GORE EXCLUDER AAA Endoprosthesis PLC121000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00733132618613), received between Nov 7, 2018 and Jun 9, 2026 — classified as 2 deaths, 26 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED SLIGHT ANEURYSM SAC ENLARGEMENT WITH A PERSISTENT TYPE II ENDOLEAK RELATED TO THE L3/L4 LUMBAR ARTERIES. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION FOR THE TYPE II ENDOLEAK AND ENDOANCHORS WERE PLACED. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25447367 ↗
• InjuryJun 5, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS IN CONJUNCTION WITH GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE PROCEDURE WAS INITIALLY PLANNED AS A UNILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE) APPROACH; HOWEVER, DUE TO TORTUOUS ILIAC ANATOMY, THIS APPROACH WAS DETERMINED TO BE NOT FEASIBLE. DURING VASCULAR ACCESS PREPARATION USING PROGLIDE, AND PRIOR TO INITIATION OF THE INTENDED ENDOVASCULAR REPAIR, A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED. AS THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECREASE, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS DEPLOYED ACROSS THE RIGHT EXTERNAL ILIAC ARTERY TO CONTROL BLEEDING. FOLLOWING HEMODYNAMIC STABILIZATION, THE TREATING TEAM ELECTED TO ABANDON THE IBE APPROACH DUE TO INCREASING PROCEDURAL COMPLEXITY AND DURATION AND PROCEEDED WITH A STANDARD AAA EVAR, WHICH INCLUDED COIL EMBOLIZATION AND COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY. FINAL INTRAOPERATIVE IMAGING DEMONSTRATED SATISFACTORY RESULTS, AND THE PATIENT WAS TRANSFERRED TO RECO

  Patient problems: Clinical Endoleak

  MAUDE report 25414745 ↗
• InjuryApr 21, 2026Complete Blockage

  ON (B)(6), 2023, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF A INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 7CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2025, FOLLOW-UP ULTRASOUND DETERMINED RIGHT LIMB DEVICE OCCLUSION WITH NO VISUALIZED ENDOLEAK. ON (B)(6), 2026, REVIEW OF THE PATIENT¿S FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2026, SHOWED A DECREASE IN DIAMETER OF THE AAA AND AN OCCLUSION OF THE RIGHT ILIAC ARTERY DEVICE. ON (B)(6), 2026, THE PATIENT UNDERWENT EXPLANT OF ALL GORE DEVICES AND PLACEMENT OF A DACRON GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24947723 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD HIGHLY CALCIFIED AORTA AND TORTUOUS ANATOMY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT HAD NO PEDAL PULSE ON THE RIGHT LEG. THE PHYSICIAN REINTERVENED AND PERFORMED A FEMORAL-FEMORAL (FEM-FEM) BYPASS AND A FEMORAL-POPLITEAL (FEM-POP) BYPASS. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. IT IS UNKNOWN WHAT OCCLUDED THE DEVICE. THE DEVICE WAS NOT COMPRESSED OR KINKED. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE USE OF THE GORE DEVICE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 24307337 ↗
• InjuryJan 7, 2026Device Endoleak

  ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES (RLT261412, PLL161407, PLL161207, AND PLC121000). ON AN UNKNOWN DATE IN (B)(6) 2025, A TYPE 1B ENDOLEAK WAS OBSERVED IN THE PATIENT'S LEFT ILIAC ARTERY THROUGH IMAGING AND A REINTERVENTION WAS PLANNED. IT IS UNKNOWN WHETHER THE ENDOLEAK WAS ASSOCIATED WITH THE PLL161407, PLL161207, OR PLC121000. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. THE ENDOLEAK LED TO ANEURYSM ENLARGEMENT; HOWEVER, GROWTH AMOUNT IS UNKNOWN. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE TYPE 1B ENDOLEAK UTILIZING A PLL161007. THE PATIENT'S LEFT HYPOGASTRIC ARTERY WAS EMBOLIZED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23994742 ↗
• MalfunctionDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 54 MM, WITH A MAXIMUM PROXIMAL LANDING ZONE DIAMETER OF 24 MM. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). REVIEW BY GORE IMAGING SERVICES (GIS) REPORTS DEVICE COMPRESSION OF THE CONTRALATERAL LIMB FOR THE LEFT COMMON ILIAC ARTERY IS COMPRESSED APPROXIMATELY IN THE MIDDLE OF THE DEVICE NEAR THE AORTIC BIFURCATION. REVIEW OF THE CTA BY THE SITE REPORTS NO ENDOLEAK WITH A DEVICE INTEGRITY ISSUE (LEFT ILIAC LIMB WITH MILD COMPRESSION WITHOUT FLOW LIMITING STENOSIS). THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURES 53 MM. THE SITE ADDITIONALLY REPORTS ALL DEVICES ARE REPORTED TO BE PATENT. THERE ARE NO SCHEDULED PROCEDURES PLANNED FOR THE PATIENT AT THIS TIME; THE EVENT IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936443 ↗
• InjuryNov 16, 2025Device Stenosis; Device Stenosis

