GORE EXCLUDER Iliac Branch Endoprosthesis CEB231010ARecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00733132635283), received between Sep 25, 2018 and Jun 3, 2026 — classified as 1 death, 43 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION (DEBRANCHED ILIAC BRANCH AND A COOK AAA ENDOGRAFT PROCEDURE) INVOLVING PLACEMENT OF A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WITHIN THE ILIAC VASCULATURE. THE PATIENT¿S ANATOMY WAS NOTABLE FOR AN ANEURYSMAL GLUTEAL ARTERY BRANCH, AND A PREVIOUSLY EMBOLIZED AND COVERED INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO ADVANCE THE COOK AAA ENDOGRAFT THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH; HOWEVER, ADVANCEMENT WAS UNSUCCESSFUL DUE TO SMALL VESSEL CALIBER AND SIGNIFICANT ARTERIAL CALCIFICATION. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURAL STRATEGY WAS MODIFIED TO PROCEED WITH THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. FOLLOWING SUCCESSFUL PLACEMENT OF THE ILIAC BRANCH COMPONENT (CEB). TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE INTRODUCED NEXT. DURING DEPLOYMENT, THE ROSEN GUIDEWIRE WAS INADVERTENTLY WITHDRAWN EXCESSIVELY, LEAVING AN UNDEPLOYED 8 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITHOUT ADEQUATE GUIDEWIRE SUPPORT. GORE FSA (FIELS SALES ASSOCIATE) ADVICE WAS PROVIDED TO RE-ADVANCE A NEW ROSEN GUIDEWIRE TO

  Patient problems: Vascular Dissection

  MAUDE report 25382859 ↗
• InjuryMay 19, 2026Material Deformation; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING ENDURANT IIS STENT GRAFT SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). ENDURANT WAS USED AS A MAIN DEVICE AND IBES WERE IMPLANTED BILATERALLY. ON THE RIGHT SIDE, IBE IMPLANTATION WAS SUCCESSFULLY DONE. ON THE LEFT SIDE, AFTER FULL DEPLOYMENT OF THE ILIAC BRANCH COMPONENT (IBC), THE GUIDEWIRE THAT HAD BEEN PASSED THROUGH THE CONTRALATERAL GATE OF THE IBC UNINTENTIONALLY SLIPPED OUT. ALTHOUGH REATTEMPTS WERE MADE TO CANNULATE THE INTERNAL ILIAC ARTERY (IIA) USING U-TURN TECHNIQUE, THE AVAILABLE SPACE WAS LIMITED, AND THE GUIDEWIRE ADVANCED ONLY TOWARD THE EXTERNAL ILIAC ARTERY (EIA) DIRECTION. DURING THESE ATTEMPTS, THE IBC DEVICE MIGRATED DISTALLY AND THE CONTRALATERAL GATE WAS COMPRESSED. AS A RESULT, CANNULATION OF THE LEFT IIA COULD NOT BE ACHIEVED, AND CONTRAST ANGIOGRAPHY FAILED TO VISUALIZE THE LEFT IIA. THEREFORE, USING AN AORTIC EXTENDER, THE CONTRALATERAL GATE OF LEFT IBC WAS INTENTIONALLY COVERED. FINAL ANGIOGRAPHY SHOWED A TYPE IV ENDOLEAK AT THE LEVEL OF ENDURANT MAIN BODY. TH

  Patient problems: Obstruction/Occlusion

  MAUDE report 25225509 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLACED ON THE LEFT SIDE. COMPLETION ANGIOGRAPHY FOLLOWING STENT GRAFT DEPLOYMENT REVEALED A TYPE II ENDOLEAK, BUT NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE ANEURYSM DIAMETER WAS APPROXIMATELY 67 MM. ON AN UNKNOWN DATE, POSTOPERATIVE FOLLOW-UP IMAGING DEMONSTRATED ENLARGEMENT OF THE ANEURYSM SAC. ON APRIL 2026 (EXACT DATE UNKNOWN), COMPUTED TOMOGRAPHY (CT) SHOWED THAT THE ANEURYSM DIAMETER HAD INCREASED TO 77 MM. DELAYED-PHASE CT IMAGING CONFIRMED A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY. THE FINDINGS SUGGESTED ANEURYSM SAC ENLARGEMENT ASSOCIATED WITH THE TYPE II ENDOLEAK. HOWEVER, A LINEAR CONTRAST ENHANCEMENT EXTENDING FROM THE RIGHT LEG OF THE STENT GRAFT WAS ALSO OBSERVED, AND THE POSSIBILITY OF A TYPE IIIB ENDOLEAK COULD NOT BE RULED OUT. ON (B)(6) 2026, REINTERVENTION WAS PERFORMED. INTRAOPERATIVE ANGIOGRAPHY IDENTIFIED A TYPE II ENDOLEAK

