GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281412Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00733132622528), received between Jul 18, 2018 and Jun 25, 2026 — classified as 3 deaths, 58 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (15 reports).

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6), 2015, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO A TYPE 1A ENDOLEAK. AN AORTIC EXTENDER WAS USED TO RESOLVE THE LEAK. IT WAS NOTED THAT THE PATIENT HAD PREVIOUS ENDOVASCULAR PROCEDURES IN 2015 AND 2020.

  Patient problems: Clinical Endoleak

  MAUDE report 25621389 ↗
• InjuryMay 28, 2026No Apparent Adverse Event

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION AND A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO EXTEND COVERAGE PROXIMALLY. IT WAS REPORTED THAT WHEN THE TECH WAS SLIPPING THE PLASTIC TUBE OFF, IT LOOKED LIKE THE STENT MOVED PROXIMAL ON THE CATHETER AND THE LINE SEEMED TO BREAK. ANOTHER GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS PREPPED AND IMPLANTED IN IT¿S PLACE. THE PATIENT TOLERATED THE PROCEDURE. THE FIRST DEVICE WAS NOT USED AND WAS DISCARDED AT THE SITE AND NOT AVAILABLE FOR EVALUATION BY GORE.

  Patient problems: Aneurysm

  MAUDE report 25325444 ↗
• InjuryApr 14, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A LEFT COMMON ILIAC ARTERY ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND AORTIC EXTENDER). REPORTEDLY, DURING DEVICE PREPARATION, THE SCRUB NURSE OPENED THE AORTIC EXTENDER DEVICE ONTO THE STERILE SETUP AND DURING THAT PREPARATION, FOUND A 1 - 1.5 CM SEPARATION OF THE STENT GRAFT FROM THE DELIVERY CATHETER ALBEIT STILL HELD ON BY A THREAD. NO DAMAGE WAS NOTED TO THE OLIVE TIP. THE YELLOW PACKING COVER OVER THE GRAFT WAS STILL IN SITU WHEN THIS WAS FOUND AND CONCERN WAS THAT THIS WOULD SNAP WITH THE REMOVAL OF THE YELLOW PROTECTIVE CAP ALONG WITH THAT THE GRAFT WOULD BE LOOSE ONCE THE YELLOW PROTECTIVE CAP WAS REMOVED. DEVICE WAS ASSUMED FAULTY AND THEREFORE NOT IMPLANTED AS PHYSICIAN SUSPECTED IT TO BE A MANUFACTURING FAULT. PATIENT WAS LEFT WITH THE TYPE 1A ENDOLEAK AND IS BEING BROUGHT BACK FOR REINTERVENTION PROCEDURE ON (B)(6) 2026 FOR INSERTION OF AN AORTIC EXTENDER AS NO SPARE DEVICE WAS AVAILABLE ONSITE DURING THE INITIAL PROCEDURE. ON (B)(6) 2026, PATIENT UNDERWENT SUCCESSFUL REINTERVENTION PROCEDURE TO TREAT THE TYPE 1A ENDOLEAK W

  Patient problems: Clinical Endoleak

  MAUDE report 24877089 ↗
• MalfunctionApr 3, 2026Difficult to Advance

  ON (B)(6) 2026, DURING AN ENDOVASCULAR PROCEDURE IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE GUIDEWIRE DURING DELIVERY OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DEVICE WAS WITHDRAWN AND UPON EXAMINATION IT WAS NOTED THAT THE TIP/OLIVE WAS BENT. THE DEVICE WAS DISCARDED AT THE SITE AND ANOTHER DEVICE WAS IMPLANTED WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782156 ↗
• InjuryMar 30, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER, TRUNK IPSILATERAL LEG C3, TWO CONTRALATERAL LEGS, TWO ILIAC EXTENDERS) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (TWO ILIAC BRANCH COMPONENTS (IBE) AND TWO INTERNAL ILIAC COMPONENTS). ON (B)(6) 2026, PATIENT UNDERWENT A BILATERAL IBE REINTERVENTION PROCEDURE FOR THE TYPE 3 ENDOLEAK WITH AN ANEURYSM GROWTH (SIZE UNKNOWN) FROM THE LAST FOLLOW-UP PATIENT HAD (DATE UNKNOWN). FIELD SALES ASSOCIATE (FSA) NOTED THAT THE INFERIOR MESENTERIC ARTERY (IMA) WAS EMBOLIZED, AFTER WHICH, PHYSICIANS EXPLAINED TO FSA THAT THE PATIENT PREVIOUSLY UNDERWENT A REINTERVENTION FOR TYPE 2 ENDOLEAK AT APPROXIMATELY 1 TO 1.5-YEARS POST-OP EVAR INITIAL PROCEDURE. THE PHYSICIANS STATED THAT THE 1-YEAR POST EVAR REPAIR WAS DONE BY COIL EMBOLIZING A LARGE INFERIOR MESENTERIC ARTERY TO STOP ANEURYSM GROWTH FROM A TYPE 2 ENDOLEAK. THE PATIENT WAS THEN LOST IN FOLLOW-UPS UNTIL RECENTLY WHEN THE IMAGING SCANS REVEALED THAT THE PATIENT'S BRIDGE LIMBS INTO BOTH IBE DEVICES HAVE PULLED OUT CAUSING A TYPE 3 ENDOLEAK. THE BRIDGE LIMBS

