GORE EXCLUDER AAA Endoprosthesis PLL161007Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132618811), received between Aug 17, 2018 and Apr 21, 2026 — classified as 2 deaths, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Complete Blockage

  ON (B)(6) 2023, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF A INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 7CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2025, FOLLOW-UP ULTRASOUND DETERMINED RIGHT LIMB DEVICE OCCLUSION WITH NO VISUALIZED ENDOLEAK. ON (B)(6) 2026, REVIEW OF THE PATIENT¿S FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2026, SHOWED A DECREASE IN DIAMETER OF THE AAA AND AN OCCLUSION OF THE RIGHT ILIAC ARTERY DEVICE. ON (B)(6), 2026, THE PATIENT UNDERWENT EXPLANT OF ALL GORE DEVICES AND PLACEMENT OF A DACRON GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24942073 ↗
• MalfunctionAug 13, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE THAT A PATIENT WAS TO BE IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER DEVICE) TO TREAT ABDOMINAL AORTIC STENOSIS. THE DEPLOYMENT KNOB WAS PULLED BUT THE DEVICE DIDN'T EXPAND IN PATIENT. THE DEPLOYMENT LINE WAS NOT STUCK. THE DEPLOYMENT KNOB WAS COMPLETED REMOVED FROM CATHETER, BUT THE DEPLOYMENT LINE WAS NOT SURE ABOUT COMPLETED REMOVED OR NOT FROM CATHETER. THE BREAKAGE OF DEPLOYMENT LINE WAS NOT SURE. THEREFORE, THE EXCLUDER DEVICE WAS WITHDRAWN, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT'S POSTOPERATIVE STATUS WAS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791128 ↗
• InjuryMar 4, 2024Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2024, THE PATIENT HAD THROMBUS. BOTH OF THEIR EXTERNAL ILIACS THROMBOSED AND A CLOT WENT NORTH. THEIR SYSTEM WAS OCCLUDED. THE PHYSICIAN HAS NOT RE-INTERVENED; HOWEVER, THEY ARE PLANNING NEXT STEPS. THEY WILL POSSIBLY PERFORM AN AXILLA-FEMORAL BYPASS. AS OF NOW, THE PATIENT IS STABLE. THE PHYSICIAN SUSPECTED THAT THE PATIENT HAD A CLOTTING DISORDER AND CLOTTED THE LEFT EXTERNAL ILIAC AND IT CONTINUED PROXIMAL INTO THE EXCLUDER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18827236 ↗
• InjuryMar 4, 2024Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON FEBRUARY 6, 2024, THE PATIENT HAD THROMBUS. BOTH OF THEIR EXTERNAL ILIACS THROMBOSED AND A CLOT WENT NORTH. THEIR SYSTEM WAS OCCLUDED. THE PHYSICIAN HAS NOT RE-INTERVENED; HOWEVER, THEY ARE PLANNING NEXT STEPS. THEY WILL POSSIBLY PERFORM AN AXILLA-FEMORAL BYPASS. AS OF NOW, THE PATIENT IS STABLE. THE PHYSICIAN SUSPECTED THAT THE PATIENT HAD A CLOTTING DISORDER AND CLOTTED THE LEFT EXTERNAL ILIAC AND IT CONTINUED PROXIMAL INTO THE EXCLUDER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18827198 ↗
• DeathOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES.

