GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281414Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00733132622535), received between Jul 9, 2018 and Mar 30, 2026 — classified as 39 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Malposition of Device; Migration

  THE FOLLOWING WAS REPORTED TO GORE OVER THE IMEDIDATA DATABASE AND THE STUDY SITE: ON (B)(6) 2026, THE PATIENT UNDERWENT A PRE-OPERATIVE PROCEDURE TO TREAT HYDRONEPHROSIS, WHICH WAS SUCCESSFULLY RESOLVED BILATERALLY. PRIOR TO THE STUDY-SITE INTERVENTION, THE PATIENT WAS TREATED AT ANOTHER HOSPITAL FOR RENAL INSUFFICIENCY. DURING THAT HOSPITALIZATION, A URETERAL STENT WAS PLACED, AND THE PATIENT REMAINED ADMITTED FOR ONE WEEK. THE PATIENT PRESENTED LATER TO THE STUDY SITE AND WAS AN EMERGENCY CASE FOLLOWING AN INCIDENTAL FINDING OF A CLINICALLY RELEVANT ANEURYSM. THE STUDY SITE PERFORMED A BILATERAL ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM AND RESOLVED THE FINDING ON (B)(6) 2026. DURING THE NIGHT OF (B)(6) 2026, A (B)(6) YEAR-OLD MALE PATIENT WAS OPERATED AND AN INTRA-PROCEDURAL RENAL ARTERY INTERVENTION TO PLACE TWO STENT GRAFTS (2X BXA062902E - GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) FOR LEFT AND RIGHT RENAL ARTERY WAS NECESSARY. IT WAS COMPLETED SUCCESSFULLY. FOLLOWING ALL PREVIOUSLY IMPLANTED GORE® DEVICES FOR THE ILIAC BRANCHES, IT WAS USED A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT, SN: (B)(6)) WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES - CONTRALATE

  Patient problems: Obstruction/Occlusion

  MAUDE report 24710522 ↗
• InjuryNov 25, 2025Migration; Device Endoleak; Migration; Device Endoleak

  ON (B)(6) 2015, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281414). THE PATIENT WAS ALSO IMPLANTED WITH A PXL161507 AND A PXC141000. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE AS THE ANEURYSM HAD RUPTURED. THE RUPTURE WAS CAUSED BY A TYPE 1A ENDOLEAK ON THE RLT281414 LEADING TO SIGNIFICANT ANEURYSM GROWTH, HOWEVER EXACT GROWTH AMOUNT PRIOR TO THE RUPTURE IS UNKNOWN. THE TYPE 1A ENDOLEAK WAS CAUSED BY THE RLT281414 MIGRATING ABOUT 15-20 MM DISTALLY FROM ITS INITIAL INTENDED LOCATION (BELOW LEFT RENAL ARTERY). A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA280005) WAS IMPLANTED PROXIMALLY TO SEAL THE ENDOLEAK. ADDITIONALLY, IT WAS REPORTED THAT THE RLT281414 IPSILATERAL LEG IN THE RIGHT ILIAC ARTERY APPEARED TO BE CLOSE TO MIGRATING INTO THE ANEURYSM SAC, AS THE IPSILATERAL LEG HAD MIGRATED PROXIMALLY GREATER THAN 10 MM FROM THE INITIAL INTENDED LOCATION. AS THERE WAS MINIMAL SEAL REMAINING IN THE RIGHT ILIAC, A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC161000) WAS PLACED TO EXTEND THE RIGHT ILIAC LIMB. IT IS UNKNOWN IF THERE WAS ANEURYSM GROWTH DUE TO THE PROX

  Patient problems: Aneurysm expansion; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 23645574 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG) AND THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (AORTIC EXTENDER) IN ZONE 9 DUE TO ANEURYSM ENLARGEMENT. THE ANEURYSM GREW TO ABOUT 2.5 CM. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE ENLARGEMENT IS DISEASE PROGRESSION.