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24719109 ↗
• InjuryNov 21, 2025Migration; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT (RLT281412), GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG (PLC) DEVICES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE RLT DEVICE WAS ADVANCED OVER THE DSF1833 (SN: (B)(6)). THE PHYSICIAN CONFIRMED THE PROXIMAL LANDING ZONE EXACTLY BELOW THE RENAL ARTERIES AND THEN CONTINUED WITH THE IMPLANT OF THE PLC DEVICE ON THE LEFT SIDE. THE PHYSICIAN CONTINUED WITH MEASURING THE LENGTH FOR THE LEFT SIDE FOR THE CONTRALATERAL LEG (PLC121200). THE TRUNK REPOSITIONING MECHANISM WAS RELEASED AT THE INTENDED POSITION. WHEN ATTEMPTING TO CANNULATE THE DISTAL END OF THE IPSI-LATERAL LEG WITH THE DRYSEAL DSF1833 TO EXTEND THIS DEVICE WITH A PLC121000, SLIGHT RESISTANCE WAS NOTED. SUBSEQUENT FLUOROSCOPY IMAGING REVEALED THE TRUNK HAD MIGRATED PROXIMALLY RESULTING IN A SIGNIFICANT GAP BETWEEN THE CONTRALATERAL LEG (PLC) AND THE CONTRALATERAL LEG GATE OF THE TRUNK. COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING CONFIRMED THAT THE TRUNK'S PROXIMAL END WAS ABOVE THE CELIAC TRUNK. REPORTEDLY, THE PHYSICIAN WAS SURE THE DILATOR TIP W

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 23623842 ↗
• InjuryNov 21, 2025Migration; Migration

