GORE EXCLUDER AAA Endoprosthesis PLC141400Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00733132618651), received between Oct 25, 2019 and Apr 10, 2026 — classified as 1 death, 22 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Obstruction of Flow

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT261412) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC141400 AND PLC161400). ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE AS THERE WAS RIGHT LIMB OCCLUSION ON THE PLC141400 CAUSED BY STENOSIS DISTAL TO THE LIMB. THE PHYSICIAN PERFORMED A THROMBECTOMY TO TREAT THE OCCLUSION AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) TO TREAT THE STENOSIS. THE GORE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE OF THE REINTERVENTION PROCEDURE ON (B)(6) 2026. THERE IS NO CLINICAL IMAGING AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24839889 ↗
• InjuryNov 17, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THERE IS A PLANNED REINTERVENTION TO REPAIR A POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REPAIR THE TYPE 1B ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23572691 ↗
• InjuryOct 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE ON AUGUST 26, 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AORTIC COMPONENT, GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT. IT WAS REPORTED THAT SPINAL CORD ISCHEMIA WAS OBSERVED ON (B)(6) 2025. TREATMENT WAS REQUIRED. THE ADVERSE EVENT WAS NOTED AS RESOLVED ON AUGUST 13, 2025. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2025.

  Patient problems: Ischemia

  MAUDE report 23397737 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO TREAT ANEURYSM ENLARGEMENT FOR AN UNDETERMINED ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN EXPLANTED ALL DEVICES DUE TO AN INFLAMMATORY ANEURYSM (POSSIBLY INFECTED BUT CULTURES CAME BACK NEGATIVE) AND FOR A PROXIMAL TYPE I ENDOLEAK. ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN PERFORMED AN OPEN CONVERSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22637746 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO TREAT ANEURYSM ENLARGEMENT FOR AN UNDETERMINED ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN EXPLANTED ALL DEVICES DUE TO AN INFLAMMATORY ANEURYSM (POSSIBLY INFECTED BUT CULTURES CAME BACK NEGATIVE) AND FOR A PROXIMAL TYPE I ENDOLEAK. ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN PERFORMED AN OPEN CONVERSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 22637745 ↗
• InjuryJul 18, 2025Structural Problem; Device Stenosis; Structural Problem; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PROCEDURE WENT WELL WITH FINAL ANGIO RUN LOOKING GOOD AND THERE WERE NO ANATOMICAL CHALLENGES. ON (B)(6) 2025, PHYSICIAN DID A REINTERVENTION BY DOING A FEM-FEM BYPASS AND PATIENT TOLERATED PROCEDURE. FIELD SALES ASSOCIATE (FSA) WAS NOT PRESENT FOR THE PROCEDURE. REINTERVENTION WAS DUE TO THE LEFT LIMB BEING CRUSHED AT THE BIFURCATION AND CAUSE IS UNKNOWN AFTER LOOKING AT THE SCANS. IT IS ALSO UNKNOWN IF THEY TRIED TO FIX IT ENDOVASCULARLY OR NOT AS PHYSICIAN ONLY CONVEYED, THEY FIXED THE ISSUE VIA FEM-FEM BYPASS. THERE WERE NO ANATOMICAL CHALLENGES.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 22546957 ↗
• InjuryJun 3, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2018, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261418 AND PLC141400). ON (B)(6) 2022, PATIENT UNDERWENT AN REINTERVENTION SURGERY TO TREAT A TYPE II ENDOLEAK. ON (B)(6) 2025, A CT REVEALED A RECURRENT TYPE II ENDOLEAK. ON (B)(6) 2025, PATIENT UNDERWENT A TRANSCAVAL EMBOLIZATION DUE TO THIS RECURRENT TYPE II ENDOLEAK. DURING REINTERVENTION SURGERY, A TYPE 1B ENDOLEAK WAS ALSO NOTED IN THE RIGHT ILIAC LIMB. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THE TYPE 1B ENDOLEAK, IN WHICH A PLC DEVICE WAS IMPLANTED TO EXTEND THE RIGHT ILIAC. IT WAS ALSO REPORTED THE TYPE1B ENDOLEAK WAS RESOLVED, AND THE TYPE II ENDOLEAK REMAINED. PHYSICIAN WILL CONTINUE TO MONITOR THIS TYPE II ENDOLEAK. FSA WAS NOTIFIED OF PREVIOUS REINTERVENTIONS (B)(6) 2022 AND (B)(6) 2025) ON (B)(6) 2025, AND DOES NOT HAVE ANY FURTHER INFORMATION, AS HE WAS NOT PRESENT. THE CAUSE OF THE PERSISTENT TYPE II ENDOEAK AS PER PHYSICIAN, IS DUE TO PATIENT FACTORS, WITH NO SPECIFIC CAUSE.

