GORE EXCLUDER AAA Endoprosthesis PLC181200Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00733132618736), received between Oct 23, 2018 and Oct 15, 2025 — classified as 1 death, 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 33 reports, in the reporter's own words as published by the FDA.

• DeathOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT ON (B)(6) 2025, FOLLOW UP IMAGES REVEALED A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN REINTERVENED AND DURING THE REINTERVENTION, THE ANEURYSM SAC RUPTURED. THE PATIENT CODED AND EXPIRED. NO FURTHER INFORMATION IS AVAILABLE. THE GORE ASSOCIATE WAS NOT AT THE REINTERVENTION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 23306650 ↗
• InjuryJul 11, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE ON JUNE 16, 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, A 78-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF A AORTO-ILIAC ARTERY ANEURYSM. THE PATIENT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. A CONTRALATERAL LEG DEVICE WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. THERE WERE ACCESS-RELATED COMPLICATIONS, AND THE LEFT COMMON ILIAC ARTERY RUPTURED. THE ESTIMATED BLOOD LOSS WAS 2000 ML FOR THE PROCEDURE AND THE PATIENT REQUIRED A TRANSFUSION. 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. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO AN IN-PATIENT REHAB FACILITY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD AN OCCLUDED RIGHT EXTERNAL ILIAC ARTERY, DISTAL RIGHT FEMORAL ARTERY, AND RIGHT POPLITEAL ARTERY. THE PATIENT ALSO HAD A THROMBUS WITHIN THE RIGHT COMMON FEMORAL ARTERY AND PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY, AND RIGHT BUTTOCK CLAUDICATION. IN-PATIENT OR PROLONGED HOSPITALIZATION WAS REQUIRED. ON (B)(6) 2025, A REINT

  Patient problems: Obstruction/Occlusion

  MAUDE report 22480903 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC AND ILIAC ARTERY ANEURYSM FROM DISSECTION AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES IN THE INFRARENAL ABDOMINAL AORTA, A GORE®EXCLUDER®AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE IN THE LEFT COMMON ILIAC ARTERY, AND TWO GORE®EXCLUDER®AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES IN THE RIGHT COMMON ILIAC ARTERY. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 56MM, WITH A PROXIMAL LANDING ZONE DIAMETER OF 25MM. ADDITIONALLY, THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND COVERED; AND THE RIGHT RENAL ARTERY WAS STENTED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THE PATIENT HAD A TYPE II ENDOLEAK AND WAS EXPERIENCING RIGHT SIDE LOWER BACK PAIN/BUTTOCK CLAUDICATION; AND WAS DETERMINED TO HAVE A TYPE II ENDOLEAK. NO TREATMENT WAS REQUIRED, HOWEVER IN PATIENT HOSPITALIZATION WAS UTILIZED, THE EVENT IS ONGOING.

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

  MAUDE report 22294210 ↗
• InjuryMay 16, 2025Device Dislodged or Dislocated; Device Endoleak; Device Dislodged or Dislocated; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE TGR23-02AA TOGETHER AORTIC REGISTRY: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) TRUNK-IPSILATERAL LEG COMPONENT IN THE INFRARENAL ABDOMINAL AORTA AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT IN THE RIGHT COMMON ILIAC ARTERY. THE DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON (B)(6) 2024, A TYPE III ENDOLEAK AND CONTAINED ANEURYSM RUPTURE WERE OBSERVED. ON (B)(6) 2024, A TYPE IV ENDOLEAK WAS ALSO REPORTED. ON THE SAME DATE, A REINTERVENTION WAS PERFORMED WHEREBY THE DEVICE SYSTEM WAS RELINED USING A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT AND BILATERAL ILIAC LIMBS. THE ANEURYSM RUPTURE WAS NOTED AS RESOLVED ON (B)(6) 2024. THE TYPE IV ENDOLEAK WAS NOTED AS RESOLVED ON (B)(6) 2024.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22040820 ↗
• InjuryJan 13, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181200). ON (B)(6) 2024 PATIENT PRESENTED WITH A DISTAL TYPE 1B ENDOLEAK, IDENTIFIED VIA ANGIOGRAM. THE ENDOLEAK WAS OBSERVED ON A PREVIOUSLY PLACED PLC181200 DEVICE IMPLANTED IN THE DISTAL LEFT COMMON ILIAC. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION SURGERY, IN WHICH PHYSICIAN DECIDED TO TREAT VIA IMPLANTATION OF A DISTAL EXTENSION. THE PHYSICIAN NOTED DISEASE PROGRESSION IN THE PATIENT'S LEFT COMMON ILIAC. CASE WAS COMPLETED WITHOUT INCIDENT AND PATIENT TOLERATED THE PROCEDURE. NO IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21144852 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OCTOBER 29TH, A GORE REPRESENTATIVE SPOKE TO THE PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE PATIENT SYMPTOMS ARE NOT RELATED TO THE GORE DEVICE OR TO THE SURGERY.