  Patient problems: Aneurysm

  MAUDE report 17865871 ↗
• InjuryAug 4, 2022Off-Label Use; Off-Label Use

  ON JULY 5TH, 2022, MEDICAL DEVICE TRACKING RECEIVED INFORMATION REGARDING THE IMPLANT AND SAME DAY EXPLANT OF A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS THAT OCCURRED ON (B)(6) 2022. THE CLINICAL SPECIALIST COVERING THE ACCOUNT WAS CONTACTED FOR ADDITIONAL INFORMATION. AS REPORTED, THE PATIENT WAS ADMITTED FOR PLANNED TREATMENT OF OCCLUSIVE AORTIC DISEASE. AS REPORTED, THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS PLACED AS THE MAIN BODY IN THE AORTA WITH THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER USED AS A CONTRALATERAL LEG, AND THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS CONFORMABLE AORTIC EXTENDER USED TO EXTEND THE GRAFT PROXIMALLY (3000-E:-DEVICE SELECTION - OTHER/UNKNOWN). AS REPORTED, THE PATIENT WAS ALSO IMPLANTED WITH GORE® VIABAHN® ENDOPROSTHESES. AS REPORTED, FOLLOWING DEVICE IMPLANTATIONS, THE PROCEDURE WAS CONVERTED TO OPEN REPAIR IN WHICH ALL DEVICES WERE EXPLANTED. AS REPORTED, THE PATIENT WAS PLACED ON COMFORT CARE AND PASSED ON AN UNSPECIFIED DATE FOLLOWING THE PROCEDURE. REPORTEDLY, THE PATIENT HAD OCCLUSIVE DISEASE LONG ENOUGH FOR THE DEVELOPMENT

  Patient problems: Unspecified Vascular Problem

  MAUDE report 15163805 ↗
• DeathJun 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON MAY 6, 2022, THE PATIENT PRESENTED WITH A RIGHT COMMON ILIAC ANEURYSM AND UNDERWENT TREATMENT UTILIZING TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (AAA). INITIAL IMAGING REVEALED A LARGE ANEURYSM, APPROXIMATELY 4CM X 5CM, AND THE PHYSICIAN NOTED A LARGE LEFT ACCESSORY RENAL SUPPLYING THE LOWER HALF OF THE LEFT KIDNEY APPROXIMATELY 56 MILIMETERS ABOVE THE AORTIC BIFURCATION. THE PHYSICIAN ELECTED TO UTILIZE THE FIRST IBE DEVICE AND PLACED IT ABOVE THE AORTIC BIFURCATION BUT BELOW THE LEFT ACCESSORY RENAL. THE PHYSICIAN THEN PLACED AN IBE EXTENDER DEVICE TO EXCLUDE A RIGHT COMMON ILIAC ANEURYSM, THE IBE DEVICE EXTENDED INTO THE RIGHT EXTERNAL ILIAC ARTERY. ON THE CONTRALATERAL SIDE, THE PHYSICIAN UTILIZED THE SECOND IBE DEVICE, THIS WAS IMPLANTED WITHOUT ISSUE. THE RIGHT HYPOGASTRIC WAS THEN COILED WITH TWO COOK NESTER COILS (6MM X 14CM) AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. FINAL IMAGING CONFIRMED EXCLUSION OF THE RIGHT COMMON ILIAC ANEURYSM AND FLOW WAS OBSERVED ON THE LEFT SIDE AND WAS CONFIRMED BY THE PHYSICIAN. APPROXIMATELY 5 HOURS POST-OP, THE PATIENT PRES

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14594041 ↗
• InjuryOct 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2021, THE PATIENT HAD AN EVAR TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE THE DECISION WAS MADE TO INTENTIONALLY COVER THE LEFT HYPOGASTRIC ARTERY. AFTER THE EVAR PROCEDURE, THE PATIENT DEVELOPED COLITIS AND HAD SURGERY ON (B)(6) 2021, TO REMOVE PART OF THE COLON. THE PATIENT IS RECOVERING WELL AFTER THE SECONDARY PROCEDURE.

