GORE EXCLUDER AAA Endoprosthesis PLC201200Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132618682), received between Apr 3, 2019 and May 20, 2026 — classified as 1 death, 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6), 2026, POST PROCEDURE IMAGES REVEALED TWO DISTAL ENDOLEAKS AND A TYPE III ENDOLEAK. THERE WAS A REINTERVENTION.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25236952 ↗
• InjuryMar 2, 2026Migration

  ON (B)(6) 2015, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN IMAGING WHICH SHOWED ANEURYSMAL DILATATION DISTAL TO THE ORIGINALLY IMPLANTED LIMBS ON BOTH SIDES. IT IS UNKNOWN IF THE LIMBS MIGRATED PROXIMALLY FROM THE ORIGINAL PLACEMENT, HOWEVER THE RIGHT LIMB IS CURRENTLY 21 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY AND THE LEFT LIMB IS 45 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY. ON (B)(6) 2025, THE PATIENT WAS BROUGHT IN FOR RE-INTERVENTION AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE DEVICES WERE IMPLANTED ON BOTH SIDES. A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS ALSO IMPLANTED ON THE LEFT SIDE LEFT SIDE PRIOR TO IBE PLACEMENT TO EXTEND THE PRIOR LIMB AND CREATE A LANDING ZONE. THIS SUCCESSFULLY EXCLUDED THE COMMON ILIAC ANEURYSMS. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Aneurysm

  MAUDE report 24483668 ↗
• InjuryFeb 23, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT WAS TREATED USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICE IN THE LEFT ILIAC, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS USED IN THE LEFT HYPOGASTRIC ARTERY, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG USED IN THE RIGHT ILIAC. ON (B)(6) 2026, THE PHYSICIAN NOTED THAT THE VBX DEVICE IN THE LEFT (IBE) SIDE HYPOGASTRIC ARTERY WAS OCCLUDED; AND THE EXCLUDER DEVICE ON THE RIGHT SIDE HAD A TYPE 1B ENDOLEAK. A REINTERVENTION IS PLANNED FOR THE TYPE 1B ENDOLEAK. IT IS UNKNOWN IF THERE WILL BE A REINTERVENTION FOR THE OCCLUSION.

  Patient problems: Clinical Endoleak

  MAUDE report 24413995 ↗
• InjuryDec 23, 2025Device Dislodged or Dislocated; Device Endoleak; Device Dislodged or Dislocated; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WITH CURVED ANATOMY UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (MAIN TRUNK COMPONENT) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT). THE DEVICES WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, IT WAS REPORTED THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) WAS DISCONNECTED FROM THE MAIN TRUNK, WITHOUT ANY MIGRATION OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (MAIN TRUNK COMPONENT). A REINTERVENTION WAS PERFORMED ON (B)(6) 2025. A DEVICE OF UNKNOWN BRAND WAS USED TO RELINE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG COMPONENT) AND IMPLANTED AS A BRIDGE STENT BETWEEN IT AND THE MAIN TRUNK COMPONENT. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 23875516 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT SHOWED UP AT SEATTLE VA AND WAS SEEN BY A PHYSICIAN WHO DETERMINED THE ANEURYSM SACK AND THE GRAFTS ARE INFECTED. THE PHYSICIAN PLANS TO EXPLANT THE DEVICES HOWEVER HOWEVER THIS PROCEDURE HAS NOT YET BEEN SCHEDULED, AS THE PATIENT WANTS TO WAIT. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES.

  Patient problems: Medical device site infection

  MAUDE report 23785485 ↗
• InjuryOct 29, 2025Positioning Failure; Positioning Failure

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WHILE ATTEMPTING A MANEUVER TO ACCORDION THE GRAFT (¿STUFF THE GRAFT 1CM¿), WHEN DEPLOYED THE GRAFT COVERED THE LEFT HYPOGASTRIC ARTERY. THERE WERE ACCESSORY VESSELS THAT SUPPLIED BLOOD FLOW, THE ARTERY WAS LEFT COVERED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 23420589 ↗
• MalfunctionMay 6, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH A 20MM X 12CM GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER DEVICE, CONTRALATERAL LEG) TO TREAT ABDOMINAL AORTIC ANEURYSM. EXCLUDER DEVICE WAS DELIVERED TO THE TARGET LESION. IT WAS FOUND THAT DEPLOYMENT KNOB COULDN'T BE PULLED AND DEPLOYED NORMALLY. AFTER SEVERAL ATTEMPTS WITHOUT SUCCESS, IT WAS WITHDRAWN FROM PATIENT. ANOTHER NEW EXCLUDER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN TESTED THE DEVICE AT BACK TABLE AFTER IT WAS WITHDRAWN. THE DEVICE WAS EXPANDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973731 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Aneurysm expansion