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

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23565431 ↗
• InjuryOct 29, 2025Microbial Contamination of Device; Patient Device Interaction Problem; Microbial Contamination of Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE ON (B)(6) 2025, FROM THE IMEDIDATA STUDY DATABASE AND IMAGING EMAIL: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND GORE®EXCLUDER®AAA ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS.THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED INFECTION RELATED TO GORE®EXCLUDER® DEVICES. REPORTEDLY, SALMONELLA SPECIES WAS THE ISOLATED MICROORGANISM IN ALL HIS MICROBIOLOGIC SPECIMENS. THE PATIENT HAD A MEDICATION TREATMENT USING CEFTRIAXONE 2G DAILY. ADDITIONALLY, THE PATIENT HAD IV BLOOD TEST AND A CTA. THE SCAN REVEALED THE INCREASING INFLAMMATORY CHANGES AROUND THE AORTIC STENTS. ALL THREE DEVICES WERE INFECTED. REPAIR WITH A SMALL ABSCESS COLLECTION FORMING WITHIN THIS. ON (B)(6) 2025, ALL DEVICES WERE EXPLANTED AND RIGHT AXILLARY BIFEMORAL GRAFT (OPEN SURGERY) WAS USED. NO NEW GORE DEVICES WERE IMPLANTED. THE PATIENT COMPLETED THE STUDY. THE PATIENT WAS DISCHARGED FROM THE CRITICAL CARE ON (B)(6) 2025 AND IS STABLE, RECOVERING ON

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 23420814 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 1, 2025, FROM THE MEDIDATA STUDY DATABASE AND IMAGING EMAIL: ON (B)(6) 2025, THIS 62-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (NO ILIAC INVOLVEMENT). THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK ¿ IPSILATERAL LEG DEVICE) IN THE INFRARENAL ABDOMINAL AORTA, A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG DEVICE) IN THE LEFT COMMON ILIAC ARTERY, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER DEVICE) IN THE RIGHT COMMON ILIAC ARTERY. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE LEFT AND RIGHT. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD A CTA THAT SHOWED A NEW FOCAL DISSECTION IN THE LEFT COMMON ILIAC ARTERY ADJACENT TO THE DISTAL END OF THE CONTRALATERAL LIMB. THIS WAS NOT PREVIOUSLY OBSERVED BEFORE THE DEVICE IMPLANTATION. EXTRACRANIAL DOPPLER EVALUATION

  Patient problems: Vascular Dissection

  MAUDE report 22736167 ↗
• InjuryAug 6, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AT (B)(6) USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM (EXCC), WITH GORE®EXCLUDER®AAA ENDOPROSTHESIS LEGS. THE EXCC TRUNK DEVICE (CXT361414) WAS PLACED SUCCESSFULLY THROUGH RIGHT FEMORAL ACCESS. AFTER PARTIAL DEPLOYMENT OF THE CXT, THE PHYSICIAN HAD DIFFICULTY CANNULATING THE CONTRALATERAL GATE. HE DECIDED TO FULLY DEPLOY THE MAIN DEVICE AND THEN SNARE THE WIRE FROM THE LEFT SIDE BY COMING UP AND OVER THE AORTIC BIFURCATION FROM THE RIGHT SIDE. AFTER DEPLOYING THE MAIN DEVICE COMPLETELY AND WHILE PASSING THE WIRE FROM THE LEFT, THE PHYSICIAN APPEARED TO CANNULATE THE CONTRALATERAL GATE AND CONFIRMED ACCESS BY SPINNING THE PIGTAIL CATHETER IN THE PROXIMAL PORTION OF THE CXT. THEREFORE, THE PHYSICIAN BELIEVED THE SNARE TECHNIQUE (UP AND OVER) WAS NO LONGER NECESSARY. THE CONTRALATERAL LIMB (PLC121200) WAS PLACED ON THE LEFT SIDE. AFTER DEPLOYMENT OF THE CONTRALATERAL LIMB THE IPSILATERAL LIMB EXTENSION (PLC121000) WAS PLACED ON THE RIGHT SIDE, EXTENDING THE CXT. THE COMPLETION ANGIOGRAM LOOKED GOOD BUT REDUCED FLOW WAS NOTED. AFTER SEVERAL ANGIOGRAMS, IT WAS DETER