  Patient problems: Clinical Endoleak

  MAUDE report 22134353 ↗
• MalfunctionMay 6, 2025Break; Break

  ON (B)(6) 2025, THIS PATIENT UNDERWENT REINTERVENTION OF A PREVIOUSLY IMPLANTED ENDOLOGIX DEVICE. THE PATIENT UNDERWENT EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY (LIIA) AND A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS THEN IMPLANTED TO EXTEND COVERAGE DOWN TO THE LEFT EXTERNAL ILIAC ARTERY WITH INTENTIONAL COVERAGE OF THE LIIA WITH ADEQUATE OVERLAP WITHIN THE EXISTING DEVICE. IT WAS REPORTED THAT THE PATIENT¿S COMMON ILIAC ARTERIES (CIIA) WERE QUITE TORTUOUS AND IT WAS REPORTED THAT POST DEPLOYMENT OF THE EXTENSION DEVICE THE GORE CONTRALATERAL LIMB CONFORMED TO THE TORTUOUS VESSEL AND CAUSED A KINK, CAUSING DECREASED BLOOD FLOW. WHEN REMOVING THE DEVICE DELIVERY CATHETER THE NOSE CONE (LEADING OLIVE) FRACTURED AND DETACHED FROM THE DELIVERY CATHETER. THE PHYSICIAN WAS CONCERNED ABOUT THE KINK AND BLOOD FLOW, SO HE PERFORMED ANGIOPLASTY OF THE KINKED AREA. NEXT THE PHYSICIAN PERFORMED AN ANGIOGRAM WHICH SHOWED THE KINK HAD RESOLVED. IT WAS NOTED THAT WITH THE BALLOON INSERTION THE NOSE CONE HAD MOVED SLIGHTLY PROXIMAL CLOSER TO THE DISTAL WAIST OF THE AORTA. AT THIS TIME WIRE ACCESS WAS LOST AT THE LEVEL OF THE DISTAL WAIST (THIS IS WHERE THE SECOND COMPONENT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973503 ↗
• InjuryMar 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. AT THE ONE MONTH FOLLOW-UP, THE CT SCAN LOOKED NORMAL. ON (B)(6) 2025, THE PHYSICIAN TOOK A CT SCAN NOTING ANEURYSMAL DISEASE IN THE LEFT COMMON ILIAC ARTERY THAT WAS NOT PRESENT EARLIER. ON (B)(6) 2025, A REINTERVENTION OCCURRED TO PLACE AN ILIAC EXTENDER DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 21692055 ↗
• InjuryOct 9, 2024Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS). REPORTEDLY, THE PHYSICIAN WENT TO DEPLOY THE CONTRALATERAL LEG AFTER CANNULATING THE GATE, AND LOST GUIDEWIRE ACCESS AT SOME POINT AS IT MIGHT HAVE COME OUT WHEN THE PIGTAIL WAS SPUN. THE CONTRALATERAL LEG ENDED UP DEPLOYING BEHIND THE GATE AND PHYSICIAN THEN HAD TO DO A FEM-FEM BYPASS PROCEDURE AND MAKE A AORTO-UNI-ILIAC (AUI), FOR WHICH, PHYSICIAN PLANS TO BRING THE PATIENT BACK WITHIN A WEEK TO COMPLETE THE AUI PROCEDURE. PATIENT IS DOING WELL, NO BLOOD FLOW ISSUES AND WAS DISCHARGED. THE MEDICAL TECH ON THE CASE WAS WORKING ON THE AAA FOR THE FIRST TIME AND THERE WERE NO DEPLOYMENT ISSUES BUT CONTINUOUS ISSUES WITH THE GUIDEWIRE CANNULATION ACCESS BEING LOST OR MOVED 3 TIMES WHICH LED TO THE DEVICE POSSIBLY BEING DEPLOYED BEHIND THE GATE. ON (B)(6) 2024, ADDITIONAL INFORMATION RECEIVED ON REINTERVENTION: THE AUI WAS PERFORMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406773 ↗
• InjuryJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDE® CONFORMABLE AAA ENDOPROSTHESES, (CXT231412/ (B)(6) THE RIGHT-SIDE CONTRALATERAL GATE WAS CANNULATED AND IMPLANTED WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC141400/ (B)(6). ADDITIONALLY, THE RIGHT INTERNAL ILIAC ARTERY (RIIA) WAS COIL EMBOLIZED AND AN ILIAC EXTENDER ENDOPROSTHESIS (PLL161407/ (B)(6) WAS IMPLANTED TO EXTEND COVERAGE DOWN WITH INTENTIONAL COVERAGE OF THE RIIA. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION FOR TREATMENT OF DISTAL TYPE I ENDOLEAKS ON THE RIGHT SIDE. THE PHYSICIAN REPORTED DISTAL TYPE I ENDOLEAKS OUTSIDE THE DISTAL END OF BOTH THE CONTRALATERAL LEG AND THE EXTENSION DEVICE (NOT BETWEEN THEM OUTSIDE THEM). A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED TO RELINE AND EXTEND COVERAGE IN THE COMMON ILIAC ARTERY. THE TYPE I ENDOLEAKS WERE RESOLVED, BUT IN THE PROCESS OF PUTTING A STIFF WIRE UP THE CONTRALATERAL LIMB, THE PLC141400 BECAME SEPARATED FROM THE CONTRALATERAL

