GORE EXCLUDER AAA Endoprosthesis PLC181000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132618743), received between Nov 9, 2018 and Jan 12, 2026 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• MalfunctionJan 12, 2026Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER AAA ENDOPROSTHESIS. IT WAS REPORTED THAT WHEN THE PHYSICIAN PULLED THE DEPLOYMENT KNOB, THE CONTRALATERAL LEG (PLC) DID NOT DEPLOY AND FAILED TO EXPAND; THE PLC REMAINED ATTACHED TO THE CATHETER. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW PLC DEVICE WAS IMPLANTED. NO ADVERSE EVENTS OCCURRED, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN NOTED THAT THE ENTIRE DEPLOYMENT LINE CAME OUT. THE CAUSE OF THE REPORTED EVENT UNCLEAR AND COULD NOT BE DETERMINED DUE TO THE DEVICE BEING DISCARDED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035500 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON (B)(6) 2025 FROM THE IMAGING DATABASE AND IMEDIDATA BASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESES. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD A CTA. IT IS NOTED THAT THE PATIENT HAD A TYPE II ENDOLEAK. IT WAS ALSO NOTED THAT THERE WAS A DISSECTION AT THE DISTAL END OF THE DEVICE IN THE RIGHT COMMON ILIAC. THIS WAS NOT VISIBLE ON THE PRE-IMPLANT IMAGES. NO REINTERVENTION HAS OCCURRED.

  Patient problems: Vascular Dissection

  MAUDE report 23680546 ↗
• InjurySep 12, 2025Patient Device Interaction Problem; Migration; Device Endoleak; Patient Device Interaction Problem; Migration; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT POST- OP. AT THE FOLLOW UP SCAN, IT WAS DETERMINED THAT THE PLC DEVICE IMPLANTED ON THE RIGHT SIDE SEPARATED FROM THE ILIAC BRANCH ENDOPROSTHESIS AND MIGRATED DISTALLY APPROXIMATELY 60MM DUE TO THE TORTUOSITY IN THE EXTERNAL ILIAC. ADDITIONALLY, A TYPE III ENDOLEAK WAS NOTICED. REPORTEDLY, THERE WAS NO VESSEL COVERAGE. THE PHYSICIAN IS PLANNING TO RELINE DEVICES USING A PLC161100 DEVICE. THE DATE OF REINTERVENTION REMAINS UNKNOWN. THE PATIENT IS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 23044695 ↗
• MalfunctionJul 18, 2025Positioning Problem; Positioning Problem

  ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. SEVERAL GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE FOLLOWING EVENTS HAPPENED DURING THE PROCEDURE. ¿ A SECOND PLC181000/(B)(6) COULD NOT TRAVERSE; SHEATH AND WIRE AGAIN DEMONSTRATED INSTABILITY AND KINKED AT SITE WITH TORTUOSITY. ADVANTAGE WIRE USED TO RE-ESTABLISH ACCESS. ¿ DESPITE REPOSITIONING, DEVICE COULD NOT BE APPROPRIATELY PLACED; ATTEMPTED WITHDRAWAL RESULTED IN PREMATURE DEPLOYMENT (PLC) OF THE GRAFT IN RIGHT COMMON ILIAC ARTERY (RCIA) EXTENDING INTO RIGHT EXTERNAL ILIAC ARTERY (REIA), UNINTENTIONALLY COVERING THE RIGHT INTERNAL ILIAC ARTERY (RIIA). ¿ PREMATURE RIGHT LIMB DEPLOYMENT LEFT A GAP BETWEEN GATE AND LIMB. PLC201000 (SN (B)(6)) DEPLOYED VIA RIGHT 12FR SHEATH TO BRIDGE THE LIMB GAP, SUCCESSFUL DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22547135 ↗
• MalfunctionJul 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW-UP IMAGES (DATE AND MODALITY OF IMAGES IS UNKNOWN) REVEALED RIGHT GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG WAS OCCLUDED. THE PATIENT WAS EXPERIENCING CLAUDICATION. NO REINTERVENTION IS PLANNED; THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE ROOT CAUSE WAS REPORTED AS A PROXIMAL NARROWING OF THE IMPLANTED DEVICE.