  Patient problems: Reduced Blood Flow

  MAUDE report 22727503 ↗
• DeathApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE 9 ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT321414) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLL161207, PLL161007, AND PLC121000). DURING THE PROCEDURE, ALL DEVICES WERE IMPLANTED WITH NO ISSUES. SOON AFTER THE PATIENT'S BLOOD PRESSURE SEEMED TO DROP, BILATERAL ILIAC RUPTURE WAS OBSERVED, AND PATIENT EXPIRED. IT WAS ALSO REPORTED PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. PHYSICIAN ALSO REPORTED PATIENT HAD A VERY THIN ARTERY. NO FURTHER PATIENT OR CASE INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 21877357 ↗
• MalfunctionJan 9, 2025Break; Activation Problem; Break; Activation Problem

  ON (B)(6) 2024, THIS PATIENT REPORTEDLY UNDERWENT AN EMERGENCY ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC121000 DEPLOYED INCOMPLETELY WITH 3 CM OF THE GRAFT REMAINING CLOSED AT ITS DISTAL END. TO OVERCOME THE RESISTANCE NOW FELT, THE PHYSICIAN PULLED THE LINE WITH FORCE WHICH RESULTED IN THE DEPLOYMENT LINE BREAKING. IN AN ATTEMPT TO SOLVE THE SITUATION, THE PHYSICIAN MANAGED TO REACH BEYOND THE FLOW DIVIDER OF THE GORE® EXCLUDER® IPSILATERAL LEG COMPONENT AND OPENED THE SLEEVE OF THE PLC121000 COMPONENT USING A BALLOON. SUBSEQUENTLY, THE PROCEDURE WAS CONCLUDED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117856 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2024, THE PATIENT WAS BEING TREATED FOR A LARGE SYMPTOMATIC LEFT COMMON ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT DURING ACCESS THE PHYSICIAN WAS HAVING ISSUES WITH THE WIRE BECOMING COILED. DURING THIS TIME THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) HAD NOTED THAT THE PATIENTS BLOOD PRESSURE WAS LOW. REPORTEDLY THE BLOOD PRESSURE WAS LOW DURING ACCESS. REPORTEDLY, THE PHYSICIAN OBTAINED BILATERAL (LEFT AND RIGHT) COMMON FEMORAL ARTERY (CFA) ACCESS AND PLACED A MEDTRONIC MVP 9Q INTO THE LEFT INTERNAL ILIAC ARTERY VIA THE RIGHT CFA ACCESS. NEXT, HE PLACED AN AMPLATZ WIRE INTO THE AORTA VIA THE LEFT CFA ACCESS WITH A 5FR 65CM GLIDECATH. THIS WIRE AND CATHETER BECAME COILED IN THE 4.6CM COMMON ILIAC ARTERY. IT HAD BEEN DETERMINED THAT THE LEFT COMMON ILIAC ANEURYSM HAD RUPTURED. THE PHYSICIAN INSERTED AN OCCLUSION BALLOON IN THE DISTAL AORTA THROUGH THE RIGHT CFA ACCESS. THE PATIENT DID NOT STABILIZE, AND BLOOD WAS ORDERED. A GORE® DRYSEAL SHEATH WAS ADVANCED AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE WAS IMPLANTED BUT WAS NOT LONG ENOUGH TO COVER THE RUPTURED LEFT COMMON ILIAC ARTERY. WIRE ACCESS WAS LO