  MAUDE report 21963423 ↗
• InjuryDec 6, 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 UNDERWENT TREATMENT OF PARARENAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THERE WAS TECHNICAL SUCCESS FROM THE TAMBE PROCEDURE PERSPECTIVE, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT EXPERIENCED A STROKE, WHICH WAS CONFIRMED BY MRI. REPORTEDLY THE PATIENT HAD A PRE-EXISTING AORTIC ARCH PENETRATING ATHEROSCLEROTIC ULCER. THIS WAS DOCUMENTED AND DISCUSSED WITH THE HOSPITAL TEAM. IT WAS DETERMINED BY THE HOSPITAL TEAM THAT THE AAA WAS A GREATER RISK. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 20860053 ↗
• DeathJul 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 6/12/2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING PLC201200. UPON BALLOONING THE PLC201200 DEVICE, THE PATIENT'S AORTA RUPTURED AND WAS BLEEDING . PATIENT'S BLOOD PRESSURE DROPPED. PATIENT WAS OPENED UP IN AN ATTEMPT TO CONTROL THE BLEEDING. AND ULTIMATELY COULD NOT BE CONTROLLED, AND PATIENT EXPIRED. IT WAS ALSO REPORTED THERE WERE NO ISSUES DURING THE PROCEDURE, WHILE IMPLANTING THE DEVICES. THE BALLOON DID NOT RUPTURE AND WAS NOT OVER INFLATED. IN ADDITION, SOME THROMBUS AND CALCIFICATION (UNKNOWN EXACT AMOUNT, MEDIUM AMOUNT WAS BELIEVED TO BE PRESENT) WAS NOTED IN THE AREA OF BALLOONING. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. NO PATIENT INFORMATION OR FURTHER CASE INFORMATION IS AVAILABLE FROM THE PHYSICIAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 19707411 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT A REINTERVENTION WILL BE PERFORMED ON (B)(6) 2024, ADDITIONAL DEVICES WILL BE IMPLANTED. REPORTEDLY, THE REINTERVENTION WAS CANCELLED DUE TO PATIENT¿S CURRENT HEALTH STATUS. THE REASON FOR THE REINTERVENTION IS LOSS OF SEAL PROXIMALLY OF THE IMPLANTED TRUNK-IPSILATERAL LEG ENDOPROSTHESIS AND ON THE DISTAL END OF THE IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS. THE ROOT CAUSE OF THE LOSS OF SEAL IS UNKNOWN. THERE IS NO ANEURYSM SAC ENLARGEMENT. THE EVENT IS ONGOING.

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

  MAUDE report 19330597 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE) AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEGS). ON (B)(6) 2024, THE PATIENT CAME IN AS AN EMERGENT PROCEDURE DUE TO A RUPTURE AS THERE WAS A TYPE 3 ENDOLEAK (NOT FULLY DISCONNECTED BUT IT WAS JUST A BIT CRUSHED AT THE OVERLAP) BETWEEN THE CONTRALATERAL LEG AND THE TRUNK IPSILATERAL LEG ALONG WITH TYPE 1A ENDOLEAK ON THE TRUNK IPSILATERAL WHICH GOT PULLED DOWN A BIT (DISTANCE UNKNOWN) DUE TO INCREASING PRESSURE CAUSED BY THE TYPE 3 ENDOLEAK AND IT IS UNKNOWN IF THERE WAS ANEURYSM GROWTH AS PRIOR SCANS FROM ORIGINAL PROCEDURE ARE NOT AVAILABLE. DURING THE REINTERVENTION, THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE) ADDED BY THE PHYSICIAN WAS PLACED HIGH AT THE LEVEL OF THE RENALS WITH LITTLE OVERLAP INTO THE EXISTING MAIN BODY (TRUNK IPSILATERAL) THEN THE GORE® EXCLUDER®AAA ENDOPROSTHESIS (AORTIC EXTENDER) WAS PLACED TO BRIDGE THEM TOGETHER AND PROVIDE MORE OVERLAP THEN PHYSICIAN REALIGNED BOTH SIDES OF THE ORIGINAL GRAFTS WITH TWO GORE® EX

  Patient problems: Clinical Endoleak

  MAUDE report 18696600 ↗
• InjuryOct 24, 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) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT POST PROCEDURE COMPUTED TOMOGRAPHY IMAGES (DATE UNKNOWN), A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON FOLLOW UP IMAGES. THE PHYSICIAN TOOK A WAIT AND WATCH APPROACH, REPORTEDLY THE PATIENT HAD A VERY ANGULATED NECK WHEN IMPLANTED. ON (B)(6) 2023, THE PHYSICIAN CHOSE TO EXPLANT (SURGICAL CONVERSION) THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES DUE TO A PERSISTENT PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM GROWTH (AMOUNT UNKNOWN). THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm expansion

