GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311415Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00733132619085), received between Sep 17, 2018 and Jun 23, 2026 — classified as 1 death, 26 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2026, A FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED OF A POTENTIAL NEED FOR REINTERVENTION FOLLOWING CTA IMAGING (DATE UNKNOWN) THAT DEMONSTRATED CONTRAST WITHIN THE ANEURYSM SAC, RAISING CONCERN FOR A SUSPECTED TYPE III ENDOLEAK. ANEURYSM SAC GROWTH WAS NOT NOTED WITH NO SIZE REPORTED ON IMAGING. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION. THE INTERVENTION TARGETED THE RIGHT (IPSILATERAL) SIDE OF THE MAIN BODY GRAFT RATHER THAN A COMPONENT JUNCTION. IT WAS REPORTED THAT THE PHYSICIAN ELECTED TO RELINE THIS SEGMENT USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC161200) TO ADDRESS THE SUSPECTED TYPE III ENDOLEAK. NO ENDOLEAK WAS IDENTIFIED ON INTRA-PROCEDURAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATION. ON (B)(6) 2026, FSA RECEIVED ADDITIONAL INFORMATION FROM THE PHYSICIAN THAT THE ENDOLEAK WAS INDETERMINATE AND THOUGHT TO BE TYPE 2 AT THE END BUT PHYSICIAN CHOSE TO REINTERVENE AND REPAIRED USING ADDITIONAL STENT BECAUSE IT HAD BEEN REPORTED AS TYPE 3 ENDOL

  Patient problems: Clinical Endoleak

  MAUDE report 25594054 ↗
• InjuryMar 23, 2025Patient-Device Incompatibility; Activation Failure; Device Stenosis; Patient-Device Incompatibility; Activation Failure; Device Stenosis

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR [EVAR] WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE CONTRALATERAL LEG OF THE AAA ENDOPROSTHESIS WAS COMPLETELY CLOSED AT THE PROXIMAL END AND THE SURGEON TRIED DURING THE PROCEDURE TO MOVE THE ENDOPROSTHESIS WITHOUT SUCCESS. IT WAS ALSO TRIED WITH HIGH AND LOW CATHETERIZATION OF THE CONTRALATERAL LEG BUT COULD NOT OPEN THE PROXIMAL END OF THE CONTRALATERAL LEG. OPACIFICATION OF THE MAIN BODY OF THE ENDOPROSTHESIS SHOWED THAT BLOOD WAS NOT CIRCULATING IN THE CONTRALATERAL LEG. REPORTEDLY, THE SURGEON TRIED TO CATHETERIZE THE SHORT LEG OF THE TRUNK VIA RADIAL ACCESS BUT ALSO VIA CONTRALATERAL ACCESS. AS NOTHING WAS SUCCESSFUL, THE SURGEON DEPLOYED THE IPSILATERAL LEG, AND THEN PERFORMED PATIENT'S RIGHT FEMORAL TO LEFT FEMORAL BYPASS. THIS CROSS-BYPASS WAS PERFORMED TO RESTORE BLOOD FLOW ON THE LEFT SIDE. THE PATIENT IS DOING WELL AND TOLERATED THE PROCEDURE.

  Patient problems: Ischemia; Obstruction/Occlusion; Reduced Blood Flow; Stenosis

  MAUDE report 21674551 ↗
• InjuryFeb 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH RIGHT UPPER QUADRANT PAIN. IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT (IMAGES FROM ORIGINAL PROCEDURE ARE NOT AVAILABLE FOR COMPARISON). THE FSA WAS NOTIFIED OF THIS EVENT ON JANUARY 30, 2025. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. A GORE® EXCLUDER® AAA CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED DISTALLY ON THE IPSILATERAL LIMB (RIGHT) SIDE. THE PATIENT TOLERATED THE PROCEDURE. THE ROOT CAUSE FOR THE ENDOLEAKS IS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 21414982 ↗
• InjurySep 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, THE PATIENT PRESENTED WITH A PERSISTENT TYPE 1A ENDOLEAK. THE MOST RECENT CT SCAN SHOWS THAT THE ENDOLEAK IS STILL PRESENT. THE PATIENT HAS BEEN APPROVED FOR A TAMBE INTERVENTION TO CORRECT THE ENDOLEAK. THIS CASE HAS NOT BEEN SCHEDULED YET.

