GORE EXCLUDER AAA Endoprosthesis PLC121200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132618712), received between Aug 10, 2018 and Jun 24, 2026 — classified as 22 injuries, 2 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. DURING THE PROCEDURE, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICE, A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE USED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FLOW LIMITING EXTERNAL ILIAC DISSECTION WAS CONDUCTED BY A CTA. IT WAS NOTED THAT THE LIKELY CAUSE OF RIGHT EXTERNAL ILIAC DISSECTION WAS DUE TO CLAMP INJURY FROM THE ILIAC CONDUIT. NO IMPLANTED DEVICES WERE ATTRIBUTED TO THE DISSECTION. ACCORDING TO THE PHYSICIAN, NO OCCLUSION OF THE DEVICE OR VESSEL WAS NOTICED. IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT UNDERWENT THE RIGHT ILIAC ARTERY STENTING (TWO GRAFTS WERE IMPLANTED). THE EVENT WAS RESOLVED. THE PATIENT IS DOING WELL. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Vascular Dissection

  MAUDE report 25616336 ↗
• InjuryAug 1, 2025Positioning Failure; Obstruction of Flow; Malposition of Device; Positioning Failure; Obstruction of Flow; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AT (B)(6) USING GORE®EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS SYSTEM (EXCC), WITH GORE®EXCLUDER®AAA ENDOPROSTHESIS LEGS. THE CXT361414 L/S#: (B)(6) WAS PLACED SUCCESSFULLY THROUGH RIGHT FEMORAL ACCESS. AFTER PARTIAL DEPLOYMENT OF THE EXCC, THE PHYSICIAN HAD DIFFICULTY CANNULATING THE CONTRALATERAL GATE. HE DECIDED TO FULLY DEPLOY THE MAIN DEVICE AND THEN SNARE THE WIRE FROM THE LEFT SIDE BY COMING UP AND OVER THE AORTIC BIFURCATION FROM THE RIGHT SIDE. AFTER DEPLOYING THE MAIN DEVICE COMPLETELY AND WHILE PASSING THE WIRE FROM THE LEFT, THE PHYSICIAN APPEARED TO CANNULATE THE CONTRALATERAL GATE AND CONFIRMED ACCESS BY SPINNING THE PIGTAIL CATHETER IN THE PROXIMAL PORTION OF THE CXT. THEREFORE, THE PHYSICIAN BELIEVED THE SNARE TECHNIQUE (UP AND OVER) WAS NO LONGER NECESSARY. THE CONTRALATERAL LIMB (PLC121200 L/S#: (B)(6)) WAS PLACED ON THE LEFT SIDE. AFTER DEPLOYMENT OF THE CONTRALATERAL LIMB THE IPSILATERAL LIMB EXTENSION (PLC121000 L/S#: (B)(6)) WAS PLACED ON THE RIGHT SIDE, EXTENDING THE CXT. THE COMPLETION ANGIOGRAM LOOKED GOOD BUT REDUCED FLOW WAS NOTED. AFTER SEVERAL ANGIOG

  Patient problems: Reduced Blood Flow

  MAUDE report 22688486 ↗
• InjuryJul 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK DEVICE, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE. ON AN UNKNOWN DATE IN (B)(6) 2024 OR (B)(6) 2025, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL FOR EXPLANTATION OF THE DEVICES AND OPEN RECONSTRUCTION DUE TO GRAFT INFECTION. THE PATIENT HAD SEVERAL RETURN TRIPS TO WASH OUT ABSCESSES, AND IN (B)(6) 2025 HE RECEIVED A TRACHEOTOMY. THE PATIENT REMAINS IN CRITICAL CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 22494415 ↗
• MalfunctionJun 18, 2025Material Deformation; Material Deformation

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT DURING THE PATIENT¿S 30-DAY POST OPERATIVE COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN, COMPRESSION OF THE CONTRALATERAL LEG COMPONENT (PLC121200/(B)(6) AT THE LEVEL OF THE BIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284389 ↗
• InjuryJun 9, 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 WITH NO COMMON ILIAC ARTERY INVOLVEMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT261412/(B)(6). PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 40MM WITH A PROXIMAL LANDING ZONE HAD A MAXIMUM DIAMETER OF 40MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD AN UNSCHEDULED IN-PERSON FOLLOW-UP WHEREIN IMAGING WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH WAS REPORTED THAT THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 36MM. ADDITIONALLY, A LOSS OF PATENCY OF THE GORE DEVICE IMPLANTED WITHIN THE LEFT COMMON ILIAC ARTERY (PLC121000/(B)(6) AND ISCHEMIA OF THE LEFT LOWER EXTREMITY WAS REPORTED TO HAVE NOT RESOLVED. THE EVENT IS NOTED AS BUTTOCK CLAUDICATION AND NOT ATTRIBUTED TO THE GORE DEVICE. THE PATIENT¿S MEDICAL HISTORY INCLUDES A HISTORY OF BUTTOCK CLAUDICATION; HOWEVER, THE PHYSICIAN REPORTS IT IS BELIEVED TO BE A NEW ONS