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

  MAUDE report 19579995 ↗
• InjuryFeb 29, 2024Adverse 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) 2023, THE PATIENT WAS IMPLANTED WITH TWO GORE® CONTRALATERAL LEG ENDOPROSTHESES, AND 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) 2024, IMAGES REVEALED THE PATIENT HAD A RIGHT COMMON ILIAC ARTERY DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18810977 ↗
• InjuryJun 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6)2023, THE PATIENT WAS TREATED FOR AN UNSPECIFIED EVENT INVOLVING ANOTHER COMPANY'S DEVICE. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6)2023, THE PATIENT WAS TREATED FOR A TYPE III ENDOLEAK. IT WAS REPORTED THAT ONE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES DID NOT EXTEND FAR ENOUGH DOWN DURNG THE PROCEDURE IN MARCH. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS ADDED, AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THE ENDOLEAK OCCURRED DISTAL TO THE EXCLUDER 14.5CM LIMB AND WITHIN THE ENDOLOGIX AFX LIMB. AT THE TIME OF THE PROCEDURE, NO LEAK WAS EVIDENT, SO IT APPEARED TO GO DOWN FAR ENOUGH.

  Patient problems: Clinical Endoleak

  MAUDE report 17134648 ↗
• InjuryMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PATIENT PRESENTED EMERGENTLY WITH AN AORTIC RUPTURE AND TYPE IB ENDOLEAK OF A MEDTRONIC GRAFT. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON EACH SIDE OF THE MEDTRONIC DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH DISEASE PROGRESSION ON THE RIGHT SIDE, RESULTING IN A TYPE IB ENDOLEAK. THE PHYSICIAN DECIDED TO EXTEND THE SEAL ZONE FROM THE RIGHT COMMON ILIAC INTO THE RIGHT EXTERNAL ILIAC AND COIL THE RIGHT INTERNAL ILIAC. THE PHYSICIAN IMPLANTED TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17008348 ↗
• InjuryDec 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE PHYSICIAN SUSPECTED A POSSIBLE INFECTION, AND THE DEVICE WAS EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Unspecified Infection

  MAUDE report 16034325 ↗
• InjuryNov 8, 2022Obstruction of Flow; Obstruction of Flow

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM IN ZONE 9 WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY DURING THE PROCEDURE ON (B)(6) 2022, THE PATIENT HAD A HIGH DEGREE OF ANGULATION IN THE COMMON ILIAC ARTERIES AND EXTERNAL ILIAC ARTERIES. THE LEFT SIDE (WHICH WAS THE SIDE OF THE CONTRALATERAL LIMB) APPEARED TO HAVE A KINK IN THE NATIVE COMMON ILIAC ARTERY FROM THE SHARP TURN IN THE ARTERY. THE TORTUOSITY DID CAUSE SOME PROBLEMS WITH GETTING THE WIRES AND SHEATHS UP ON BOTH SIDES, BUT THE PHYSICIAN WAS ABLE TO TRAVERSE BOTH SIDES AND THEN EXCHANGE FOR STIFF WIRES, WHICH HELPED STRAIGHTEN THE ANATOMY OUT. IN THE FINAL ANGIO RUN AT END OF PROCEDURE, IT WAS NOTED THE CONTRA LATERAL LIMB COMING AROUND THAT SHARP BEND IN THE COMMON ILIAC ARTERY. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO EMERGENCY. IT WAS DETERMINED THAT THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS COLLAPSED FROM THE SUPERIOR LEADING EDGE, ALL THE WAY DOWN TO THE DISTAL PORTION OF THE IPSILATERAL LIMB JUST ABOVE THE RIGHT HYPOGASTRIC AR