  Patient problems: Aneurysm expansion

  MAUDE report 22071813 ↗
• MalfunctionMay 9, 2025Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PRODUCT HANDLE COULD NOT BE TURNED, COULD NOT DEPLOY DEVICE. IT WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED OF THE EVENT AND REQUEST FOR DEVICE PICKUP FOR AN EVALUATION. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE CUSTOMER THAT THE DEVICE IS LOST AT THE FACILITY AND POSSIBLY DISCARDED. ADDITIONAL INFORMATION IS NOT AVAILABLE ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997749 ↗
• InjuryMar 28, 2025Positioning Problem; Positioning Problem

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RIGHT ILIAC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED, THE PHYSICIAN FOUND IT DIFFICULT TO CANNULATE THE CONTRALATERAL GATE WITH A GUIDEWIRE DUE TO TORTUOSITY, AND ATTEMPTS WERE NOT SUCCESSFUL. THEREFORE, THE PROCEDURE WAS CHANGED TO AN AORTO-UNI-ILIAC (AUI). THE MAIN BODY DEVICE WAS ADVANCED THROUGH THE RIGHT SIDE AND THE LEFT COMMON ILIAC ARTERY WAS OCCLUDED, AND A FEMORAL-FEMORAL BYPASS WAS CREATED. IT WAS ALSO REPORTED THE MAIN BODY COMPONENT WAS ROTATED MULTIPLE TIMES WHEN ATTEMPTING TO CANNULATE THE GATE, THUS LEADING TO DIFFICULTY IN REMOVING THE CONSTRAINING MECHANISM AND LOCK WIRE. AS THE CLEAR HOUSING COULD NOT BE REMOVED, PHYSICIAN WAS ABLE TO OPEN THE HATCH AND RELEASE WIRES 2, 3, AND 4 MANUALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721106 ↗
• InjuryDec 1, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2019, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6)2024, A TYPE 1B ENDOLEAK WAS OBSERVED. IN ADDITION, A POSSIBLE TYPE IA ENDOLEAK WAS ALSO OBSERVED. THE PHYSICIAN IS PLANNING TO PERFORM A REINTERVENTION SURGERY, BUT A DATE HAS NOT BEEN SCHEDULED YET. IT IS UNKNOWN IF THERE WAS ANY ANEURYSM ENLARGEMENT.

  Patient problems: Clinical Endoleak

  MAUDE report 20814863 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281414 AND PLC181200) WERE IMPLANTED TO TREAT AN ABDOMINAL ANEURYSM ON (B)(6) 2016. THE CT SCAN BEFORE IMPLANTATION ON (B)(6) 2015, ALREADY SHOWED A SLIGHT ANEURYSMAL WIDENING OF THE AORTA AT THE LEVEL OF THE ORIGIN OF THE LEFT RENAL ARTERY. A LEAK THAT WAS ASSESSED AS TYPE 2 AND WAS MAINTAINED VIA THE INFERIOR MESENTERIC AND/OR LUMBAR ARTERIES WAS ALREADY PRESENT IN THE CT SCAN IMMEDIATELY AFTER IMPLANTATION. DUE TO PROGRESSION OF THE ANEURYSM DIAMETER, THE LEAK WAS EMBOLIZED ON (B)(6) 2018. THE ANEURYSM SAC CONTINUED TO GROW. AN INCIPIENT ENDOLEAK TYPE 1A, WHICH ORIGINATES FROM THE LARGE CALIBER ORIGIN OF THE LEFT RENAL ARTERY, CAN BE SUSPECTED RETROSPECTIVELY AS EARLY AS THE CHECK ON (B)(6) 2018. ON (B)(6) 2023, ANOTHER TYPE 2 ENDOLEAK WAS EMBOLIZED, HOWEVER, THE DIAMETER OF THE ANEURYSM SAC CONTINUED TO INCREASE. DURING THE LAST CHECKS ON (B)(6) 2024 AND (B)(6) 2024, THE FINDINGS OF THE ENDOLEAKS ARE CONFIRMED. THE DEVICE HAS NOT MIGRATED. THE EXTENSIVE TYPE 1 ENDOLEAK AT THE PROXIMAL ANCHOR WAS TREATED WITH MULTIPLE POST-DILATATION WITH A FLEXIBLE BALLOON. IMPROVEMENT IS SEEN BUT THE MAIN BODY IS PARTIALLY N

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20520347 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281414) WAS IMPLANTED IN A PATIENT FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER A SUCCESSFUL DEVICE DEPLOYMENT, UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS DISCOVERED THAT THE OLIVE TIP BECAME DISCONNECTED FROM THE CATHETER AND COULD SLIDE FREELY ON THE LUNDERQUIST® EXTRA-STIFF WIRE GUIDE. THE PATIENT IS DOING WELL AND WAS NOT AFFECTED BY THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504681 ↗
• InjuryAug 23, 2024Obstruction of Flow; Activation, Positioning or Separation Problem; Migration; Obstruction of Flow; Activation, Positioning or Separation Problem; Migration

