GORE EXCLUDER AAA Endoprosthesis PLC121400Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00733132618644), received between Nov 12, 2018 and Nov 7, 2025 — classified as 1 death, 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Device Endoleak; Device Endoleak

  THE CLINICAL SPECIALIST REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ISSUES, AND NO ENDOLEAKS WERE OBSERVED AT THE CLOSE OF THE PROCEDURE. A BXB057902A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS IMPLANTED IN THE LEFT RENAL ARTERY. IT WAS REPORTED ON AN UNKNOWN DATE, FOLLOW-UP IMAGING WAS PERFORMED AND A SUSPECTED TYPE III ENDOLEAK WAS OBSERVED FROM THE LEFT RENAL PORTAL. IT WAS SUSPECTED THAT ADDITIONAL BALLOONING MAY BE REQUIRED AND MAY BE THE CAUSE OF THE ENDOLEAK. A REINTERVENTION PROCEDURE IS SCHEDULE FOR (B)(6) 2025. THE FSA WAS NOTIFIED ABOUT THIS ENDOLEAK ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT UPON SCHEDULED REINTERVENTION SURGERY ON (B)(6) 2025, THE PHYSICIAN ANGIOGRAPHICALLY INTERROGATED THE STENT BRANCHES, ESPECIALLY THE LEFT RENAL BRANCH, AND COULD NOT PRODUCE AN ENDOLEAK. PHYSICIAN CONCLUDED THAT THE LEAK EVIDENCED ON THE PREVIOUS CT SCAN, WAS MOST LIKELY READ INCORRECTLY AS A TYPE 3, AND IS ACTUALLY A TYPE 2 LEAK. PHYS

  Patient problems: Clinical Endoleak

  MAUDE report 23498481 ↗
• DeathNov 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS TRUNK (CXT) AND 3 GORE®EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. BECAUSE OF THE SHORT PROXIMAL AORTIC NECK, THE PHYSICIAN ELECTED TO PROCEED WITH AN OFF-LABEL CHIMNEY TECHNIQUE TO PRESERVE THE SMA AND RIGHT RENAL ARTERY. INTRAOPERATIVELY, A SMALL TYPE 1A ENDOLEAK WAS OBSERVED. THE PHYSICIAN WAS SATISFIED WITH THE FINAL ANGIOGRAPH, AND INDICATED THE PATIENT WAS STABLE. ON (B)(6) 2025, THE PATIENT LOST FEMORAL PULSE. ON FOLLOW-UP CT SCAN, THE PHYSICIAN SAW THE TYPE 1A ENDOLEAK CONTINUING AND DISCUSSED A REINTERVENTION. ON (B)(6) 2025, THE PATIENT PASSED. THE CAUSE OF DEATH IS UNKNOWN. REPORTEDLY, THE PHYSICIAN BELIEVED THAT THE LOSS OF FEMORAL PULSE WAS DUE TO A CLOT IN THE RIGHT FEMORAL ARTERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23490458 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL COMPONENT) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (4 CONTRALATERAL LEG COMPONENTS). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON (B)(6) 2025, THE PATIENT PRESENTED WITH LEG PARALYSIS. THE PATIENT WAS TREATED WITH VASOPRESSOR MEDICATION TO INCREASE BLOOD FLOW. IT WAS ALSO REPORTED THERE WAS NO SPINAL CORD ISCHEMIA, AND NEUROLOGIST BELIEVES FULL LEG FUNCTION WILL RETURN. THE CAUSE OF PARALYSIS IS UNKNOWN. THERE WERE NO ISSUES NOTED DURING THE INITIAL IMPLANT PROCEDURE. NO FURTHER PATIENT OR CASE INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 23069812 ↗
• InjuryAug 18, 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 IMAGING DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS DEVICE AND TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THERE WAS ONE ADDITIONAL PROCEDURE STATED IN THE STUDY DATABASE: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE RIGHT COMMON ILIAC ARTERY (VESSEL DILATATION WAS DONE, WITH AN UNKNOWN BALLOON). THERE WAS SUCCESSFUL ACCESS, DELIVERY AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A COMPUTED TOMOGRAPHY IMAGE (CTA). THE PATIENT WAS NOTED TO HAVE A FOCAL DISSECTION WITHIN THE RIGHT COMMON ILIAC ARTERY BEGINNING AT THE DISTAL ASPECT OF THE CONTRALATERAL LEG GRAFT. THE STUDY CONTAINS THE VESSEL DIAMETERS AND THE MAXIMUM DIAMETER OF RIGHT COMMON ILIAC ARTERY WAS 9 MM (PRE-PROCEDURE MEASUREMENT).

