GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351416Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00733132618484), received between Jun 28, 2018 and Dec 10, 2025 — classified as 23 injuries, 2 malfunctions.

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

• InjuryDec 10, 2025Adverse 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 WITH A MAXIMUM DIAMETER OF 50MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT351416/(B)(6), PLC231200/(B)(6). AT THE TIME OF THE INDEX PROCEDURE THE PROXIMAL LANDING ZONE DIAMETER RANGED 31.4MM TO 29MM. THE RIGHT COMMON ILIAC ARTERY MAXIMUM DISTAL LANDING ZONE DIAMETER MEASURED 13MM, THE RIGHT MINIMAL DISTAL LANDING ZONE MEASURED 11MM. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 44MM. ON (B)(6) 2017, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 47MM. ON (B)(6) 2025, A NEW DEGENERATIVE RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) WAS DETERMINED AND REPORTED TO BE AN ¿EVENT NOT RELATED TO THE DEVICE OR PROCEDURE¿. IT WAS REPORTED THAT THE DEVICE WAS STILL SEALING THE AORTIC ANEURYSM DISTALLY, HOWEVER THE PROXIMAL NECK OF THE ANEURYSM HAD DEGENERATED. IT WAS EITHER A SUBOPTIMAL NECK OR NEW DEGENERATION A TYPE 1A ENDOLEAK WAS SEEN AND THE AAA HAD GROWN TO 7CM. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION AND A RECEIVED A RIGHT ILIAC

  Patient problems: Aneurysm expansion

  MAUDE report 23772501 ↗
• InjuryAug 22, 2025Migration; Device Endoleak; Migration; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. IN (B)(6) 2025, A CT WAS TAKEN OF THE PATIENT, AND THE PHYSICIAN NOTED A TYPE I PROXIMAL ENDOLEAK WITH ANEURYSM EXPANSION. THE PHYSICIAN IS PLANNING TO SEND THE PATIENT TO UAB FOR EVALUATION FOR A REINTERVENTION WITH A POSSIBLE COOK FENESTRATED DEVICE. REPORTEDLY, THE PROXIMAL AORTIC NECK DILATED, CAUSING THE EXCLUDER TO COME DOWN AND LOSE SEAL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22878549 ↗
• InjuryJul 31, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2025, A CTA WORK-UP REPORT WAS PROVIDED TO FIELD SALES ASSOCIATE SHOWING A GORE EXCLUDER DEVICE THAT HAS MIGRATED 26MM DISTALLY AND SHOWS OBSERVABLE EVIDENCE OF GRAFT INTEGRITY FAILURE (NITINOL FRACTURES WITH A DILATED PROXIMAL NECK). BILATERAL HYPOGASTRIC ARTERIES OCCLUDED NATIVELY WITH DISTAL RIGHT COMMON ILIAC ARTERY ANEURYSMAL AND THE RIGHT EXTERNAL ILIAC ARTERY IS CALCIFIED. PHYSICIAN PLANS TO DO A ENDOVASCULAR ANEURYSM REPAIR (EVAR) REINTERVENTION AT SOME POINT (DATE NOT SCHEDULED YET) TO RELINE THE ORIGINAL GRAFTS WITH A CONFORMABLE TRUNK IPSILATERAL GRAFT AND A CONTRALATERAL LIMB IN OFF-LABEL USE DUE TO DILATED PROXIMAL NECK ANEURYSMAL. THE ANEURYSM GROWTH (SIZE UNKNOWN) IS DUE TO THE MIGRATION.