  IT WAS REPORTED BY GORE THAT ON (B)(6) 2025 A PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE (RLT281412) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG (PLC) DEVICES. THE FIELD SALES ASSOCIATE (FSA) REPORTED THAT THE PHYSICIAN RELEASED THE RLT EXCLUDER MAIN BODY AND DEPLOYMENT OF THE IPSILATERAL LEG WAS FINISHED ON THE RIGHT SIDE. THEN, HE PROCEEDED WITH THE PLC (SN: (B)(6)) DELIVERY SYSTEM TO CANNULATE ON THE LEFT SIDE AND PUSHED THE PLC CATHETER UPWARDS. THIS PLC CATHETER WAS ADVANCED WITHOUT A SHEATH (UNKNOWN REASON WHY SHEATH WAS NOT USED) AND ADVANCED VIA ACCESS VESSEL PROXIMALLY TO THE TRUNK. THE PHYSICIAN WANTED TO PROCEED RAPIDLY TO ADVANCE THE PLC CATHETER INTO THE CONTRALATERAL GATE OF THE MAIN BODY AND THE FSA COULD SEE THAT HE PROCESSED VERY QUICKLY TO PUSH THE PLC CATHETER INSIDE. EVENTUALLY, HE COULD FINISH THE LEG'S GATE CANNULATION, BUT THIS QUICK ACTION HAS LIFTED THE WHOLE TRUNK ABOVE THE LEFT RENAL ARTERY. THE PLC COULD BE DEPLOYED AT THIS STAGE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE AN EXTRA BENTLEY STENT (7 MM) FOR THE LEFT RENAL ARTERY AND HAD TO MAINTAIN THE BLOOD FLOW. ALSO, HE TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622187 ↗
• InjuryJul 25, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE®EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ALTHOUGH THE PATIENT HAD AN 80 DEGREE TURN IN THE PROXIMAL AORTIC NECK, DUE TO THE EMERGENT NATURE OF THE CASE A GORE®EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK DEVICE COULD NOT BE OBTAINED. ADDITIONALLY, THE PATIENT'S ILIAC ARTERIES WERE TOO WIDE TO GET DISTAL SEAL, SO DUE TO THE EMERGENT NATURE OF THE CASE 32MM AND 36MM GORE®EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS CUFFS WERE IMPLANTED IN THE LEFT AND RIGHT ILIAC ARTERIES. AT THE TIME, THE PHYSICIAN EXPECTED THESE MEASURES TO BE SHORT-TERM FIXES. ON (B)(6) 2025, THE PATIENT UNDERWENT AN OPEN REPAIR OF THE ANEURYSM, WITH EXPLANTATION OF ALL OF THE GORE DEVICES EXCEPT FOR THE CUFF IN THE RIGHT ILIAC ARTERY. REPORTEDLY, THERE WERE NO ACTIVE ENDOLEAKS, BUT THE PHYSICIAN WAS STILL VERY CONCERNED ABOUT THE MARGINAL NATURE OF THE PROXIMAL SEAL ZONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609342 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 100MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6) 2015 TO (B)(6) 2019 THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED FROM 98MM TO 65MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6) 2020 TO (B)(6) 2022 THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 66MM TO 83MM. ON (B)(6) 2021 A CONSISTENT GROWTH OF THE ANEURYSM SAC WITHOUT IDENTIFIABLE SOURCE OF ENDOLEAK WAS REPORTED. ACCORDING TO THE SITE, THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. ON (B)(6) 2021 AN ILIAC ANGIOGRAM WAS PERFORMED. NO DISCERNIBLE ENDOLEAK WAS FOUND. THE PHYSICIAN RECOMMEND AN OPEN REPAIR OF THE ANEURYSM TO PREVENT RUPTURE AND POSSIBLY DEATH. THE PATIENT REFUSED TO DO ANY ADDITIONAL PROCEDURES. THE FOLLOW UP CTA SHOWED THAT ON (B)(6) 2024 THE AORTIC ANEURYSM WAS

  Patient problems: Aneurysm expansion

  MAUDE report 22172437 ↗
• InjuryJun 9, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN ZONE 2. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS ALSO IMPLANTED. IT WAS REPORTED THAT THERE WAS A TYPE 1A ENDOLEAK AND A TYPE 2 ENDOLEAK. AN AORTIC EXTENDER WAS PLACED ON THE TRUNK IPSILATERAL COMPONENT TO RESOLVE THE TYPE 1A ENDOLEAK. NO TREATMENT WAS REQUIRED FOR THE TYPE 2 ENDOLEAK. THE CTAG WAS USED TO TREAT A SEPARATE DISSECTION UNRELATED TO THE ENDOLEAK TREATMENT AREA. THIS DID NOT CAUSE THE REINTERVENTION; HOWEVER, THE PHYSICIAN DECIDED TO TREAT BOTH CONDITIONS DURING THE SAME PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT TO OCCUR.

  Patient problems: Clinical Endoleak

  MAUDE report 22168058 ↗
• MalfunctionApr 25, 2025Defective Device; Defective Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE FIRST STAGE OF DEPLOYMENT WAS DONE WITH THE HANDLE PULLED ALL THE WAY BUT THE DEPLOYMENT STRING WAS STILL ATTACHED DEVICE DID NOT OPEN. PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ISSUES WITHDRAWING THE DEVICE FROM THE PATIENT AND NO ANATOMICAL ISSUES OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912701 ↗
• InjuryAug 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLA-AORTIC EXTENDER) WAS PLACED DURING THE REINTERVENTION AND EVERYTHING WENT SMOOTHLY THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19994884 ↗
• InjuryAug 14, 2024Patient Device Interaction Problem; Device Endoleak; Patient Device Interaction Problem; Device Endoleak

  ON AUGUST 29, 2016, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 56MM. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP IMAGING FROM SEPTEMBER 27, 2016 TO AUGUST 9, 2017 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 57MM TO 61MM. ON SEPTEMBER 15, 2017, A TYPE II ENDOLEAK FROM MESENTERIC AND LUMBAR ARTERIES WAS NOTICED AND THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE FOLLOW UP IMAGING FROM (B)(6) 2017 TO (B)(6) 2018 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 58MM TO 74MM. ADDITIONALLY, THE FOLLOW UP CTA ON (B)(6) 2018 DETERMINED THE CONTINUED EVIDENCE OF TYPE II ENDOLEAK. ON (B)(6) 2018, A REINTERVENTION PROCEDURE OCCURRED WHEREBY EMBOLIZATION OF THE TYPE II ENDOLEAK WAS PERFORMED. THE ENDOLEAK WAS RESOLVED. ((THIS INFORMATION WAS COVERED BY THE MFR REPORT # 3007284313-2019-00012 AND WAS ELECTRONICALLY SUBMITTED TO FDA ON JANUARY 14, 2019). ACCORDING TO THE