  Patient problems: Vascular Dissection

  MAUDE report 22825207 ↗
• InjuryJul 14, 2025Separation Problem; Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT PRESENTED TO EMERGENCY ROOM FOR AN EMERGENT ANEURYSM RUPTURE IN AN ENDOVASCULAR PROCEDURE UTILIZING A 15FR GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THE 15FR SHEATH WAS USED FOR THE IPSILATERAL SIDE IN ORDER TO PLACE THE 23MM TRUNK IPSILATERAL LEG CONFORMABLE. THE GRAFT WAS DEPLOYED FULLY, HOWEVER, WHEN TRYING TO REMOVE THE CATHETER, THE OLIVE TIP BROKE OFF AS IT CAUGHT ON THE SHEATH. FORTUNATELY, PHYSICIAN WAS ABLE TO SNARE THE OLIVE TIP BACK INTO THE SHEATH WITH NO HARM TO PATIENT (NO PIECE LEFT INSIDE) AND REPLACED THE SHEATH WITH A 16FR SHEATH TO CONTINUE THE PROCEDURE. THE PATIENT'S ILIACS WERE NOTED TO BE TORTUOUS AND AT END OF PROCEDURE, THERE WAS A TYPE 1A ENDOLEAK WHICH PHYSICIAN ATTEMPTED TO FIX BY ADDING AN AORTIC EXTENDER BUT IT DID NOT FIX THE PROBLEM. AT THIS POINT, PHYSICIAN TRIED TO PLACE ENDO ANCHORS INTO THE GRAFT, HOWEVER, PHYSICIAN WAS ONLY ABLE TO PLACE ONE ENDOANCHOR WHEN PATIENT'S PRESSURES STARTED TO WORSEN AND THEY HAD TO OPEN THE PATIENT'S ABDOMEN. AFTER THEY SUCTIONED OUT THE PATIENT¿S BELLY, THEY WENT BACK IN AND TRIED TO PLACE THE O

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22493045 ↗
• InjuryApr 30, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM USING A CXT321414 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. A PLC121400 GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS IMPLANTED MOST DISTAL IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2025, A DISTAL TYPE I ENDOLEAK WAS OBSERVED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ANEURYSM GROWTH WAS OBSERVED (AMOUNT UNAVAILABLE). ON THE SAME DAY A REINTERVENTION WAS PERFORMED WHEREBY A GORE® EXCLUDER® ILIAC BRANCH COMPONENT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED AT THE CLOSE OF THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21938434 ↗
• InjuryFeb 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL AND A COMMON ILIAC ARTERY ANEURYSM (CIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WITH GREAT RESULTS. FINAL ANGIOGRAPY DEPICTED GOOD RESULTS CONSIDERING THE LENGTH AND TORTUOSITY AND CONDITION OF THE PATIENT¿S ANATOMY. THE PHYSICIAN REPORTS THE PATIENT HAD NOT BEEN A GOOD CANDIDATE FOR OPEN OR ENDOVASCULAR TREATMENT AND HE HAD VERY STRONGLY ATTEMPTED TO CONVINCE THE PATIENT TO OPT FOR PALLIATIVE CARE/COMFORT CARE. LATER THIS SAME DAY OR EARLY MORNING OF (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR A KINK/OCCLUSION OF THE OVERLAP ZONE OF THE TWO CONTRALATERAL LEG COMPONENTS LOCATED AROUND THE CIAA WHICH WAS EXTREMELY TORTUOUS. THE PATIENT ADDITIONALLY HAD A COMMON FEMORAL ARTERY ANEURYSM (CFAA) AND THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS OUT, CLOGGED AND OCCLUDED AND DISEASED. THE PHYSICIAN CHOSE TO BYPASS THE COMMON FEMORAL ARTERY (CFA) AND OPENED THE RIGHT SIDE AND PERFORMED A BYPASS GRAFT DIRECTLY TO THE PROFUNDA TO ELIMINATE THE ISSUES WITH THE CFA. THE PATIENT TOLERATED THE PROCEDURE AND IS

