GORE EXCLUDER AAA Endoprosthesis PLC231400Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00733132618583), received between Aug 8, 2018 and May 28, 2026 — classified as 1 death, 23 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• DeathMay 28, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. REPORTEDLY, THE DEVICES WERE USED ACCORDING TO THE GORE INSTRUCTIONS FOR USE (IFU). ON (B)(6) 2026 A PROXIMAL TYPE I ENDOLEAK WAS NOTICED. ACCORDING TO THE PHYSICIAN, CALCIUM IN THE NECK AND IN THE INFERIOR ASPECT OF THE RENAL ARTERY CAUSED A PROXIMAL TYPE I ENDOLEAK. REPORTEDLY, ON (B)(6) 2026, THE TYPE I ENDOLEAK WAS BALLOONED USING A COOK CODA BALLOON. ACCORDING TO THE PHYSICIAN, BALLOONING IN ANATOMY WAS THE CAUSE OF THE AORTIC RUPTURE, HOWEVER, THE PHYSICIAN INFLATED THE BALLOON IN STANDARD PRACTICE. REPORTEDLY, AT THE PROCEDURE, THE PATIENT WAS CONVERTED TO AN OPEN REPAIR AND A BIFURCATED SURGICAL GRAFT WAS INSERTED. IT WAS REPORTED THAT BOTH AORTIC EXTENDERS AND THE PROXIMAL PART OF THE MAIN BODY WERE EXPLANTED. THE PHYSICIAN CUT THE BIFURCATED BODY AND LEFT THE LIMBS IN. THEN A GRAFT TO THE LIMBS WAS SUTURED. THE RUPTURE WAS SOLVED. THE PATIENT WAS RECOVERING IN THE HOSPITAL. (THIS INFORMATION WAS COVERED AND REPORTED UNDER THE REPORT# 3007284313-2026-04758). ALSO, THE

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

  MAUDE report 25322733 ↗
• InjuryApr 7, 2026Improper or Incorrect Procedure or Method; Migration; Device Endoleak

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, ON (B)(6) 2026, AT THE PATIENT'S 30-DAY POST-OP CTA, IT WAS DISCOVERED THAT THERE WAS A TYPE 3 ENDOLEAK (COMPONENT DISCONNECTION) BETWEEN THE CXT261412 AND PLC231400. THE CAUSE OF THE ENDOLEAK IS DUE TO THE PLC231400 MIGRATING 2.5 CM DISTALLY AND SITTING AT THE OPENING OF THE CXT261412 GATE, AS THE DEVICES WERE NOT IMPLANTED WITH A 3 CM OVERLAP. IT WAS REPORTED THAT THE DEVICES WERE ONLY OVERLAPPED BY 2.5 CM DURING THE INITIAL PROCEDURE DUE TO A TECHNICAL ERROR. THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE ON MARCH 26, 2026 THAT THE PHYSICIAN WAS PLANNING TO REINTERVENE. THERE WAS NO ANEURYSM ENLARGEMENT DUE TO THE ENDOLEAK. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE ENDOLEAK. ANOTHER PLC231400 WAS IMPLANTED AND ADEQUATE DEVICE OVERLAP WAS ENSURED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24800483 ↗
• InjuryNov 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2025, A PATIENT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES FOR ABDOMINAL AND ILIAC ANEURYSM. SIGNIFICANT THROMBUS WAS MEASURED IN THE PROXIMAL AORTIC NECK (7 MM AND 50% OF THE VESSEL CIRCUMFERENCE IN THE INTENDED SEAL ZONE). THE ANEURYSM IN THE LEFT COMMON ILIAC ARTERY ALSO HAD SIGNIFICANT THROMBUS WITH MINIMAL TRUE LUMEN AND NARROW INTERNAL ILIAC ARTERY (WHICH LEAD TO THE DECISION TO OVERSTENT/EMBOLIZE THE INTERNAL ILIAC ARTERY). A FOLLOW-UP CT ON (B)(6) 2025 SHOWED A COLLAPSE/INFOLDING OF THE PROXIMAL PART OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL COMPONENT RLT281448), LEADING TO A TYPE 1A ENDOLEAK. THE CT ALSO SHOWED THAT BOTH THE LEFT (PLC121000) AND THE RIGHT (PLC231400) CONTRALATERAL LEG COMPONENTS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE THROMBOSED. ON AN UNKNOWN DATE, A REINTERVENTION WAS PERFORMED ON THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RIGHT CONTRALATERAL LEG DEVICE (PLC231400) INVOLVING THROMBECTOMY, AS WELL AS DILATION OF THE PROXIMAL NECK FOR THE RLT281448. REPORTEDLY, A FULL PROXIMAL EXPANSION OF THE RLT281448 WAS NOT ACHIEVABLE. A NEW CONTROL CT ON (B)(6) 2025 STILL SHOWED A PROXIMAL

