GORE EXCLUDER AAA Endoprosthesis PLC181400Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00733132618699), received between Nov 7, 2018 and Sep 29, 2026 — classified as 4 deaths, 20 injuries, 2 malfunctions.

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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic dissection

  MAUDE report 50929830 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449443 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) , 2026, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS. ACCESS WAS GAINED THROUGH THE RIGHT SIDE USING A GORE® DRYSEAL FLEX SHEATH (DSF). DURING THE PROCEDURE, ILIAC ACCESS WAS INADEQUATE (8MM) FOR THE 22 FR DSF, AND THE PHYSICIAN STRUGGLED TO ADVANCE THE SHEATH, BUT WAS EVENTUALLY ABLE TO GAIN ACCESS. THE REST OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) , 2026, THE PATIENT WAS NO LONGER ABLE TO MOVE THEIR LEGS. THEIR PULSE WAS LOW, AND THEIR LEGS WERE COLD. A THROMBECTOMY WAS PERFORMED ON BOTH LEGS, DISTAL TO THE GORE GRAFTS. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR A POST-OP SPINAL DRAIN - HOWEVER, NO FLUID WAS ABLE TO BE DRAINED, SO THE PROCEDURE WAS UNSUCCESSFUL. ON(B)(6) , 2026 WAS DISCHARGED INTO REHAB. REPORTEDLY, THE PARAPLEGIA IS NOW RESOLVED.

  Patient problems: Ischemia

  MAUDE report 24944747 ↗
• InjuryJan 21, 2026Malposition of Device

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INFRARENAL AORTIC ANEURYSM (AAA) WHICH HAS ENLARGED TO 5.7CM IN DIAMETER AND A 4CM PARAVISCERAL ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. IT WAS REPORTED THAT THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED, HOWEVER 1.5 CM OF THE DISTAL END OF THE DEVICE WAS STILL IN THE SHEATH AND HAD UNINTENTIONALLY COVERED THE HYPOGASTRIC ARTERY. WHEN PULLING ON THE DELIVERY CATHETER TO REMOVE THE DISTAL PORTION OF THE DEVICE FROM THE SHEATH THE LEADING END OF THE CATHETER WAS DAMAGED. THE CAUSE OF THE DEPLOYMENT ERROR WAS ATTRIBUTED TO POOR IMAGING AND INACCURATE POSITIONING OF THE DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133186 ↗
• InjuryNov 18, 2025Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED BY GORE THAT ON (B)(6) 2025 A PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE (RLT281412) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG (PLC) DEVICES. THE PHYSICIAN RELEASED THE RLT EXCLUDER MAIN BODY AND DEPLOYMENT OF THE IPSILATERAL LEG WAS FINISHED ON THE RIGHT SIDE. THEN, A PLC (SN: (B)(6)) WAS TRIED TO CANNULATE ON THE LEFT SIDE AND WAS PUSHED THE PLC CATHETER UPWARDS. IT WAS USED THE PLC CATHETER WITHOUT A SHEATH (UNKNOWN REASON WHY THE SHEATH WAS NOT USED) AND REPORTEDLY, THE CATHETER WAS ABLE TO BE ADVANCED VIA AN ACCESS VESSEL PROXIMALLY TO THE TRUNK. THE PHYSICIAN WANTED TO PROCEED RAPIDLY TO ADVANCE THE PLC CATHETER INTO THE CONTRALATERAL GATE OF THE MAIN BODY, THUS IS WAS A QUICK PROCESS BY THE PHYSICIAN TO PROCEED, AND EVENTUALLY, HE COULD FINISH THE GATE CANNULATION INTO THE RLT. BUT DURING THIS QUICK ACTION IT WAS LIFTED UP THE WHOLE RLT TRUNK AND LANDED ABOVE THE LEFT RENAL ARTERY. THE PLC COULD BE DEPLOYED AT THIS STAGE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE AN EXTRA BENTLEY STENT (7 MM) FOR THE LEFT RENAL ARTERY AND HAD TO MAINTAIN THE BLOOD FLOW. ALSO, HE TRIED TO USE S