  Patient problems: Reduced Blood Flow

  MAUDE report 21439190 ↗
• InjuryOct 18, 2024Obstruction of Flow; Obstruction of Flow

  SUPPLEMENTAL INFO: THE PATIENT HAD A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS ADMITTED TO THE EMERGENCY ON MAY 16TH.

  Patient problems: Ischemia

  MAUDE report 20478983 ↗
• InjuryOct 3, 2024Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE PHYSICIAN USED A SNORKEL FOR A VERY LOW RENAL ARTERY WHICH HE PUT IN FROM THE ARM AND THE PHYSICIAN DEPLOYED THE MAIN BODY TRUNK IPSILATERAL GRAFT AT THE SAME TIME. THE DEPLOYMENT WENT FINE AND THEN PHYSICIAN PUT A GUIDEWIRE DOWN FROM THE ARM TO THE EXCLUDER GRAFT WHICH ENDED UP OUTSIDE OF THE DEVICE. THE ILIAC BRANCH COMPONENT WAS DEPLOYED FIRST BEFORE THEY DID THE TRUNK IPSILATERAL C3 DEPLOYMENT AND THEN THEY WENT TO DO THE BRIDGING WITH THE CONTRALATERAL LEG AND AT THIS TIME THE GUIDEWIRE WAS OUTSIDE OF THE MAIN BODY GRAFT BUT INSIDE THE ILIAC BRANCH COMPONENT. PHYSICIAN THEN DID AN ANGIOGRAM AND FOUND NO BLOOD FLOW IN THE ILIAC BRANCH COMPONENT AS THE BRIDGING GRAFT (CONTRALATERAL LEG) DID NOT CONNECT PROPERLY BECAUSE IT WAS CONNECTED DISTALLY BUT NOT ON THE PROXIMAL LEVEL WITH THE TRUNK IPSILATERAL GRAFT. PHYSICIAN WAS THEN ABLE TO SET A WIRE THROUGH THE ILIAC BRANCH COMPONENT AND OUTSIDE OF THE BRIDGING GRAFT AND INTO THE TRUNK IPSILATERAL GATE

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 20363830 ↗
• InjuryJun 18, 2024Device Stenosis; Device Stenosis

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-9 INFRARENAL ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENTS-PLC141200 ON THE LEFT AND PLC121400 ON THE RIGHT). ON (B)(6) 2024 DURING A FOLLOW-UP IMAGING, PLC141200 DEVICE APPEARED TO BE THROMBOSED. PHYSICIAN ALSO REPORTED THE LIMB WAS CRUSHED. IT WAS ALSO REPORTED THAT THE PHYSICIAN MENTIONED THERE WAS STENOSIS AT THE EDGE OF THE PLC121400 DEVICE (IMPLANTED ON THE RIGHT SIDE), AND THE DEVICE REMAINED PATENT. ON (B)(6) 2024. PATIENT UNDERWENT A REINTERVENTION SURGERY. PHYSICIAN PERFORMED A FEM BYPASS TO TREAT THE THROMBOSIS AND TREATED THE STENOSIS BY EXTENDING THE RIGHT SIDE WITH ANOTHER LIMB. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF REPORTED THROMBOSIS AND COMPRESSION IS UNKNOWN. FSA WAS NOT AT THE PROCEDURE. AND NO FURTHER INFORMATION IS AVAILABLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563840 ↗
• InjuryJun 14, 2024Adverse 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) 2021, A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). DUE TO THE PATIENT¿S TORTUOUS ANATOMY, THE PHYSICIAN CHOSE TO EXPLANT THE PREVIOUSLY IMPLANTED GRAFTS AND PERFORM A SURGICAL CONVERSION. THE PATIENT TOLERATED THE REINTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm expansion