  Patient problems: Ischemia

  MAUDE report 22172331 ↗
• InjuryJan 23, 2025Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, A FOLLOW-UP CT SCAN WAS TAKEN. ON (B)(6) 2024, THE PHYSICIAN NOTIFIED THE FSA THAT THERE WAS COMPRESSION OF THE CONTRALATERAL LIMB ON THE CT SCAN. BASED ON THE CT SCANS FROM THE ORIGINAL PROCEDURE, THE COMPRESSION APPEARS TO BE LOCATED WHERE THE AORTA NARROWS. ON (B)(6) 2024, THE PHYSICIAN IS REINTERVENED BY IMPLANTING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE PROXIMAL PORTION OF THE EXCLUDER AND BALLOONING. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE FSA WHO COVERED THE INITIAL PROCEDURE, THE PHYSICIAN DID NOT USE THE KISSING BALLOON TECHNIQUE WHEN BALLOONING IN THE NARROW PART OF THE AORTA.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21224755 ↗
• InjuryOct 29, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. POST DEPLOYMENT OF THE CONTRALATERAL LEG (PLC121200/28678193) IT WAS DETERMINED THE RIGHT HYPOGASTRIC ARTERY HAD BEEN UNINTENTIONALLY COVERED DUE TO SPASMS FROM THE RIGHT EXTERNAL ILIAC ARTERY HAVING BEEN SMALL (MAXIMUM 9MM DIAMETER) AND WE COULDN'T SEE CLEARLY. THE PHYSICIAN BALLOONED THE GRAFT AND WHEN THEY BALLOONED THE DISTAL END OF THE RIGHT SIDE, WE RUPTURED THE RIGHT EXTERNAL ILIAC ARTERY JUST BELOW THE ORIGIN OF THE RIGHT INTERNAL ILIAC ARTERY WITH A GORE® MOLDING AND OCCLUSION BALLOON (MOB) CATHETER. THE CAUSE OF THE RUPTURE IS THOUGHT TO HAVE BEEN DUE TO THE VESSEL DIAMETER COUPLED WITH OVER INFLATION OF THE MOB. AT THIS TIME THE PATIENT¿S PRESSURE WAS NOT STABLE AND THE TREATED THE RUPTURE WITH 2 GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS AND EXTENDED COVERAGE DOWN TO THE FEMORAL HEAD. AS THE PATIENT WAS STILL UNSTABLE THE PHYSICIAN SUSPECTED A BLEED IN THE HYPOGASTRIC ARTERY THEY LIGATED THE RIGHT HYPOGASTRIC ARTERY. THE PATIENT BECAME STABLE AND THE PROCEDURE WAS CONCLUDED. BLOOD LOSS WAS