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

  MAUDE report 23586262 ↗
• DeathNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT WAS CONVERTED TO OPEN AND EXPLANT OF ALL THE DEVICES WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT'S AORTA WAS SEVERELY INFECTED WITH AREAS OF HARD INFECTION AND OTHER AREAS FULL OF CLEAR PUSS WHICH WAS SUCKED OUT AND REMOVED. THE PHYSICIAN WONDERED WHETHER OR NOT THE PATIENT HAD A PRE-EXISING INFECTION. HE DID NOT KNOW AS THE INDEX PROCEDURE WAS PERFORMED BY ANOTHER PHYSICIAN AT A DIFFERENT HOSPITAL. POST EXPLANT OF ALL DEVICES DURING CLOSING, WHEN THE PHYSICIAN REMOVED THE CLAMP ON THE SUPER CELIAC, THE PATIENT'S BLOOD PRESSURE TANKED AND THE PATIENT CODED. CPR WAS PERFORMED BUT THEY WERE NOT ABLE TO GET THE PATIENT BACK, HE EXPIRED DURING CLOSING. ACTUAL CAUSE OF DEATH WAS NOT KNOWN.

  Patient problems: Pyogenic Infection

  MAUDE report 23472202 ↗
• DeathJun 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG WAS ALSO USED IN THE AORTA. PROXIMAL ACCESS WAS GAINED THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH IN THE RIGHT SUBCLAVIAN ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. EARLY ON (B)(6) 2025, WITHIN 24 HOURS OF THE INITIAL PROCEDURE, THE PATIENT HAD SOME WATERSHED INFARCTS. A CT OF THE CHEST SHOWED NOTHING UNUSUAL. ON (B)(6) 2025, THE PATIENT STARTED HAVING SEIZURES AND WAS INTUBATED. ACCORDING TO THE FSA, THERE WAS NO NOTABLE THROMBUS. POST-OPERATIVE IMAGES ARE NOT AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 22132059 ↗
• InjuryMar 21, 2025Migration; Migration

  ON (B)(6) 2024, THIS 87-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED CUT-DOWN PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND TWO GORE® EXCLUDER® ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. HE WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6), 2025, THE PATIENT HAD A CTA FOLLOW UP. THERE WAS NO LOSS OF PATENCY TO ANY DEVICES. IT WAS NOTED THAT THE RIGHT ILIAC LEG COMPONENT NOW COVERED THE RIGHT INTERNAL ILIAC ARTERY. THIS EVENT IS ONGOING AND NO TREATMENT WAS PROVIDED AT THIS POINT. IT IS NOT KNOWN WHICH OF THE DEVICES IS COVERING THE RIGHT INTERNAL ILIAC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21665270 ↗
• DeathSep 17, 2024Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR INDEX PROCEDURE TO TREAT A RUPTURED ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES (TRUNK IPSILATERAL, ILIAC EXTENDER, CONTRALATERAL LEG, AND AORTIC EXTENDER) IT WAS REPORTED THAT AFTER THE PHYSICIAN DEPLOYED THE MAIN BODY, THE GATE WAS CANNULATED AND THE WIRE POSITION WAS CONFIRMED WITH A PIGTAIL CATHETER. THE FSA LEFT THE ROOM TO GRAB A DIFFERENT LIMB AND THE WIRE POSITION WAS LOST AND PUSHED BACK UP WITHOUT CONFIRMING AGAIN WITH A PIGTAIL. THE FSA WAS UNAWARE OF THE REPOSITIONING OF THE WIRE. THE CONTRALATERAL LIMB WAS THEN DEPLOYED OUTSIDE OF THE GATE. THIS LEAD TO THE PROCEDURE BEING CONVERTED TO AN AUI WITH FEM-FEM BYPASS. THE AUI WAS UNPLANNED. THE PATIENT TOLERATED THE PROCEDURE. THE FSA RECEIVED A CALL AND WAS NOTIFIED THAT THE PATIENT PASSED AWAY OVER THE WEEKEND. IT IS UNKNOWN WHAT CAUSED/CONTRIBUTED TO THE DEATH OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241535 ↗
• InjuryMay 26, 2024Patient-Device Incompatibility; Material Split, Cut or Torn; Patient-Device Incompatibility; Material Split, Cut or Torn