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19988494 ↗
• InjuryJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 55.8MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 56MM. ON (B)(6) 2022, FOLLOW-UP CTA DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 71MM. ON (B)(6) 2022, IT WAS DETERMINED THAT THE PATIENT HAD A PERSISTENT TYPE II ENDOLEAK. ON (B)(6) 2023, THE PATIENT UNDERWENT COIL EMBOLIZATION TO TREAT THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, FOLLOW-UP CTA DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 73MM.

  Patient problems: Aneurysm expansion

  MAUDE report 19819511 ↗
• InjuryJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM AORTIC DIAMETER MEASURING 88MM; 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) 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 90MM. ON (B)(6) 2023, IT WAS DETERMINED THAT THE PATIENT HAD A TYPE II ENDOLEAK. ON (B)(6) 2024, THE PATIENT UNDERWENT IR ARTERIOGRAM EMBOLIZATION. THE PATIENT TOLERATED THE PROCEDURE. IT WAS NOT REPORTED IF THIS PROCEDURE RESOLVED THE ENDOLEAK. ON (B)(6) 2024, FOLLOW-UP CTA DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 112MM.

  Patient problems: Aneurysm expansion

  MAUDE report 19799725 ↗
• DeathMay 2, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT PRESENTING WITH SEVERE LEG CLAUDICATION, A PENETRATING AORTIC ULCER AND AORTIC DILATION EVIDENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE IN 2022, THE PATIENT'S LEFT PACEMAKER WAS INFECTED. THE INFECTED DEVICE WAS REMOVED AND A NEW PACEMAKER WAS IMPLANTED ON THE RIGHT SIDE. IN (B)(6) 2024, THE PATIENT PRESENTED WITH GENERAL FATIGUE, FEVER, LOWER BACK PAIN, IRON DEFICIENCY ANEMIA AND NEGATIVE BLOOD CULTURES. COMPUTED TOMOGRAPHY IMAGING (CT) SHOWED CONTINUED EXCLUSION OF THE ANEURYSM AND NO EVIDENCE OF AN ENDOLEAK. IN (B)(6) 2024, A CT THORAX, ABDOMEN AND PELVIS (CT TAP) AND TRANSTHORACIC ECHOCARDIOGRAM WERE PERFORMED TO RULE OUT AN OCCULT SOURCE OF INFECTION. THE RESULTS WERE 'UNREMARKABLE.' IN (B)(6) 2024, THE PATIENT CONTINUED TO PRESENT WITH FATIGUE AND LOWER BACK PAIN. POSITRON EMISSION TOMOGRAPHY (PET) SHOWED THICKENING OF SOFT TISSUE SURROUNDING THE INVERSE STENT IN THE ABDOMINAL AORTA COMPARED TO EARLIER PATIENT IMAGING. ON (B)(6) 2024, THE DEVICES WERE EXPLANTED. DURING THE PROCEDURE, THE PATIENT ENTERED CARDIAC ARREST FOR 11 MINUTES. THE PATIENT WAS REVIVED WITH C

  Patient problems: Sepsis

  MAUDE report 19228817 ↗
• InjuryApr 18, 2024Obstruction of Flow; Patient-Device Incompatibility; Migration; Obstruction of Flow; Patient-Device Incompatibility; Migration

  ON (B)(6), 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2024, THE FOLLOW UP SCAN SHOWED THAT THE DEVICE MIGRATED 2CM DISTALLY TO THE FULCRUM POINT ON THE INNER CURVE AND APPEARED TO BE FLOW LIMITING DUE TO ANGLE ¿ DYNAMICALLY OPENING AND CLOSING. REPORTEDLY, THE AORTIC NECK WAS ANGULATED (UNKNOWN), AND THE PHYSICIAN BELIEVED THAT THIS ANGULATION MAY CONTRIBUTED TO THE EVENT. THE PHYSICIAN COULDN¿T UNDERSTAND THE REASON FOR MOVEMENT ¿ THE DEVICE WAS NOT UNDERSIZED AND ANGLE APPEARS ADEQUATE. REPORTEDLY, NO VESSELS WERE COVERED OR OCCLUDED. ON (B)(6) 2024, THE PATIENT HAS SUBSEQUENTLY HAD A CONFORMABLE CUFF IMPLANTED WHICH HAS RESOLVED THE ISSUE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: Reduced Blood Flow

