6) 2024, FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN ABOUT A PATIENT HAVING A LARGE TYPE 1A ENDOLEAK. A REINTERVENTION WAS PLANNED FOR (B)(6) 2024 WITH REALIGNMENT OF THE ORIGINAL GRAFTS. ON (B)(6) 2024, AN ENDOVASCULAR REINTERVENTION WAS DONE IN ZONE 8 -RENALS TO TREAT A TYPE 1A ENDOLEAK UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), HOWEVER, THE CONFORMABLE DEVICE WAS TOO LONG AS IT WOULD HAVE OCC

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19600921 ↗
• InjuryMay 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) IN ZONE 9 INFRARENAL UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). ON (B)(6) 2024, PATIENT CAME IN TO EMERGENCY ROOM WITH SYMPTOMS FOR A POSSIBLE RUPTURE WITH AN UNDETERMINABLE ENDOLEAK. REPORTEDLY, AN EMERGENT PROCEDURE WAS PLANNED AS PHYSICIAN ASSUMED IT WAS A TYPE 2 ENDOLEAK BUT COULD NOT DETERMINE WHERE IT WAS COMING FROM AS THERE WAS TOO MUCH CONTRAST OR POOR QUALITY SCAN WITH THE ANGIOGRAM AND THERE WAS CONTINUOUS ANEURYSM GROWTH BUT SIZE OF GROWTH IS UNKNOWN. PHYSICIAN COULD NOT TELL THE ORIGIN OF THE ENDOLEAK AND BASED ON PATIENT'S AGE, ELECTED TO DO OPEN REPAIR AND EXPLANT THE DEVICES. FSA WAS NOT PRESENT FOR THE PROCEDURE AND WAS INFORMED BY THE PHYSICIAN ABOUT THE EXPLANT PROCEDURE. ON APRIL 30, 2024, THE FSA WAS TOLD BY THE PHYSICIAN THAT THE CASE WENT FINE AND PATIENT IS DOING FINE.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19397655 ↗
• InjuryMar 7, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2021 UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING DEPLOYMENT, THE STENT GRAFT MOVED DOWN (DISTANCE IS UNKNOWN) WHILE CANNULATING THE GATE. DEVICE WAS LEFT IN THIS POSITION AND NO CORRECTION WAS PERFORMED. ON 2(B)(6) 2024 PATIENT UNDERWENT A REINTERVENTION SURGERY DUE TO A TYPE 1A ENDOLEAK WITH ENLARGING ANEURYSM SAC (GROWTH AMOUNT IS UNKNOWN). AN AORTIC EXTENDER WAS IMPLANTED AND THE ENDOLEAK WAS RESOLVED. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN ATTRIBUTES THIS ENDOLEAK TO THE GRAFT MOVING DOWN DURING THE ORIGINAL PROCEDURE WHILE CANNULATING THE GATE . THE AORTA CONTINUED TO DETERIORATE AND A TYPE 1A RESULTED DUE TO THIS. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 18861581 ↗
• MalfunctionJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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. IT WAS REPORTED THAT WHILE RETRACTING THE DELIVERY CATHETER OF THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS THROUGH THE VALVE OF THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (18FR) THE OLIVE BECAME DISLODGED/SEPARATED. THE OLIVE WAS OUTSIDE THE PATIENT BUT WEDGED IN THE VALVE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE OLIVE WITH NO ISSUE. REPORTEDLY THERE WAS NO RESTRICTIONS WHILE ADVANCING OR RETRACTING THE DELIVERY CATHETER. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17260301 ↗
• InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281418, PLC141400 AND PLA280300). ON (B)(6) 2023, THE PATIENT WAS SEEN FOR A FOLLOW UP AND A TYPE 1A PROXIMAL ENDOLEAK WAS NOTICED ON THE UPPER BODY OF THE GRAFTS RLT281418 AND PLA280300. THE LEAK REMAINS STABLE (GROWTH SIZE UNKNOWN), BUT THE PHYSICIAN DECIDED TO TREAT IT AND A REINTERVENTION IS PLANNED. ON (B)(6) 2023, UNDERWENT AN ENDOVASCULAR ZONE 9-INFRARENAL REINTERVENTION TO TREAT THE TYPE 1A PROXIMAL ENDOLEAK WITH AN AORTIC CUFF (AORTIC EXTENDER) TO EXTEND PROXIMALLY AND THEY ADDED AN ADDITIONAL PIECE (CONTRALATERAL LEG) TO EXTEND DISTALLY. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN WHICH GORE® EXCLUDER® AAA ENDOPROSTHESIS FROM THE ORIGINAL IMPLANT IS ALLEGED TO HAVE THE TYPE 1A PROXIMAL ENDOLEAK, HENCE BOTH DEVICES HAVE BEEN CAPTURED.

