GORE EXCLUDER AAA Endoprosthesis PLC271400Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00733132618606), received between Oct 31, 2018 and May 25, 2026 — classified as 4 deaths, 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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.

• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ALLEGEDLY, ON (B)(6) 2026, DURING A CT SCAN, AN ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN) WAS OBSERVED DISTALLY. NO ENDOLEAK OR OTHER ISSUES WERE NOTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH A PLC231000 DEVICE WAS IMPLANTED DISTAL TO AN EXISTING CONTRALATERAL LIMB ON THE RIGHT SIDE, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 25273234 ↗
• DeathMay 6, 2026No Apparent Adverse Event

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED IN THE ABDOMINAL AND THORACIC AORTA ALONG WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE AORTIC MAIN VISCERAL VESSELS. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON APRIL 29, 2026, IT WAS REPORTED THAT THE PATIENT EXPIRED; THE PHYSICIAN REPORTS THE CAUSE OF DEATH DEAD BOWL/BOWEL ISCHEMIA. THE PHYSICIAN DOES NOT ALLEGE ANY DEFICIENCY OF THE GORE DEVICES AND STATES THEY ALL PERFORMED AS INTENDED AND THE PROCEDURE HAD BEEN CONCLUDED WITH GOOD TECHNICAL RESULTS. FOLLOW-UP COMPUTED TOMOGRAPHY HAD SHOWN ALL DEVICES TO BE PATENT, WITH NO ENDOLEAK OR INDICATION OF DISSECTION.

  Patient problems: Ischemia

  MAUDE report 25107129 ↗
• InjuryApr 9, 2026Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL ANEURYSM IV USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, INCLUDING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE. MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES AND MULTIPLE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) DEVICES WERE PLACED IN THE VISCERAL VESSELS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, AT ONE-MONTH FOLLOW-UP, CT SHOWED THE FOLLOWING: A TYPE 1B ENDOLEAK ON THE EXCLUDER RIGHT ILIAC LIMB, DUE TO STENT RETRACTION INTO ANEURYSMAL ILIAC. ON (B)(6) 2026, A REINTERVENTION OCCURRED. A STENT GRAFT WAS PLACED EXTENDING THE RIGHT ILIAC LIMB.

  Patient problems: Clinical Endoleak

  MAUDE report 24831303 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA24-01 TAMBE POST APPROVAL STUDY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA CLINICAL 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) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH A CONTAINED RUPTURE OF THE PERIVISCERAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2026, ENDOVASCULAR REPAIR OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH A LEFT ILIAC EXTENSION INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED. THERE WAS AN AORTIC CUFF IMPLANTED PROXIMALLY TO THE TAMBE DEVICE TO OVERLAP THIS REGION TO PREVENT A POSSIBLE JUNCTIONAL ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2026 PATIENT DEVELOPED ACUTE KIDNEY FAILURE, THE EVENT IS ONGOING.

  Patient problems: Ruptured Aneurysm

  MAUDE report 24677225 ↗
• MalfunctionMay 13, 2025Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AS WELL AS GORE® AORTIC EXCLUDER AAA ILIAC BRANCH ENDOPROSTHESIS DEVICES TO TREAT A LEFT COMMON ILIAC ARTERY ANEURYSM MEASURING 13 CM. A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT (B)(6) WAS SELECTED AS A BRIDGE GRAFT BETWEEN THE GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT (RLT) AND THE GORE® AORTIC EXCLUDER AAA ILIAC BRANCH ENDOPROSTHESIS (CEB). DUE THE ANATOMY OF THE PATIENT, THE TRUNK COMPONENT SHOWED AN ANGLE OF APPROXIMATELY 60 DEGREES. THE CONTRALATERAL LEG COMPONENT WAS INSERTED INTO A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH AND ADVANCED, BUT DIFFICULTIES IN CANNULATING THE CONTRALATERAL GATE WITH THE SHEATH WERE REPORTEDLY EXPERIENCED DUE TO ANGLE OF THE AORTIC NECK. IT WAS THEREFORE DECIDED TO RETRACT THE (B)(6) COMPONENT OUT OF THE PATIENT. HOWEVER, DURING DEVICE REMOVAL IT WAS OBSERVED THAT THE STENT HAD DETACHED FROM THE DELIVERY CATHETER AND HAD REMAINED INSIDE THE SHEATH. IT WAS ALSO NOTICED THAT THE LEADING END HAD SEPARATED AND WAS HANGING BY THE WIRE. REPORTEDLY, THE CAUSE WAS BELIEVED TO BE A "WEAK