  Patient problems: Aneurysm expansion

  MAUDE report 22675181 ↗
• InjuryApr 1, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2015, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 54.3 MM. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP IMAGING FROM (B)(6) 2015 TO (B)(6) 2019 SHOWED THAT THE ANEURYSM DECREASED IN SIZE FROM 51.5 MM TO 32.8 MM. THE FOLLOW UP IMAGING FROM (B)(6) 2020, SHOWED THAT THE ANEURYSM INCREASED IN SIZE AND WAS MEASURED AT 38 MM. THE FOLLOW UP IMAGING FROM (B)(6) 2021 TO (B)(6) 2024, SHOWED THAT THE ANEURYSM DECREASED IN SIZE FROM 37.1 MM TO 36.4 MM. ON (B)(6) 2024, A FOLLOW UP CTA SHOWED EVIDENCE OF TYPE IA ENDOLEAK. ON (B)(6) 2024, A THORACIC ENDOVASCULAR AORTIC REPAIR WAS PERFORMED TO TREAT A PROXIMAL TYPE 1 ENDOLEAK AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) DEVICE WAS PLACED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21747598 ↗
• InjuryMar 3, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, DURING A ROUTINE FOLLOW-UP, THE PHYSICIAN DETECTED A TYPE IA ENDOLEAK. ON (B)(6) 2025, THE PHYSICIAN IMPLANTED TWO AORTIC EXTENDER DEVICE TO FIX THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21507173 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO TREAT WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351416) AN ABDOMINAL ANEURYSM REPAIR [AAA]. THE PHYSICIAN NOTICED THAT AFTER RELEASING THE ENDOPROSTHESIS, THE OLIVE (LEADING TIP) DETACHED FROM THE CATHETER. THEN, HE USED A GOOSENECK CATHETER TO CATCH IT AND TAKE IT OUT OF THE GORE ® DRYSEAL FLEX INTRODUCER SHEATH. THE EVAR PROCEDURE WAS COMPLETED AND THE STENT GRAFT REMAINS SUCCESSFULLY IMPLANTED. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363953 ↗
• InjuryJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONALLY, IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT HAS DISCONTINUED FOLLOW-UP WITH VASCULAR SURGERY SECONDARY TO HER AGE BEING (B)(6) YEARS OLD. THE TYPE ENDOLEAK IS REPORTED TO BE A TYPE I-A AND TYPE II ENDOLEAK.

  Patient problems: Aneurysm expansion

  MAUDE report 19800703 ↗
• InjuryApr 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2015, 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) 2024, THE PHYSICIAN PERFORMED A REINTERVENTION PROCEDURE TO REVISE THE PREVIOUS GORE® EXCLUDER® AAA ENDOPROSTHESES. IT APPEARED THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS PER THE PHYSICIAN ¿APPEARS FRACTURED¿. THERE WAS POSSIBLE DISTAL MIGRATION OF THE DEVICE (AMOUNT IS UNKNOWN) AND DISEASE PROGRESSION. THE PHYSICIAN IMPLANTED A ZENITH® FENESTRATED AAA ENDOVASCULAR GRAFT, ZENITH FLEX® AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GRAFT, AND USED GORE® VIABAHN® ENDOPROSTHESES IN BOTH RENAL ARTERIES, THE SUPERIOR MESENTERIC ARTERY, AND THE CELIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 19092085 ↗
• InjuryFeb 9, 2024Complete Blockage; Material Separation; Premature Separation; Complete Blockage; Material Separation; Premature Separation

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS INTENDED TO BE USED FOR AN INFRA RENAL ANEURYSM REPAIR. THE DEVICE WAS PLACED VIA THE RIGHT SIDE ACCESS THROUGH A 18FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. INITIAL DEPLOYMENT WAS DONE ABOVE THE INTENDED LANDING ZONE IN ORDER TO CANNULATE THE CONTRA LATERAL LIMB. AFTER CANNULATION, THE PROXIMAL PART OF THE DEVICE WAS RE-CONSTRAINED AND PULLED DOWN TO THE INTENDED LANDING ZONE. BEFORE LANDING ZONE WAS REACHED THE PROXIMAL PART OF THE DEVICE SUDDENLY OPENED UP AGAIN WHILE THE DEPLOYMENT KNOB WAS STILL IN ITS CONSTRAINED POSITION. THE SUDDEN RELEASE OF THE CONSTRAINING WAS REPORTED TO BE FASTER THAN A NORMAL ROTATION OF THE CONSTRAINING MECHANISM. IT IS HOWEVER NOT CONFIRMED IF THE PHYSICIAN FELT ANY LINE BREAKAGE. THE PHYSICIAN TRIED TO PULL THE DEVICE SLIGHTLY DOWN IN ORDER TO GET TO LANDING ZONE. THE DEVICE DISLODGED AND DEPLOYED FROM THE DELIVERY SYSTEM WITHOUT THE PHYSICIAN COMPLETING THE DEPLOYMENT STEPS OR ACCESS THE LINE HATCH. THE DELIVERY CATHETER WAS REMOVED AND THE PATIENT WAS CONVERTED TO OPEN SURGERY AND THE DEVICE WAS EXPLANTED AS ALL RENAL ARTERIES AND SMA WAS COVERED. THE PATIENT HAS RECOVERED FROM