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25212099 ↗
• InjuryMay 11, 2026Device-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). AS A BRIDGING DEVICE, AN ENDURANT LEG WAS PLACED BETWEEN THE ILIAC BRANCH COMPONENT (IBC) AND THE TRUNK-IPSILATERAL LEG DUE TO A SIZING ISSUE. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED FOR AN ENDOLEAK, WHICH HAD BEEN FOUND DURING A FOLLOW-UP EXAMINATION. THE TYPE OF ENDOLEAK WAS JUDGED AS TYPE IIIA BETWEEN THE IBC AND ENDURANT, SO AN ADDITIONAL STENT GRAFT WAS PLACED TO RELINE THE PREVIOUS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ALTHOUGH THERE WAS A POSSIBILITY OF TYPE II OR TYPE IV ENDOLEAK, THE ENDURANT LEG GRADUALLY MIGRATED AND THE OVERLAPPING BECAME SHORT, SO THE ADDITIONAL DEVICE WAS PLACED TO REINFORCE THE CONNECTION. AS FOR IBE PLACEMENT, THERE ARE SOME CASES WHERE THE PROCEDURE COULD NOT BE COMPLETED USING ONLY GORE DEVICES DUE TO LIMITATIONS OF THE TREATMENT LENGTH. IDEALLY, THE PROCEDURE SHOULD BE COMPLETED USING ONLY GORE DEVICES.