  Patient problems: Inflammation

  MAUDE report 12618202 ↗
• InjuryMar 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ARTERIAL OCCLUSIVE DISEASE USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT A GORE® EXCLUDER® ILIAC BRANCH COMPONENT (IBC) WAS PLACED IN THE PATIENT'S AORTA, A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS PLACED IN THE PATIENT'S RIGHT ILIAC ARTERY, AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT AND GORE® EXCLUDER® AAA ILIAC EXTENDER COMPONENT WERE PLACED IN THE PATIENT'S LEFT ILIAC ARTERY. IT WAS ALSO REPORTED THAT THERE WAS NOT ENOUGH ROOM IN THE PATIENT'S AORTA FOR THE IBC DEVICE. ON AN UNKNOWN DATE, DEVICE OCCLUSION WITH NO DISTAL BLOOD FLOW WAS REPORTED THROUGH THE DEVICES LOCATED IN THE PATIENT'S LEFT ILIAC ARTERY. THE GORE REPRESENTATIVE WAS MADE AWARE OF THE ISSUE ON (B)(6) 2021. IT WAS REPORTEDLY SUSPECTED THAT THE DEVICE OCCLUSION MAY HAVE BEEN RELATED TO THERE NOT BEING ENOUGH ROOM IN THE PATIENT'S AORTA FOR THE IBC DEVICE. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. IT WAS REPORTED THAT THE CONTRALATERAL LEG COMPONENT IN THE PATIENT'S RIGHT LIMB WAS REINFORCED USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. A FEMORAL-F

  Patient problems: Obstruction/Occlusion

  MAUDE report 11547544 ↗
• MalfunctionDec 26, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE III ENDOLEAK ORIGINATING IN A COMPETITOR'S DEVICE. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED TO TREAT THE ENDOLEAK. THE PHYSICIAN ADVANCED THE GRAFT TO THE DESIRED POSITION. WHEN THE DEVICE WAS DEPLOYED, AND THE PHYSICIAN ATTEMPTED TO RETRACT THE DELIVERY CATHETER, THE DEVICE BECAME STUCK IN THE SHEATH. WHEN THE PHYSICIAN CONTINUED TO REMOVE THE DEVICE FROM THE SHEATH, THE OLIVE DETACHED FROM THE DEVICE. THE PHYSICIAN DEFLATED THE SHEATH, AND USED FORCEPS TO REMOVE THE DEPLOYED DEVICE AND OLIVE FROM THE PATIENT. A SECOND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED USING THE SAME SHEATH. THE DEVICE WAS IMPLANTED SUCCESSFULLY, AND THE PATIENT IS DOING FINE. THE PHYSICIAN HAD NO OPINION ON THE CAUSE OF THE EVENT, BUT THE FSA SUSPECTED THAT THE FIRST DEVICE WAS DEPLOYED PARTIALLY IN THE SHEATH. I WAS ALSO REPORTED THAT THE COMMON AND EXTERNAL ILIAC ARTERIES HAD SIGNIFICANT TORTUOSITY, AND THAT THE DEVICE HAD TO BE ADVANCED THROUGH EXISTING DEVICES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE EVALUATION WAS COMPLETED USING THE INFORMATION PROVIDED FOR THE EVENT. THE FOLLOWING WAS REPORTED FOR THE EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521534 ↗
• MalfunctionNov 4, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ISOLATED ILIAC AND HYPOGASTRIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER THE SUCCESSFUL DEPLOYMENT OF A GORE® EXCLUDER® ILIAC EXTENDER ENDOPROSTHESIS, THE PROXIMAL OLIVE OF THE DEVICE CATHETER BROKE OFF AND MIGRATED INTO THE ANTERIOR TIBIAL ARTERY. SINCE GUIDEWIRE ACCESS WAS LOST, IT WAS NOT TRIED TO REMOVE THE BROKEN PART WITH ENDOVASCULAR TECHNIQUES AND IT WAS DECIDED NOT TO PERFORM SURGERY. ADDITIONAL IT WAS STATED THAT THE PATIENT HAD NORMAL TORTUOSITY AND NO PARTICULAR CALCIFICATION. ALSO RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE DEVICE THAT WAS RELATED TO NORMAL ANATOMY OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE BROKEN PART REMAINED IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE AND NO REINTERVENTION IS CURRENTLY PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9271438 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2019. ON (B)(6) 2019, THE GORE FSA WAS INFORMED THAT THE PATIENT HAD UNDERGONE A REINTERVENTION FOR A SUSPECTED MYCOTIC ANEURYSM. THE DEVICE WAS EXPLANTED AND WAS SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT, SO IT WAS UNAVAILABLE FOR RETURN. THE PHYSICIAN STATED THAT THE PATIENT "HAD A PRIMARY DUODENAL TO ANEURYSM FISTULA. I'VE NEVER SEEN THAT BEFORE." THE PATIENT IS DOING WELL AFTER THE PROCEDURE.