  Patient problems: Clinical Endoleak

  MAUDE report 16639076 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ANEURYSM RUPTURE AND WAS IMPLANTED WITH A GORE® EXCLUDER® AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS (RLT281418) AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (PLC141400). ON AN UNSPECIFIED DATE FOLLOW UP WAS PERFORMED WITH CT IMAGING AND REVEALED A TYPE I ENDOLEAK. THE PATIENT WAS ADMITTED FOR REINTERVENTION ON (B)(6) 2022. AS REPORTED, THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A GORE® EXCLUDER®AAA AORTIC EXTENDER ENDOPROSTHESIS. IMPLANTATION OF THE GORE® EXCLUDER®AAA AORTIC EXTENDER ENDOPROSTHESIS DID NOT RESOLVE THE ENDOLEAK. THE PATIENT WAS ALSO IMPLANTED WITH A NON-GORE DEVICE(S) (ENDURANT ANCHORS). THE EDNDOLEAK WAS CONFIRMED AS RESOLVED. AS REPORTED, THE PATIENT HAD CALCIFICATION PRESENT IN THE SEAL ZONE OF THE NECK.

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

  MAUDE report 14189915 ↗
• InjuryMar 24, 2022Adverse 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) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND AN ILIAC AORTIC ANEURYSM TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A REINTERVENTION (ADVERSE EVENT IS UNKNOWN). A (B)(4) WAS IMPLANTED TO EXTEND ONE OF THE ALREADY IMPLANTED DEVICES. THE FSA THAT ATTENDED THE PROCEDURE WAS COVERING FOR ANOTHER FSA AND DID NOT REPORT THIS REINTERVENTION TO PRODUCT SURVEILLANCE. ON (B)(6) 2022, A DIFFERENT FSA REPORTED THAT HE WAS IN A CASE AND RAN INTO THE IMPLANTING PHYSICIAN. THE PHYSICIAN STATED THAT THIS PATIENT HAD AN INFECTION, AND ALL DEVICES WERE EXPLANTED (DATE OF EXPLANT IS UNKNOWN) AND AN OPEN CONVERSION WAS PERFORMED. THE INFECTION WAS IN THE IMPLANTED DEVICE AREA, BUT IT IS UNKNOWN WHAT THE CAUSE OF THE INFECTION WAS. THE PHYSICIAN DID NOT ATTRIBUTE THE INFECTION TO THE GORE DEVICES OR PROCEDURE. THE EXPLANT OCCURRED AT A DIFFERENT HOSPITAL AND WITH A DIFFERENT VASCULAR PHYSICIAN. THE PATIENT TOLERATED THE EXPLANT PROCEDURE. THE EXACT DATE OF TH

  Patient problems: Aneurysm

  MAUDE report 13896520 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A STAGED REINTERVENTION FOR TREATMENT OF A THORACOABDOMINAL AORTIC DISSECTION AND COMPLETION OF TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM RCIA. FEMORAL CUTDOWNS WERE PERFORMED RATHER THAN PERCUTANEOUS ACCESS FOR THIS REPAIR. USING A CURVED CATHETER WE ATTEMPTED TO ENTER THE TRUE LUMEN ON THE LEFT SIDE AND WERE IN THE TRUE LUMEN IN THE AREA OF THE LEFT COMMON ILIAC GRAFT. A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT WAS DEPLOYED JUST DISTAL TO THE LOWEST RENAL ARTERY AND DEPLOYED DOWN TO THE OPEN THE GATE. THE REST OF THE MAIN BODY REMAINED UNDEPLOYED. A GORE® CONTRALATERAL LEG COMPONENT WAS THEN ADVANCED AND EXTENDED DOWN INTO THE PREVIOUSLY REPAIRED LEFT COMMON ILIAC ARTERY AND BALLOONED. ON THE RIGHT SIDE WE THE REST OF THE MAIN BODY WAS FULLY DEPLOYED AND AN EXTENSION LIMB WAS PLACED INTO THE EXTERNAL ILIAC ARTERY PAST THE AREA OF THE EMBOLIZED HYPOGASTRIC VESSEL. THE PROXIMAL END OF THE MAIN TRUNK WAS NOT BALLOONED DUE TO THE DISSECTION, HOWEVER THE REST OF THE GRAFT INCLUDING AT THE BIFURCATION WAS BALLOONED ON BOTH SIDES. EXCELLENT FLOW WAS SEEN INTO THE EXTERNAL ILIAC ARTERY ON THE RIGHT AND TO BOTH THE INTERNAL AND EXTERNAL ILIAC