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010099 ↗
• InjuryJan 9, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2015, THIS PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES TO TREAT A RIGHT COMMON ILIAC ARTERY ANEURYSM MEASURING 48 MM. ON (B)(6) 2015 COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING REVEALED AN ANEURYSM DIAMETER OF 36,3 MM, FOLLOWED BY 41 MM (CTA IMAGING) ON (B)(6) 2018. ON (B)(6) 2018, COIL EMBOLISATION OF THE INTERNAL ILIAC ARTERY DUE TO ANEURYSM GROWTH WAS PERFORMED. THE PROCEDURE REPORTEDLY SERVED TO PREPARE THE IMPLANT OF AN ADDITIONAL STENT DUE TO A TYPE 1B ENDOLEAK PRESUMABLY RELATING TO THE GORE® EXCLUDER® INTERNAL ILIAC COMPONENT HGB161007. ON (B)(6) 2018, THE PATIENT RECEIVED AN ADDITIONAL ENDOPROSTHESIS AS PLANNED. ON (B)(6) 2019, FOLLOW-UP CTA IMAGING FOUND THE ANEURYSM TO MEASURE 46 MM IN DIAMETER.

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

  MAUDE report 21116018 ↗
• InjurySep 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, IT WAS DETERMINED THE CONTINUED LEFT COMMON ILIAC ARTERY EXPANSION WHICH WAS REQUIRED THE ILIAC ARTERY EXTENSION. ON THE SAME DAY, A REINTERVENTION PROCEDURE OCCURRED AND THE PLC271400/(B)(6) WAS EXTENDED BY GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC121400/(B)(6) AND PLC121400/(B)(6)). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 20242972 ↗
• InjurySep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 5 DESCENDING AORTIC ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® ABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). AT THE CONCLUSION OF THE PROCEDURE A SLIGHT DISTAL TYPE I ENDOLEAK WAS NOTED AND DETERMINED TO BE ASSOCIATED WITH THE GORE® EXCLUDER® CONTRALTERAL LEG COMPONENT (PLC271400/28148793) IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN CHOSE TO WATCH AND WAIT TO SEE IF THE ENDOLEAK WOULD RESOLVE ITSELF. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOLLOW-UP IMAGING AND THE PATIENT WAS DETERMINED TO HAVE A PSEUDOANEURYM IN THE BRACHIAL ARTERY, WHICH IS BELIEVED TO BE PROCEDURE, NOT DEVICE RELATED. ON (B)(6) 2024, THE PATIENT UNDERWENT RE-INTERVENTION AND THE GORE® EXCLUDER® CONTRALTERAL LEG COMPONENTS IN THE COMMON ILIAC ARTERY EXTENDED FROM THE TAMBE SYSTEM WERE BILATERALLY EXT

  Patient problems: Clinical Endoleak

  MAUDE report 20131611 ↗
• InjuryMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. FINAL ANGIOGRAM ALSO REVEALED A DISTAL TYPE I ENDOLEAK COMING FROM THE RIGHT IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS. ONE UNIT OF BLOOD WAS GIVEN DURING THE PROCEDURE DUE TO THE RUPTURED ANEURYSM UPON PATIENT¿S HOSPITAL ARRIVAL. REPORTEDLY, THE FINAL ANGIOGRAPHY IMAGES WERE POOR QUALITY DUE TO THE PATIENT¿S OBESITY. BOTH A PROXIMAL TYPE I AND A DISTAL TYPE I ENDOLEAK REMAINED. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO REPAIR THE UNRESOLVED ENDOLEAKS FROM THE PROCEDURE ON (B)(6) 2024. THE PHYSICIAN PLANNED A PHYSICIAN MODIFIED ENDOGRAFT (PMEG) PROCEDURE. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) WAS IMPLANTED TO TREAT THE DISTAL TYPE I ENDOLEAK ON THE RIGHT LIMB SIDE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 19374488 ↗
• MalfunctionApr 30, 2024