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

  MAUDE report 22400903 ↗
• MalfunctionApr 28, 2025Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. WHEN ATTEMPTING TO DEPLOY THE CONTRALATERAL LEG DEVICE, THE DEPLOYMENT LINE DETACHED FROM THE DEPLOYMENT KNOB. WHILE THE LINE WAS STILL ACCESSIBLE, THE PHYSICIAN CHOSE TO WITHDRAW THE DEVICE AND USE ANOTHER DEVICE. THE PROCEDURE TERMINATED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922795 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES CONTRALATERAL LEGS TO RELINE A PREVIOUS IMPLANTED ENDOLOGIX ALTO DEVICE LIMBS FOR AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW-UP IMAGES (DATE OF IMAGES IS UNKNOWN, DATE OF EVENT WILL BE 3/24/2025) THAT THE ANEURYSM SAC CONTINUED TO GROW (8.3 CM TO 8.7 CM). A TYPE II ENDOLEAK WAS FEEDING INTO THE ANEURYSM SAC. ON (B)(6) 2025, THE PHYSICIAN CHOSE TO EXPLANT THE DEVICES AND PERFORM AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21912425 ↗
• InjuryFeb 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN AORTIC ANEURYSM IN A HIGHLY CALCIFIED AREA WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. AFTER DEPLOYMENT, THE DISTAL EDGE OF THE DEVICE WAS SITTING ON THE AORTIC BIFURCATION, BUT AFTER BALLOONED IT WAS MOVED HIGHER. ON (B)(6), THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF HIP PAIN. AFTER PERFORMING A CT SCAN, THE PHYSICIAN NOTED THAT THE LEFT COMMON FEMORAL ARTERY WAS OCCLUDED, AND THE DISTAL END OF THE RIGHT EXTERNAL ILIAC WAS THROMBOSED. THE PHYSICIAN SUSPECTS THAT THE LEFT COMMON FEMORAL ARTERY WAS OCCLUDED WHEN SEALING THE INCISION FOR THE ANGIOGRAPH. IT IS UNCERTAIN WHAT THE CAUSE WAS OF THROMBOSIS IN THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS NOT SIGNIFICANT THROMBUS PRESENT IN THE PATIENT. A REINTERVENTION TOOK PLACE TO CLEAR THE THROMBUS AND THE OCCLUSION.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21442191 ↗
• InjuryFeb 20, 2025Deformation Due to Compressive Stress; Material Deformation; Device Stenosis; Deformation Due to Compressive Stress; Material Deformation; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 79-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS AN PLANNED PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES IN THE INFRARENAL ABDOMINAL AORTA AND BILATERAL COMMON ILIAC ARTERIES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED BY CUTDOWN. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WERE NO ADJUNCTIVE PROCEDURES. THERE WAS NO TYPE I OR TYPE III ENDOLEAKS OBSERVED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A ¿CRUSH AND OCCLUSION OF ILIAC BRANCH¿. THE EVENT IS ON-GOING BUT LEAD TO INPATIENT HOSPITALIZATION. THIS EVENT IS NOTED TO BE RELATED TO TREATMENT/PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THE AFFECTED GRAFT IS THE PLC181000 ON THE LEFT SIDE. THE SITE OFFERS A HYPOTHESIS THAT THE DIMENSIONS OF THE AORTIC BIFURCATION AND THE POST-PROCEDURAL BALLOONING OF THE ENDOPROSTHETIC BR

  Patient problems: Obstruction/Occlusion

  MAUDE report 21418633 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON JANUARY 22, 2025, THE PHYSICIAN NOTIFIED FIELD SALES ASSOCIATE (FSA) ABOUT A PATIENT IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3) APPROXIMATELY 3-4 YEARS AGO. REPORTEDLY, THE ANEURYSM HAS GROWN BY ABOUT 2CM IN THAT TIME AND IS NOW IN THE 7CM RANGE. PATIENT HAS HAD MULTIPLE ANGIOGRAMS AND NEITHER THEY NOR THE CTA¿S SHOW EVIDENCE OF TYPE 1 OR TYPE 2 ENDOLEAKS. PHYSICIAN SUSPECTS THAT IT IS A TRANSGRAFT TYPE PHENOMENON. IT IS ALSO WORTH NOTING THAT THIS PATIENT IS ON ELOQUIST FOR AFIB. HE IS GETTING A WATCHMAN PROCEDURE IN THE NEAR FUTURE WITH THE HOPE THAT THEY CAN DISCONTINUE THE ELOQUIST AS PHYSICIAN SUSPECTS THAT COULD BE A FACTOR, AND HOPEFUL THAT MIGHT ELIMINATE THE SAC ENLARGEMENT. 1001-E: UNKNOWN IS USED TO CAPTURED THE GROWTH OF ANEURYSM WITHOUT ENDOLEAK.