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 13691419 ↗
• InjuryJan 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  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, A GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT PRESENTED EMERGENTLY. IT WAS FOUND THAT THE RIGHT LIMB OF THE EXCLUDER TRUNK WAS OCCLUDED. THE PHYSICIAN STATED THAT THE AORTIC BIFURCATION WAS TIGHT, AND THE IBE DEVICE COMPETED WITH IT FOR SPACE AGAINST THE LIMB AND PINCHED IT OFF. A THROMBECTOMY WAS PERFORMED, AND THE PHYSICIAN IMPLANTED A VBX. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13258731 ↗
• DeathJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 53.6 MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. ON (B)(6) 2016, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 43 MM. ON (B)(6) 2016, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TO CTA WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 40 MM. ON (B)(6) 2017, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 34 MM. ON (B)(6) 2017, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 36 MM. ON (B)(6) 2018, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 38 MM. ON (B)(6) 2019, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 41 MM. ON (B)(6) 2020, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 41 MM. ON (B)(6) 2021, THE PATIENT UNDERWENT MEDIC

  Patient problems: Unspecified Infection

  MAUDE report 13233107 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK CAUSED BY DILATION OF THE PROXIMAL NECK DUE TO CONTINUED DEGENERATION OF THE AORTA (ONSET DATES UNKNOWN). A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY TO EXTEND COVERAGE. IT WAS REPORTED THAT THE LAST STENT ROW OF THE EXTENDER GOT CAUGHT UP ON THE TRUNK, CAUSING IT TO DEPLOY DIFFERENTLY THAN EXPECTED. ANGIOPLASTY WAS PERFORMED WITH GOOD RESULTS AND RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13027741 ↗
• InjuryNov 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  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, A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12844997 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PHYSICIAN INFORMED A GORE FIELD SALES ASSOCIATE OF A SUSPECTED ENDOLEAK INVOLVING TWO PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS. (SINCE IT IS CURRENTLY UNKNOWN WHICH DEVICE IS DIRECTLY ASSOCIATED WITH THE ALLEGED ENDOLEAK, BOTH WILL BE INCLUDED IN THIS REPORT: RLT281418/ (B)(4) & PLC271000/ (B)(4).) ON (B)(6) 2021, A REINTERVENTION TOOK PLACE AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE. NO ANEURYSM ENLARGEMENT WAS REPORTED. THE ENDOLEAK WASN'T CONFIRMED NOR TYPE OR RESOLUTION. FURTHER INFORMATION WAS REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760827 ↗
• InjuryJun 7, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2017 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT'S ABDOMINAL AORTIC ANEURYSM REPORTEDLY MEASURED 6.5CM. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ADEQUATE PROXIMAL AORTIC NECK LENGTH WITH WHICH TO LAND THE DEVICE. REPORTEDLY A TYPE I ENDOLEAK WAS NOTED. THE ENDOLEAK WAS MONITORED. ON (B)(6) 2021 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. THE PROXIMAL TYPE I ENDOLEAK REMAINED AND THE ABDOMINAL AORTIC ANEURYSM HAD EXPANDED TO 7.5CM. IT WAS NOTED THAT THE PATIENT'S COMMON ILIAC ARTERY ANEURYSMS HAD SHRUNK. THE ENDOLEAK AND SUBSEQUENT ANEURYSM ENLARGEMENT WERE REPORTEDLY ATTRIBUTED TO THE PATIENT'S ANATOMY. ON THE SAME DAY AN INTERVENTION WAS PERFORMED. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE PLACED IN THE PATIENT'S RENAL ARTERIES. TWO GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS WERE PLACED FROM THE PATIENT'S SUPERIOR MESENTERIC ARTERY DOWN TO THE AORTIC BIFURCATION. THE ANEURYSM WAS EXCLUDED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11952248 ↗
• InjuryMay 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A TYPE IA ENDOLEAK FROM THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED. THE ENDOLEAK WAS STOPPED, AND THE PATIENT TOLERATED THE PROCEDURE. IT WAS STATED THAT THE ENDOLEAK WAS LIKELY CAUSED BY DISEASE PROGRESSION AND CALCIFICATION OF THE AORTA.