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 23565433 ↗
• MalfunctionOct 28, 2025Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (EXCLUDER DEVICES) TO TREAT ABDOMINAL AORTIC ANEURYSM. RLT281412 AND PLC121200 WERE SUCCESSFULLY EXPANDED. PLC231400 WAS ADVANCED TO THE DISTAL OF PLC121200. WHEN THE STENT WAS EXPANDED AROUND 3CM, IT GOT STUCK. AFTER FURTHER ATTEMPTS, THE DEPLOYMENT LINE WAS BROKEN. PLC231400 COULDN'T BE DEPLOYED. THE DISTAL DELIVERY SYSTEM OF PLC231400 WAS SEPARATED. THE REMAINING PART OF CATHETER AND DEPLOYMENT LINE WERE REMOVED FROM PATIENT. SINCE PLC121200 WAS MOVED WITH PLC231400, THEY WERE PULLED AND REMAINED IN ANEURYSM. ANOTHER PLC121400 + PLC231200 WERE SUCCESSFULLY EXPANDED AND IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE, AND HIS VITAL SIGNS WERE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400061 ↗
• InjuryOct 22, 2025Break; Difficult to Remove; Material Separation; Activation Failure; Break; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT UNDERWENT AN INNER BRANCHED ENDOVASCULAR ANEURYSM REPAIR (IBEVAR) PROCEDURE DUE TO AN INFRARENAL ABDOMINAL ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM. DURING DEPLOYMENT OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS), THE DEPLOYMENT LINE FROM THE DELIVERY CATHETER BROKE. THE STENT WAS DEPLOYED FOR 3 CM AT THAT MOMENT (OVERLAP WITHIN THE HOST (TRUNK) DEVICE). THE PHYSICIAN TRIED TO CONTINUE DEPLOYING THE STENT BY PULLING BACK THE DELIVERY SYSTEM. BY PULLING BACK THE DELIVERY CATHETER, THE DEVICE CAME BACK OUTSIDE OF THE HOST DEVICE (TRUNK), AND THE LEADING OLIVE BROKE OFF. THE TRUNK WAS NOT AFFECTED BY THIS ACTION AND THE OLIVE WAS SNARED. THE PHYSICIAN TRIED TO PULLED BACK THE DEVICE BACK IN THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (WITH THE PARTIALLY DEPLOYED PART OUTSIDE THE SHEATH), AND PULLED BACK EVERYTHING OUTSIDE THE GROIN (AS IT WAS PERCUTANEOUS APPROACH). DUE TO THE DEPLOYED PART OF THE DEVICE, THERE WAS A BLEEDING IN THE COMMON FEMORAL ARTERY AND PHYSICIAN HAD TO PERFORM A CUT DOWN. THE PATIENT REQUIRED BLOOD TRANSFUSION DUE TO THE BLOOD LOSS. THE BLEEDING WAS AT THE END UNDER CONTROL A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23356675 ↗
• InjurySep 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 19, 2025 FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 78-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AORTIC COMPONENT. THE GORE® DEVICE WAS SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A STROKE. THIS ADVERSE EVENT IS NOTED AS ONGOING (NOT RECOVERED/NOT RESOLVED). REPORTEDLY, THE EVENT IS NOT RELATED TO THE DEVICE, PROCEDURE OR DISEASE, AND WAS NOT POTENTIALLY CAUSED BY A GORE ACCESSORY.

  Patient problems: Stroke/CVA

  MAUDE report 23083860 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Clinical Endoleak

  MAUDE report 22637866 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE RESULTS OF THE NICKEL TEST WERE FOUND TO BE NEGATIVE.