  Patient problems: Aneurysm expansion

  MAUDE report 21404074 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, THE TRUNK IPSILATERAL LEG DEPLOYED AS EXPECTED. THE CONTRALATERAL LEG EXTENSION THEN GOT STUCK IN THE SHEATH. THE PHYSICIAN PULLED THE DEVICE BACK AND THE DELIVERY SYSTEM OLIVE FELL OFF IN THE PATIENT. THE OLIVE WAS REMOVED USING A SNARE. NO PATIENT HARM IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507159 ↗
• InjuryJul 17, 2024Adverse 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 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT DURING IMPLANT OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT THE DEVICE WAS ALMOST COMPLETELY PULLED OUT OF THE 3CM OVERLAP ZONE DURING REMOVAL OF THE DEVICE DELIVERY SYSTEM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO BRIDGE ANY GAP AND RELINE THE AREA. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED AS BRANCH DEVICES IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, RIGHT AND LEFT RENAL ARTERIES. A GORE® TRI LUMEN CATHETER WAS USED TO GAIN THROUGH AND THROUGH WIRE ACCESS TO THE BRANCH ARTERIES. THE PROCEDURE WAS COMPLETED WITH GOOD TECHNICAL RESULTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT AWOKE AND HAD NO FEELING IN HIS LEGS. THE PATIENT UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PARAPLEGIA. THE PATIENT IS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO HAVE STARTED REGAINING MOVEMENT IN HIS RIGHT LEG AN

  Patient problems: Paraplegia

  MAUDE report 19767599 ↗
• InjuryMar 21, 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) 2024, 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 ON (B)(6) 2024, ALL THREE GORE DEVICES WERE EXPLANTED DUE TO INFECTION. AN OPEN REPAIR WAS THEN PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICES WERE CULTURED AT HOSPITAL AFTER EXPLANT AND SALMONELLA WAS THE CAUSE OF THE INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 18949565 ↗
• 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 SEPTEMBER 15, 2023: PATIENT IS STABLE MEDICALLY BUT IS REQUIRING DIALYSIS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17864680 ↗
• InjuryFeb 14, 2023Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, BILATERAL TYPE I DISTAL ENDOLEAKS WERE REPORTED FOR THE PATIENT. THE ENDOLEAKS WERE IDENTIFIED WITHIN THE CONTRALATERAL LEG COMPONENTS. THE PHYSICIAN PLANNED TO REINTERVENE ON (B)(6) 2023 AND IMPLANT BI-LATERAL EXTENSIONS AND EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY. IT WAS LATER REPORTED THAT ON (B)(6) 2023, THE PHYSICIAN PERFORMED REINTERVENTION SURGERY IN WHICH BI-LATERAL EXTENSIONS WERE IMPLANTED AND THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16376417 ↗
• InjuryFeb 22, 2021Unintended Movement; Unintended Movement

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A DISTAL TYPE I ENDOLEAK (DATE AND MODALITY OF IMAGES IS UNKNOWN) AND ONE OF THE IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS HAD MIGRATED PROXIMALLY INTO THE ANEURYSM SAC. THERE IS NO ANEURYSM SAC ENLARGEMENT. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED IN EACH ILIAC ARTERY DURING THE ORIGINAL PROCEDURE. IT IS UNKNOWN WHICH OF IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS DEVICE HAD MIGRATED THEREFORE BOTH WILL BE REPORTED ON. ON (B)(6) 2021, THE PHYSICIAN REINTERVENED AND EXTENDED THE LEFT LIMB DEVICE WHICH HAD PULLED UP INTO THE ANEURYSM SAC. LANDING THE PROXIMAL END AT THE FLOW DIVIDER AND THE DISTAL END IN THE LEFT EXTERNAL ILIAC. THE ANEURYSM WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11360572 ↗
• InjurySep 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WHICH WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. TO EXCLUDE THE ANEURYSM THE FOLLOWING DEVICES WERE USED: RIGHT SIDE: CXT231412E (SN (B)(4) AND PLC181000 (SN (B)(4) LEFT SIDE: PLC231200 (SN (B)(4) AND PLC231000 (SN (B)(4) ON COMPLETION ANGIOGRAPHIC IMAGING OF THE IMPLANT PROCEDURE IT WAS UNDETERMINED WHETHER THERE WAS AN ENDOLEAK TYPE IB OR TYPE II ON THE RIGHT SIDE. ON (B)(6) 2020, A COMPUTED TOMOGRAPHY SCAN WAS DONE WHICH PROVED INCONCLUSIVE. ON (B)(6) 2020, A SECOND COMPUTED TOMOGRAPHY SCAN WAS DONE WHICH ALSO PROVED INCONCLUSIVE. ON (B)(6) 2020, A THIRD COMPUTED TOMOGRAPHY SCAN WAS DONE AT WHICH POINT IT WAS CONCLUDED IT WAS AN ENDOLEAK TYPE IB AND TO PERFORM AN ENDOVASCULAR REINTERVENTION TO EXTEND WITH A DEVICE OF LARGER DIAMETER. THERE HAS BEEN NO SAC EXPANSION REPORTED. THE PHYSICIAN HAS SAID THAT THE REASON FOR THE ENDOLEAK WAS AN UNDERSIZING ISSUE: INITIALLY THE RIGHT LIMB PLC181000 WAS UNDERSIZED. A SMALLER DIAMETER PLC DEVICE WAS USED THAN WHAT ACTUALLY SHOULD HAVE BEEN USED. REPORTEDLY, THE PLAN IS TO EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY AND EXTEND THE RIGHT PLC181000 LIMB INTO THE RI