  Patient problems: Paresis

  MAUDE report 20312242 ↗
• InjuryJul 17, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(6) WAS IMPLANTED ON (B)(6) 2023 IN A PATIENT FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING A FOLLOW-UP IN ANOTHER CLINIC ABOUT ONE YEAR LATER, A TYPE 1B ENDOLEAK WAS DISCOVERED AT THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN IS PLANNING TO PERFORM AN ENDOVASCULAR EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY AND OVERSTENT TO THE EXTERNAL ILIAC ARTERY WITH 2 GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(6).

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760755 ↗
• InjuryJun 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT HAD AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM WITH A POSSIBLE TYPE 1 B ENDOLEAK ON A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRA LEG). THE CONTRA LEG WAS IMPLANTED IN 2022 AND THERE ARE NO CT IMAGES TO CONFIRM THE ENDOLEAK. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED WITHOUT ISSUE. IN ADDITION, A 11 MM X 79 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS INTENDED FOR USE IN THE RIGHT HYPOGASTRIC ARTERY AS AN EXTENSION OF THE IBE. IT WAS REPORTED THAT ACCESS WAS GAINED THROUGH THE LEFT BRACHIAL ARTERY AND A 0.035¿ CORDIS STORQ STEERABLE GUIDEWIRE WAS USED. REPORTEDLY, THERE WAS DIFFICULTY WITH ADVANCEMENT OF VBX STENT GRAFT DELIVERY CATHETER THROUGH A UPSIZED 9 F COOK INTRODUCER SHEATH, THE CONTRA LEG, THE IBE, AND THE PATIENT¿S TORTUOUS ANATOMY. CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE VBX STENT GRAFT DELIVERY CATHETER PRIOR TO DEPLOYMENT TO POSSIBLY USE A 11 MM X 59 MM INSTEAD TO HAVE BETTER TRACKABILITY. IT WAS NOTED, THAT WHEN THE PHYSICIAN PULLED BACK ON THE VBX STENT GRAFT DELIVERY CATHETER HUB WITH NORMAL

  Patient problems: Clinical Endoleak

  MAUDE report 19619587 ↗
• InjuryJun 24, 2024Insufficient Device Problem Information; Device Endoleak; Insufficient Device Problem Information; Device Endoleak

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 56MM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 64MM. ADDITIONALLY, ON NOVEMBER 24, 2020, THE TYPE I ENDOLEAK WAS DETERMINED. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. NO TREATMENT WAS REQUIRED. THE EVENT IS ONGOING. THE PHYSICIAN IS MONITORING THE PATIENT. ON (B)(6) 2021, FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 67MM. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19602620 ↗
• InjuryMay 24, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. ON AN UNKNOWN SUBSEQUENT DATE, THE PATIENT PRESENTED WITH CRANIAL DISPLACEMENT OF THE IMPLANTED DEVICES RESULTING IN THE COMPLETE COVERAGE OF THE RENAL ARTERIES. ALL DEVICES WERE EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 19391775 ↗
• InjuryMar 20, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (A TOTAL OF (B)(4) COMPONENTS: ONE TRUNK-IPSILATERAL LEG (RLT261212), TWO CONTRALATERAL LEGS (PLC121000 ON THE RIGHT, PLC181200 ON THE LEFT), AND ONE ILIAC EXTENDER ON THE RIGHT) WAS IMPLANTED ON (B)(6) 2018 FOR AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR (EVAR). IN (B)(6) 2024, A FOLLOW-UP WITH CT SHOWED SUBOPTIMAL SEAL IN THE LEFT LIMB (PLC181200). ON (B)(6) 2024, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231410 - SN (B)(6)) WAS IMPLANTED ON THE LEFT SIDE, LANDING IN THE PLC181200.