  Patient problems: Clinical Endoleak

  MAUDE report 20212919 ↗
• InjuryJul 17, 2024Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE FSA REPORTED THAT A PATIENT HAD COME IN WITH AN EXCLUDER IMPLANT. THE ANEURYSM WAS REPORTED TO BE ENLARGED TO 14CM, AND THE DEVICE HAD MIGRATED 7CM BELOW THE RENAL ARTERIES. THE PATIENT IS BEING CONSIDERED FOR A TAMBE DEVICE.

  Patient problems: Aneurysm expansion

  MAUDE report 19761506 ↗
• InjuryJun 5, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415, PLC271200, AND PLC231000) AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231410 AND HGB161407) WAS IMPLANTED ON (B)(6) 2024 IN ORDER TO TREAT A PATIENT WITH AN AORTIC ANEURYSM. THE MAIN TRUNK OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415) WAS EXTENDED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC271200) ON ONE SIDE WHICH CONTINUED TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE OTHER SIDE OF THE MAIN TRUNK OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311415) WAS EXTENDED WITH THE OTHER GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC231000). THE PROCEDURE WENT WELL. ON AN UNKNOWN DATE A FEW DAYS AFTER THE INITIAL IMPLANT, THE FOLLOW-UP CT SCAN SHOWED THAT THE PROXIMAL PART OF THE CONTRALATERAL LEG COMPONENT PLC271200 WAS NOT INSIDE THE MAIN TRUNK RLT311415. IT WAS REPORTED THAT DURING THE IMPLANT OF THE PLC271200, THE DEVICE WAS DEPLOYED OUTSIDE OF THE MAIN TRUNK AND DUE TO A MISINTERPRETATION OF THE ANGIOGRAPHIC IMAGING, THIS WAS NOT FOUND OUT UNTIL THE FOLLOW-UP SCAN A FEW DAYS POST-IMPLANT. THE PATIENT DID NOT SHOW ANY SYMPTOMS. A N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466234 ↗
• InjuryMar 22, 2024Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6), 2022, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM MEASURING 5.7 CM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. IN (B)(6), 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL PRESENTING WITH SEPSIS, TEMPERATURE SPIKES, WEIGHT LOSS, ACUTE KIDNEY INJURY, COVID, A POSTIVE BLOOD CULTURE FOR S. AUREUS AND NEGATIVE ECHOCARDIOGRAM RESULTS FOR INFECTIVE ENDOCARDITIS. MAXIMUM ABDOMINAL AORTIC ANEURYSM WAS MEASURED AT 5 CM. NO ENDOLEAK WAS DETECTED. ON (B)(6), 2024, COMPUTED TOMOGRAPHY (CT) SHOWED A MAXIMUM AORTIC ANEURYSM DIAMETER OF 5 CM. ON (B)(6), 2024, THE PATIENT UNDERWENT CT IMAGING DUE TO A PERSISTENT FEVER. MILD LIENAR HYPODENSITY ADJACENT TO THE POSTERIOR / POSTERIOR MEDIAL ASPECT OF THE TREATED AREA OF THE PROXIMAL LEFT COMMON ILIAC ARTERY. ON (B)(6), THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) OF A SHOULDER ARTROSCOPY PERFORMED IN 2023. THE PHYSICIAN SUSPECTED INFLAMMATORY ARTROPTHY/SEPTIC ARTHRITIS. THE PATIENT STARTED RECEIVING ANTIBIOTICS. ON (B)(6), THE PATIENT PRESENTED WITH NEW MILD PERIAORTIC INFLAMMATORY FAT STRANDING SUGGESTIVE OF AORTITIS OR DEVICE INFECTION. MILD AORTIC SAC ENHANCEMENT, WITH SURROUNDING FAT STR