  Patient problems: Ruptured Aneurysm

  MAUDE report 20562188 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS TO BE IMPLANTED WITH A 12 MM X 12 CM GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER DEVICE) TO TREAT AORTIC ANEURYSM. IT WAS FOUND THAT THE DEPLOYMENT LINE WAS BROKEN DURING THE DEPLOYMENT OF THE ILIAC LEG. THE DEVICE WAS PARTIAL DEPLOYED AND COULDN'T BE FULLY EXPANDED. IT WAS WITHDRAWN THROUGH A LARGE SHEATH AND REMOVED FROM PATIENT. ANOTHER EXCLUDER DEVICE WAS USED COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790107 ↗
• InjuryJun 24, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AT THE TIME OF THE INITIAL PROCEDURE, THE PATIENT HAD THROMBUS IN THE AORTIC NECK NEAR THE PROXIMAL LANDING ZONE. BECAUSE THERE WAS THROMBUS, PHYSICIAN AT THE TIME ELECTED NOT TO BALLOON IN THE AREA OF THE AORTIC NECK AND PHYSICIAN BELIEVES BECAUSE THEY DID NOT BALLOON THE AORTIC NECK THAT'S WHY THE DEVICES SLIPPED (8CM) INTO THE ANEURYSM SAC (GROWTH SIZE GREATER THAN 5MM) AND HAD TYPE 1A ENDOLEAK ON THE TRUNK IPSILATERAL LEG. THE AORTIC NECK ALSO GREW IN DIAMETER AS THE NECK WAS DILATED. ON MAY 28, 2024, FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN ABOUT A PATIENT HAVING A LARGE TYPE 1A ENDOLEAK. A REINTERVENTION WAS PLANNED FOR (B)(6) 2024 WITH REALIGNMENT OF THE ORIGINAL GRAFTS. ON (B)(6) 2024, AN ENDOVASCULAR REINTERVENTION WAS DONE IN ZONE 8 -RENALS TO TREAT A TYPE 1A ENDOLEAK UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE), HOWEVER, THE CONFORMABLE DEVICE WAS TOO LONG AS IT WOULD HAVE OC

  Patient problems: Aneurysm expansion

  MAUDE report 19594947 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND ONE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON 16-NOV-2023, THE FSA WAS NOTIFIED THAT THE PATIENT HAD A TYPE IB ENDOLEAK. A REINTERVENTION IS PLANNED.

  Patient problems: Clinical Endoleak

  MAUDE report 18344754 ↗
• InjuryJul 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A 4CM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT'S AORTIC BIFURCATION WAS NARROW AND, AFTER BALLOON DILATION OF THE PATIENT'S LEFT LIMB, COMPRESSION OF THE RIGHT LIMB OCCURRED DUE TO THE NARROW BIFURCATION. REPORTEDLY, THE CONTRALATERAL LEG COMPONENT WAS ONLY COMPRESSED NEAR THE AORTIC BIFURCATION WHERE THE BALLOONING OF THE RIGHT LIMB HAD OCCURRED. IT WAS REPORTED THAT, ON THE MORNING OF (B)(6) 2023, THE PATIENT COMPLAINED OF LEG PAIN AND THE CONTRALATERAL LEG COMPONENT WAS FOUND TO BE THROMBOSED UP TO THE AORTIC BIFURCATION WHERE COMPRESSION HAD OCCURRED. THE LIMB WAS REPORTED AS FULLY OCCLUDED. IT WAS NOTED THAT THE TRUNK AND CONTRALATERAL LEG GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT WERE FREE FROM THROMBUS, OCCLUSION, AND/OR COMPRESSION. THE PHYSICIAN PERFORMED A FEM-FEM BYPASS ON THE SAME DAY. THE REINTERVENTION WAS REPORTED AS SUCCESSFUL. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Limb Pain; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17399201 ↗
• InjuryJul 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION ENDOVASCULAR TREATMENT TO RELINE ONE OF THE GORE® EXCLUDER® ENDOPROSTHESES LIMBS. THE PATIENT TOLERATED THE REINTERVENTION. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF GROWTH IS UNKNOWN, AN UNKNOWN TYPE ENDOLEAK). ON (B)(6) 2023, THE PHYSICIAN EXPLANTED ALL THE GORE® EXCLUDER® ENDOPROSTHESES LIMBS AND PERFORMED AN OPEN REPAIR. THE ANEURYSM SAC CONTINUED TO ENLARGE (AMOUNT OF GROWTH IS UNKNOWN, AN UNKNOWN TYPE ENDOLEAK). THE EXPLANTED DEVICES WERE DESTROYED AT THE HOSPITAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17375369 ↗
• InjuryApr 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6), 2022 THE PATIENT UNDERWENT EVAR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH THE FOLLOWING GORE ENDOPROSTHESES: CXT261412 (LOT/SN:(B)(4)) GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS - TRUNK IPSILATERAL LEG; PLC121200 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG; PLC141000 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG; PLL161407 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - ILIAC EXTENDER. AT THE ONE MONTH FOLLOW UP VISIT CT IMAGING REVEALED STENOSIS IN THE RIGHT LIMB. THIS WAS REPORTEDLY THE RESULT OF THE PREVIOUSLY IMPLANTED STENTS COMPETING FOR SPACE WITHIN THE SMALL VESSEL AREA (1000-E:-OTHER). AS REPORTED, THE PATIENT WAS ASYMPTOMATIC. ON (B)(6), 2022 THE PATIENT UNDERWENT A PLANNED REINTERVENTION IN WHICH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE RIGHT LIMB. THE LEFT SIDE WAS ACCESSED, BUT ONLY TO PLACE A BALLOON IN ORDER TO COUNTERACT THE STENT INFLATION (KISSING BALLOON TECHNIQUE). AS REPORTED, THE PATIENT TOLERATED THE PROCEDURE. INFORMATION REGARDING WHICH ENDOPROSTHESES WENT DOWN THE RIGHT LEG AND WHICH WENT DOWN THE LEFT LEG WAS REQUESTED BUT WAS