  Patient problems: Paraplegia; Rash

  MAUDE report 21930322 ↗
• InjuryNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER WAS NOT PROVIDED, POST PROCEDURE COMPUTED TOMOGRAPHY PERFORMED THE SAME DAY REPORTED THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION (MM) MEASURED 100MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION AND ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM TREATMENT WAS PERFORMED WITH BILATERAL LIMB EXTENSIONS AND EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY. THE SITE REPORTS CONCERN FOR TYPE IB ENDOLEAK AFTER FOLLOW-UP IMAGING. PROCEDURE PERFORMED AND REPORTS NO LEAK SEEN ON IMAGING AFTER TREATMENT. PATIENT DISCHARGED STABLE

  Patient problems: Aneurysm expansion

  MAUDE report 20760241 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) DEVICE SYSTEM. A TAMBE AORTIC COMPONENT, GORE® EXCLUDER® ILIAC BRANCH COMPONENT, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WERE IMPLANTED. A GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS ALSO USED AS AN ACCESSORY. IT WAS NOTED THAT MURAL THROMBUS WAS PRESENT IN THE PATIENT'S AORTA. ON JULY 22, 2024, THE GORE REPRESENTATIVE BECAME AWARE THAT THE PATIENT HAD DEVELOPED PARALYSIS IN THEIR ARMS AND LEGS ON (B)(6) 2024. THE MURAL THROMBUS WAS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT'S ARMS RECOVERED FULLY ON AN UNKNOWN DATE AND THEIR LEGS REGAINED SENSATION, BUT NO MOTOR FUNCTION. ON (B)(6) 2024, THE PATIENT WAS PLACED ON COMFORT CARE.

  Patient problems: Paralysis

  MAUDE report 20021433 ↗
• InjuryAug 13, 2024Insufficient Device Problem Information; Device Endoleak; Insufficient Device Problem Information; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2014, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2014, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED BY MAGNETIC RESONANCE IMAGING (MRI) WAS 55.1 MM. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING FROM AN UNKNOWN DATE IN 2018 SHOWED NO ENDOLEAK AND GOOD POSITIONING OF THE IMPLANTED DEVICES. IN (B)(6) 2022, A PHYSICIAN NOT ASSOCIATED WITH THE HOSPITAL IDENTIFIED ANEURYSM GROWTH USING SONOGRAPHIC IMAGING. AN ENDOLEAK WAS SUSPECTED. ON (B)(6) 2022, AN ENDOLEAK WAS CONFIRMED USING CTA IMAGING. ON (B)(6) 2023, ANGIOGRAPHY PERFORMED. NO REINTERVENTION WAS REQUIRED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH A COVERED RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM. THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM AS MEASURED BY CTA WAS 91 MM. AN ADDITIONAL DEVICE WAS IMPLANTED TO TREAT THE RUPTURE.

  Patient problems: Aneurysm expansion; Ruptured Aneurysm

  MAUDE report 19971496 ↗
• MalfunctionNov 8, 2023Premature Activation; Difficult to Remove; Use of Device Problem; Difficult to Advance; Insufficient Device Problem Information; Premature Activation; Difficult to Remove; Use of Device Problem; Difficult to Advance; Insufficient Device Problem Information