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT IT WAS A NORMAL ENDOVASCULAR ACCESS TO PREPARE FOR A DELIVERY OF THE MAIN BODY TO THE LOWER RENAL ARTERY VIA AN 18FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE RLT281414/27042944 DEVICE WAS DELIVERED FOLLOWED BY AN ANGIO RUN. THE PHYSICIAN DECIDED THAT THE DEVICE WAS POSITIONED SLIGHTLY HIGH; SO, IT WAS RECONSTRAINED AND MOVED A FEW MM LOWER, AND REOPENED UNTIL A HARD STOP WAS REACHED. THE ANGIO RUN CONFIRMED THAT THE DEVICE WAS BELOW THE LOWER RENAL ARTERY. THEN, THE DEVICE WAS CANNULATED VIA NORMAL TECHNIQUE, CONFIRMED CANNULATION, CONFIRMED POSITION BELOW RENAL ARTERY AGAIN, AND THEN CONFIRMED LENGTH OF CONTRALATERAL LEG DEVICE. REPORTEDLY, CONTRALATERAL LEG ENDOPROSTHESES WERE DELIVERED VIA THE SHEATH TAKEN UP INTO THE GATE. THEN, THE PHYSICIAN COMPLETED THE IPSILATERAL EXTENSION BEFORE PROCEEDING TO BALLOON THE PROXIMAL NECK AND ALL OVERLAPS AND DISTAL SEAL ZONE. THE COMPLETION RUN SHOWED THAT THERE WAS NO ENDOLEAK, HOWEVER THE DEVICE WAS COVERING BOTH RENAL ARTERIES AND HAD PROXIMALLY MIGRATED 15MM. IT WAS REPORTED T

  Patient problems: Reduced Blood Flow

  MAUDE report 20047148 ↗
• InjuryAug 21, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED USING COMPUTED TOMOGRAPHY (CTA) ANGIOGRAPHY WAS 56 MM. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED USING CTA ANGIOGRAPHY WAS 56.6 MM. ON (B)(6) 2020, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED USING CTA ANGIOGRAPHY WAS 73 MM. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK CAUSED BY FURTHER DILATION OF THE AORTA PROXIMAL TO THE TRUNK IPSILATERAL LEG. THE PATIENT WAS TREATED WITH EXTENSION OF THE ORIGINALLY IMPLANTED DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 20012942 ↗
• InjuryAug 13, 2024Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND ENDOVASCULAR ILIAC ANEURYSM REPAIR (IBE) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, TWO CONTRALATERAL LEGS, AND ILIAC EXTENDER) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT). ON (B)(6) 2024, THE PATIENT CAME IN TO EMERGENCY ROOM WITH ABDOMINAL PAIN AND CT SCANS WERE DONE THAT SHOWED THE TRUNK IPSILATERAL GRAFT HAD MIGRATED DISTALLY BY 9CM FROM THE RENAL ARTERIES INTO THE ANEURYSM SAC (UNKNOWN SIZE). THERE IS A BIG TYPE 1A ENDOLEAK AND THE GRAFT HAD FLIPPED OVER WHILE PULLING THE WHOLE GRAFT DOWN INTO THE AORTA AND ANEURYSM SAC. PHYSICIAN BELIEVES THAT ITS DUE TO DISEASE PROGRESSION AT THE PROXIMAL SEAL ZONE THAT LED TO THE MIGRATION OF THE GRAFT. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION IN ZONE 9 INFRARENAL WITH REALIGNMENT OF THE ORIGINAL MAIN BODY GRAFT WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND TWO CONTRALATERAL LEGS). PROCEDURE ENDED SUCCESSFULLY.

  Patient problems: Abdominal Pain; Aneurysm expansion; Clinical Endoleak

  MAUDE report 19971797 ↗
• InjuryMay 16, 2024Adverse 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 THAT A REINTERVENTION WILL BE PERFORMED ON (B)(6) 2024, ADDITIONAL DEVICES WILL BE IMPLANTED. REPORTEDLY, THE REINTERVENTION WAS CANCELLED DUE TO PATIENT¿S CURRENT HEALTH STATUS. THE REASON FOR THE REINTERVENTION IS LOSS OF SEAL PROXIMALLY OF THE IMPLANTED TRUNK-IPSILATERAL LEG ENDOPROSTHESIS AND ON THE DISTAL END OF THE IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS. THE ROOT CAUSE OF THE LOSS OF SEAL IS UNKNOWN. THERE IS NO ANEURYSM SAC ENLARGEMENT. THE EVENT IS ONGOING.