  Patient problems: Stenosis

  MAUDE report 13995742 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT EVAR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH THE FOLLOWING GORE® EXCLUDER® EVAR ENDOPROSTHESES: TRUNK IPSILATERAL LEG COMPONENT (RLT261216), CONTRALATERAL LEG COMPONENT (PLC121200), AND AORTIC EXTENDER (PLA280300). ON (B)(6) 2022 CTA WAS PERFORMED AND IDENTIFIED TYPE1B ENDOLEAK ON THE LEFT LIMB. ON (B)(6) IMAGING WAS CONDUCTED IN ORDER TO CONFIRM THE SUSPECTED TYPE1B ENDOLEAK. AS REPORTED IT WAS CAUSING THE ANEURYSM SACK TO DILATE. ON (B)(6) 2022 THE PATIENT UNDERWENT A REINTERVENTION IN WHICH COVERAGE DOWN THE LEFT SIDE WAS EXTENDED. THE PROCEDURE WAS CONDUCTED WITHOUT ISSUE AND IT WAS CONFIRMED THAT THERE WERE NO REMAINING SIGNS OF ENDOLEAK. AS REPORTED, THERE WAS A LARGE AMOUNT OF CALCIUM OBSERVED DURING THE INTERVENTION BUT NO THROMBUS WAS NOTED. IT WAS ALSO NOTED THAT THE PATIENT SUFFERS FROM KAWASAKI DISEASE (KD). IT WAS REQUESTED, BUT INFORMATION WAS NOT PROVIDED ON WHETHER OR NOT THE LEAK WAS ON THE CONTRALATERAL OR THE IPSILATERAL SIDE OR HOW MUCH THE ANEURYSM HAD GROWN.

  Patient problems: Aneurysm

  MAUDE report 13795918 ↗
• InjurySep 15, 2021Adverse 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 AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, A POSSIBLE TYPE IB ENDOLEAK WAS DISCOVERED WHEREBY A CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE RIGHT LEG. ON (B)(6) 2021, A REINTERVENTION OCCURRED WHEREBY COIL EMBOLIZATION TO THE EXTERNAL ILIAC ARTERY AND EXTENSION WITH AN ADDITIONAL COMPONENT WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 12475194 ↗
• InjuryMay 19, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ELECTIVE ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. REPORTEDLY, THE PATIENT HAD PRESENTED WITH A VERY SHORT RIGHT COMMON ILIAC ARTERY. DURING THE PROCEDURE, THE INTERNAL ILIAC ARTERY WAS OVERSTENTED AS PLANNED. HOWEVER, INTRA-OPERATIVE IMAGING REVEALED THAT THE STENT ONLY JUST COVERED THE INTERNAL ILIAC ARTERY WITH THE PHYSICIAN DECIDING NOT TO EXTEND THE STENTGRAFT AT THIS TIME. POSTOPERATIVE IMAGING PERFORMED ON (B)(6) 2021, IDENTIFIED THAT THE IMPLANTED GORE¿ EXCLUDER¿ CONTRALATERAL LEG COMPONENT PLC121200 INTO THAT SHORT COMMON ILIAC ARTERY HAD NOW MIGRATED PROXIMALLY RESULTING IN A TYPE 1B ENDOLEAK. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED AND THE TYPE 1B ENDOLEAK SITUATION WAS SOLVED BY EXTENDING THE PLC121200 COMPONENT TOWARDS DISTAL WITH AN ADDITIONAL ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11850119 ↗
• InjuryMay 10, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2021 THE PATIENT UNDERWENT TREATMENT OF AN INFRARENAL DISSECTION WITH A NARROW, CALCIFIED DISTAL AORTA USING A GORE® EXCLUDER® ILIAC BRANCH COMPONENT (MAIN BODY LEFT), GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT (LEFT ILIAC ARTERY EXTENSION), AND CONTRALATERAL LEG COMPONENT (RIGHT ILIAC ARTERY EXTENSION). IT WAS REPORTED THAT CUT DOWNS AND INTRODUCER SHEATHS WERE INSERTED SUCCESSFULLY. REPORTEDLY, THE CALCIFIED DISSECTION IN THE PATIENT'S INFRARENAL AORTA WAS DIFFICULT TO CROSS WITH A 0.035 GUIDEWIRE. THEREFORE, A LEFT RADIAL APPROACH WAS USED AND THE GUIDEWIRE WAS SNARED FROM THE GROIN INCISIONS. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED AND DEPLOYED WITHOUT DIFFICULTY, THE CONTRALATERAL LEG GATE WAS CANNULATED AND CONFIRMED, AND THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED SUCCESSFULLY INTO THE PATIENT'S RIGHT COMMON ILIAC ARTERY (CIA). THE TRUNK-IPSILATERAL LEG COMPONENT WAS FULLY DEPLOYED AND THE CONTRALATERAL LEG COMPONENT WAS DEPLOYED SUCCESSFULLY INTO THE LCIA. A KISSING BALLOON TECHNIQUE WAS PERFORMED USING GORE® MOLDING & OCCLUSION BALLOON CATHETERS. THE KISSING BALLOON TECHNIQUE WAS PERFORMED FROM THE FLOW DIVIDER DOWN THROUGH THE