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT IN ZONE 9 - INFRARENAL TO TREAT AN ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRA LEG) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER). IT WAS REPORTED THAT THEY PUT IN THE MAIN BODY AND THE PLC ON THE RIGHT SIDE, THEY GOT ALL THE LIMBS IN AS WELL AND EVERYTHING WENT FINE. THEY WERE BALLOONING THE GRAFT ON THE RIGHT HYPO (INTERNAL ILIAC) (PLC 1418000) WHEN IT "GAVE" A LOT MORE THAN IT SHOULD HAVE. THE FSA CHECKED WITH THE PHYSICIAN AND THERE WAS NO CHANGE IN PRESSURE SO THEY FINISHED BALLOONING EVERYTHING AND DID A QUICK DYE SHOOT ON THE RIGHT SIDE TO CHECK THE COMMON ILIAC AND THERE WAS A LITTLE EXTRAVASATION IN THE MIDDLE OF THE COMMON BUT IT DID NOT LOOK LIKE IT WAS COMING FROM BELOW. THEY WERE SEALED DISTAL AND MAY HAVE ACTUALLY RUPTURED THE GRAFT WITH THE BALLOON. THEY REALIGNED THE GRAFT WITH A PLC161000 TO COVER THE HOLE. THEY WERE ABLE TO GET SEAL JUST ABOVE THE HYPO SO THEY DIDN'T HAVE TO COVER THE HYPO. THEY BALLOONED IT SLIGHTLY WITH A PTA BALLOON AND THE EXTRAVASATION

  Patient problems: Extravasation; Rupture

  MAUDE report 19398943 ↗
• InjuryApr 22, 2024Adverse 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) 2023, THE PATIENT WAS IMPLANTED WITH GORE® CONTRALATERAL LEG ENDOPROSTHESES, AND THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2023, IMAGES REVEALED THE PATIENT HAD A RIGHT COMMON ILIAC ARTERY DISSECTION. THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 19159389 ↗
• InjuryNov 22, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE RIGHT COMMON ILIAC WAS ANEURYSMAL PROXIMALLY AT THE TIME OF INITIAL REPAIR. REPORTEDLY, PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 58MM. THE RIGHT ILIAC ARTERY MEASUREMENT WAS 18 MM PROXIMALLY AND 16MM DISTALLY. PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2016 TO (B)(6) 2022 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 58MM TO 40.4MM. HOWEVER, THE RIGHT COMMON ILIAC ARTERY ANEURYSM GREW TO 25 MM JUST BEYOND THE END OF THE GRAFT. REPORTEDLY, WITH THAT DISTAL GROWTH, THE DISTAL LIMB LOST APPOSITION TO THE WALL OF THE ARTERY AS IT BECAME MORE ANEURYSMAL, BUT IT SHOULD BE NOTED THAT THERE HAS NEVER BEEN AN ENDOLEAK IN THAT AREA. ACCORDING TO THE PHYSICIAN, THERE WAS NOT A FAILURE OF THE GRAFT. ON (B)(6) 2023, IT WAS CONFIRMED THE RIGHT COMMON ILIAC ARTERY ANEURYSM ENLARGEMENT AND THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE. THE (B)(4)WAS EXTENDED WITH A 14X10 BRIDGE AND THEN A 27X14 BELL BOTTOM CONTRALATERAL LIMB. THE PHYS