  MAUDE report 19543328 ↗
• 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 19219857 ↗
• InjuryJul 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR TREATMENT PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2023, A NARROWING IN THE LEFT COMMON ILIAC DISTAL TO THE LEFT EXCLUDER LIMB WAS OBSERVED DUE TO OUTFLOW STENOSIS. DEVICE THAT WAS IMPLANTED MOST DISTALLY ON THE LEFT WAS CONTRALATERAL LEG COMPONENT PLC121200, LOT#: 22340938. PHYSICIAN ATTRIBUTES THIS TO DISEASE PROGRESSION. ON (B)(6) 2023, A REINTERVENTION PROCEDURE WAS PERFORMED. A ILIAC EXTENDER COMPONENT PLL161407 DEVICE WAS IMPLANTED, AND USED TO EXTEND DISTALLY 2CM. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 17419976 ↗
• InjuryJun 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AN ILIAC BRANCH COMPONENT (IBC) WAS PLACED ON THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE PATIENT'S INTERNAL ILIAC ARTERY WAS HIGHLY CALCIFIED WITH LITTLE FLOW, AND IT WAS ANTICIPATED THAT THE ARTERY WOULD LIKELY REQUIRE BYPASS. REPORTEDLY, THE PHYSICIAN MADE AN ATTEMPT TO PRESERVE THE ARTERY BY PLACING AN INTERNAL ILIAC COMPONENT, BUT AS EXPECTED THE DEVICE WAS UNABLE TO REMAIN PATENT DUE TO THE ANATOMICAL RESTRICTIONS. THEREFORE, THE IBC WAS RELINED USING A 27X12 GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT, AND THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY COVERED USING A 12X14 CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE PATIENT'S RIGHT ILIAC ARTERY WAS PATENT POST OP. THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT A FOLLOW-UP CT WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM. IT WAS REPORTED THAT THE PATIENT'S RIGHT LEG WAS ISCHEMIC, AND THE DEVICES IN THE PATIENT'S RIGHT ILIAC ARTERY WERE THROMBOSED AN

  Patient problems: Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17122232 ↗
• InjuryJun 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN DISCOVERED A LIMB SEPARATION BETWEEN THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND ONE OF THE EXCLUDERS. THE PHYSICIAN HAS SCHEDULED A REINTERVENTION, AND HAS NO OPINION ON THE CAUSE OF THE SEPARATION.

  Patient problems: Clinical Endoleak

  MAUDE report 17108099 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE WHILE BALLOONING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IN THE LEFT COMMON ILIAC ARTERY THE NATIVE VESSEL ON EDGE OF IMPLANTED DEVICE RUPTURED. REPORTEDLY THE PHYSICIAN WAS AGGRESSIVELY BALLOONING THE EDGE OF THE IMPLANTED GRAFT. A GORE® VIABAHN® STENT WAS IMPLANTED IN THE AREA OF RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION OBTAINED FROM FSA. THE NATIVE VESSEL AT EDGE OF IMPLANTED WAS RUPTURED. A BLOOD TRANSFUSION DURING THE PROCEDURE WAS REQUIRED (2-3 UNITS OF PACKED RED BLOOD CELLS). A MOB37 BALLOON WAS BEING USED (THE LOT/SERIAL NUMBER IS UNKNOWN; IT WAS HOSPITAL INVENTORY). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 17007068 ↗
• MalfunctionMay 3, 2022Break; Material Separation; Stretched; Break; Material Separation; Stretched