  Patient problems: Obstruction/Occlusion

  MAUDE report 11803170 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, 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. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR AN INFECTION OF THE DEVICES CAUSED BY THE DEVELOPMENT OF AN AORTODUODENAL FISTULA (ADF). THE DEVICES WERE EXPLANTED AND AN AXILLOBIFEMORAL BYPASS WAS PERFORMED. THE ADF WAS NOT THOUGHT TO HAVE BEEN PRE-EXISTING AT THE TIME OF ORIGINAL IMPLANT. THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE RETAINED BY THE SITE AND WILL BE RETURNED TO GORE FOR ANALYSIS.

  Patient problems: Fistula

  MAUDE report 11734748 ↗
• InjuryMar 16, 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-FEMORAL BYPASS

  Patient problems: Obstruction/Occlusion

  MAUDE report 11496927 ↗
• InjuryJan 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK ASSOCIATED WITH THE CONTRALATERAL LEG COMPONENT ON THE LEFT SIDE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED AND COVERED WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT; AND PROXIMALLY A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT TO EXTEND COVERAGE OF THE TRUNK. THE PHYSICIAN BELIEVES EXTENSIVE CALCIUM IN THE NECK AND THE LEFT COMMON ILIAC ARTERY MAY HAVE HELD THE GRAFT OFF THE WALL AND CONTRIBUTED TO THE ENDOLEAKS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT BEING ON WARFARIN MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE WITH THE DISTAL TYPE I ENDOLEAK HAVING BEEN RESOLVED. RESOLUTION OF THE PROXIMAL TYPE I ENDOLEAK WAS INDETERMINATE AND THE PATIENT WILL UNDERGO REPEAT COMPUTED TOMOGRAPHY ANGIOGRAPHY IN THREE WEEKS.