  Patient problems: Clinical Endoleak

  MAUDE report 25133985 ↗
• InjuryApr 28, 2026Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC AND ILIAC ARTERY ANEURYSMS USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. A TOTAL OF 6 STENT GRAFTS WERE IMPLANTED. A RESIDUAL TYPE II ENDOLEAK WAS SUSPECTED AT THE FINAL ANGIOGRAPHY; HOWEVER, THE PROCEDURE WAS COMPLETED WITH FOLLOW-UP OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE WELL. ON AN UNKNOWN DATE, AS PERSISTENCE OF A TYPE II ENDOLEAK WAS IDENTIFIED, COIL EMBOLIZATION OF THE LEVEL 4 LUMBER ARTERIES WAS PERFORMED. ON (B)(6) 2025, FOLLOW-UP CT DEMONSTRATED ENLARGEMENT OF THE ANEURYSM SAC. CONTRAST ENHANCEMENT WAS OBSERVED NEAR THE BIFURCATION OF THE TRUNK IPSILATERAL LEG. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THE ENDOLEAK WAS ASSESSED AS MOST LIKELY A TYPE II ORIGINATING FROM FLOW VIA THE LEVEL 3 LUMBAR ARTERIES. THREE ADDITIONAL STENT GRAFTS WERE IMPLANTED, AND DISAPPEARANCE OF THE ENDOLEAK WAS CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25011971 ↗
• MalfunctionApr 17, 2026Material Deformation; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM USING A NON-GORE STENT GRAFT (MAIN DEVICE: AFX), GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE NON-GORE STENT GRAFT WAS IMPLANTED IN THE ABDOMINAL AORTA. AN 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED FROM THE RIGHT SIDE, AND THREE AORTIC EXTENDER ENDOPROSTHESES (TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS) WERE IMPLANTED PROXIMALLY. AN ILIAC BRANCH COMPONENT WAS DELIVERED FROM THE RIGHT SIDE AND DEPLOYED. A 14 FR SHEATH WAS INSERTED ALONGSIDE AN 18 FR SHEATH, AND THE IPSILATERAL U TURN TECHNIQUE WAS PERFORMED. ALTHOUGH THE U TURN WAS ACHIEVED, THERE WAS STRONG RESISTANCE AND THE ILIAC BRANCH COMPONENT MIGRATED DISTALLY. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) CONFIRMED THAT THE GATE OF THE ILIAC BRANCH COMPONENT WAS NOT COMPRESSED AT THAT TIME. CANNULATION OF THE INTERNAL ILIAC ARTERY WAS ATTEMPTED USING A RADIFOCUS WIRE AND A KMP CATHETER, AND THE INTERNAL ILIAC ARTERY WAS DILATED USING A PTA BALLOON. THE WIRE WAS THEN E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907642 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON (B)(6) 2026, IT WAS REPORTED THAT A DEVICE INFECTION WAS CONFIRMED, AND A REPLACEMENT TREATMENT IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 24854592 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLACED ON THE LEFT SIDE. AT AN UNSPECIFIED DATE DURING POSTOPERATIVE FOLLOW-UP, IMAGING CONFIRMED ENLARGEMENT OF THE ANEURYSM SAC ASSOCIATED WITH A TYPE II ENDOLEAK. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THE INFERIOR MESENTERIC ARTERY (IMA) AND ITS BRANCHES WERE EMBOLIZED TO TREAT THE TYPE II ENDOLEAK. IN ADDITION, DUE TO THE ANEURYSM ENLARGEMENT THAT RESULTED IN AN INSUFFICIENT DISTAL SEALING LENGTH OF THE RIGHT COMMON ILIAC ARTERY, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND A STENT GRAFT WAS EXTENDED TO THE RIGHT EXTERNAL ILIAC ARTERY. PHYSICIAN COMMENT: APPROXIMATELY THREE YEARS AFTER THE INITIAL PROCEDURE, A TYPE II ENDOLEAK ARISING FROM THE INFERIOR MESENTERIC ARTERY LED TO ENLARGEMENT OF THE ANEURYSM SAC.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24738158 ↗
• InjuryMar 19, 2026Material Deformation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. AFTER DEPLOYING THE IBE (ILIAC BRANCH ENDOPROSTHESIS) IN THE LEFT ILIAC ARTERY, THE TRUNK¿IPSILATERAL LEG COMPONENT WAS DEPLOYED FROM BELOW THE RENAL ARTERIES. AT THE TIME A STIFF GUIDEWIRE WAS INSERTED INTO THE CONTRALATERAL SIDE, THE PROXIMAL PORTION OF THE TRUNK¿IPSILATERAL LEG COMPONENT MIGRATED SLIGHTLY IN THE DISTAL DIRECTION. AN AORTIC EXTENDER COMPONENT WAS SUBSEQUENTLY PLACED PROXIMALLY, AND THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. ON AN UNKNOWN DATE ON (B)(6) 2026, POSTOPERATIVE FOLLOW-UP IMAGING REVEALED A STENOSIS OF THE ILIAC BRANCH COMPONENT IN THE LEFT EXTERNAL ILIAC ARTERY. ON (B)(6) 2026, AS A TREATMENT, AN ADDITIONAL STENT GRAFT WAS PLACED AT THE SITE OF THE LEFT EXTERNAL ILIAC ARTERY STENOSIS. PHYSICIAN¿S COMMENT: WHEN DEPLOYING THE ILIAC BRANCH COMPONENT, THE CONTRALATERAL GATE COULD NOT BE POSITIONED APPROPRIATELY TOWARD THE INTERNAL ILIAC ARTERY AND HAD TO BE DEPLOYED IN AN ANTERIOR-FACING ORIENTATION. AS A RESULT, TH

  Patient problems: Stenosis

  MAUDE report 24636437 ↗
• InjuryDec 12, 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 OF THE INFRARENAL AORTA FOR AORTOILIAC OCCLUSIVE DISEASE (AIOD) AND WAS IMPLANTED WITH A GORE® EXCLUDER® LLIAC BRANCH ENDOPROSTHESIS (CEB) AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 1 HOUR POST IMPLANT THE PATIENT BEGAN TO EXHIBIT SYMPTOMS AND THE PHYSICIAN DETERMINED THE DEVICES (CEB/VBX¿S X2) WERE OCCLUDED. THE PATIENT UNDERWENT A THROMBECTOMY AND IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED RHABDOMYOLYSIS. THE PATIENT TOLERATED THE PROCEDURE HOWEVER IT IS BELIEVED THAT THE PATIENT MAY REQUIRE AMPUTATION.