  Patient problems: Ruptured Aneurysm

  MAUDE report 20856702 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® MOLDING AND OCCLUSION BALLOON CATHETER (MOB) IN ZONE 9. IT WAS REPORTED THAT THE PATIENT HAD CALCIFIED ILIACS, ESPECIALLY ON THE LEFT SIDE. AFTER PLACING THE TRUNK IPSILATERAL COMPONENT (RLT311413) UP THE RIGHT SIDE AND THE CONTRALATERAL LEG COMPONENT (PLC121000) UP LEFT, THE PHYSICIAN BALLOONED WITH A MOB37 AT THE PROXIMAL NECK AND THEN AT THE LEFT COMMON ILIAC. THE STENT ENDED RIGHT ABOVE THE ILIAC BIFURCATION. THE PROXIMAL COMMON WAS STENOTIC. IT APPEARS THE MOB INFLATION TORE THE ILIAC BIFURCATION. THE STENTS WERE UNDAMAGED. SHORTLY AFTER BALLOONING, THE PATIENT'S PRESSURE AND HEART RATE DROPPED. THEY DID COMPRESSIONS AND TRANSFUSIONS ALONG WITH EPINEPHRINE. THEY PLACED AN 1159 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS BUT IT WASN'T PLACED HIGH ENOUGH. THE PHYSICIAN PLACED AN ILIAC EXTENDER (PLL16207) AND BALLOONED WITH A MOB37. THIS SEALED THE LEAK. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN BELIEVES BALLOONING AGGRESSIVELY CAUSED THE REPORTE

  Patient problems: Rupture

  MAUDE report 20831485 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR OF A 54MM ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PATIENT HAS EXTENSIVE VASCULAR DISEASE WITH PRIOR STENTING OF BOTH COMMON ILIAC ARTERIES, LEFT EXTERNAL ILIAC ARTERY, AND SUPERIOR MESENTERIC ARTERY (SMA). BOTH INTERNAL ILIACS HAVE KNOWN OCCLUSIONS AND THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) HAS STENOSIS AS WELL. THE PATIENT COMPLAINED OF LEFT LEG CLAUDICATION. ON (B)(6) 2024, A CTA WAS PERFORMED, WHICH REVEALED A NEAR OCCLUSION OF THE LEFT COMMON FEMORAL ARTERY AT THE ACCESS SITE OF THE EVAR. THE VESSEL HAD BEEN CLOSED WITH A PERCLOSE DEVICE AND AN ANGIOSEAL PLUG DURING PROCEDURE FROM (B)(6) 2024. THE POOR OUTFLOW THIS CREATED APPEARS TO BE CREATING THROMBUS THROUGH THE LEFT SIDED GORE EXCLUDER CONTRALATERAL LEG. IT IS STILL PATENT, BUT THE FLOW LUMEN THROUGH THE LIMB IS ABOUT 5 MM. AS FOR NOW, THE PHYSICIANS ARE GOING TO CONTACT THE PATIENT TO PLAN INTERVENTION ON THE ACCESS SITE OCCLUSION. CONSIDERATION IS BEING GIVEN TO RELINE THE LEFT LIMB AS WELL. ON (B)(6) 2024 THE PATIENT UNDERWENT SURGICAL REINTERVENTION TO REPA