  Patient problems: Aneurysm

  MAUDE report 9615524 ↗
• InjuryNov 26, 2019Adverse 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, AND TREATMENT OF AN ILIAC ANEURYSM TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. REPORTEDLY THE PATIENT HAD EXTREME TORTUOSITY IN HIS ABDOMINAL AND ILIAC ARTERIES. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2019, REVEALED THE GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS (PLC121200/20695184) MIGRATED PROXIMALLY (AMOUNT OF MIGRATION IS UNKNOWN) AND PULLED UP INTO THE ANEURYSM SAC. THE GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESES (PLC271000/18600079) WHICH WAS USED TO BRIDGE THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (RLT281218/20189804) AND THE AORTIC EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (CEB231210A/20775751) HAD ALL LOST SEAL IN THE ILIAC ARTERY. THE PHYSICIAN REINTERVENED ON (B)(6) 2019, AND RELINED THE TWO CONTRALATERAL LEG ENDOPROSTHESES WITH AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS, EXTENDED THE ILIAC ARTERY WITH IMPLANTING AN ADDITIONAL DEVICE AND IMPLANTED AN AORTIC EXTENDER ENDOPROSTHESIS. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9378573 ↗
• InjuryNov 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT WAS UNDERGOING A REINTERVENTION TO RELINE A COOK ZENITH LIMB DUE TO DISEASE PROGRESSION, RESULTING IN A TYPE 1B ENDOLEAK. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED IN THE GATE OF THE COOK DEVICE. THEN A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS UTILIZED TO EXTEND FROM THE ILIAC BRANCH COMPONENT INTO THE EXTERNAL ILIAC ARTERY WITH AN ESTIMATED 3CM OF OVERLAP BETWEEN THESE DEVICES. FOLLOWING DEPLOYMENT, A CODA BALLOON WAS ADVANCED AND INFLATED. HOWEVER, DURING BALLOONING, THERE APPEARED TO BE SOME MOVEMENT OF THE OVERLAP OF THE TWO COMPONENTS WITH REDUCTION OF THE OVERLAP, BUT IT WAS NOT SEEN AS SIGNIFICANT. ON (B)(6) 2018 A FOLLOW-UP CTA REVEALED FURTHER REDUCTION OF THE OVERLAP BETWEEN THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. A REINTERVENTION TOOK PLACE TO TREAT THIS TYPE III ENDOLEAK WHEREBY AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS POSITIONED AND DEPLOYED. A CODA BALLOON WAS INFLATED WITHIN THE DEVICE AND THE FINAL ANGIO RUN SHOWED RESOLUTION OF THE TYPE III ENDOLEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096677 ↗
• InjuryAug 13, 2018Positioning Failure; Positioning Failure

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A LARGE RIGHT ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. COMPUTED TOMOGRAPHY WAS PERFORMED WHICH REVEALED THAT THE ENTIRE RIGHT ILIAC ARTERY WAS NOW ANEURYSMAL, POST REPAIR IN 2011. ON (B)(6) 2018, A REINTERVENTION OCCURRED WHEREBY TREATMENT OF THE ENLARGED RIGHT ILIAC ARTERY ANEURYSM WAS PERFORMED. AS THE RIGHT ILIAC ARTERY WAS FULLY ANEURYSMAL, THERE WAS NO ROOM TO ADD AN EXTENSION TO THE PREVIOUSLY IMPLANTED DEVICE. THE PHYSICIAN WANTED TO SPARE THE RIGHT HYPOGASTRIC ARTERY USING A GORE EXCLUDER ILIAC BRANCH DEVICE, HOWEVER THIS WAS DETERMINED NOT TO BE A VIABLE OPTION. THEREFORE TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS WERE IMPLANTED IN THE RIGHT ILIAC ARTERY, AND THE HYPOGASTRIC ARTERY WAS INTENTIONALLY COVERED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 7778396 ↗
• InjuryAug 10, 2018Material Separation; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Material Separation; Failure to Advance; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT PRESUMABLY FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. HAVING PERFORMED INITIAL DEPLOYMENT OF A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT, THE PHYSICIAN ADVANCED A 12 FRENCH GORE® DRYSEAL SHEATH THROUGH THE CONTRALATERAL GATE ON THE LEFT PATIENT SIDE. TO CONFIRM THE LOCATION OF THE INTERNAL ILIAC ARTERY DURING INTRA-OPERATIVE IMAGING, THE SHEATH WAS AGAIN RETRACTED TO THE LEVEL OF THE ILIAC ARTERY AXIS. HOWEVER, IT HAD ALSO BEEN NOTICED THAT THE RADIOPAQUE MARKER RING OF THE CONTRALATERAL GATE WAS NOT ORIENTED AS TYPICALLY AND APPEARED TILTED TOWARDS THE ANTERIOR. FOLLOWING CONSULTATION WITH THE FIELD SALES ASSOCIATE ATTENDING THE PROCEDURE, THE PHYSICIAN DECIDED TO ADVANCE THE CONTRALATERAL LEG COMPONENT PLC121200 TO THE INTENDED LOCATION OUTSIDE OF THE SHEATH. WHEN THE PLC121200 ENDOPROSTHESIS WAS SUBSEQUENTLY TRANSVERSED THROUGH THE 12 FRENCH DRYSEAL SHEATH, THE DEVICE CATHETER¿S LEADING OLIVE GOT CAUGHT AT THE EDGE OF THE CONTRALATERAL GATE AND WOULD NOT PASS THROUGH. IN AN ATTEMPT TO FREE THE OLIVE, THE CATHETER

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7771856 ↗

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)