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

  MAUDE report 18196389 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9 INFRARENAL PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, IT WAS NOTICED THAT THE RENALS WERE COVERED BY THE DEVICE (TRUNK IPSILATERAL) AND PATIENT WAS BROUGHT BACK IN THE NEXT DAY FOR AN EXPLANT PROCEDURE. PHYSICIAN DID A SURGICAL PROCEDURE WITH AN AORTIC BYPASS WITH A DACRON GRAFT. PATIENT IS DOING OKAY BUT BEING MONITORED FOR RENAL FUNCTION AND IF THEY WILL NEED DIALYSIS. REPORTEDLY, THE PHYSICIAN THINKS THE STENT GRAFT EITHER GOT PUSHED UP OR DEPLOYED TOO HIGH. THERE WERE NO PATIENT ANATOMICAL CONSTRAINTS OR ISSUES WITH BLOOD FLOW. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: PATIENT IS STABLE MEDICALLY BUT IS REQUIRING DIALYSIS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17864676 ↗
• InjuryMar 27, 2023Activation, Positioning or Separation Problem; Activation Problem; Activation, Positioning or Separation Problem; Activation Problem

  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 62.2.MM. PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2014 TO (B)(6) 2014, THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 62MM TO 67.6MM. FROM (B)(6) 2015 TO (B)(6) 2018, THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 65.2MM TO 56MM. FROM (B)(6) 2019 TO (B)(6) 2021, THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 57MM TO 60MM. REPORTEDLY, ON (B)(6) 2022, AN INFRARENAL ABDOMINAL AORTIC ANEURYSM ENLARGEMENT WITH RIGHT AND LEFT ILIAC DISTAL TYPE I ENDOLEAKS WERE NOTICED. REPORTEDLY, ON (B)(6) 2023, THE PATIENT HAD A RIGHT AND A LEFT ILIOFEMORAL ANGIOGRAM PROCEDURE WITH A DISTAL LIMB EXTENSION ON THE RIGHT SIDE USING A PLC231000/25278865 DEVICE AND ON THE LEFT SIDE USING A PLC271200/24923176 DEVICE. THE DEVICES WERE POST DILATED USING A RELIANT ANGIOPLAS

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16625263 ↗
• InjuryFeb 15, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. TWO YEARS POST OPERATIVELY, DISTAL DEVICE MIGRATION OF 12.2 MM WAS DETECTED VIA CT IMAGING. A REINTERVENTION IS NOT CURRENTLY PLANNED.

  Patient problems: Aneurysm

  MAUDE report 16379748 ↗
• DeathAug 18, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS PATIENT HAD A HISTORY OF OCCLUSIVE DISEASE. ON AN UNKNOWN DATE, THE PATIENT HAD SEVERAL PROCEDURES TO TREAT A LIMB OCCLUSION USING NON-GORE DEVICES. REPORTEDLY, THE PATIENT ATTENDED FOR THE CHECK IN, AND THE PHYSICIAN NOTICED THAT ONE SIDE HAD OCCLUSION AND ANOTHER SIDE HAD AN ANEURYSM DISEASE PROGRESSION. ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DUE TO THE DIFFICULTIES RELATED WITH MANY DEVICES IMPLANTED BEFORE, PLC181400/23893028 WAS BEING REVERSED AND PLACED INSIDE THE AORTA EXTENDING TO THE ILIAC. THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS USED OUTSIDE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU). REPORTEDLY, THE DEPLOYMENT WAS DONE SUCCESSFULLY, HOWEVER, IN SEVERAL MINUTES, IT WAS NOTICED THAT THE DEVICE COVERED THE RENAL ARTERY. THE PHYSICIAN USED A BALLOON CATHETER TRYING TO MAINTAIN THE FLOW, HOWEVER, IT WAS UNSUCCESSFUL. REPORTEDLY, THE ANGIOGRAPHY VISUALIZATION WAS NOT GOOD AND IT WAS HARD TO DETERMINE THE LOWEST RENAL ARTERY. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND THE PATIENT ULTIMATELY EXPIRED. REPORTEDLY, THE FSA WAS INFORMED ABOUT THE PROCEDURE ON (B)(6) 2022, HOWEVER, THE