  Patient problems: Fever; Sepsis

  MAUDE report 18958772 ↗
• InjuryApr 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A 6.7CM X 7.0CM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS ON THE PATIENT'S LEFT SIDE, AND AN 18X12MM CONTRALATERAL LEG COMPONENT WAS LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ON (B)(6)2023, IT WAS REPORTED THAT THE ANEURYSM HAD ENLARGED TO 7.0CM X 7.5CM. A TYPE II ENDOLEAK WAS SUSPECTED. A REINTERVENTION WAS PERFORMED WHEREBY THE TYPE II ENDOLEAK WAS COILED, AND A 32MM AORTIC EXTENDER COMPONENT WAS USED TO EXTEND THE TRUNK PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 16773751 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, 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) 2022, THE PATIENT UNDERWENT FOLLOW-UP IMAGING AND THE PHYSICIAN REPORTED THAT THE ANEURYSM HAD GROWN PROXIMALLY AND NOW INVOLVED THE RENAL ARTERIES AND THE DESCENDING THORACIC AORTA. THE PHYSICIAN PLANS TO REINTERVENE ON (B)(6) 2022 TO SNORKEL THE RENAL ARTERIES AND EXTEND COVERAGE PROXIMALLY INTO THE DESCENDING THORACIC AORTA WITH GORE® TAG® THORACIC STENT GRAFTS. THE PHYSICIAN REPORTED NO ENDOLEAK JUST ENLARGEMENT OR ELONGATION OF THE ANEURYSM. ADDITIONALLY, IT WAS UNKNOWN IF THERE WAS MIGRATION OF THE DEVICE AS A DIFFERENT PHYSICIAN PERFORMED THE INDEX PROCEDURE AND IT IS UNKNOWN IF PLACEMENT OF THE ORIGINAL TRUNK COMPONENT HAD BEEN LANDED JUST DISTAL TO THE LOWEST RENAL ARTERY.

  Patient problems: Aneurysm

  MAUDE report 15807877 ↗
• InjuryOct 11, 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) 2015, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM (INFRARENAL-ZONE 9). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). REPORTEDLY THE PATIENT HAD VERY TORTUOUS ANATOMY, A SEVERELY ANGULATED AORTIC NECK AND BILATERAL RENAL ARTERY STENOSIS. THERE WAS A REINTERVENTION ON (B)(6) 2022. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE PHYSICIAN PLANNED TO COVER THE LEFT RENAL ARTERY, DUE TO STENOSIS AT THE PROXIMAL CONNECTION TO AORTA AND DUE TO THE SEVERELY ANGULATED AORTIC NECK. THE FIRST IMPLANTED AORTIC EXTENDER ENDOPROSTHESIS (CXA360005/24322716) PARTIALLY COVERED THE LEFT RENAL ARTERY AND WAS NOT LONG ENOUGH TO COVER THE ANGULATION. TWO ADDITIONAL AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED FOR COVERAGE OF THE ANGULATION. THE PHYSICIAN ATTEMPTED TO STENT THE PARTIALLY COVERED LEFT RENAL ARTERY, BUT THE TERUMO SHEATH

  Patient problems: Aneurysm

  MAUDE report 15580019 ↗
• InjuryMay 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED EMERGENTLY WITH A PROXIMAL TYPE 1A ENDOLEAK THAT RESULTED IN A VESSEL RUPTURE. THE PHYSICIAN EXPLANTED THE THREE AAA DEVICES AND THE RUPTURE WAS REPAIRED SURGICALLY. THE ENDOPROSTHESES WERE DISCARDED AT THE FACILITY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Abdominal Pain; Ruptured Aneurysm