  Patient problems: Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 19927759 ↗
• InjuryMay 1, 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) 2024, 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 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BOTH THE LEFT CONTRALATERAL LEG ENDOPROSTHESES CLOTTED/OCCLUDED WITH THROMBUS. THE DISTAL END OF ONE OF THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC121000/(B)(6) WAS KINKED AT THE DISTAL END OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO DECLOT FROM THE FLOW DIVIDER TO THE LOWEST SECTION OF THE IMPLANTED DEVICES. IT WAS UNSUCCESSFUL, A FEMOROFEMORAL BYPASS WAS PERFORMED TO RESTORE BLOOD FLOW. THERE WAS NO REINTERVENTION TO CORRECT THE KINKED DEVICE, THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 19219882 ↗
• InjuryMar 4, 2024Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2024, THE PATIENT HAD THROMBUS. BOTH OF THEIR EXTERNAL ILIACS THROMBOSED AND A CLOT WENT NORTH. THEIR SYSTEM WAS OCCLUDED. THE PHYSICIAN HAS NOT RE-INTERVENED; HOWEVER, THEY ARE PLANNING NEXT STEPS. THEY WILL POSSIBLY PERFORM AN AXILLA-FEMORAL BYPASS. AS OF NOW, THE PATIENT IS STABLE. THE PHYSICIAN SUSPECTED THAT THE PATIENT HAD A CLOTTING DISORDER AND CLOTTED THE LEFT EXTERNAL ILIAC AND IT CONTINUED PROXIMAL INTO THE EXCLUDER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18827244 ↗
• InjuryJan 5, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2023, A PATIENT WAS PRESENTED WITH AN AORTOILIAC RUPTURED ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT WAS IN A BAD CONDITION DUE TO THE ANEURYSM RUPTURE. IT WAS REPORTED THAT THE PATIENT HAD AN ANGULATED AORTIC NECK AND A LARGE AORTOILIAC ANEURYSM. REPORTEDLY, DURING THE PROCEDURE, BOTH LEFT AND RIGHT INTERNAL ILIAC ARTERIES WERE COIL EMBOLIZED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE TWO HOURS FOLLOWING THE PROCEDURE. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR. THE PHYSICIAN OBSERVED THAT THE TRUNK IPSILATERAL LEG MIGRATED DISTALLY OUT OF THE PROXIMAL NECK FOR SEVERAL CMS. THE PHYSICIAN DID AN OPEN RECONSTRUCTION. ON (B)(6) 2023, THE PATIENT SUBSEQUENTLY DIED TO OPEN CONVERSION AND BLOOD LOSS COMPLICATIONS. IT IS UNKNOWN IF THE DEATH WAS DUE TO THE RUPTURED ANEURYSM. ALSO, IT IS UNKNOWN IF THE DEVICE MIGRATION WAS DUE TO THE RUPTURED ANEURYSM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm

  MAUDE report 18461055 ↗
• InjuryMay 18, 2023Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE RIGHT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED. REPORTEDLY, THE PHYSICIAN FELT THAT THE DEVICE WAS LANDED SAFELY ABOVE THE INTERNAL ILIAC ARTERY (IIA) OSTIUM. HOWEVER, THE FINAL ANGIOGRAM DETERMINED THAT THE RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE UNINTENTIONALLY COVERAGE OF THE RIGHT INTERNAL ILIAC ARTERY WAS DUE TO THE SHORT COMMON ILIAC ARTERY, SMALL/STENOSED ORIGIN OF THE INTERNAL ILIAC ARTERY HIGHER THAN VIEWED ON INTRAOPERATIVE IMAGE. THE PHYSICIAN FELT THEY MARKED THE RT IIA OSTIUM ACCURATELY AND LANDED CONSERVATIVELY. THEY ONLY FOUND THE RTIIA OCCLUDED ON FINAL ANGIOGRAM. AT THE TIME OF REPORTING, THE PATIENT WAS DOING WELL. IT WAS REPORTED THAT THE CASE WAS OCCURRED WITHOUT GORE FSA SUPPORT. IT WAS NOT ABLE TO GET THE INFORMATION FROM THE PHYSICIAN IF THE VESSEL OCCLUSION WAS SOLVED OR IS MONITORING. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Foreign Body Embolism

  MAUDE report 16957452 ↗
• MalfunctionMar 17, 2023Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED TO GORE, THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WAS SUPPOSED TO BE TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS - PLC DEVICE). IT WAS STATED THAT DURING THE PROCEDURE THE PLC DEVICE DID NOT PASS THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. WHEN THE PHYSICIAN RETRIEVED THE PLC DEVICE FROM THE SHEATH TO UNDERSTAND WHY HE FELT RESISTANCE, HE SAW THAT THE PLC DEVICE WAS PARTIALLY OPEN AND DISCONNECTED FROM THE PROXIMAL OLIVE. THE PLC DEVICE WAS NOT IMPLANTED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563311 ↗
• InjuryMar 6, 2023Complete Blockage; Collapse; Complete Blockage; Collapse

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE RIGHT SIDE WAS BALLOONED WITH A MOB BALLOON, AND THEN REPEATED ON THE LEFT SIDE. FLOW LOOKED GOOD THROUGH BOTH LIMBS. HOWEVER, ON (B)(6) 2023, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A FEM-FEM BYPASS. A POST-OP SCAN SHOWED THAT THE RIGHT LIMB LOOKED "TOTALLY CRUSHED" IN THE WORDS OF THE PHYSICIAN.