  OPENED A 16MM X 27MM GORE CONTRALATERAL LEG STENT TO THE STERILE FIELD. SCRUB NURSE ATTEMPTED TO FLUSH STENT WITH HEPARINIZED SALINE, BUT WAS UNABLE. DOCTOR ATTEMPTED TO TROUBLESHOOT. THEY COULD NOT SUCCESSFULLY FEED AN ENDOWIRE THROUGH THE FRONT OR BACK PART OF THE STENT, INDICATING SOME TYPE OF BLOCKAGE/OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213365 ↗
• DeathApr 18, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF AN UNRUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE IPSILATERAL LIMB WAS REPORTEDLY ON THE LEFT SIDE WITH THE CONTRALATERAL LEG GATE BEING ON THE RIGHT. ON (B)(6) 2024, THE PATIENT REPORTEDLY PRESENTED TO THE EMERGENCY ROOM WITH PAIN. A CT WAS PERFORMED AND IMAGING REPORTEDLY REVEALED THAT THE ANEURYSM HAD RUPTURED. APPROXIMATELY ONE HOUR LATER, THE PATIENT WAS RESCANNED AND WAS TRANSFERRED TO A DIFFERENT FACILITY. IT WAS REPORTED THAT, BEFORE THE PATIENT WAS ABLE TO UNDERGO REINTERVENTION, THE PATIENT EXPIRED. IT IS UNKNOWN IF ANEURYSM ENLARGEMENT WAS PRESENT PRIOR TO THE RUPTURE. IT WAS SUSPECTED THAT THERE MAY HAVE BEEN A TYPE III ENDOLEAK AT THE FLOW DIVIDER AS CONTRAST WAS REPORTEDLY OBSERVED IN THE ANEURYSM SAC AT OR NEAR THE FLOW DIVIDER.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19139666 ↗
• InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2017, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND TWO LIMBS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT PRESENTED WITH MID BACK PAIN. IMAGING SHOWED A DESCENDING AORTIC PAU. THE PHYSICIAN ALSO NOTED A POSSIBLE TYPE IA ENDOLEAK ON THE MAIN BODY, AND TYPE IB ENDOLEAKS ON EACH OF THE LIMBS. WHILE ATTEMPTING TO TREAT THE PAU, THE PHYSICIAN TORE THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN USED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM TO REPAIR THE PAU. THE PHYSICIAN THEN RELINED THE EXISTING GRAFTS, WHICH REPAIRED THE ENDOLEAKS AND THE TORN REIA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18980180 ↗
• DeathMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS TREATED WITHIN INSTRUCTIONS FOR USE BUT REPORTEDLY HAD A HIGHLY ANGULATED NECK. THE PATIENT REMAINED IN THE HOSPITAL RECEIVING IN-PATIENT CARE. ON (B)(6) 2024, THE PATIENT COMPLAINED ABDOMINAL PAIN. DEVICE MIGRATION OF A CONTRALATERAL LEG AND A POSSIBLE TYPE IA ENDOLEAK AFFECTING THE TRUNK IPSILATERAL LEG WERE SUSPECTED BUT WERE NOT CONFIRMED WITH IMAGING (THIS EVENT IS DOCUMENTED IN FDA MEDWATCH REPORT 3007284313-2024-03102, MANUFACTURER REF. NO. (B)(4)). A REINTERVENTION WAS PERFORMED AND A MEDTRONIC AORTIC EXTENDER WAS IMPLANTED. IT WAS REPORTED THAT THE AORTIC EXTENDER DID NOT SEAL AND THAT IT EITHER MIGRATED OR WAS NOT EXTENDED FAR ENOUGH. THE ANEURYSM WAS NOT SUCCESSFULLY EXCLUDED AND RUPTURED FOLLOWING THE PROCEDURE. THE PATIENT WAS NOT IN GOOD ENOUGH CONDITION FOR CONVERSION TO AN OPEN PROCEDURE. THE PATIENT DIED DUE TO THE RUPTURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18895372 ↗
• DeathMar 12, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS TREATED WITHIN INSTRUCTIONS FOR USE BUT REPORTEDLY THE ANEURYSM HAD A HIGHLY ANGULATED NECK. THE PATIENT REMAINED IN THE HOSPITAL RECEIVING IN-PATIENT CARE. ON (B)(6) 2024, THE PATIENT COMPLAINED ABDOMINAL PAIN. DEVICE MIGRATION OF A CONTRALATERAL LEG AND A POSSIBLE TYPE IA ENDOLEAK AFFECTING THE TRUNK IPSILATERAL LEG WERE SUSPECTED BUT WERE NOT CONFIRMED WITH IMAGING. A REINTERVENTION WAS PERFORMED AND A MEDTRONIC-BRAND AORTIC EXTENDER (UNKNOWN MODEL) WAS IMPLANTED TO TREAT THE TYPE IA ENDOLEAK. IT WAS REPORTED THAT THE AORTIC EXTENDER DID NOT SEAL AND THAT IT EITHER MIGRATED OR WAS NOT EXTENDED FAR ENOUGH. IT WAS REPORTED THAT THE AORTIC EXTENDER DID NOT SEAL AND THAT IT EITHER MIGRATED OR WAS NOT EXTENDED FAR ENOUGH. IT WAS ALSO REPORTED THAT THE ADDITIONAL DEVICES MAY HAVE CAUSED MIGRATION OF THE ALREADY IMPLANTED DEVICES. THE ANEURYSM WAS NOT SUCCESSFULLY EXCLUDED AND RUPTURED FOLLOWING THE PROCEDURE. THE PATIENT WAS NOT IN GOOD ENOUGH CO