  MAUDE report 14380965 ↗
• InjuryOct 18, 2021Adverse 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) 2016 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT EXPERIENCED AN ABDOMINAL AORTIC ANEURYSM RUPTURE. THE PHYSICIAN PERFORMED AN EMERGENCY ENDOVASCULAR REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 12648031 ↗
• InjurySep 17, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. SEVERAL FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED OVER THE NEXT TWO YEARS WITH THE PHYSICIAN REPORTEDLY NOTING A SMALL POSSIBLE TYPE II ENDOLEAK CAUSING MINOR SAC EXPANSION DURING THIS TIME. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT. ON (B)(6) 2021, THE PATIENT PRESENTED WITH A SLOW RUPTURE AND A TYPE 1A ENDOLEAK. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THE TYPE II ENDOLEAK HAVING LED TO THE SAC EXPANSION AND THE RUPTURE. ALSO ON (B)(6) 2021, ALL ENDOPROSTHESES WERE EXPLANTED. REPORTEDLY, THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Aneurysm; Ruptured Aneurysm

  MAUDE report 12492140 ↗
• MalfunctionMar 4, 2021Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  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, THE DEVICE WAS COMPLETELY DEPLOYED. WHEN ATTEMPTING TO REMOVE THE DELIVERY CATHETER, IT WAS GRIPPING THE WIRE AND WOULD NOT RELEASE FROM THE WIRE, PULLING THE WIRE ALONG WITH THE DELIVERY CATHETER. WIRE ACCESS WAS LOST AT THE LEVEL OF THE COMMON FEMORAL ARTERY. THE CATHETER WITH THE WIRE ADHERED TO IT WERE REMOVED FROM THE SHEATH. THE WIRE WAS THEN WAS THEN PULLED OFF THE WIRE WITH DIFFICULTY OUTSIDE OF THE PATIENT. THIS WAS ACCOMPLISHED BY CLAMPING THE WIRE AT THE HUB OF THE SHEATH AND PULLING ON THE DELIVERY CATHETER. 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. IT WAS REPORTED THAT THE AORTIC NECK WAS HIGHLY ANGULATED. THE PHYSICIAN ALSO MENTIONED THAT THE CATHETER HANDLE WAS LEAKING MORE THAN USUAL. HOWEVER, THE LEAKAGE DID NOT REQUIRE A TRANSFUSION OR LEAD TO A HURRIED DEPLOYMENT. NO UNPLANNED PROCEDURE WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER WILL BE PROVIDE

  Patient problems: Aneurysm

  MAUDE report 11418424 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, THE DEVICE WAS SITTING JUST DISTAL OF THE LEFT RENAL ARTERY, WHICH CAUSED A ¿BIRD BEAK¿. THE PHYSICIAN RE-CONSTRAINED THE DEVICE AND MOVED IT DISTALLY. THEN A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. THE PHYSICIAN CHOSE TO BALLOON (MANUFACTURER OF BALLOON WAS NOT GORE) LIGHTLY THE PROXIMAL AREA. THE PROXIMAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN CHOSE TO BALLOON MORE AGGRESSIVELY AND A DISSECTION ADJACENT TO THE PROXIMAL PORTION OF THE GRAFT PRESENTED. THE PHYSICIAN IMPLANTED AN AORTIC EXTENDER ENDOPROSTHESIS. THE DISSECTION WAS COVERED AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE PATIENT¿S AORTIC NECK ANGLE WAS 50 DEGREES AND WITHIN INSTRUCTIONS FOR USE, THERE WAS NO TORTUOSITY IN THE ANATOMY.

  Patient problems: Aneurysm

  MAUDE report 10789149 ↗
• MalfunctionOct 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. BEFORE INSERTING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM INTO THE GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING, IT WAS NOTED THAT A WIRE WAS PROTRUDING FROM THE DELIVERY SYSTEM JUST BELOW THE OLIVE. IT WAS REPORTED TO BE A GOLD-SILVER COLOR. THE DEVICE WAS INSERTED INTO THE SHEATH, AND THE SHEATH BALLOON VALVE WAS PUNCTURED. THE DEVICE AND SHEATH WERE REMOVED AND DISCARDED, AND A NEW SHEATH AND DELIVERY SYSTEM WERE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT TOLERATED THE PROCEDURE. THE FSA STATED THAT THE OBSERVED WIRE WAS DEFINITELY NOT THE LOCK PIN, NOR WAS IT PART OF THE STRUCTURE OF THE DEVICE. HE BELIEVES THAT IT WAS THE CONSTRAINING WIRE LOOP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10737800 ↗
• MalfunctionOct 16, 2020Break; Break