  Patient problems: Rupture

  MAUDE report 23794745 ↗
• InjuryFeb 11, 2025Material Deformation; Material Deformation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER®AAA ENDOPROSTHESES AND EXCLUDER® IBE. THERE WAS NO ISSUE IN BLOOD FLOW AFTER STENT GRAFT PLACEMENT. ON AN UNKNOWN DATE IN (B)(6) 2025, POSTOPERATIVE CT EXAMINATION SHOWED COMPRESSION IN THE IPSILATERAL LEG OF THE ILIAC BRANCH COMPONENT (IBC). THE COMPRESSION SEEN BELOW THE FLOW DIVIDER. REPORTEDLY ABI WAS WITHIN NORMAL RANGE. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, AND A STENT GRAFT WAS RELINED IN THIS SITE.

  Patient problems: Insufficient Information

  MAUDE report 21360889 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (CERAB OR COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION) UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) TO TREAT PENETRATING AORTIC ULCER (PAU) AND AORTOILIAC OCCLUSIVE DISEASE IN AN OFF-LABEL CASE. REPORTEDLY, PATIENT HAD PRE-OPERATIVE COMMON ILIAC ARTERY OCCLUSION WITH SIGNIFICANT CALCIUM AND THROMBUS BUILD UP ALONG WITH NARROW INFRARENAL AORTA. DURING THE PROCEDURE, THE FIRST STEP OF DEPLOYMENT FOR THE ILIAC BRANCH COMPONENT OPENED FROM THE MAIN BODY DOWN TO THE GATE, HOWEVER, THE AORTIC FLOW LUMEN WAS QUITE NARROW AND THE GATE DID NOT OPEN FULLY AND NOT THE WAY PHYSICIAN WANTED IT AS PHYSICIAN COULD NOT GET THE WIRE IN THROUGH THE GATE AS HE TRIED COMING IN FROM ABOVE AND BELOW THE GATE TO GET THE WIRE IN THEN BALLOON THE GATE. THE IBE DEVICE COVERED THE PAU SECTION OF THE TREATMENT AREA BUT NOT THE OCCLUSIVE DISEASE. THERE WAS BLOOD FLOW ON THE IPSILATERAL SIDE OF THE IBE BUT NO FLOW ON THE GATE SIDE. ULTIMATELY, THE GATE CANNULATION WAS UNSUCCESSFUL AND PHYSICIAN DECIDED TO SWITCH TO FEM-FEM CROSSOVER TO COMPLETE THE PROCEDURE. PATIENT TOLERATED T

  Patient problems: Reduced Blood Flow

  MAUDE report 21029248 ↗
• InjurySep 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). AS A BRIDGING DEVICE BETWEEN THE IBE AND TRUNK-IPSILATERAL LEG, ENDURANT II STENT GRAFT SYSTEM LIMB WAS USED. THE PATIENT TOLERATED THE PROCEDURE. IN JULY 2024, A CT SCAN SHOWED MIGRATION OF THE ENDURANT LIMB INTO THE ANEURYSM SAC (TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECTION) AND ANEURYSM ENLARGEMENT. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO BRIDGE THE IBE. NO ENDOLEAK WAS NOTED DURING THE FINAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ORIGINALLY, OVERLAPPING BETWEEN THE ENDURANT LIMB AND ILIAC BRANCH COMPONENT WAS SLIGHTLY SHORT. ALSO, USING A NON-GORE DEVICE FOR BRIDGING WAS CONSIDERED A FACTOR OF THE MIGRATION.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20263879 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A LEFT ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. DUE TO THE SHORT LEFT INTERNAL ILIAC ARTERY, A ILIAC BRANCH COMPONENT (IBC, CEB 231010A/(B)(6)) WAS PLACED FROM MORE PROXIMALLY THAN USUAL, HOWEVER, THE CEB 231010A WAS MOVED DISTALLY BY MANIPULATION OF A 12FR SHEATH INSERTED FROM THE RIGHT SIDE. DUE TO THE SHORT LENGTH OF THE LEFT INTERNAL ILIAC ARTERY, A INTERNAL ILIAC COMPONENT (IIC, HGB161007A/(B)(6)) WAS IMPLANTED WITH THE PROXIMAL PART PROTRUDING INTO THE TRUNK OF THE CEB 231010A. SUBSEQUENTLY, A CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200J/(B)(6)) FOR BRIDGING WITH THE IBE DEVICE ON THE LEFT SIDE WAS MOVED PROXIMALLY DUE TO MANIPULATION OF A NON-GORE BALLOON INSERTED TO DILATE THE PROXIMAL PART OF THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT231412J/(B)(6)). FOR REPAIR, AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS (RLC271000J/(B)(6)) WAS IMPLANTED OVER THE LEFT COMMON ILIAC ARTERY INLET. REPORTEDLY, THE PATIENT COMPLAINED OF DISCOMFORT IN THE LEG IMMEDIATELY AFTER T