  Patient problems: Clinical Endoleak

  MAUDE report 18946243 ↗
• InjuryFeb 16, 2024Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. A CONFORMABLE TRUNK-IPSILATERAL LEG COMPONENT AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS WERE IMPLANTED. ON (B)(6) 2024, THE PHYSICIAN INFORMED THE GORE REPRESENTATIVE THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED DISTALLY APPROXIMATELY 3CM DOWN INTO THE ANEURYSM SAC. ADDITIONALLY, THROMBUS WAS OBSERVED IN THE DISTAL LIMBS AND IN THE PATIENT'S LEFT RENAL ARTERY. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT PRESENT. THERE WAS NO REPORTED PATIENT ANATOMY THAT WAS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ON THE SAME DAY, THE DEVICE SYSTEM WAS EXPLANTED. A LEFT RENAL ARTERY BYPASS WAS PERFORMED, A THROMBECTOMY WAS PERFORMED IN BOTH ILIAC ARTERIES, A DACRON GRAFT WAS SURGICALLY IMPLANTED, AND A CUT DOWN WAS PERFORMED AT THE PATIENT'S LEFT GROIN TO RESOLVE REMAINING THROMBUS. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18718545 ↗
• InjuryOct 9, 2023Break; Break

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9- INFRARENAL ABDOMINAL AORTIC ANEURYSM MEASURING 7CM IN DIAMETER. ADDITIONALLY, THE PATIENT WAS REPORTED TO HAVE A HIGHLY ANGULATED NECK (DEGREE UNKNOWN) AND A DISSECTION THAT EXTENDED FROM THE LEFT SUBCLAVIAN ARTERY ALL THE WAY TO THE RENAL ARTERIES. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS ADVANCED UP THE LEFT SIDE AND LANDED JUST FINE BELOW THE LOWEST RENAL ARTERY AND AVOIDING THE AREA OF DISSECTION. THE PHYSICIAN CAME UP THE LEFT SIDE TO CANNULATE THE GATE HOWEVER THERE WAS SOME ANGULATION OF THE GATE DUE TO THE SIZE OF THE ANEURYSM. A COUPLE OF TRIES WERE MADE BEFORE SUCCESSFUL CANNULATION OF THE GATE WAS ACHIEVED AND A CONTRALATERAL LEG COMPONENT ADVANCED WAS DEPLOYED; HOWEVER HALFWAY INTO DEPLOYING THE JUST DEPLOYMENT LINE JUST ¿LOCKED UP¿. THE LOOKED UNDER FLUOROSCOPY TO SEE IF THEY COULD DETERMINE A CAUSE OF THE STUCK DEPLOYMENT LINE AS THE DEVICE WAS ALREADY HALFWAY DEPLOYED, BUT WERE UNABLE TO DETERMINE A CAUSE. AS THEY WERE UNABLE TO ADVANCE A BALLOON CATHETER FROM THE TOP DUE TO THE DISSECTION