  Patient problems: No Code Available

  MAUDE report 10573306 ↗
• InjuryMar 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON FEBRUARY 21, 2020 IMAGES WERE RECEIVED FROM THE PHYSICIAN (POST-IMPLANTATION COMPUTED TOMOGRAPHY ANGIOGRAPHY DATED (B)(6) 2020) IDENTIFYING A DISTAL TYPE I ENDOLEAK ON THE CONTRALATERAL LEG COMPONENT LOCATED ON THE PATIENT'S RIGHT SIDE. THE CAUSE OF THE ENDOLEAK WAS SUSPECTED TO BE DILATION OF THE PATIENT'S ILIAC ARTERY. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED. A GORE® EXCLUDER® ILIAC BRANCH COMPONENT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED. REPORTEDLY THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9838720 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING ENDOLOGIX® AFX STENT GRAFTS. ON AN UNKNOWN DATE, A TYPE III ENDOLEAK WAS DISCOVERED. ON (B)(6) 2020, TREATMENT FOR THE ENDOLEAK WAS PERFORMED WHEREBY A GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. DURING IMPLANT OF A CONTRALATERAL LEG COMPONENT, IT WAS REPORTED THAT THE PHYSICIAN UNINTENTIONALLY COVERED THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY. THE DEVICE DID NOT MOVE DURING DEPLOYMENT. THE PHYSICIAN REPORTS THAT THERE WAS A VISUALIZATION ISSUE THAT CAUSED THE UNINTENTIONAL OBSTRUCTION OF THE RIIA, ALTHOUGH DETAILS WERE NOT PROVIDED TO GORE. THE PATIENT OUTCOME INCLUDES LIMITED AND SLUGGISH FLOW INTO THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY.

  Patient problems: Occlusion

  MAUDE report 9830862 ↗
• InjurySep 15, 2019Device Damaged by Another Device; Device Damaged by Another Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 DATE A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC AND COMMON ILIAC ARTERY ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WITH GOOD ANGIOGRAPHIC RESULTS. ON (B)(6) 2019 FOLLOW-UP IMAGES REVEALED THE LEFT SIDE, IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS BEING COMPRESSED BY THE PROXIMAL END OF THE IBE COMPONENT IN THE DISTAL AORTA. THIS WAS THOUGHT TO BE DUE TO A TIGHT DISTAL BIFURCATION. THE PATIENT WAS ASYMPTOMATIC AND HAD FEMORAL PULSES. HOWEVER THE SURGEON WAS CONCERNED ABOUT LIMB THROMBOSIS AND PLANNED TO REINFORCE THE NARROWED LIMB WITH A BALLOON EXPANDABLE STENT. ON (B)(6) 2019 A REINTERVENTION TOOK PLACE WHEREBY A BARE METAL BALLOON EXPANDABLE STENT WAS IMPLANTED AND DILATED TO 12 MM. THE ANGIOGRAPHIC OUTCOME WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9060654 ↗
• InjuryNov 9, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. COMPUTED TOMOGRAPHY (CT) IMAGES RECEIVED ON OCTOBER 15, 2018, REPORTEDLY REVEALED A LACK OF DISTAL DEVICE APPOSITION TO THE VESSEL WALL ON THE LEFT SIDE, CONTRIBUTING TO A TYPE IB ENDOLEAK. ANEURYSMAL GROWTH WAS REPORTEDLY NOTED IN THE LEFT COMMON ILIAC ARTERY (AMOUNT UNKNOWN). A TYPE II ENDOLEAK WAS ALSO REPORTEDLY IDENTIFIED. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY THE ANEURYSM WAS COIL-EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED DISTALLY ON THE LEFT SIDE TO TREAT THE TYPE II AND IB ENDOLEAKS, RESPECTIVELY. THE ENDOLEAKS WERE RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8055955 ↗

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