  IT WAS REPORTED TO GORE THAT DURING AN IMPLANT OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS, THE TIP (THE OLIVE) OF THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC121400) WAS DISCONNECTED FROM THE SHAFT WHILE THE PHYSICIAN WAS RETRIEVING THE SYSTEM AFTER THE DEPLOYMENT. THE TIP CAME OUT FROM THE PATIENT WITH THE CATHETER AND THERE WERE NO ISSUES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268867 ↗
• InjuryDec 29, 2021Migration; Migration

  ON (B)(6) 2021 THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE ® EXCLUDER ® CONFORMABLE AAA ENDOPROSTHESIS (CXT261412) AND WITH GORE ® EXCLUDER ® AAA ENDOPROSTHESES (PLC14100, PLC201200, AND PLC121400). THE PLC 121400 WAS EXTENDED INTO THE IPSILATERAL LIMB ON THE RIGHT SIDE OF THE PATIENT. A 3CM OF OVERLAP WAS OBSERVED BETWEEN THE CXT261412 AND THE PLC121400 AT THE TIME OF THE PROCEDURE. A FOLLOW UP CT SCAN WAS PERFORMED ON AN UNSPECIFIED DATE AND IT WAS OBSERVED THAT THE THERE WAS NO OVERLAP BETWEEN CXT261412 AND THE PLC121400 ENDOPROSTHESES. THE PLC121400 HAD MIGRATED TO THE END OF THE IPSILATERAL LIMB ON THE CXT261412. A TYPE III ENDOLEAK WAS OBSERVED. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED IN WHICH A PLC 161400 WAS IMPLANTED TO TREAT THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 13114616 ↗
• InjuryDec 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECOVERED AND DISCHARGED FROM THE HOSPITAL. THE RESULTS OF FOLLOW-UP WERE GOOD. THE PHYSICIAN DID NOT COMPLAIN ABOUT GORE'S PRODUCTS.

  Patient problems: Numbness; Thrombosis/Thrombus

  MAUDE report 12966023 ↗
• InjuryMar 25, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6), 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6), 2021, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING REPORTEDLY APPEARED TO SHOW A TYPE 1B ENDOLEAK AS WELL AS AN INFECTION AROUND THE GRAFT WITH A SLIGHT ENLARGEMENT OF THE ANEURYSM SAC. A BACTERIAL INFECTION OF THE GRAFTS WAS REPORTEDLY ASSUMED AND ONGOING WITH THE PATIENT LIKELY HAVING RECEIVED ANTIBIOTIC TREATMENT. THE AMOUNT OF GROWTH WAS DIFFICULT TO DETERMINE DUE TO THE INFECTED STATE OF THE ANEURYSM BUT WAS REPORTEDLY BELIEVED TO BE LESS THAN 5 MM. HOWEVER, THERE WAS NO ADDITIONAL INFORMATION OF CAUSE, TYPE, TREATMENT, AND CURRENT STATE OF THE INFECTION AVAILABLE AND THERE REPORTEDLY HAD NOT BEEN ANY OTHER DIAGNOSES THAT CONFIRMED THE INFECTION. ALSO, THE PATIENT WAS REPORTED TO HAVE BEEN ASYMPTOMATIC. ON (B)(6), 2021, A RE-INTERVENTION WAS PERFORMED AND THE SUSPECTED TYPE 1B ENDOLEAK OF THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC161200 INITIALLY IMPLANTED ON THE LEFT WAS EXTENDED WITH A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC141200. ADDITIONALLY, THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED. ON THE RIGHT