  Patient problems: Obstruction/Occlusion

  MAUDE report 18674602 ↗
• InjuryOct 30, 2023Migration; Migration

  ON (B)(6) 2017 THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED EMERGENTLY, REPORTING PAIN. IMAGING NOTED AORTIC NECK GROWTH TO A DIAMETER OF 36-37MM. A LARGE TYPE IA ENDOLEAK WITH POSSIBLE RUPTURE WAS SEEN. THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR WITH THE EXPLANT OF ALL COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT NECK DILATATION EVENTUALLY CAUSED THE DEVICE TO MIGRATE DISTALLY.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18030076 ↗
• InjurySep 13, 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) 2019, 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 A RUPTURED ANEURYSM. PATIENT HAD A HISTORY OF A KNOWN TYPE II ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN) AND A DISTAL TYPE I ENDOLEAK. PHYSICIAN STATED PROGRESSION OF ANEURYSMAL DISEASE CAUSED THE LOSS OF THE PROXIMAL SEAL OF IMPLANTED DEVICE. THE PHYSICIAN REINTERVENED AND RELINED THE IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PHYSICIAN DID NOT FEEL THE PATIENT WOULD TOLERATE AN EXPLANT AND CONVERSION PROCEDURE AND CHOSE TO INTENTIONALLY COVER THE LEFT RENAL ARTERY TO HAVE ADEQUATE SEAL ZONE. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17738778 ↗
• InjurySep 7, 2023Obstruction of Flow; Activation, Positioning or Separation Problem; Obstruction of Flow; Activation, Positioning or Separation Problem

  ON AUGUST 30, 2023, THE MEXICO SANITARY REPRESENTATIVE WAS AWARE THAT ON (B)(6) 2023 THERE WAS A RUPTURED ABDOMINAL ANEURYSM IN THE (B)(6) AND THE DEVICES WERE PREPARED TO ASSIST THE CASE SCHEDULED ON (B)(6) 2023. ACCORDING TO THE INFORMATION PROVIDED BY THE FSA, EVERYTHING WENT SMOOTH IN THE PROCEDURE, THAT ALL GORE® EXCLUDER® AAA ENDOPROSTHESES DEPLOYED WELL AND NO RESISTANCE WAS EVER OBSERVED. A FINAL CONTROL ANGIOGRAM WAS PERFORMED, AND THE RESULTS SEEMS APPARENTLY SUCCESSFUL. AFTER AROUND 30 MIN, WHILE TAKING IMAGES AND DISCUSSING FINAL THOUGHTS THE PATIENT HAD CARDIAC ARREST. THEY PERFORMED ANGIOGRAM AND IT SEEMED THAT THE RLT351416 DEVICE LOOKED ¿FUNNY¿ AS ¿ACCORDION¿ IN THE CONTRALATERAL GATE/IPSILATERAL SIDE ZONE, AFTER THE FLOW DIVIDER, AND THEY TRIED TO BALLOON THAT ZONE IN KISSING TECHNIQUE WITH THE BARD ATLAS BALLOONS AND IT LOOKED BETTER. WHILE DOING THIS, THE PATIENT WENT TO CARDIAC ARREST SEVERAL TIMES AND AFTER THE 4-5 TIME, THE PATIENT DIED. THE PHYSICIAN MENTIONED THAT WAS VERY UNLIKELY THAT THE EXCLUDER DEVICE CAUSED THE CARDIAC ARREST, BUT THE PHYSICIAN WAS A LITTLE CONFUSED BY THE WAY THE DEVISE LOOKED IN THE IMAGES. THE PHYSICIAN LOOKED OF THE DEVICE AFTER TH

  Patient problems: Reduced Blood Flow; Ruptured Aneurysm

  MAUDE report 17696139 ↗
• InjuryNov 30, 2022Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED LOW INITIALLY (DISTANCE FROM THE PATIENT'S RENAL ARTERIES IS UNKNOWN). ON (B)(6) 2022, IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED DISTALLY. IT WAS SUSPECTED THAT THE MIGRATION WAS RELATED TO THE INITIAL LOW PLACEMENT OF THE DEVICE, AS WELL AS A LACK OF FULL CIRCUMFERENTIAL DEVICE APPOSITION AS THE INITIAL SEAL WAS REPORTEDLY OPPOSED TO CLOT. IT WAS NOTED THAT THE ANEURYSM WAS THROMBOSED AND NO ENDOLEAK WAS REPORTED. IT WAS REPORTED THAT A REINTERVENTION WAS PERFORMED WHEREBY TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENTS WERE IMPLANTED PROXIMALLY TO TREAT THE DISTAL MIGRATION. THE TREATMENT WAS REPORTEDLY SUCCESSFUL AND THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15890545 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2019, 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 IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED A DISTAL MIGRATION (AMOUNT OF MIGRATION IS UNKNOWN, CAUSE OF MIGRATION IS UNKNOWN) OF THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. A REINTERVENTION IS PLANNED, THE DATE IS UNKNOWN AT THIS TIME. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 13726424 ↗
• MalfunctionJun 14, 2021Material Separation; Material Separation