  Patient problems: Fistula

  MAUDE report 9211195 ↗
• MalfunctionAug 6, 2019Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE CASE A CONTRALATERAL LEG COMPONENT (PLC121400/20569329) WAS IMPLANTED. AN ILIAC EXTENDER COMPONENT (PLL161007/1878556) WAS NEEDED TO COMPLETE APPROPRIATE COVERAGE FROM THE CONTRALATERAL LEG COMPONENT INTO THE LEFT EXTERNAL ILIAC ARTERY. UPON REMOVAL OF THE DELIVERY CATHETER, THE OLIVE TIP AND APPROXIMATELY 3-4" OF THE POLYIMIDE TUBING SEPARATED FROM THE REST OF THE DELIVERY CATHETER. THE PHYSICIAN NOTED RESISTANCE AS THE OLIVE TIP WAS BEING PULLED INTO THE SHEATH (DSF1833/UNK). AN AUDIBLE SOUND WAS HEARD JUST AS THE CATHETER POPPED BACK INTO THE SHEATH. THE CATHETER DELIVERY SYSTEM WAS REMOVED. THE BROKEN PORTION OF THE CATHETER AND THE OLIVE TIP WERE STILL OVER THE WIRE (BOSTON SCIENTIFIC AMPLATZ, 260CM, .035 IN). THE SHEATH WAS ADVANCED OVER THE OLIVE TIP. THE SHEATH, WIRE, AND CATHETER WERE PULLED BACK SIMULTANEOUSLY UNTIL THE SHEATH AND BROKEN PIECE WERE OUTSIDE THE PATIENT'S BODY. ONCE THE BROKEN PIECE WAS DETERMINED BY EXAMINATION AND FLUOROSCOPY TO BE INTACT AND OUT OF THE BODY, THE CASE PROCEEDED IN THE USUAL FASHION. THE DELIVERY C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8867523 ↗
• InjuryAug 17, 2018Collapse; Improper or Incorrect Procedure or Method; Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AORTIC STENT PLACEMENT USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ¿AORTIC BLOCKAGE.¿ ACCORDING TO THE COMPLAINT, "THE STENT THAT WAS PLACED IN [THE PATIENT] WAS MUCH TOO LARGE AND COLLAPSED, CAUSING (B)(6) DOLLARS FOR FURTHER MEDICAL TREATMENT. ALSO CAUSING PERMANENT DAMAGE TO [THE PATIENT¿S] LEFT LEG AND FOOT AND EXTENSIVE LONG TERM HEALTH ISSUES." THE COMPLAINT ALLEGES THAT "AT THE FOLLOW UP APPOINTMENT WITH DR. (B)(6) ON (B)(6) 2018, DR. (B)(6) TOLD [THE PATIENT AND HER HUSBAND] THAT HE HAD NEVER SEEN ANYTHING LIKE THIS. [THE PATIENT] HAD CLOTS ON BOTH FEMORAL ARTERIES AND MULTIPLE CLOTS THROUGHOUT HER LEGS. HE SAID THERE WAS NOTHING TO DO AT THIS POINT TO REPAIR IT, AND TO PUSH HERSELF TO WALK FARTHER AND DO MORE AND THAT SHE WOULD BE ON BLOOD THINNERS THE REST OF HER LIFE. DR. (B)(6) DID NOT WANT TO SEE HER BACK IN HIS OFFICE FOR A FOLLOW UP VISIT FOR 6 MONTHS. HE OFFERED A REFERRAL TO A VEIN CLINIC AND THAT APPOINTMENT WAS ALSO 6 MONTHS OUT." IT WAS REPORTED THAT SINCE HER (B)(6) 2018 FOLLOW UP APPOINTMENT, THE PATIENT HAS SEEN MULTIPLE ADDITIONAL VASCULAR SURGEONS, AND HAS UNDERGONE SIX SURGERIE

  Patient problems: No Code Available; Thrombus

  MAUDE report 7795664 ↗

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