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1433/UNKNOWN) WAS USED FOR ACCESS. REPORTEDLY, THE PLC231400/ (B)(6) WAS ADDED INTO A BRIDGE PLL161407 INTO THE RIGHT ILIAC ARTERY BUT THE RESISTANCE WAS FELT AFTER PLC CAME OUT OF THE SHEATH. REPORTEDLY, THE 14FR SHEATH WAS NOT PLACED UP IN THE BRIDGE LIMB. ON FLUOROSCOPY, IT WAS NOTICED THAT THE PLC231400 HAD PRE-DEPLOYED ABOUT 1CM. THE CAUSE OF THE PLC231400 UNINTENTIONAL DEPLOYMENT REMAINS UNKNOWN. THE SURGEON TRIED TO MOVE THE DEVICE INTO THE SHEATH BUT WAS UNABLE TO. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE DEVICE INTO THE SHEATH, THE OLIVE TIP PULLED INTO THE PROXIMAL END OF THE REDEPLOYED LIMB. THEY ENDED UP LANDING THE PLC231400 IN THE AORTA AT THE BOTTOM OF THE BRIDGE AND ACCORDIONING THE 23MM LIMB INTO THE AAA SAC AND LANDING ABOUT THE INTERNAL AND EXTERNAL ILIAC ARTERIES AS PLANNED. THEN THE PHYSICIAN JOINED THE BRIDGE AND PLC231400 WITH ANOTHER LIMB. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND THE COMPLETION RUN LOOKED GOOD. THE DEVICE HAD A COMPLETE DEPLOYMENT. REPORTEDLY, THE OL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097879 ↗
• MalfunctionAug 11, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AFTER THE GORE® DRYSEAL SHEATH INSERTION, THE END PART OF THE CATHETER BROKE OFF AND HAD TO BE SNARED OUT. ACCORDING TO THE PHYSICIAN, IT IS UNKNOWN WHAT CAUSED THE PROBLEM. THERE WAS NOTHING STRANGE ABOUT THE PATIENT¿S ANATOMY AND THERE WAS NO RESISTANCE FELT OR ANY DIFFICULTY MOVING THE DEVICE. THE DAMAGE WAS NOTED AT THE TIP OF THE DEVICE AFTER THE DEPLOYMENT SYSTEM HAD BEEN REMOVED. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 17515844 ↗
• InjuryJun 15, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. WHEN PLACING THE CONTRALATERAL LEG ENDOPROSTHESIS PLC231400 ON THE LEFT SITE IT REPORTEDLY WAS HARD TO SEE THE ILIAC BIFURCATION VERY WELL WITH THE AVAILABLE IMAGING AND THE CONTRAST AGENT APPLIED TO THE PATIENT. REPORTEDLY THE PHYSICIAN DECIDED TO NO FURTHER USE CONTRAST AGENT WITH THIS PATIENT AT THE CURRENT STAGE OF THE PROCEDURE. HE DEPLOYED THE DEVICE AND UNINTENTIONALLY COVERED THE LEFT INTERNAL ILIAC ARTERY. AT THE END OF THE PROCEDURE THE INTERNAL ILIAC ARTERY WAS STILL COVERED, HOWEVER IT WAS PATENT.

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

  MAUDE report 17133591 ↗
• InjuryMay 23, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 37MM. PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2015 TO (B)(6) 2020, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE TO 36MM. FROM (B)(6) 2021 TO (B)(6) 2023 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 42MM TO 47MM. ON (B)(6) 2021, A LEFT COMMON ILIAC ARTERY ANEURYSM WAS DETERMINED. ACCORDING TO THE SITE, THE EVENT WAS NOT RELATED TO AORTIC DEVICE OR PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT THE LEFT INTERNAL ILIAC ARTERY COIL EMBOLIZATION PROCEDURE AND ENDOVASCULAR LEFT COMMON ILIAC ARTERY ANEURYSM REPAIR.

  Patient problems: Aneurysm

  MAUDE report 16990015 ↗
• InjuryNov 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2022, THE PHYSICIAN REPORTED THE PATIENT HAS A DISTAL TYPE I ENDOLEAK ASSOCIATED WITH THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT IMPLANTED ON THE RIGHT SIDE. A LACK OF SEAL OF THE DEVICE IS BELIEVED TO BE THE CAUSE. THE PATIENT IS SCHEDULED FOR REINTERVENTION ON (B)(6) 2022.

  Patient problems: Aneurysm

  MAUDE report 15800926 ↗
• InjuryOct 26, 2022Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 51MM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, A RIGHT FEMORAL ARTERY PSEUDOANEURYSM WAS DETERMINED. ACCORDING TO THE SITE, THE EVENT WAS UNRELATED TO THE DEVICE OR PROCEDURE. NO TREATMENT WAS REQUIRED. THE EVENT IS ONGOING. THE PHYSICIAN IS MONITORING THE PATIENT. FOLLOW UP CT SCANS FROM (B)(6) 2019 TILL (B)(6) 2022, SHOWED THAT THE MAXIMUM ABDOMINAL AORTIC ANEURYSM DIAMETER DECREASED IN SIZE FROM 56MM TO 52MM. FOLLOW UP ON (B)(6) 2020, SHOWED THAT THE MAXIMUM ABDOMINAL AORTIC ANEURYSM DIAMETER WAS 57MM. ON (B)(6) 2019, A RIGHT COMMON ILIAC ARTERY PSEUDOANEURYSM WAS DETERMINED. ACCORDING TO THE SITE, THE EVENT WAS UNRELATED TO THE DEVICE OR PROCEDURE. NO TREATMENT WAS REQUIRED. THE EVENT IS ONGOING. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm; Pseudoaneurysm