  ON (B)(6) 2021 THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE LEADING OLIVE TIP SEPARATED FROM THE CATHETER IN THE INTRODUCER SHEATH AFTER IMPLANT DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996178 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT RE-INTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK. APTUS SCREWS WERE PLACED PROXIMALLY AND TWO AORTIC EXTENDER COMPONENTS WERE PLACED TO EXTEND COVERAGE. NO ENLARGEMENT OF THE ANEURYSM WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE WITH RESOLUTION OF THE ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 11950598 ↗
• InjuryJun 4, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2015 WITH A THORACOABDOMINAL AORTIC ANEURYSM (PRE-IMPLANT CT DIAMETER 87 MM) THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESIS IN A CHIMNEY PROCEDURE. ON (B)(6) 2020, A TYPE IA AND A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY WERE IDENTIFIED THAT CONTRIBUTE TO ANEURYSM GROWTH (CT DIAMETER 127 MM) WERE IDENTIFIED. ON (B)(6) 2020, THE ENDOLEAKS WERE TREATED WITH THE IMPLANTATION OF A PROXIMAL AORTIC CUFF AND EMBOLIZATION OF THE LUMBAR ARTERY AND THE ANEURYSM SAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11936936 ↗
• InjuryOct 2, 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 GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 49MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 44MM. ON (B)(6) 2015, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 46MM. FROM (B)(6) 2014 TILL (B)(6) 2018, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 36 TO 48MM. IT WAS REPORTED THAT ON (B)(6) 2018, A TYPE II ENDOLEAK WAS DETERMINED. REPORTEDLY, THE TYPE II ENDOLEAK SUPPLIED VIA BRANCHES OF THE RIGHT THIRD LUMBAR ARTERY AND INFERIOR MESENTERIC ARTERY, AND CAUSED THE ANEURYSM ENLARGEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A MESENTERIC ANGIOGRAPHY AND AN EMBOLIZATION PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2018 TILL (B)(6) 2019, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 47 TO 37MM. ON (B)(6) 2020, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 50MM. REPORTEDLY, THE CAUSE OF THE ANEURYSM ENLARGEMEN

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10623824 ↗
• InjuryJun 27, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. WITH AN ONSET DATE OF (B)(6) 2019, AN EXPANSION OF THE JUXTARENAL ANEURYSM NECK WAS REPORTED. ON (B)(6) 2019, FIXATION OF THE STENT GRAFT WAS PERFORMED WITH 10 ENDOANCHOR¿ IMPLANTS.

  Patient problems: Aneurysm

  MAUDE report 10204263 ↗
• InjuryJul 22, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR TO TREAT AN ABDOMINAL AORTIC DISSECTION WITH AN INTERNAL ILIAC ARTERY ANEURYSM. THE PATIENT WAS REPORTED TO HAVE POOR ANATOMY AND POOR AORTIC TISSUE PRIOR TO THE PROCEDURE. THE INTERNAL ILIAC ARTERY ANEURYSM WAS COIL EMBOLIZED. THEN A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM WAS ADVANCED INTO THE ABDOMINAL AORTA. WHEN THE DEVICE WAS DEPLOYED, THE CONTRALATERAL LEG GATE OPENED INTO A DISSECTED PLANE. THEREFORE, THE PHYSICIAN WAS UNABLE TO CANNULATE THE GATE. THE DECISION WAS MADE TO CONVERT TO AN OPEN REPAIR. THE GORE® EXCLUDER® DEVICE WAS EXPLANTED AND DISCARDED AT THE FACILITY. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE. THE PHYSICIAN STATED THAT THE PATIENT'S ANATOMY WAS POOR, AND THIS WAS THE CAUSE OF THE CONVERSION TO OPEN REPAIR.