  Patient problems: Aneurysm

  MAUDE report 17901955 ↗
• InjuryMay 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH A SUSPECTED TYPE IB ENDOLEAK FROM THE CONTRALATERAL LEG LIMB IN THE LEFT COMMON ILIAC. THE PHYSICAN EXTENDED THE LIMB WITH TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES DISTALLY TO THE ORIGIN OF THE LEFT HYPOGASTRIC. THE PHYSICIAN ALSO USED A MEDTRONIC BALLOON TO BALLOON THE DEVICES ON THE LEFT SIDE, AS WELL AS THE RIGHT COMMON ILIAC, AS THERE WAS A POSSIBLE TYPE IB ENDOLEAK ON THE RIGHT LIMB EXTENSION OFF THE MAIN BODY. THE PROCEDURE WAS SUCCESSFUL, AND THE ENDOLEAKS WERE RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16964677 ↗
• MalfunctionOct 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, THE PATIENT WAS TREATED EMERGENTLY FOR AN ABDOMINAL AORTIC ANEURYSM. AS PART OF THE PROCEDURE, THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DEVICE WAS IMPLANTED, AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY CATHETER, THE OLIVE TIP BROKE OFF. IT WAS RECOVERED, AND THE DELIVERY CATHETER AND OLIVE WILL BE RETURNED FOR EVALUATION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615933 ↗
• InjuryAug 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 5.5 CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED THAT THE PATIENT HAD A PERSISTENT TYPE II ENDOLEAK AND THE ANEURYSM MEASURED APPROXIMATELY 6.2 CM IN DIAMETER. THE PHYSICIAN REPORTED THE DEVICE LOOKED GOOD. THE PHYSICIAN BASED ON THE PATIENT¿S AGE IS PLANNING TO EITHER OPEN THE PATIENT AND EITHER REMOVE THE DEVICE OFF THE LUMBAR'S OR REMOVE THE DEVICE AND SEW OFF THE LUMBAR'S AND PLACE AN OPEN GRAFT. THE PHYSICIAN REPORTED THIS IS IN DESPITE OF NOTHING BEING WRONG WITH THE DEVICE, IT HASN'T MOVED. THERE IS NO TYPE 1 ENDOLEAK TYPE 3, NO TYPE 4. SO NOT COMPLETELY CLEAR, THERE IS NO FAILURE POINT THE PHYSICIAN CAN SEE. PHYSICIAN REPORTS THE PATIENT HAS A VERY ANGLED NECK EXCEEDING; OR RIGHT AT A 60 DEGREE ANGLE. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION WHEREIN THEY OPENED THE PATIENT, CLAMPED THE AORTA ABOVE THE DEVICE AND CONVERTED THE PATIENT TO OPEN SURGICAL REPAIR AND EXPLANTED THE DEVICES. NO ENDOLEAK WAS ABLE TO BE CONFIRMED, THE PHYSICIAN REPORTED

  Patient problems: Aneurysm

  MAUDE report 15263296 ↗
• InjuryJul 20, 2022Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH ABDOMINAL AORTIC ANEURYSM AND ON (B)(6) 2022, WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DEVICES WERE ADVANCED USING AN 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT TOLERATED THE PROCEDURE. POST-OPERATIVE CT IMAGES FROM (B)(6) 2022, SHOWED A DISSECTION PROXIMAL TO THE RIGHT ILIAC BIFURCATION THAT HAD NOT BEEN PRESENT PRIOR TO THE PROCEDURE. IT IS ASSUMED THAT ADVANCING THE SHEATH WITHOUT THE DILATOR IN THIS AREA MAY HAVE CONTRIBUTED TO THE EVENT. NO REINTERVENTION IS PLANNED.

  Patient problems: Vascular Dissection

  MAUDE report 15064027 ↗
• InjuryJun 29, 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) 2020, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS STENT GRAFT CONTRALATERAL LEG COMPONENT AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DOWN THE LEFT SIDE. THE PATIENT WAS ALSO IMPLANTED GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT PRESENTED WITH LOWER LEFT EXTREMITY ISCHEMIA. ON (B)(6) 2022, THERE WAS A REINTERVENTION IN WHICH THE FOLLOWING OCCURRED: LEFT COMMON FEMORAL ARTERY (CFA) CUTDOWN, SUPERFICIAL FEMORAL ARTERY (SFA) AND PROFUNDA THROMBECTOMY, BELOW THE KNEE-POP CUTDOWN, ENDARTERECTOMY OF TIBIOPERONEAL TRUNK WITH PATCH ANGIOPLASTY, POP ANEURYSM LIGATION, FEMORAL TO TIBIOPERONEAL TRUNK BYPASS WITHIN SITU THE GREAT SAPHENOUS VEIN (GSV). ADVERSE EVENT OUTCOME, THE PATIENT RECOVERED.