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

  MAUDE report 19330985 ↗
• InjuryMay 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND THREE CONTRALATERAL LEGS). ON (B)(6) 2024, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE NURSE (RN) THAT THE PATIENT HAS A SUSPECTED TYPE 2 ENDOLEAK. AN ANGIOGRAM WILL BE DONE NEXT WEEK TO TRY AND DETERMINE WHAT TYPE OF LEAK IT IS. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ANGIOGRAM TO DETERMINE THE TYPE OF ENDOLEAK, PHYSICIAN SUSPECTED IT TO BE A TYPE 1A OR 2 ENDOLEAK BUT THEY WERE UNABLE TO CONFIRM. THERE WAS ALSO ANEURYSM GROWTH OF 7.9CM. DURING THE SAME DAY, AS THEY WERE UNABLE TO CONFIRM EITHER TYPE 1A OR 2 ENDOLEAK, PHYSICIAN DID A REINTERVENTION BY EXTENDING PROXIMALLY FROM THE TRUNK IPSILATERAL LEG C3 WITH A GORE® EXCLUDER®AAA ENDOPROSTHESIS (AORTIC EXTENDER) WHICH RESOLVED THE SUSPECTED TYPE 1A ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19251822 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  ON (B)(6) 2016, IT WAS REPORTED THAT A PATIENT PRESENTED WITH A ABDOMINAL AORTIC ANEURYSM (MEASURED 53 MM) WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT UNDERWENT A SERIES OF FOLLOW-UP CONTROLS WITHOUT ANY SIGNIFICANT ANEURYSM GROWTH. ON (B)(6) 2018, THE PATIENT'S ANEURYSM WAS MEASURED 59 MM DUE TO A TYPE II ENDOLEAK AND UNDERWENT EMBOLIZATION ON (B)(6) 2018. A SLOW BUT CONTINUES GROWTH WAS STILL OBSERVED AND ON (B)(6) 2023, THE SIZE INCREASED TO 76 MM. EMBOLIZATION WAS PERFORMED AGAIN ON (B)(6) 2023. NO FURTHER SAC ENLARGEMENT WAS DETECTED DURING THE FOLLOW-UPS (THE LAST ONE DOCUMENTED ON (B)(6) 2024).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18910639 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON 9-JAN-2024, THE PHYSICIAN NOTED A INCREASE IN THE SIZE OF THE ANEURYSMAL SAC. HE BELIEVED IT WAS DUE TO A TYPE II ENDOLEAK, AND EXPLANTED ALL OF THE DEVICES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18640099 ↗
• InjuryDec 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). ON DECEMBER 01, 2023, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT HE PLANS TO DO AN ANGIOGRAM ON (B)(6) 2023, AS THE PHYSICIAN SUSPECTS THERE MIGHT BE AN ENDOLEAK BUT NOT SURE WHICH TYPE AND A POSSIBLE REINTERVENTION WILL BE DONE THE SAME DAY, IF ENDOLEAK IS PRESENT. ON (B)(6) 2023, DURING THE FOLLOW UP ANGIOGRAM, A TYPE 2 ENDOLEAK WAS FOUND AND PHYSICIAN TREATED WITH COIL EMBOLIZATION IN THE LUMBAR ARTERY AND THAT SHOULD RESOLVE THE ENDOLEAK AS THE LUMBAR ARTERY WAS FEEDING THE ANEURYSM SAC THAT LED TO THE TYPE 2 ENDOLEAK AND SIZE OF THE ANEURYSM GROWTH IS UNKNOWN. PHYSICIAN DID NOT IMPLANT ANY NEW DEVICES. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18376594 ↗
• InjuryAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 58MM 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) 2015, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 64.7MM. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 71 MM AND THE PRESENCE OF A TYPE II ENDOLEAK. THE CSD INDICATES THE RELATIONSHIP IS RELATED TO THE AORTIC DEVICE OR PROCEDURE. ADDITIONAL TREATMENT IS REQUIRED THE DATE AND TYPE OF TREATMENT IS NOT INDICATED OR PROVIDED. THE PATIENT IS SCHEDULED FOR AN ANGIOGRAM ON (B)(6) 2013.