  Patient problems: No Code Available

  MAUDE report 8811736 ↗
• InjuryMay 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH LOW CARDIAC OUTPUT DUE TO HYPOVOLEMIA. IT WAS DETERMINED THAT THE PATIENT HAD A TYPE III ENDOLEAK, AND SUBSEQUENT ABDOMINAL AORTIC ANEURYSM RUPTURE. REPORTEDLY THE ILIAC EXTENDER COMPONENT HAD BECOME SEPARATED FROM THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS ALSO REPORTED THAT THE CONTRALATERAL LEG COMPONENT, LOCATED ON THE PATIENT'S LEFT SIDE, WAS THROMBOSED. IT WAS NOTED THAT THE CONTRALATERAL LEG COMPONENT APPEARED TO BE KINKED. A FEMORAL TO FEMORAL BYPASS WAS PERFORMED TO TREAT THE ANEURYSM RUPTURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Blood Loss; Perforation of Vessels

  MAUDE report 8638686 ↗
• InjuryMay 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH LOWER LIMB CLAUDICATION. COMPUTED TOMOGRAPHY (CT) DATED (B)(6) 2019, REVEALED THE RLT351416/18460773 DEVICE WAS COMPRESSED BELOW THE FLOW DIVIDER ON THE IPSILATERAL LIMB. THE LIMB WAS PATENT. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® VIABAHN® DEVICE IN THE COLLAPSED AREA. THE AREA WAS OPENED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8571701 ↗
• InjuryApr 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  GORE RECEIVED THE FOLLOWING INFORMATION: ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM MEASURING 87 MM IN DIAMETER AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED AN ANEURYSM DIAMETER OF 99 MM AND A PROXIMAL ENDOLEAK. ON (B)(6) 2018, AN ADDITIONAL STENT WAS IMPLANTED BELOW THE SUPERIOR MESENTERIC ARTERY IN AN ATTEMPT TO SOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8524737 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, 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 COMPUTED TOMOGRAPHY (CT) IMAGES (DATE UNKNOWN) REVEALED THE PROXIMAL PORTION OF THE IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS HAD MIGRATED INTO THE AORTIC ANEURYSM SAC (EXACT AMOUNT OF MIGRATION IS UNKNOWN). REPORTEDLY, THE IMAGES REVEALED THAT APPROXIMATELY THREE OF THE ANCHORS WERE STILL IN THE ABDOMINAL AORTA BUT THE GRAFT HAD SEPARATED FROM THE ANCHORS AND THE GRAFT HAD SLIPPED INTO THE ANEURYSM SAC. THE TRUNK OF THE DEVICE WAS FOUND AT THE BOTTOM OF THE ANEURYSM SAC, BOTH LIMBS OF THE DEVICE WERE PATENT, AND THE ANCHORS OF THE STENT WERE FOUND IN THE INTRAMURAL THROMBUS. ON (B)(6) 2019, THE PHYSICIAN PERFORMED A PARTIAL EXPLANT OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351416) AND LEFT THE BIFURCATION OF THE ENDOPROSTHESIS AND THE LIMBS AND SEW A DACRON GRAFT TO THE EXISTING EXCLUDER® DEVICE AND THE PROXIMAL AORTIC NECK. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8445365 ↗
• InjuryJun 28, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-OPERATIVE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 61 MM. ON (B)(6) 2014, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING REVEALED A TYPE II ENDOLEAK FROM THE LUMBAR ARTERIES. BETWEEN (B)(6) 2014, AND (B)(6) 2015, CTA IMAGING CONFIRMED A MAXIMUM ANEURYSM DIAMETER INCREASE OF 10 MM AS 48 AND 58 MM WERE MEASURED AT THOSE TIME POINTS WITH AN ONGOING TYPE II ENDOLEAK. ON (B)(6) 2015, THE TYPE II ENDOLEAK WAS EMBOLIZED. ON (B)(6) 2016, THE SAME TYPE II ENDOLEAK WAS NOTED TO BE ACTIVE AGAIN AND IT WAS DECIDED TO SURVEIL THE PATIENT. ON (B)(6) 2018, CTA IMAGING FINDINGS IDENTIFIED AN ANEURYSM DIAMETER OF 67 MM AND A TYPE II ENDOLEAK. ON (B)(6) 2018, THE ENDOLEAK WAS EMBOLIZED. A FOLLOW-UP VISIT HAS BEEN SCHEDULED WITH THE PATIENT TO VERIFY SUCCESSFUL EMBOLIZATION.

  Patient problems: No Code Available

  MAUDE report 7645819 ↗

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