  Patient problems: Ischemia

  MAUDE report 14851507 ↗
• InjuryMay 27, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261412) AND TWO CONTRALATERAL LIMBS (PLC181200 AND PLC201200). ON (B)(6) 2022 IT WAS REPORTED THAT ONE OF THE LIMBS HAD CLOTTED OFF IN THE PATIENT. IT WAS LATER CONFIRMED THAT THIS WAS ON THE CONTRALATERAL SIDE AND DID NOT INVOLVE THE TRUNK. IT REMAINS UNKNOWN WHICH IMPLANTED CONTRALATERAL LIMB WAS INVOLVED IN THE EVENT. THIS INFORMATION WAS REQUESTED BUT WAS NOT CONFIRMED. A REINTERVENTION PROCEDURE WAS CONSIDERED. THE PLAN FOR THE REINTERVENTION WAS TO PERFORM ADDITIONAL ANGIOGRAPHY AND THEN LYSE AND REMOVE THE CLOT THAT HAD FORMED. IF THAT WAS NOT SUCCESSFUL THAN THE PHYSICIAN HAD PLANNED TO PERFORM A FEMORAL-TO-FEMORAL BYPASS IN ORDER TO PRESERVE ADEQUATE BLOOD FLOW TO THE LIMB. DURING THE PRE-REINTERVENTION ANGIOGRAPHY IT WAS NOTED THAT THERE DID NOT APPEAR TO BE A CLOT AS HAD BEEN ORIGINALLY INDICATED/SUSPECTED. IT APPEARED THAT THERE WAS A KINK IN THE GRAFT. AS REPORTED, THERE WERE NO OBSERVED ANATOMICAL RESTRICTIONS AND THE CAUSE OF THE KINK REMAINS UNKNOWN. A FEMORAL-TO-FEMORAL BYPASS WAS CO

  Patient problems: Obstruction/Occlusion

  MAUDE report 14523309 ↗
• InjuryFeb 25, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, THE RIGHT HYPOGASTRIC ARTERY WAS INADVERTENTLY COVERED. THE PHYSICIAN DECIDED TO MONITOR THE SITUATION, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN COVERED THE ARTERY BECAUSE HE DIDN'T NOTICE ONE OF THE MARKERS ON THE GRAFT DURING THE PROCEDURE, RESULTING IN INCORRECT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599257 ↗
• InjuryFeb 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA TRUNK IPSILATERAL ENDOPROSTHESIS, RLT311413 (B)(4), AND TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES, PLC181200 (B)(4) AND PLC201400 (B)(4) FOR AN UNSPECIFIED DIAGNOSIS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES PLC231000 (B)(4) AND A PLC271000 (B)(4). AS REPORTED, A TYPE 1B ENDOLEAK WAS OBSERVED AND THE GORE® EXCLUDER® AAA PLC271000 (B)(4) WAS IMPLANTED IN ORDER TO TREAT THE ENDOLEAK. THE DETAILS OF THIS PROCEDURE WERE REQUESTED BUT REMAIN UNKNOWN. IT WAS REQUESTED BUT IS UNKNOWN WHICH SIDE OF THE BODY THE ENDOLEAK WAS OBSERVED ON AND THEREFORE WHICH ENDOPROSTHESIS IT IS RELATED TO.

  Patient problems: Insufficient Information

  MAUDE report 13538257 ↗
• InjuryAug 10, 2021Break; Break

  ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNCOMPLICATED ENDOVASCULAR AORTIC ANEURYSM REPAIR USING THE FOLLOWING GORE® EXCLUDER® ENDOPROSTHESES: RLT261412, PLC181200, PLC141400 AND PLL161407. COMPLETION CONTROL WAS PERFORMED USING FLUOROSCOPY IMAGING WHICH LOOKED FINE. SIX WEEKS LATER A PLANNED CONTROL COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED. IT WAS REPORTED THAT THE IMAGES DEMONSTRATE, THAT A 14 CM LONG BROKEN PART OF THE DELIVERY CATHETER WITH STILL ATTACHED LEADING OLIVE IS STILL PRESENT INSIDE THE AORTA. IT WAS STATED THAT IT WAS LOCATED AT A BEND AND THEREFORE IT DID NOT MOVE DISTALLY DESPITE THE BLOOD PRESSURE. REPORTEDLY, THE PATIENT DID NOT HAVE DISORDERS, DISCOMFORT OR ANY OTHER MEDICAL CONDITION BECAUSE OF THE FOREIGN BODY. HE WAS ASYMPTOMATIC. IT WAS STATED THAT THE BROKEN CATHETER PART WAS NOT SEEN DURING COMPLETION FLUOROSCOPY IMAGING OF THE INDEX PROCEDURE FOR TWO REASONS: THE FLUOROSCOPY IMAGING FIELD OF INTEREST WAS DISTAL THE RENAL ARTERIES WHILE THE LEADING OLIVE WAS LOCATED PROXIMAL THE RENAL ARTERIES. THEREFORE THE RADIO-OPAQUE LEADING OLIVE WAS NOT DETECTED. THE DELIVERY CATHETER ITSELF COULD NOT BE VISUALIZED WITH THE ACQUIRED FLUOROSCOPY IMAGING. THEY