  Patient problems: Reduced Blood Flow

  MAUDE report 16485713 ↗
• InjuryNov 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS OBTAINED FROM VOLUNTARY USER FACILITY MDR REPORT #5112721: ON AN UNKNOWN DATE, GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO TREAT AN UNKNOWN ETIOLOGY. ON OR ABOUT (B)(6) 2022, ACUTE OCCLUSION OF THE RIGHT LIMB OF THE EXCLUDER ENDOGRAFT, GORE EXCLUDER MAIN BODY (28.5X14.5X12), GORE LEFT LIMB (12X10), AND GORE RIGHT LIMB (12X7) WAS REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15850165 ↗
• InjuryJul 15, 2022Off-Label Use; Off-Label Use

  AS REPORTED, ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER AAA ENDOPROSTHESES (PLC121000 L/S#: (B)(4); PLL161207 L/S#: (B)(4)). AS REPORTED, THE ENDOPROSTHESES WERE SIZED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE. AS REPORTED, NO GORE® EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT WAS IMPLANTED DURING THE INITIAL PROCEDURE. AS REPORTED THE PATIENT PRESENTED ON AN UNSPECIFIED DATE FOR POSSIBLE ENDOLEAK IN THE AREA OF THE ORIGINAL TREATMENT IN THE RIGHT COMMON ILIAC ARTERY. AS REPORTED AN ENDOLEAK WAS ABLE TO BE CONFIRMED, BUT IT WAS NOT CLEAR IF IT WAS A TYPE I OR A TYPE II ENDOLEAK. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. AS REPORTED THE PHYSICIAN FIRST TREATED THE RIGHT SIDE OF THE PATIENT USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231412, L/S#:(B)(4)). THE PHYSICIAN THEN TREATED THE LEFT SIDE OF THE PATIENT BY PLACING THE FOLLOWING TWO DEVICES FROM THE GORE® EXCLUDER AAA ENDOPROSTHESIS (RLT231412, L/S#:(B)(4)) INTO THE LEFT COMMON ILIAC ARTERY: GORE® EXCLUDER AAA ENDOPROSTHESES (PLC161000 L/S#: (B)(4) AND PLC161400 L/S#: (B)(4)). AS REPORTED THE ENDOLEAK WAS TREATED AND RESOLVED AT THE EN

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

  MAUDE report 15026833 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER® AFTERMARKET DEVICES, AS WELL AS THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2022, FOLLOW UP IMAGES REVEALED A LEFT EXTERNAL ILIAC ARTERY DISSECTION. NO TREATMENT IS PLANNED AT THIS TIME.

  Patient problems: Aneurysm

  MAUDE report 14698978 ↗
• DeathJun 6, 2022Inadequate User Interface; Inadequate User Interface

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (EXCC). AFTER GAINING ACCESS VIA BILATERAL FEMORAL CUTDOWNS, SHEATHS WERE ADVANCED INTO THE MID AND PROXIMAL INFRARENAL AORTA. THE EXCC WAS ADVANCED THRU A 16 FRENCH SHEATH AND PLACED AT THE LEVEL OF THE RENAL ARTERIES. ANGIOGRAPHY WAS PERFORMED AND THE DEVICE WAS DEPLOYED WITHOUT INCIDENT, HOWEVER THE CONTRALATERAL GATE WAS NOTED TO BE COMPRESSED. CANNULATION OF THE GATE WAS PERFORMED WITHOUT DIFFICULTY AND A PIGTAIL WAS ADVANCED AND SPUN TO CONFIRM THAT THE WIRE WAS IN THE BODY OF THE GRAFT. A CONTRALATERAL LIMB (PLC121000/(B)(4)) WAS THEN ADVANCED AFTER THE SHEATH AND DILATOR WERE PLACED INTO THE GATE OF THE TRUNK. THE SHEATH WAS DRAWN BACK BELOW THE LEVEL OF THE LEFT HYPOGASTRIC ARTERY AND DEPLOYED. THE TRUNK WAS THEN FULLY DEPLOYED AND AN EXTENSION LIMB (PLC121200/(B)(4)), WHICH WAS MARKED AFTER DOING AN INJECTION OF CONTRAST THRU THE SHEATH WAS PLACE TO THE LEVEL OF THE RIGHT HYPOGASTRIC ARTERY. THE PROXIMAL PART OF THE TRUNK WAS BALLOONED WITH A CODA BALLOON AND KISSING 12 MM PTA BALLOONS WERE USED IN THE LIMBS. T

  Patient problems: Aneurysm

  MAUDE report 14607624 ↗

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)