  Patient problems: Aneurysm; Embolism/Embolus; Foreign Body Embolism

  MAUDE report 15254683 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX), GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, GORE® MOLDING & OCCLUSION BALLOON CATHETERS, GORE® TRI-LOBE BALLOON CATHETERS, GORE® DRYSEAL FLEX INTRODUCER SHEATHS, AND GORE® TRI LUMEN CATHETERS IN THE AAA1701 TAMBE PIVOTAL STUDY. ON THE MORNING OF (B)(6) 2021 THE PATIENT REPORTED BLURRED VISION (DIPLOPIA). THE PATIENT WAS EVALUATED BY THE HOSPITAL STROKE TEAM AND AN MRI OF THE PATIENT'S BRAIN WAS PERFORMED. IT WAS REPORTED THAT THE MRI WAS WITHOUT EVIDENCE OF ACUTE STROKE. IT WAS REPORTED THAT THE PATIENT'S BLURRED VISION RESOLVED ITSELF LATER ON THE MORNING OF (B)(6) 2021. THERE WAS REPORTEDLY NO RESIDUAL.

  Patient problems: Transient Ischemic Attack

  MAUDE report 14795922 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT HAD THEIR INTERNAL ILIAC COIL EMBOLIZED AND HAD A GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED TO REPAIR A RIGHT COMMON ILIAC ARTERY ANEURYSM. ON (B)(6) 2021 AN AORTOILIAC DUPLEX WAS PERFORMED AND DEMONSTRATED AND ENDOLEAK/FLOW INTO THE ANEURYSMAL SAC. ON (B)(6) 2021 A RE-INTERVENTION WAS PERFORMED AND 3 ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PHYSICIAN REPORTEDLY DECIDED TO DO A FULL IVAR AND SEAL DISTALLY INTO THE EXTERNAL ARTERY THAT WAS PREVIOUSLY COILED AND BELL BOTTOM THE LEFT SIDE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

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

  MAUDE report 12924603 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A THORACOABDOMINAL AORTIC ANEURYSM CLASS IV THAT WAS TREATED WITH SEVERAL GORE MEDICAL DEVICES. THE DEVICE IMPLANTED MOST DISTAL IN THE LEFT LEG WAS A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC181400. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. ONCE THE IMPLANT PROCEDURE WAS COMPLETED, BUT PRIOR TO THE PATIENT LEAVING THE OPERATING ROOM, IT WAS NOTED THAT THE PATIENT¿S LEFT LEG WAS ISCHEMIC. THE PATIENT THEREFORE UNDERWENT A LEFT POPLITEAL EMBOLECTOMY TO REMOVE THE ARTERIAL THROMBUS AND ATHEROSCLEROTIC EMBOLIC DEBRIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED, THAT THIS ISCHEMIC EVENT IS LIKELY RELATED TO THE PROCEDURE AND IT IS UNLIKELY THAT IT IS RELATED TO THE IMPLANTED DEVICES.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 12683324 ↗
• MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. POST DEPLOYMENT OF A CONTRALATERAL LEG COMPONENT, DURING REMOVAL OF THE DEVICE DELIVERY CATHETER THE LEADING OLIVE BECAME DETACHED FROM THE CATHETER AND REMAINED IN THE PATIENT. THE DETACHED PORTION WAS SNARED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11290031 ↗
• MalfunctionSep 21, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT UNDERWENT TREATMENT OF A TYPE IV THORACO-ABDOMINAL AORTIC ANEURYSM WITH AN INVESTIGATIONAL GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. ADDITIONALLY, GORE® EXCLUDER® AAA AND IBE ENDOPROSTHESES WERE UTILIZED. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN THE BRANCH VESSELS. ON (B)(6) 2020, FOLLOW-UP IMAGING REVEALED AN EXTRINSIC COMPRESSION OF THE CONTRALATERAL LEG COMPONENT FROM THE IPSILATERAL LEG AND IPSILATERAL ILIAC EXTENDER COMPONENTS WITHIN THE AORTA JUST PROXIMAL OF THE AORTIC BIFURCATION. ALSO NOTED WAS A DEVICE OVALIZATION OF THE LEFT RENAL ARTERY SIDE BRANCH COMPONENT AT THE ORIGIN OF THE LEFT RENAL ARTERY. THIS IS BELIEVED TO BE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. NO INTERVENTIONS HAVE BEEN REPORTED AT THIS TIME. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS REPORTED SEPARATELY UNDER CASE 831-2. THIS REPORT ADDRESSES THE GORE® EXCLUDER® AAA ENDOPROSTHESIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10564038 ↗
• InjuryJun 9, 2020Adverse 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 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 51.6MM, WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 THE MAXIMUM AORTIC DIAMETER WAS 56MM. ON (B)(6) 2020 THE MAXIMUM AORTIC DIAMETER WAS 64MM. ON (B)(6) 2020 A TYPE IB ENDOLEAK WAS DISCOVERED AND TREATED BY MEANS OF AN ADDITIONAL UNKNOWN PERIPHERAL STENT GRAFT.