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN UNCOMPLICATED ABDOMINAL AORTIC ANEURYSM, AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE CATHETER RETRACTION OF A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT311415 FOLLOWING DEPLOYMENT, IT WAS NOTED THAT THE LEADING END HAD BECOME COMPLETELY DETACHED. REPORTEDLY, IT HAD SLIPPED OFF THE GUIDEWIRE AND HAD COME TO REST IN THE COMMON ILIAC ARTERY FROM WHERE IS WAS SUBSEQUENTLY RETRIEVED BY THE PHYSICIAN USING ENDOVASCULAR MEANS. THERE WAS NO RESISTANCE FELT, BUT A SLIGHT NOISE WAS HEARD WHEN THE CATHETER WAS REMOVED. ALSO, NO ANATOMICAL ISSUES WERE REPORTEDLY IDENTIFIED TO HAVE CONTRIBUTED TO THE EVENT. GORE IS CURRENTLY AWAITING THE RETURN OF THE DELIVERY CATHETER OF THE RLT311415 COMPONENT TO PERFORM AN EVALUATION OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10689985 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT DURING FOLLOW UP IMAGES (MODALITY AND DATE OF IMAGES IS UNKNOWN), THE PHYSICIAN STATED THE PATIENT CAME IN FOR ONE MONTH FOLLOW UP SCAN (DATE OF EVENT WILL BE (B)(6) 2020, A MONTH AFTER THE PROCEDURE) WITH HIGH CREATININE AND A THROMBOSED RENAL ARTERY. THE EVENT IS ONGOING AT THIS TIME WITH NO PLANNED REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 10318000 ↗
• InjuryJul 21, 2020Migration; Migration

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2020, IT WAS NOTED DURING FOLLOW UP THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED DISTALLY DUE TO DISEASE PROGRESSION. NO ENDOLEAK WAS NOTED, AS THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS OPPOSED AGAINST THROMBUS IN THE AORTIC NECK. ON THE SAME DAY, A REINTERVENTION OCCURRED WHEREBY ANOTHER TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED INSIDE THE PREVIOUSLY IMPLANTED DEVICE. THE DEVICE WAS IMPLANTED PROXIMALLY IN ORDER TO SECURE APPROPRIATE AORTIC SEAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10302425 ↗
• InjuryJul 16, 2020Migration; Migration

  ON (B)(6) 2019, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY (CT) IMAGING AS HE WAS FEELING UNWELL.

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 10284148 ↗
• MalfunctionJul 13, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WAS IMPLANTED AND DEPLOYED SUCCESSFULLY. WHEN RETRACTING THE DELIVERY CATHETER, THE LEADING OLIVE BECAME STUCK IN THE SEAL OF THE GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING. IN THE ATTEMPT TO REMOVE THE CATHETER FROM THE SHEATH, THE DELIVERY CATHETER SEPARATED APPROXIMATELY 3 INCHES DISTAL TO THE LEADING OLIVE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN HAS NO OPINION REGARDING THE CAUSE OF THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264928 ↗
• InjuryMay 6, 2020Use of Device Problem; Use of Device Problem