  Patient problems: Aneurysm

  MAUDE report 15752038 ↗
• InjurySep 15, 2022Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC).. THE PHYSICIAN POSITIONED AND DEPLOYED THE PLC DEVICE TOO FAR DISTAL AND UNINTENTIONALLY PARTIALLY COVERED THE ORIGIN OF THE LEFT HYPOGASTRIC. THE PHYSICIAN WAS ABLE TO RETRACT THE ENDOPROSTHESIS PROXIMALLY TO THE INTENDED LOCATION BY INFLATING THE BALLOON. FLOW TO THE HYPOGASTRIC WAS RESTORED AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 15426647 ↗
• InjurySep 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS NOTED THAT THERE WAS A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) IMPLANTED IN THE PATIENT'S DISTAL LEFT COMMON/PROXIMAL EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT HAD EXTENSIVE PLAQUE AND A CHRONICALLY OCCLUDED LEFT INTERNAL ILIAC ARTERY. BECAUSE OF THE PLAQUE, THE PHYSICIAN OPTED TO EXTEND INTO THE PATIENT'S LEFT EXTERNAL ILIAC ARTERY. THERE WAS ALSO SIGNIFICANT PLAQUE REPORTED DISTALLY NEAR THE PATIENT'S FEMORAL ARTERY. THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS LOCATED ON THE PATIENT'S RIGHT SIDE. ON AN UNKNOWN DATE, THROMBOSIS AND OCCLUSION OF THE PATIENT'S LEFT LIMB WAS OBSERVED. THE THROMBOSIS EXTENDED UP TO THE AORTIC BIFURCATION. IT WAS REPORTED THAT REVIEW OF THE POST OPERATIVE CTA IMAGING APPEARED TO SHOW THAT THE DEVICE IN THE PATIENT'S LEFT LIMB APPEARED TO BE ADEQUATE IN SIZE WITH NO AREAS OF COMPRESSION. THE THROMBOSIS WAS SUSPECTED TO BE RELATED TO THE PATIENT'S PRE-EXISTING EXTENSIVE PLAQUE. THERE WERE NO REPORTED ISSUES ON THE PATIENT'S RIGHT SIDE. ON (B)(6) 2022,

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15422801 ↗
• MalfunctionAug 23, 2022Mechanical Jam; Activation Problem

  ON (B)(6) 2021, THE PATIENT WAS ADMITTED FOR ENDOVASCULAR AORTIC REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, A GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT CONTRALATERAL LEG) WAS PREPPED FOR USE IN THE PROCEDURE, INSERTED, AND POSITIONED WITHIN THE PATIENT. AS REPORTED, THE PHYSICIAN UNSCREWED THE DEPLOYMENT KNOB AND ATTEMPTED TO PULL THE DEPLOYMENT LINE BUT IT WAS REPORTEDLY STUCK. THE DEVICE WAS REMOVED FROM THE PATIENT AND SET ASIDE. ANOTHER DEVICE WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. AS REPORTED, THERE WERE NO ADVERSE EVENTS, AND THE PATIENT TOLERATED THE PROCEDURE. AS REPORTED, THERE WERE NO ANATOMICAL CONSTRAINTS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280003 ↗
• InjuryJun 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH TWO GORE® CONTRALATERAL LEG ENDOPROSTHESES, A GORE® ILIAC BRANCH ENDOPROSTHESIS AND THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). TWO GORE® DRYSEAL FLEX INTRODUCER SHEATH¿S WERE 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) 2020, IMAGES REVEALED THE PATIENT HAD A DISTAL LEFT COMMON ILIAC DISSECTION. IT IS UNKNOWN WHICH GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED IN THE LEFT COMMON ILIAC ARTERY. FURTHER INVESTIGATION IS BEING CONDUCTED. THE ADVERSE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 14794865 ↗
• InjuryJun 23, 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) 2021, THE PATIENT WAS IMPLANTED WITH TWO GORE® CONTRALATERAL LEG ENDOPROSTHESES AND A GORE® ILIAC BRANCH ENDOPROSTHESIS WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). FOUR THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2021, IMAGES REVEALED A PSEUDOANEURYSM OF LEFT FEMORAL ARTERY. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 14794516 ↗
• DeathMay 6, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABAORTIC ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENT REINTERVENTION TO TREATMENT A RUPTURE OF THE ANEURYSM. THE PHYSICIAN REPORTED THE GRAFT AT THE PROXIMAL NECK (INFRARENAL AORTA) WAS COLLAPSED IN, LIKE LOOKING AT A SLIVER OF THE MOON ON AN AXIAL CT. DURING THE PROCEDURE ANGIOPLASTY OF THE PREVIOUS GRAFT WAS PERFORMED AND THEN A 26 MM GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT WAS IMPLANTED. THE PHYSICIAN SUSPECTS THE RUPTURE WAS CAUSED BY A PROXIMAL TYPE I ENDOLEAK CAUSED BY SOME BIRD BEAKING WHICH LED TO ENLARGEMENT AND THEN RUPTURE. THIS IS UNCONFIRMED DUE TO THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED THIS SAME DATE. A CAUSE OF DEATH WAS UNKNOWN BUT THOUGHT TO RELATED TO THE RUPTURE. THERE WERE NO ADDITIONAL REINTERVENTIONS PERFORMED ON THE PATIENT AND THERE WAS NO COMPLAINT AGAINST THE AORTIC EXTENDER THAT WAS USED TO TREAT THE RUPTURE.