  Patient problems: Ruptured Aneurysm

  MAUDE report 18886750 ↗
• InjuryNov 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC271400). ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 10 LEFT COMMON ILIAC REVISION PROCEDURE TO A PRIOR EVAR UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE-(B)(6), GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC201200), AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (B)(6). REPORTEDLY, THE ORIGINAL GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC271400) IMPLANT FROM (B)(6) 2017 HAD LOST WALL APPOSITION AND BECAME ANEURYSMAL IN THE LEFT COMMON ILIAC ARTERY. THERE WAS NO ENDOLEAK OR MIGRATION. THE IBE REINTERVENTION WAS DONE BY FIRST PLACING THE PLC201200 INSIDE THE PLC271400 THEN THE (B)(6) WAS PLACED INSIDE TO ENSURE ADEQUATE WALL APPOSITION, AFTER WHICH, BOTH VBX DEVICES CAME DOWN FROM THE ARM INTO THE LEFT INTERNAL ILIAC ARTERY. PATIENT IS DOING WELL AFTER THE PROCEDURE. PHYSICIAN INDICATED THE WALL APPOSITION LOSS WAS DUE TO DISEASE PROGRESSION IN THE LEFT COMMON ILIAC ARTERY AS IT BECAME ENLARGED (ANEURYSM SIZE UNKNOWN) BUT THERE WAS CONTINUED GROWTH.

  Patient problems: Aneurysm expansion

  MAUDE report 18127721 ↗
• InjuryNov 2, 2023Positioning Failure; Positioning Failure

  ON (B)(6), 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A LACK OF CIRCUMFERENTIAL APPOSITION OF THE RIGHT COMMON ILIAC LIMB (PLC271400/ 18460808). IT WAS REPORTED THAT SEAL HAD BEEN LOST AS THE RIGHT COMMON ILIAC ARTERY HAD BECOME ANEURYSMAL CAUSING DILATION OF THE ARTERY. THE PHYSICIAN WENT IN AND EXTENDED THE LIMB DOWN TO THE EXTERNAL ILIAC ARTERY, WITH INTENTIONAL COVERAGE OF THE INTERNAL ILIAC ARTERY WHICH WAS OCCLUDED. NO ENDOLEAK WAS SEEN, JUST THE ILIAC ARTERY ANEURYSM THAT HAD DEVELOPED HAD CAUSED THE LIMB TO LOSE APPOSITION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 18062339 ↗
• InjuryOct 16, 2023Unintended Movement; Unintended Movement

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9 INFRARENAL PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (TWO INTERNAL ILIAC COMPONENTS AND ILIAC BRANCH COMPONENT), GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER AND 3 CONTRALATERAL LEGS) AND GORE® MOLDING & OCCLUSION BALLOON CATHETER AS AN ACCESSORY. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT PRESENTED IN EMERGENCY AS A SYMPTOMATIC ANEURYSM WITH VERY CHALLENGING (TORTUOUS) ANATOMY AND MULTIPLE (8) HEALTH ISSUES. PATIENT APPEARS TO HAVE AN IBE JUNCTION LEAK ON THE RIGHT SIDE AND PHYSICIAN PLANS TO DO A REINTERVENTION IN THE FUTURE BUT FIRST THEY ARE TREATING THE PATIENT'S MANY OTHER HEALTH ISSUES NOT RELATED TO THE ABDOMINAL AORTIC ANEURYSM (AAA) AND COMMON ILIAC ANEURYSM THAT WILL BE EXTENDING THE LIMB DISTALLY. REINTERVENTION IS PLANNED BUT DATE IS UNKNOWN AS THE OTHER HEALTH ISSUES ARE MORE PRESSING CONCERNS.