  Patient problems: Aneurysm

  MAUDE report 11567051 ↗
• InjurySep 16, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. THE TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED SUCCESSFULLY, HOWEVER, THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED OUTSIDE THE CONTRALATERAL GATE AND INTO THE ANEURYSM SAC. THE REASON FOR THE DEPLOYMENT ERROR WAS NOT REPORTED TO GORE. THE PHYSICIAN THEN CONVERTED TO AN AORTO-UNI-ILIAC BY DEPLOYING AN ADDITIONAL TRUNK-IPSILATERAL LEG COMPONENT INSIDE OF FIRST TRUNK-IPSILATERAL LEG COMPONENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10541757 ↗
• InjuryMar 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, A TYPE IB ENDOLEAK ON THE GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS WAS IDENTIFIED THAT APPEARS TO HAVE LIMITED SEAL. ADDITIONALLY A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY (IMA) WAS IDENTIFIED. ON (B)(6) 2020, THE TYPE IB ENDOLEAK WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL ENDOPROSTHESIS (GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS)THAT SERVES AS AN EXTENSION ON THE CONTRALATERAL SIDE. THE TYPE II ENDOLEAK WAS SOLVED BY COILING OF THE IMA ON THE SAME DAY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9828786 ↗
• InjuryNov 1, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH A GORE® EXCLUDER CONTRALATERAL LEG COMPONENT IN THE RIGHT COMMON/EXTERNAL ILIAC ARTERY. THE DEVICE WAS LANDED DISTAL TO THE AORTIC BIFURCATION; RESULTING IN A TYPE 1A ENDOLEAK. ON (B)(6) 2019,AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND COVERAGE PROXIMALLY AND RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9267061 ↗
• MalfunctionOct 28, 2019Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET LESION AND INITIATED THE DEPLOYMENT LINE. HOWEVER, THE ENTIRE DEPLOYMENT LINE WAS PULLED OUT AND THE ENDOPROSTHESIS COULD NOT BE EXPANDED. BOTH THE ENDOPROSTHESIS AND DELIVERY SYSTEM WERE RETRACTED OUT OF THE PATIENT. THE PHYSICIAN USED ANOTHER NEW GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND DEPLOYED SUCCESSFULLY WITHOUT ANY REPORTED ISSUE TO THE PATIENT. THE DEPLOYMENT LINE WAS BROKEN WHEN THE DEVICE WAS CHECKED.

  Patient problems: Not Applicable

  MAUDE report 9248391 ↗
• MalfunctionMay 21, 2019Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUSLY IMPLANTED BIFURCATED STENT WITH EXOSKELETON (TYPE UNKNOWN). THE PREVIOUSLY IMPLANTED DEVICE WAS BEING RELINED WITH THE GORE® EXCLUDER® AAA SYSTEM. REPORTEDLY THE TRUNK-IPSILATERAL LEG COMPONENT WAS SUCCESSFULLY DEPLOYED. THE CONTRALATERAL GATE WAS CANNULATED, AND THE CONTRALATERAL LEG COMPONENT WAS ADVANCED. UPON INITIATING DEPLOYMENT OF THE CONTRALATERAL LIMB, THE DEVICE REPORTEDLY DEPLOYED ABOUT 4CM AND THEN STOPPED. IT WAS NOTED THAT DEPLOYMENT STOPPED AT THE LEVEL OF THE FLOW DIVIDER OF THE PREVIOUSLY IMPLANTED DEVICE. IT WAS SUSPECTED THAT THE DEPLOYMENT LINE WAS CAUGHT ON THE EXOSKELETON OF THE DEVICE. THE DEPLOYMENT LINE WAS PULLED WITH EXCESSIVE FORCE IN AN ATTEMPT TO DEPLOY THE REMAINING CONSTRAINED LIMB. REPORTEDLY THE DEPLOYMENT LINE BROKE. NO FURTHER DEVICE DEPLOYMENT WAS NOTED. BALLOONING WAS ATTEMPTED MULTIPLE TIMES WITHOUT SUCCESS. REPORTEDLY ACCESS WAS GAINED THROUGH THE PATIENT'S ARM AS A PRECAUTIONARY MEASURE. THE PHYSICIAN THEN PULLED THE CATHETER FROM THE LOWER LIMB ACCESS SITE WITH E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629917 ↗

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