  MAUDE report 17999690 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6), 2023 THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WILL UNDERGO A REINTERVENTION FOR A TYPE 1B ENDOLEAK ON THE CONTRALATERAL LEG (PLC201200). THERE IS GROWTH IN ANEURYSM SIZE AS THE AAA IS 9CM, PRIOR SIZE IS UNKNOWN BUT GROWTH HAS BEEN NOTICED THAT LED TO THE LEFT COMMON ILIAC ARTERY (LCIA) BEING DILATED AND ENLARGED. PHYSICIAN PLANS TO COIL THE LEFT INTERNAL ILIAC ARTERY (LIIA) AND EXTEND INTO THE LEFT EXTERNAL ILIAC ARTERY (LEIA). ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE IN ZONE11-INTERNAL/EXTERNAL ILIAC TO TREAT THE TYPE 1B ENDOLEAK UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND ILIAC EXTENDER) BY COILING THE LEFT INTERNAL ILIAC ARTERY (LIIA) THEN THE PHYSICIAN EXTENDED DISTALLY WITH CONTRALATERAL LEG (PLC141200) FROM THE FLOW DIVIDER DOWN AND EXTENDED WITH ILIAC EXTENDER (PLL161007) INTO THE LEFT EXTERNAL ILIAC ARTERY (LEIA). REPORTEDLY, PHYSICI

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17737271 ↗
• InjurySep 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN INTERNAL ILIAC ARTERY ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON THE SAME DAY, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PATIENT WAS TREATED WITH AN ADDITIONAL ILIAC BRANCH COMPONENT WHICH WAS COMPLETED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INSERTED THROUGH THE RIGHT AXILLARY ARTERY. AFTER CANNULATION, A 8F COOK FLEXOR INTRODUCER SHEATH WAS INSERTED: THE BXA117902E DEVICE COULD NOT ADVANCE THROUGH THE INTRODUCER SHEATH AND HAD TO BE EXCHANGED WITH AN 8LX79 CONFIG VBX, WHICH WAS CORRECTLY ADVANCED AND DEPLOYED. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE END OF THE PROCEDURE. IMAGING IS NOT AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 17711373 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE ORIGINAL PLAN WAS TO DO A COMPONENT PROCEDURE WITH NO MAIN BODY. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS, BUT DUE TO A MEASURING ERROR, THE DEVICE WAS TOO SHORT. IT WAS REMOVED, AND A LONGER GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED. WHILE BALLOONING THIS DEVICE, THE ANEURYSM RUPTURED. AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED TO HELP COVER THE RUPTURE. IT WAS THEN DECIDED TO PROPHYLACTICALLY IMPLANT MORE GRAFTS IN ORDER TO ENSURE THE RUPTURE WAS SEALED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 17002485 ↗
• InjuryJun 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY (AAA 17-01) FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE. ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH TWO GORE® CONTRALATERAL LEG ENDOPROSTHESES, A GORE® ILIAC BRANCH ENDOPROSTHESIS AND THE 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 THIS SAME DAY THE PATIENT EXPERIENCED A RUPTURE OF THE AORTIC BIFURCATION, PARAPLEGIA, HEMORRHAGIC SHOCK AND SPINAL CORD ISCHEMIA. IT IS NOT KNOWN IF THESE ADVERSE EVENTS OCCURRED INTRAPROCEDURAL OR POST PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14793257 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, ANEURYSM ENLARGEMENT WAS IDENTIFIED DUE TO A TYPE 1B ENDOLEAK ORIGINATING FROM THE DISTAL END OF THE RIGHT LIMB. ON THE SAME DAY, TREATMENT WAS PERFORMED WHEREBY EXTENSION OF THE RIGHT LIMB WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 11671520 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON OR AROUND (B)(6) 2021, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REPORTEDLY IDENTIFIED ANEURYSMAL DISEASE PROGRESSION DISTAL TO THE CONTRALATERAL LIMB AND INTO THE INTERNAL ILIAC ARTERY ON THE LEFT SIDE. ON (B)(6) 2021, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED AS TREATMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11484165 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019 AN IN STENT STENOSIS WAS SEEN ON CT IN THE RIGHT COMMON ILIAC ARTERY. THE ILIAC ARTERY STENT IS PATENT. THERE HAS BEEN NO REINTERVENTION. THE PATIENT IS ASYMPTOMATIC. THE EVENT IS ONGOING.

  Patient problems: Stenosis

  MAUDE report 8672223 ↗
• InjuryApr 3, 2019Complete Blockage; Complete Blockage

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA (EXCLUDER) ENDOPROSTHESES. ON (B)(6) 2019 ANGIOGRAPHY IDENTIFIED THAT THE CONTRALATERAL LEG COMPONENT OF THE EXCLUDER SYSTEM WAS OCCLUDED. REPORTEDLY THE CONTRALATERAL LIMB, LOCATED ON THE PATIENT'S RIGHT SIDE, WAS OCCLUDED TO THE LEVEL OF THE FLOW DIVIDER. IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMOROFEMORAL BYPASS. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Occlusion

  MAUDE report 8481224 ↗

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