  Patient problems: Aneurysm expansion

  MAUDE report 17643918 ↗
• InjuryDec 22, 2022Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE BY CLINICAL SPECIALIST. ON (B)(6) 2015, PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING TWO GORE EXCLUDERS RLT281414 (RIGHT) AND PXC121200 (LEFT). PRIOR TO THE IMPLANT IN 2015, PATIENT SUFFERED FROM RIGHT LOWER EXTREMITY ISCHEMIA DUE TO EMBOLIZATION FROM ABDOMINAL AORTIC ANEURYSM. PATIENT ALSO DIAGNOSED WITH LUNG CANCER THAT RADIOLOGY/ONCOLOGY REFUSED TO TREAT UNTIL ANEURYSM WAS ADDRESSED. ACCORDING TO THE PHYSICIAN, THE AORTIC ANATOMY WAS NOT IDEAL FOR ENDOVASCULAR REPAIR BUT WAS LIKELY PATIENT¿S BEST OPTION CONSIDERING COMORBIDITIES AND URGENCY TO BEGIN CANCER TREATMENT. PATIENT HAD SHORT, REVERSE TAPERED NECK WITH THE AORTIC DIAMETER AT THE RENALS WAS 18MM AND QUICKLY DILATED TO ~30MM OVER 12MM LENGTH. DURING A FOLLOW-UP SOMETIME IN (B)(6) 2022 (DATE UNKNOWN), THE PATIENT PRESENTED WITH GRAFT MIGRATION / DISEASE PROGRESSION PROXIMAL EDGE OF THE GRAFT MIGRATED DOWN (DISTALLY) AT THE LEVEL OF THE RENALS AND DID NOT COVER THE RENALS. AORTIC DIAMETER AT RENALS HAD GROWN TO 4-5CM. THE ORIGINAL GRAFT MIGRATED ~3CM. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH OPEN REPAIR; GRAFT EXPLANT WAS PERFORMED. PROCEDURE WAS SUCCESSFUL WITH NO HARM TO THE PATI

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040279 ↗
• InjurySep 17, 2022Material Invagination; Material Deformation; Material Invagination; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT WAS TREATED WITH AN GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, THE PATIENT PRESENTED WITH BACK PAIN AND NO PULSE OR FEELING IN THE LEGS. THE PATIENT RECEIVED A CT SCAN WHICH SHOWED THAT THE ENDOGRAFT WAS OCCLUDED AND HAD COLLAPSES IN THE AORTIC NECK. THE PHYSICIAN CANALIZED THE OCCLUDED STENT GRAFT AND THEN DILATED WITH A GORE® MOLDING AND OCCLUSION BALLOON. THE PHYSICIAN ALSO REMOVED THROMBUS. THE PATIENT TOLERATED THE REINTERVENTION BUT IS STILL PRESENTING WITH NEUROLOGICAL SYMPTOMS IN THE LEGS.

  Patient problems: Diminished Pulse Pressure; Numbness; Obstruction/Occlusion

  MAUDE report 15442961 ↗
• InjuryAug 26, 2022Migration; Migration or Expulsion of Device; Migration

  ON (B)(6) 2015 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 55 (MM) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015 FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 55MM. ON (B)(6) 2022 FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 55MM. ON (B)(6) 2022 FOLLOW-UP IMAGING DETERMINED SIGNIFICANT (APPROXIMATELY 5CM) MIGRATION OF THE ENDOGRAFT AND A PROXIMAL TYPE 1 ENDOLEAK; AND A LARGE NECK FROM THE MOST POSTERIOR RIGHT RENAL ARTERY (RRA) DOWN TO THE BEGINNING OF THE TRUNK IPSILATERAL COMPONENT. SIGNIFICANT TORTUOSITY IS NOTED THROUGHOUT THE AORTOILIAC SYSTEM. THE LEFT RENAL ARTERY (LRA) IS PATENT. HOWEVER; STENOSIS OF AROUND 50% AT THE ORIGIN IS SEEN AND THE RIGHT POSTERIOR RENAL ARTERY IS SEVERELY DISEASED. ON (B)(6) 2022 THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF THE PROXIMAL TYPE I ENDOLEAK CAUSED BY APPROXIMATELY 5CM PROXIMAL MIGRATION OF THE MAIN BODY OF THE TRUNK COMPONENT. A ¿CHIMNEY¿ PROCEDURE WAS PERFORMED UTILIZ