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300686 ↗
• InjuryFeb 19, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN AORTIC ANEURYSM WITH WAS ENDOVASCULARLY TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. IN TOTAL SIX DEVICES HAVE BEEN IMPLANTED. ON UNKNOWN DATE THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK WHICH OCCURRED AT THE DISTAL END OF THE CONTRALATERAL LEG OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181200). ON (B)(6) 2021, DURING AN ENDOVASCULAR REINTERVENTION, THE TYPE 1B ENDOLEAK WAS TREATED BY EXTENDING THE CONTRALATERAL LEG INTO THE COMMON INTERNAL ARTERY WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES (PLL161407 AND PLC231200).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11351657 ↗
• MalfunctionDec 18, 2020Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON DECEMBER 8, 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (RLT281416) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181200). AFTER TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (RLT281416) WAS DEPLOYED, CONTRALATERAL LEG ENDOPROSTHESIS (PLC181200) WAS ADVANCED VIA SHEATH (DSF1233) TO TARGET LESION. WHEN THE PHYSICIAN PULLED OUT THE DEPLOYMENT LINE TOTALLY WITHOUT ANY RESISTANCE, THE CONTRALATERAL LEG ENDOPROSTHESIS DIDN'T DEPLOY. THEN THE CONTRALATERAL LEG ENDOPROSTHESIS AND DELIVERY CATHETER WERE REMOVED FROM PATIENT. DURING THE INSPECTION, IT WAS FOUND THE DEPLOYMENT LINE WAS BROKEN AT DISTAL END OF ENDOPROSTHESIS. THE PHYSICIAN USED THE SCISSORS TO CUT THE DEPLOYMENT LINE ON THE ENDOPROSTHESIS AND DEPLOYED THE CONTRALATERAL LEG ENDOPROSTHESIS OUTSIDE THE PATIENT. ANOTHER NEW CONTRALATERAL LEG ENDOPROSTHESIS (PLC181400) WAS USED TO COMPLETE THE SURGERY. THE PATIENT TOLERANT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11033990 ↗
• InjuryDec 10, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, THIS PATIENT PRESENTED TO THE HOSPITAL WITH A RUPTURED 10 CM ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A 90° PROXIMAL AORTIC NECK. A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED SUCCESSFULLY ALONG WITH THE LIMBS ON THE LEFT SIDE. AN EXTENSION WAS NEEDED ON THE RIGHT SIDE. THE C-ARM IN THE ROOM USED FOR IMAGING OVERHEATED, SO ANOTHER C-ARM WAS BROUGHT IN THE OPERATING ROOM. HOWEVER, THAT C-ARM WAS AN OLDER UNIT, AND HAD POOR IMAGE QUALITY. THEREFORE, THE CONTRALATERAL LEG WAS DEPLOYED IN THE INCORRECT POSITION AND WAS DEPLOYED 4 CM LOWER THAN INTENDED AND UNINTENTIONALLY COVERED THE RIGHT HYPOGASTRIC ARTERY. AS THE LEFT HYPOGASTRIC ARTERY HAD GOOD PERFUSION, THE PHYSICIAN DECIDED TO LEAVE IT AS IS. THE PATIENT WAS LEFT IN ICU TO RECOVER FOR 6 HOURS, BUT AS HE WAS BEING TRANSFERRED TO THE RECOVERY FLOOR, HE CODED. AFTER HIS VITALS WERE RECOVERED HE WAS TAKEN BACK INTO THE CATHETER LAB, WHERE IMAGING SHOWED THAT THE CONTRALATERAL LEG IN THE RIGHT LIMB HAD BECOME DISLODGED AND MOVED DISTALLY. THEREFORE, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED ON THE RIGHT SIDE TO BRIDGE THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG AND THE TRUNK-I

  Patient problems: Occlusion

  MAUDE report 10987334 ↗

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