  ON (B)(6) 2017 THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION OF AN EXISTING NON-GORE STENT GRAFT USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2020 THE PATIENT UNDERWENT AN ADDITIONAL REINTERVENTION TO TREAT A PROXIMAL TYPE I ENDOLEAK IDENTIFIED ON THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT ANEURYSM GROWTH WAS ALSO IDENTIFIED. THE SUSPECTED CAUSE OF THE TYPE I ENDOLEAK WAS A LACK OF APPOSITION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ON THE PREVIOUSLY IMPLANTED NON-GORE DEVICE. THE REINTERVENTION WAS AN OPEN SURGERY TO TREAT AND BYPASS THE ENDOLEAK BY SEWING IN AN ADDITIONAL GRAFT. THE REINTERVENTION SUCCESSFULLY TREATED THE TYPE I ENDOLEAK, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 10030901 ↗
• InjuryApr 9, 2020Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  ON (B)(6) 2020 THE PATIENT PRESENTED WITH A RUPTURED AND BLEEDING ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A PRE-EXISTING ENDOLOGIX DEVICE WITH A PROXIMAL TYPE I ENDOLEAK. THE ENDOLOGIX DEVICE WAS RELINED USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 THE PATIENT COMPLAINED OF BELLY PAIN. A CT WAS PERFORMED AND A PROXIMAL TYPE I ENDOLEAK WAS REPORTED ON THE GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THAT THE ENDOLEAK WAS CAUSED BY THE ENDOLOGIX DEVICE NOT ALLOWING THE TRUNK TO FULLY EXPAND. APTUS STAPLES WERE PLACED TO RESOLVE THE ENDOLEAK. ON (B)(6) 2020 THE ENDOLEAK PERSISTED, AND THE PHYSICIAN REPORTEDLY CONVERTED TO OPEN REPAIR. THE TRUNK OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS REPORTEDLY CUT AT THE FLOW DIVIDER. THE TRUNK OF THE GORE® EXCLUDER® AND THE ENDOLOGIX DEVICE WERE EXPLANTED. THE IPSILATERAL LIMB AND CONTRALATERAL LEG COMPONENT REMAINED IMPLANTED. A TUBE GRAFT WAS REPORTEDLY SEWN INTO THE PATIENT'S PROXIMAL AORTIC NECK, AND ATTACHED TO THE FLOW DIVIDER THUS CONNECTING THE TUBE GRAFT TO THE REMAINING EXCLUDER® LIMBS DISTALLY. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Pain

  MAUDE report 9945906 ↗
• InjuryNov 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT311415 WAS EXTENDED WITH A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC231200 ON THE PATIENT¿S RIGHT SIDE. ADDITIONALLY, A PLC161000 COMPONENT WAS EXTENDED WITH A PLC181200 COMPONENT ON THE LEFT. ON AN UNKNOWN DATE, THE PATIENT PRESENTED AS AN EMERGENCY DUE TO A MANIFESTATION OF BILATERAL LEG ISCHEMIA, WHICH PARTIALLY HAD AFFECTED HIS RIGHT, AND COMPLETELY HAD AFFECTED HIS LEFT LEG. ON (B)(6) 2019, COMPUTED TOMOGRAPHY (CT) IMAGING IDENTIFIED THE RLT311415 COMPONENT COMPLETELY COMPRESSED APART FROM ITS MOST PROXIMAL PORTION WHICH REPORTEDLY HAD REMAINED FULLY DEPLOYED AND FIXATED TO THE AORTA. THE COMPONENT HAD THUS NOT MIGRATED TOWARDS DISTAL. THE PHYSICIAN ASSESSED THE RLT COMPONENT¿S COMPRESSION WAS APPROXIMATELY 95% AND THE OVERLAP ZONES OF THE PLC COMPONENTS APPEARED COMPRESSED AS WELL, LEADING TO A LACK OF WALL APPOSITION IN THOSE ZONES. AS A POTENTIAL REASON FOR THE COMPRESSION, THE PHYSICIAN CONSIDERED THAT THE PATIENT¿S AORTIC NECK ANGULATION MIGHT HAVE CA

  Patient problems: Aneurysm; Ischemia; No Code Available

  MAUDE report 9326158 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC (CTAG) ENDOPROSTHESES, GORE® EXCLUDER® AAA (EXCLUDER) ENDOPROSTHESES, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE (VBX) ENDOPROSTHESES. IMAGES (DATE AND MODALITY) REVEAL A POSSIBLE UNKNOWN ENDOLEAK OR A ¿POSSIBLE GUTTER¿ (BETWEEN WHICH DEVICES IS UNKNOWN). THERE IS ANEURYSM SAC ENLARGEMENT, AMOUNT IS UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2019, THERE WAS A REINTERVENTION. THE PHYSICIAN EXTENDED THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE (VBX) ENDOPROSTHESES AND THEN PLACED A 40 MM CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9218822 ↗

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