  Patient problems: Aneurysm; Clinical Endoleak; Stenosis

  MAUDE report 15303511 ↗
• MalfunctionJul 19, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, DURING THE PROCEDURE A GORE® EXCLUDER® AAA ENDOPROSTHESIS, TRUNK IPSILATERAL LEG COMPONENT (RLT281414) WAS USED WITH A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AS REPORTED, THERE WAS AN ATTEMPT TO PUSH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS THROUGH THE SHEATH BUT ¿THE ANCHORING PIN THAT HOLDS THE RESHAPING MECHANISM BECAME DISLODGED FROM THE WHITE NOSECONE AND PIERCED THE VALVE OF THE SHEATH¿. AS REPORTED, THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE SAME PROTRUSION THAT HAD PUNCTURED THE VALVE WAS EXTENDED OUT FROM THE TIP OF THE CATHETER. AN IMAGE OF THE PROTRUSION WAS PROVIDED FOR CONSIDERATION. AS REPORTED, AN ALTERNATE GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060649 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE HOSPITAL WITH A STABLE RUPTURED ABDOMINAL AORTIC ANEURYSM. ON COMPUTED TOMOGRAPHY, CONTRAST WAS SEEN IN THE ANEURYSM SAC AND IN THE RIGHT ILIAC ARTERY. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE HAD AN UNDIAGNOSED ENDOLEAK. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED WHEREBY A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS (PLA320400) WAS PLACED PROXIMALLY, AND A GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS (PLC201200) WAS PLACED IN THE RIGHT ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 14290580 ↗
• MalfunctionMay 4, 2022Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281414) WAS INTENDED TO BE USED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE DEVICE WAS INTRODUCED IN THE AORTA AND PLACED UNDER THE RENAL ARTERIES. UPON INITIAL THE DEPLOYMENT, RESISTANCE WAS EXPERIENCED WHEN PULLING THE HANDLE. THE DEPLOYMENT LINE WAS NOT VISIBLE AND THE PHYSICIAN BELIEVED THAT THE DEPLOYMENT LINE BROKE INSIDE THE CATHETER VERY SHORTLY AFTER THE HANDLE. THE PHYSICIAN TRIED TO UNFOLD THE PROSTHESIS VIA THE BACKUP DEPLOYMENT MECHANISM, HOWEVER, IT WAS NOT POSSIBLE TO PULL THE FIRST DEPLOYMENT LINE FURTHER. THE DEVICE WAS REMOVED THROUGH THE SHEATH STILL UNDEPLOYED AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT281412E) WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278143 ↗
• InjuryMar 23, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018, AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, A TYPE II ENDOLEAK WAS DETECTED, NO INTERVENTION WAS DEEMED NECESSARY. ON (B)(6) 2019, ANEURYSM SAC GROWTH WAS OBSERVED AND WAS TREATED WITH EMBOLIZATION OF ONE LUMBAR ARTERY ON (B)(6) 2019. AFTER THE EMBOLIZATION, CT SCAN INDICATED THAT THERE WAS NO LEAK AND AN EMBOLIZATION OF THE SECOND LUMBAR ARTERY WAS NOT CARRIED OUT. THIS EVENT WAS REPORTED PREVIOUSLY WITH MANUFACTURER¿S REFERENCE NUMBER (B)(4). FURTHER GROWTH OF THE ANEURYSM SAC WAS OBSERVED ON (B)(6) 2022. EMBOLIZATION OF THE SECOND LUMBAR ARTERY WAS SUCCESSFULLY CARRIED OUT ON (B)(6) 2022.

  Patient problems: Aneurysm

  MAUDE report 13862706 ↗
• InjuryMar 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM ON MARCH 14, 2018, AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, A TYPE II ENDOLEAK WAS DETECTED. ON (B)(6) 2019, ANEURYSM SAC GROWTH WAS OBSERVED AND WAS TREATED WITH EMBOLIZATION OF ONE LUMBAR ARTERY ON (B)(6) 2019. AFTER THE EMBOLIZATION, CT SCAN INDICATED THAT THERE WAS NO LEAK AND AN EMBOLIZATION OF THE SECOND LUMBAR ARTERY WAS NOT CARRIED OUT.

  Patient problems: Aneurysm

  MAUDE report 13693149 ↗

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)