  Patient problems: Clinical Endoleak

  MAUDE report 17940489 ↗
• InjuryOct 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6), 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT'S COMMON ILIAC ARTERY TAPERED FROM 23MM TO 15MM AND, DURING CASE PLANNING, IT WAS DETERMINED THAT THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY MAY REQUIRE COILING AND COVERAGE IN ORDER TO OBTAIN SEAL. HOWEVER, AFTER DISCUSSIONS, THE PHYSICIAN AND PATIENT OPTED TO KEEP THE INTERNAL ILIAC ARTERY PATENT AND MONITOR THE IMPLANTED LIMB. THEREFORE, A CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY AND ENDED APPROXIMATELY 15MM FROM THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY. THERE WERE NO REPORTED ISSUES AT THE CLOSE OF THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE. DURING FOLLOW-UP ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK WAS OBSERVED ON THE CONTRALATERAL LEG COMPONENT IN THE PATIENT'S RIGHT LIMB. ON (B)(6), 2023, THE PATIENT UNDERWENT REINTERVENTION. THE PATIENT'S INTERNAL ILIAC ARTERY WAS COILED. AN ILIAC EXTENDER COMPONENT AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WERE USED TO EXTEND THE RIGHT LIMB DISTALLY AND OBTAIN ANEURYSM

  Patient problems: Clinical Endoleak

  MAUDE report 17909651 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL SPECIALIST (CS) REPORTED THE FOLLOWING: ON (B)(6) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR A RIGHT ILIAC AORTIC ANEURYSM WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT DURING FOLLOW UP IMAGES ON (B)(6) 2023, THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN) AND A TYPE III ENDOLEAK (COMPONENT DISCONNECTION). A REINTERVENTION WAS PERFORMED TO BRIDGE THE DISCONNECTION BETWEEN THE GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (LOT/SERIAL NUMBER IS UNKNOWN) AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES ILIAC BRANCH COMPONENT. DURING THE REINTERVENTION PROCEDURE THE PHYSICIAN WAS USING A 18FR SHEATH SO HE COULD ADVANCE THE DELIVERY CATHETER AND A APTUS TOURGUIDE 6FR SHEATH TOGETHER. HE PLANNED TO ADVANCE COLLAGEN PLUGS INTO THE ANEURYSM SAC WITH THE APTUS TOURGUIDE SHEATH. THERE WAS NO RESISTANCE WHILE ADVANCING THE DELIVERY CATHETER OR THE 6FR SHEATH. WHEN DEPLOYING THE GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS THERE WAS DIFFICULTY WITH THE DEPLOYMENT. THE LAST 2CM OF THE DEVICE WOULD NOT FULLY DEPLOY. THE PHYSICIAN USED FORCE TO GET THE DEPLOYMENT COMPLETE AND THE DEPLOYMENT L

  Patient problems: Aneurysm

  MAUDE report 16806708 ↗
• InjuryApr 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN EVAR PROCEDURE UTILIZING FIVE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 -RMT261418, CONTRALATERAL LEG - PXC121400 & PLC271400, ILIAC EXTENDER - PXL161407 AND AORTIC EXTENDER - PLA320400). ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 11 - INTERNAL/EXTERNAL ILIAC TO REALIGN EXISTING GRAFTS UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT CONTRALATERAL LEG - PLC141400 AND PLC121200) TO EXTEND DISTALLY THE LEFT LIMB OF THE GRAFT FROM THE GATE RING TO THE EXTERNAL ILIAC (LEFT). THERE WERE NO COMPLICATIONS, AND THE PATIENT¿S ANEURYSM IS GROWING BUT THERE IS NO TYPE 1A/1B, 2, OR 3 ENDOLEAK THAT CAN BE VISUALIZED ON THE CTA OR ANGIOGRAM. THE PHYSICIAN EXTENDED THE LEFT SIDE BECAUSE HE THOUGHT IT WAS A POTENTIAL ENDOLEAK SITE THAT WAS NOT BEING OBSERVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PATIENT WAS SEEN FOR FOLLOW-UPS ONCE A YEAR (DATES UNKNOWN) PRIOR TO REINTERVENTION ON (B)(6) 2023, AND WILL HAVE A 3-MONTH FOLLOW UP AFTER THE REINTERVENTION (DATE UNKNOWN).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16769992 ↗
• InjuryJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2014, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, IT WAS OBSERVED THAT THREE OF THE EXCLUDERS HAD MIGRATED PROXIMALLY, AND THERE WAS NOW BILATERAL ANEURYSMS DISTAL TO THOSE DEVICES. A REINTERVENTION IS PLANNED. IMAGES WERE RETURNED FOR EVALUATION. EMAIL RECEIVED ON 22-DEC-2022 REPORTED THAT THE PLANNED REINTERVENTION TOOK PLACE ON (B)(6) 2022, MOVE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126761 ↗
• InjuryDec 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® LLIAC BRANCH ENDOPROSTHESIS (IBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED THE PATIENT HAD A DISTAL TYPE I ENDOLEAK DUE TO A LACK OF APPOSITION OF THE CONTRALATERAL LEG COMPONENT CAUSED BY DILATION OF THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN INTENDS TO RE-INTERVENE ON THE PATIENT, HOWEVER ONE HAS NOT YET BEEN SCHEDULED.