  MAUDE report 19131212 ↗
• InjuryJan 24, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 22, 2015, IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (MEASURED 58 MM) WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6), 2020, THE PATIENT'S ANEURYSM GREW TO 81 MM DUE TO A TYPE II ENDOLEAK. ON (B)(6) 2020, ONYX® EMBOLIZATION WAS PERFORMED. THE DIAMETER OF THE ANEURYSM WAS STILL INCREASING DURING THE FOLLOW-UP PERFORMED ON (B)(6), 2021 (MEASURED 94 MM), AND (B)(6), 2022 (MEASURED 100 MM). ON (B)(6), 2023 THE PATIENT'S ANEURYSM WAS MEASURED 103 MM DUE TO THE TYPE II ENDOLEAK AND WAS TREATED AGAIN WITH EMBOLIZATION WITH COILS.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18570940 ↗
• InjuryDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, THIS PATIENT UNDERWENT REINTERVENTION FOR A TYPE II ENDOLEAK. IT WAS REPORTED THAT DURING PREPARATION OF A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WHEN REMOVING THE PACKAGING SHEATH, THE CONSTRAINED DEVICE BECAME SEPARATED FROM THE DELIVERY CATHETER. THE DEVICE WAS SET ASIDE AND ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE ALONG WITH THE PLACEMENT OF ENDO-ANCHORS. THE ENDOLEAK WAS RESOLVED. THERE WAS NO ANEURYSM ENLARGEMENT REPORTED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Fluid Discharge

  MAUDE report 18268970 ↗
• InjuryNov 17, 2023Patient 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 MAIN BODY AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS LIMBS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS FOUND TO HAVE A TYPE IA ENDOLEAK, AS WELL AS A POSSIBLE TYPE II ENDOLEAK. THE PHYSICIAN WILL SCHEDULE A REINTERVENTION TO TREAT THE ENDOLEAKS. THE PHYSICIAN HAS NO OPINION REGARDING THE CAUSE OF THE ENDOLEAKS.

  Patient problems: Clinical Endoleak

  MAUDE report 18160192 ↗
• InjuryNov 3, 2023Complete Blockage; Collapse; Complete Blockage; Collapse

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS LIMBS. THE PATIENT TOLERATE THE PROCEDURE AND WAS THEN LOST TO FOLLOW UP. IN (B)(6) 2023, THE PATIENT PRESENTED WITH A LEFT HEMISPHERIC STROKE WITH RIGHT HEMIPARESIS, WHICH HAS SINCE RESOLVED. AT THAT TIME, A CT ANGIGRAM REVEALED A 75% STENOSIS OF THE INTERNAL CAROTID ARTERY ON THE LEFT SIDE. IT WAS ALSO NOTED THAT THE LEFT LIMB OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS OCCLUDED FROM THE GATE TO THE COMMON ARTERY. A PENUMBRA WAS ATTAMPTED FROM A BRACHIAL APPROACH. SEVERAL ATTEMPTS WERE MADE TO CREATE A LUMEN FOR FLOW. A VIABAHN WAS PLACED FROM INGUINAL LIGAMENT UP THROUGH THE LIMB. A VBX WAS THEN OVERLAPPED IN THE VIABAHN TO THE TOP OF THE GATE. THE VBX WAS POST DILATED TO 12.8MM USING A BALLOON. IT WAS THEN NOTED THAT THE RIGHT LIMB HAD BEEN CLOSED DOWN. SEVERAL PENUMBRA PASSED WERE MADE, FOLLOWED BY PLASTY TO CREATE A LUMEN. IT WAS DECIDED TO IMPLANT AN EKOS CATHETER UNTIL THE NEXT MORNING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 18066400 ↗
• InjuryAug 10, 2023Leak/Splash; Patient-Device Incompatibility; Device Dislodged or Dislocated; Leak/Splash; Patient-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED TO GORE, THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM HAS BEEN TREATED INITIALLY ON (B)(6) 2022, WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK - IPSILATERAL LEG ENDOPROSTHESIS RLT281412), A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (CEB231410), ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT HGB161407) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS PLC271000). REPORTEDLY A TYPE II ENDOLEAK HAS BEEN IDENTIFIED AFTER THE SURGICAL PROCEDURE ON (B)(6) 2022. ON (B)(6) 2022, A TYPE IB ENDOLEAK AT THE ANEURYSM OF THE LEFT COMMON AND INTERNAL ILIAC ANEURYSM WAS DIAGNOSED. REPORTEDLY A REINTERVENTION HAS BEEN PERFORMED ON (B)(6) 2022, TO TREAT THE ENDOLEAK WITH THREE DEVICES FROM IVASCULAR GMBH AND PLUSMEDICA. ACCORDING TO THE PATIENT IT WAS STATED THAT THE NON-GORE DEVICES WERE CHOSEN TOO SMALL, SO THAT THERE IS NOW NO LONGER ANY OVERLAP BETWEEN THE DEVICES AND BOTH WERE OFFSET IN POSITION TO ONE ANOTHER. SMALL (NOT FURTHER SPECIFIED) ANEURYSM GROWTH IS REPORTED WITH AN ACTUAL ANEURYSM SIZE OF 6 CM. THE SURGEON CONFIRMED THAT NO DEVICE MIGRATION OF THE GORE STENT GRAFT SYSTEM IMPLANTE