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

  MAUDE report 11777863 ↗
• MalfunctionApr 15, 2021Entrapment of Device; Entrapment of Device

  ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AFTER THE SUCCESSFUL DEVICE DEPLOYMENT, THE PHYSICIAN FELT A RESISTANCE WHILE WITHDRAWING THE CATHETER. AFTER INSPECTION AND CONFIRMATION THAT THERE WAS NOTHING PREVENTING THE CATHETER TO WITHDRAW, IT WAS CONCLUDED THAT THE CATHETER WAS STUCK IN THE GUIDE WIRE. THE PHYSICIAN REMOVED THE CATHETER IN CONJUNCTION WITH THE GUIDE WIRE WITH NO PROBLEM OR CONSEQUENCE. THE DEVICE WAS INSPECTED ON THE TABLE AND IT WAS CONFIRMED THAT THE CATHETER WAS STUCK ON THE WIRE AND IT WAS IMPOSSIBLE TO REMOVE THE CATHETER OFF THE WIRE. IT WAS CONFIRMED THAT THE PROBLEM WAS NOT RELATED WITH THE PATIENT¿S ANATOMY LIKE CALCIUM OR TORTUOSITY AS INSERTION/DEPLOYMENT WAS WITHOUT ANY PROBLEMS. REPORTEDLY, THERE WAS NO HARM TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN WHAT CAUSED THE DELIVERY CATHETER TO BECOME STUCK ON THE WIRE DURING WITHDRAWAL. THE CATHETER DID NOT APPEAR DAMAGED. THE DELIVERY CATHETER WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. HOWEVER, THE VIDEO WAS PROVIDED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676128 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE IDE STUDY FOR THE ILIAC BRANCH ENDOPROSTHESIS (IBE): ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF A 51 MM ABDOMINAL AORTIC ANEURYSM AND 33 MM LEFT ILIAC ARTERY ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® ILIAC BRANCH ENDOPROSTHESES. COMPLETION ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020 A TYPE IA ENDOLEAK WAS DETECTED. ON (B)(6) 2021 A REINTERVENTION OCCURRED IN WHICH THE PATIENT WAS IMPLANTED WITH A NON-GORE AORTIC CUFF (ENDURANT) WHICH WAS PLACED AT THE LEVEL OF THE LEFT RENAL ARTERY JUST ABOVE THE BIFURCATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER BALLOONING THERE WAS NO OBSERVED ENDOLEAK AND IT APPEARED TO HAVE BEEN RESOLVED. CT IMAGING ON (B)(6) 2021 SHOWED NO TYPE 1A ENDOLEAK, CONFIRMING THE RESOLUTION. IT ALSO SHOWED THE PRESENCE OF A TYPE II MA ENDOLEAK. THE DECISION WAS MADE TO FOLLOW UP IN ONE YEAR. THE EVENT IS STILL ONGOING.

  Patient problems: Aneurysm

  MAUDE report 10950249 ↗
• InjuryMar 26, 2020Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2016 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND A LEFT INTERNAL ILIAC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM AORTIC DIAMETER WAS 58.6MM. ON (B)(6) 2016 THE MAXIMUM AORTIC DIAMETER BY CT WAS 65MM. ON (B)(6) 2019 THE MAXIMUM AORTIC DIAMETER BY CTA WAS 55MM. A TYPE 1B ENDOLEAK WAS DISCOVERED IN THE RIGHT COMMON ILIAC ARTERY. PROXIMAL MIGRATION OF THE GRAFT LIMB INTO THE AORTIC SAC WAS ALSO REPORTED. ON (B)(6) 2020 A REINTERVENTION TOOK PLACE WITH EXTENSION OF THE ENDOPROSTHESIS. ON (B)(6) 2020 THE TYPE 1B ENDOLEAK WAS DEEMED AS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 9885461 ↗

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