  Patient problems: Aneurysm

  MAUDE report 16035248 ↗
• InjuryJul 13, 2022Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS ON (B)(6) 2019. ON (B)(6) 2022, THE ENDOPROSTHESIS WAS EXPLANTED DUE TO INFECTION. THE INFECTION ORIGINATED IN THE PSOAS MUSCLE, WHICH CAUSED AN ABSCESS AND EVENTUAL SPREAD TO THE ENDOPROSTHESIS. THE INFECTION DID NOT PREDATE THE IMPLANTATION.

  Patient problems: Unspecified Infection

  MAUDE report 15000136 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013 THE PATIENT WAS IMPLANTED WITH THE BELOW IDENTIFIED GRAFTS (PER MEDICAL DEVICE TRACKING). THE IPSILATERAL LEG COMPONENT WAS IMPLANTED DOWN THE RIGHT SIDE OF THE PATIENT AND THE PLC271400 CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED DOWN THE LEFT SIDE. (B)(4), RMT281414, GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT TRUNK IPSILATERAL LEG C3 (B(4) PLC271400 - GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT CONTRALATERAL LEG (B)(4) PXC121200 - GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT CONTRALATERAL LEG ON (B)(6) 2022 THE PATIENT UNDERWENT A SCHEDULED REINTERVENTION. AS REPORTED, THERE WAS NOTED DISEASE PROGRESSION DOWN INTO THE LEFT COMMON ILIAC ARTERY. THERE WAS NO NOTED ISSUE IDENTIFIED REGARDING GORE DEVICES. DURING THE REINTERVENTION PROCEDURE, THE LEFT HYPOGASTRIC WAS PLUGGED AND TWO LIMBS WERE USED TO EXTEND THE EXISTING GRAFT DOWN THE LEFT SIDE. DIAGNOSTIC IMAGES PRIOR TO THE REINTERVENTIONS WERE PROVIDED FOR CONSIDERATION. IMAGING CONFIRMED THE PRESENCE OF A TYPE I DISTAL ENDOLEAK AND THAT THERE WAS A LACK OF WALL APPOSITION IN THE LCI. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14316997 ↗
• InjuryJun 1, 2021Device Damaged by Another Device; Patient Device Interaction Problem; Device Damaged by Another Device; Patient Device Interaction Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC & BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PROCEDURE WAS REPORTEDLY COMPLETED SUCCESSFULLY, WITH NO APPARENT COMPLICATIONS. THE PATIENT'S ANATOMY WAS NOT REPORTED AS TORTUOUS OR CALCIFIED. ON OR ABOUT (B)(6) 2021 THE PATIENT REPORTEDLY HAD A FOLLOW-UP APPOINTMENT WITH THE PHYSICIAN. THE PATIENT REPORTED FEELING GOOD, BUT DID NOTE SOME LEG CRAMPING. ON (B)(6) 2021 FOLLOW-UP CTA IDENTIFIED THAT THE TRUNK OF THE TRUNK-IPSILATERAL LEG COMPONENT HAD COLLAPSED. DISTAL BLOOD FLOW WAS NOTED BILATERALLY DESPITE THE DEVICE COLLAPSE. THE PHYSICIAN DID NOT REPORT A SUSPECTED CAUSE FOR THE DEVICE COLLAPSE. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED. SIGNIFICANT THROMBUS ACCUMULATION WAS REPORTED THROUGH THE IMPLANTED CONTRALATERAL LEG COMPONENTS BILATERALLY, AS WELL AS THROUGH THE GORE® EXCLUDER® ILIAC BRANCH COMPONENTS. THE GORE® EXCLUDER® INTERNAL ILIAC COMPONENT LOCATED IN THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS REPORTEDLY PARTIALLY OCCLUDED. IT WAS NOTED THAT THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHE

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11914443 ↗

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)