  Patient problems: Aneurysm

  MAUDE report 14311320 ↗
• InjuryFeb 23, 2022Migration; Migration

  ON (B)(6), 2022 THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS USED TO EXTEND THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT. REPORTEDLY 3CM OF DEVICE OVERLAP WAS PRESENT BETWEEN THE IPSILATERAL LIMB AND THE CONTRALATERAL LEG COMPONENT. NO ENDOLEAK WAS NOTED AT THE CLOSE OF THE PROCEDURE. THERE WERE NO REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2022 IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF BACK PAIN. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE CONTRALATERAL LEG COMPONENT HAD MIGRATED DISTALLY AND A TYPE III ENDOLEAK WAS PRESENT. THERE WAS NO SUSPECTED CAUSE OF THE DISTAL DEVICE MIGRATION. IT WAS REPORTED THAT THERE WAS A VERY SLIGHT OVERLAP BETWEEN THE IPSILATERAL LIMB AND THE CONTRALATERAL LEG COMPONENT TO WHERE THE PHYSICIAN WAS ABLE TO ADVANCE A GUIDEWIRE AND PERFORM A RELINING OF THE DEVICES. THE DEVICE OVERLAP WAS RELINED USING A PLC181000 CONTRALATERAL LEG COMPONENT. THE TYPE III ENDOLEAK WAS REPORTEDLY RESOLVED. THERE WERE NO FURTHER REPORTED ISSU

  Patient problems: Pain

  MAUDE report 13588490 ↗
• MalfunctionNov 26, 2021Break; Break

  IT WAS STATED THAT AFTER THE GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOYED, THE DEVICE CATHETER WAS RETRACTED INTO THE USED GORE® DRYSEAL FLEX SHEATH. THE PHYSICIAN STATED THAT DURING THE REMOVAL OF THE CATHETER OUT OF THE VALVE OF THE SHEATH HE CONFUSED THE PROXIMAL CATHETER PART WITH THE LUNDERQUIST GUIDEWIRE AND FORCEFULLY RETRACTED IT. IN THAT SITUATION THE PROXIMAL OLIVE DETACHED FROM THE CATHETER INSIDE THE SHEATH BUT REMIANED ON THE GUIDEWIRE. IT WAS STATED THAT THE OLIVE REMAINED ON THE GUIDEWIRE AND WAS REMOVED TOGETHER WITH THE SHEATH OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM TO THE PATIENT WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT A PHYSICAL SAMPLE TO EVALUATE, THE PHYSICIAN¿S OBSERVATIONS COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877518 ↗
• InjuryOct 23, 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 (B)(6) STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AND PARARENAL AORTIC ANEURYSM WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT DURING THE PROCEDURE THERE WAS A LEFT COMMON ILIAC ARTERY. A STENT WAS PLACED AND THE STUDY REPORTED THAT THE OUTCOME WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10731110 ↗

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)