  MAUDE report 15677596 ↗
• InjuryJul 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED: LEFT SIDE RLT281416 AND PLC231000, CONTRALATERAL RIGHT SIDE PLC231400. ON (B)(6) 2021, CT IMAGES SHOWED AN TYPE 1B ENDOLEAK WITH ANEURYSM GROWTH ON THE RIGHT INTERNAL ILIAC ARTERY, DISTAL TO THE PRIMARY IMPLANT. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT UNDERWENT EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. ON (B)(6) 2022, TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED ON THE RIGHT SIDE (PLC141400 WITH OVERLAP OF PLC141200). BOTH GRAFTS WERE BALLOONED WITH EQUALIZER BALLOON CATHETER (BOSTON SCIENTIFIC). THE SUBSEQUENT ANGIOGRAPHY SHOWS THAT THE PROSTHESIS IS PROPERLY SEATED. NO EVIDENCE OF AN ENDOLEAK.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 15128159 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® CONTRALATERAL LEG ENDOPROSTHESES WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). FOUR THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2021, IMAGES REVEALED A PSEUDOANEURYSM OF LEFT FEMORAL ARTERY. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 14795261 ↗
• InjuryNov 23, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (PRE-IMPLANT CT DIAMETER 65 MM). ON (B)(6) 2021, A TYPE IB ENDOLEAK WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL AORTIC ENDOGRAFT ((B)(6) 2021 CT DIAMETER: 105 MM). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12861938 ↗
• MalfunctionAug 23, 2021Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES, AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY IN THE PROCEDURE. IT WAS REPORTED THAT RESISTANCE WAS NOTED WHILE ATTEMPTING TO INSERT THE CONTRALATERAL LEG COMPONENT INTO AND THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE DEVICE WAS BARELY ABLE TO ENTER THE INTRODUCER SHEATH VALVE WITHOUT NOTED RESISTANCE. THERE WAS NO SUSPECTED CAUSE FOR THE DIFFICULTY ADVANCING THE DEVICE THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED DIFFICULTY WHILE INITIALLY ADVANCING THE INTRODUCER SHEATH INTO THE PATIENT, AND NO PATIENT ANATOMY OR TORTUOSITY WAS REPORTED OR SUSPECTED TO BE INVOLVED. THE CONTRALATERAL LEG COMPONENT DID NOT ENTER THE PATIENT. IT WAS REPORTED THAT, AS THE PHYSICIAN ATTEMPTED TO REMOVE THE CONTRALATERAL LEG COMPONENT FROM THE INTRODUCER SHEATH, THE DEVICE INADVERTENTLY DEPLOYED WITHIN THE SHEATH. THE PHYSICIAN STATED THAT HE PULLED TOO HARD ON THE DEVICE AS IT WAS BEING REMOVED FROM THE SHEATH AFTER RESISTANCE WAS NOTED AND IT WAS SUSPECTED THAT THE DEVICE DEPLOYMENT WAS CAUSED BY PULLING TOO HARD DURING DEVICE REMOVAL. THE CONTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354590 ↗
• InjuryMay 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) , 2021 THE PATIENT UNDERWENT REINTERVENTION OF A PREVIOUSLY IMPLANTED MEDTRONIC ENDURANT¿ DEVICE DUE TO CONTINUING ILIAC ARTERY ANEURYSM ENLARGEMENT. IT WAS REPORTED THAT TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS WERE IMPLANTED BILATERALLY. THERE WERE NO REPORTED ISSUES WITH THE BILATERAL LIMB EXTENSION. THE PATIENT TOLERATED THE PROCEDURE. ON OR ABOUT (B)(6) 2021 (REPORTED AS ABOUT ONE MONTH AFTER THE REINTERVENTION PROCEDURE) THE PATIENT PRESENTED WITH AN INFECTION. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A PRE-EXISTING INFECTION PRIOR TO THE REINTERVENTION ON (B)(6) 2021. THE PHYSICIAN DID NOT REPORT ANY ALLEGATIONS OF DEFICIENCY AGAINST THE GORE DEVICES, BUT NOTED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN. ON (B)(6) 2021 ALL DEVICES WERE EXPLANTED. A RIFAMPIN ANTIBIOTIC SOAKED OPEN REPLACEMENT GRAFT WAS IMPLANTED. THE DEVICES WERE DISCARDED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 11807853 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, FOLLOW UP CT REVEALED A DISSECTION PROXIMAL TO THE CELIAC ARTERY AND A TYPE 3 DISCONNECT ENDOLEAK AND TYPE 1B ENDOLEAK ON THE RIGHT SIDE. IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE ON (B)(6) 2019, THERE WAS DIFFICULTY SNARING THE GUIDEWIRE, WHICH MIGHT HAVE LED TO WIRE TRAUMA IN THE AORTA, CAUSING OR CONTRIBUTING TO A DISSECTION. THIS WAS REPORTED TO FDA ON MFR REPORT # 3007284313-2019-00143. ON (B)(6) 2020, THE PHYSICIAN TREATED THE DISSECTION WITH A 36 MM AORTIC EXTENDER COMPONENT THAT COVERED THE FENESTRATION. HOWEVER, DURING DEPLOYMENT OF THE AORTIC EXTENDER, THE DEVICE WAS INADVERTENTLY DEPLOYED OVER THE SOFT PORTION OF THE GUIDEWIRE, WHICH CAUSED THE DELIVERY CATHETER TO ROTATE AND MOVE DISTALLY DURING DEPLOYMENT, AND THE CELIAC ARTERY WAS PARTIALLY COVERED. THE PHYSICIAN THEN CANNULATED THE CELIAC ARTERY AND DEPLOYED AN 8X20 MM GORE® VIABAHN® VBX DEVICE AND EXTENDED PROXIMALLY IN THE AORTA WITH ANOTHER 36 MM AORTIC EXTENDER COMPONENT. THE TYPE 3 ENDOLEAK BETWEEN THE CEB ENDOPROSTHESIS AND THE PLC231400 IN THE RIGH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11032710 ↗
• InjuryMar 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT DURING THE ADVANCEMENT OF THE GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (PLC) POSITIONING ISSUES OCCURRED AND THAT THE DEVICE WAS DEPLOYED IN AN INADEQUATE POSITION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT AFTER A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (PLC) WAS ADVANCED OUTSIDE OF THE SHEATH, IT WAS TRIED TO RETRACT THE DEVICE BACK INTO THE SHEATH. IT WAS STATED THAT DUE TO THAT THE DEVICE STARTED TO DEPLOY AND IT DEPLOYED IN AN UNINTENDED POSITION. IT WAS REALIZED THAT AFTER THE DEVICE CATHETER WAS RETRACTED THROUGH THE SHEATH, THE LEADING END SEPARATED FROM THE CATHETER. IT WAS POSSIBLE TO REMOVE THE SEPARATED LEADING END WITH A MOSQUITO SCISSOR THROUGH THE VALVE OF THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795141 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE A LEFT INTERNAL ILIAC ARTERY WAS OCCLUDED. ACCORDING TO THE INFORMATION REPORTED, THE OCCLUSION WAS RELATED WITH A DEVICE USED IN THE LEFT COMMON ILIAC ARTERY. REPORTEDLY, THERE WAS KNOWN CALCIFIED ATHEROSCLEROTIC DISEASE INVOLVING COMMON AND INTERNAL ILIAC ARTERIES BILATERALLY AT BASELINE. NO TREATMENT WAS REQUIRED. THERE WAS NEVER A CONCERN WITH THE OCCLUSION AS THERE WAS FILLING VIA COLLATERALS FROM THE RIGHT SIDE. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. ON MAY 22, 2019, A FOLLOW UP IMAGING CONFIRMED THAT THERE WAS NO CONCERN ABOUT THE LEFT INTERNAL ILIAC ARTERY.

  Patient problems: Occlusion

  MAUDE report 8755747 ↗

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