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17497512 ↗
• InjuryJul 18, 2023Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PHYSICIAN REPORTED THAT THE AORTIC MAIN BODY (RLT281412 INCLUDING THE IPSILATERAL LEG) AND THE CONTRALATERAL LEG (PLC271400) WERE SUCCESSFULLY DEPLOYED BELOW THE RENAL ARTERIES AND ABOVE THE INTERNAL ILIAC ARTERY ON THE IPSILATERAL SIDE, RESPECTIVELY. FOLLOWING CANNULATION, THE AORTIC MAIN BODY (RLT281412) APPEARED TO MIGRATE PROXIMALLY BY 1.5 CM AS MEASURED VIA ANGIORAPHY. THE RENALS WERE PARTIALLY OCCLUDED. THE PHYSICIAN ATTEMPTED TO PULL DOWN THE AORTIC MAIN BODY (RLT281412) USING TWO RELIANT® STENT GRAFT BALLOON CATHETERS AND PULLING DOWN ON THE CROSSOVER WIRE. THE PHYSICIAN WAS ABLE TO PARTIALLY REPOSITION THE DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICE WAS 1 CM PROXIMAL TO THE PLANNED LANDING ZONE. REPORTEDLY, ON THE POST-OPERATIVE COMPUTED TOMOGRAPHY SCAN THE RENAL ARTERIES WERE PATENT BUT WITH A SLIGHTLY SLOWER FLOW ON THE LEFT RENAL ARTERY. NO ENDOLEAKS WERE APPARENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body Embolism; Reduced Blood Flow

  MAUDE report 17341840 ↗
• InjuryMay 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESES ON A UNKNOWN DATE. THE PATIENT TOLERATED THE INITIAL IMPLANT PROCEDURE. ON AN UNKNOWN SUBSEQUENT DATE, THE PATIENT PRESENTED WITH GROIN PAIN ON A BIKE RIDE. ON (B)(6) 2023, THE PHYSICIAN OBSERVED DEVICE INFOLDING. THE WEEKEND OF (B)(6) 2023, THE AORTIC MAIN BODY AND THE RIGHT ILIAC CONTRALATERAL LEG WERE EXPLANTED. THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ON THE LEFT REMAIN IN SITU. RECONSTRUCTION WAS ACHIEVED BY IMPLANTING A BIFURCATED AORTIC GRAFT, PROXIMALLY ANASTOMOSED TO THE INFRA-RENAL AORTIC NECK OF THE ANEURYSM, RIGHT COMMON ILIAC ARTERY ORIGIN AND LEFT COMMON FEMORAL ARTERY DISTALLY.

  Patient problems: Pain

  MAUDE report 16983386 ↗
• InjuryApr 21, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON (B)(6)2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, AN INDETERMINATE ENDOLEAK, SUSPECTED TO BE A TYPE II, WAS OBSERVED. A REINTERVENTION WAS PERFORMED WHEREBY A TERUMO TREO® AORTIC EXTENDER CUFF WAS PLACED ACROSS THE PATIENT'S RENAL ARTERIES. STENT/LASER FENESTRATION OF THE RENAL ARTERIES WAS PERFORMED, AND MEDTRONIC ENDOANCHORS WERE PLACED AT THE OVERLAP. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT REPORTEDLY RECOVERED.

  Patient problems: Aneurysm; Ruptured Aneurysm; Unspecified Infection

  MAUDE report 16792291 ↗

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)