  Patient problems: Aneurysm

  MAUDE report 10136379 ↗
• InjuryFeb 13, 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 FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY THE PATIENT HAD EXTREME TORTUOSITY IN HIS ILIAC ARTERIES. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES (DATE UNKNOWN), REVEALED THE GORE® EXCLUDER® LEG ENDOPROSTHESIS ON THE LEFT SIDE (PREVIOUSLY IMPLANTED PLC181400/20899999) MIGRATED PROXIMALLY AND PULLED UP INTO THE ANEURYSM SAC. THERE WAS A REINTERVENTION ON (B)(6) 2020, THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181400) INTO THE LEFT COMMON ILIAC ARTERY AND EXTENDED IT ALL THE WAY UP INTO THE EXISTING PLC181400/20899999 (WHICH IS THE GRAFT THAT MIGRATED INTO THE ANEURYSM SAC). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 9706966 ↗
• InjuryMay 23, 2019Partial Blockage; Partial Blockage

  ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH LOW CARDIAC OUTPUT DUE TO HYPOVOLEMIA. IT WAS DETERMINED THAT THE PATIENT HAD A TYPE III ENDOLEAK, AND SUBSEQUENT ABDOMINAL AORTIC ANEURYSM RUPTURE. REPORTEDLY THE ILIAC EXTENDER COMPONENT HAD BECOME SEPARATED FROM THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS ALSO REPORTED THAT THE CONTRALATERAL LEG COMPONENT, LOCATED ON THE PATIENT'S LEFT SIDE, WAS THROMBOSED. IT WAS NOTED THAT THE CONTRALATERAL LEG COMPONENT APPEARED TO BE KINKED. A FEMORAL TO FEMORAL BYPASS WAS PERFORMED TO TREAT THE ANEURYSM RUPTURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 8638736 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED PROCEDURE. IT WAS REPORTED THAT ON FOLLOW UP COMPUTED TOMOGRAPHY (CT DATE IS UNKNOWN) SCANS REVEALED ANEURYSM SAC EXPANSION WITHOUT OBVIOUS ENDOLEAK. FOLLOW UP DYNAMIC MRA (DATE IS UNKNOWN) REVEALED CONTRAST JET AT END OF RIGHT CONTRA LIMB AS WELL AS AN AREA OF MALAPPOSITION. ANGIO CONFIRMED, THERE WAS 2CM OF LENGTH NOTED FROM STENT TO HYPOGASTRIC ARTERY. A DISTAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN REINTERVENED ON (B)(6) 2018, AND EXTENDED TO THE HYPOGASTRIC ARTERY WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC181000/18556838). COMPLETION ANGIO REVEALED ABSENCE OF ENDOLEAK AND COMPLETE APPOSITION OF EXTENSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8192736 ↗

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