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19915559 ↗
• InjuryJul 3, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND NON-GORE STENT GRAFT. AFTER DEPLOYING AN ILIAC BRANCH COMPONENT FROM THE LEFT COMMON ILIAC ARTERY TOWARDS THE LEFT EXTERNAL ILIAC ARTERY, TWO INTERNAL ILIAC COMPONENTS WERE IMPLANTED TO THE LEFT INTERNAL ILIAC ARTERY. THEN, A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED BELOW LOWER RENAL ARTERY AND LANDED TO THE RIGHT EXTERNAL ILIAC ARTERY. THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS AND THE ILIAC BRANCH COMPONENT WERE BRIDGED BY A NON- GORE STENT GRAFT (ENDURANT II, MEDTRONIC). AFTER BALLOON TOUCH-UPS WERE PERFORMED, THE FINAL ANGIOGRAPHY REVEALED THE DECREASED BLOOD FLOW OF THE LEFT INTERNAL ILIAC ARTERY. ANOTHER ANGIOGRAPHY AROUND THE AREA CONFIRMED THE OCCLUSION OF THE OSTIUM OF THE LEFT INTERNAL ILIAC ARTERY. THE PHYSICIAN TRIED TO CANNULATE THE VESSEL TO SECURE THE BLOOD FLOW, WHICH WAS UNSUCCESSFUL. THE RETROGRADE FLOW WAS CONFIRMED AT THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES; THEREFORE, NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT TOLERATED

  Patient problems: Obstruction/Occlusion

  MAUDE report 19672089 ↗
• InjuryApr 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2020, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON AN UNKNOWN DATE, A TYPE III ENDOLEAK FROM THE JUNCTION BETWEEN THE ILIAC BRANCH COMPONENT AND THE CONTRALATERAL LEG COMPONENT WAS OBSERVED. REPORTEDLY, THE CONTRALATERAL LEG COMPONENT WAS COMPLETELY DISENGAGED FROM THE ILIAC BRANCH COMPONENT. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED, TWO ADDITIONAL STENT GRAFTS WERE PLACED, THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, IT SEEMS THE PROXIMAL EDGE OF THE INTERNAL ILIAC COMPONENT WAS IMPLANTED ABOUT 1CM BEYOND THE ILIAC BRANCH COMPONENT FLOW DIVIDER, WHICH SHORTENED THE OVERLAP LENGTH AND CAUSED THE CONTRALATERAL LEG COMPONENT TO BE DISENGAGED.

  Patient problems: Clinical Endoleak

  MAUDE report 19048689 ↗
• InjuryMar 27, 2024Migration; Migration

  ON (B)(6) 2018, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED 3 COMPETITOR'S DEVICES AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT SUFFERED A DISCONNECT BETWEEN THE COMPETITOR'S DEVICES AND THE GORE DEVICE. ANOTHER COMPETITOR'S DEVICE WAS USED TO BRIDGE THE GAP. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18987729 ↗
• InjuryMar 24, 2024Material Deformation; Material Deformation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE). IBE DEVICES WERE IMPLANTED ON THE LEFT SIDE. ON AN UNKNOWN DATE IN 2024, CT SHOWED COMPRESSION/STENOSIS OF THE UPPER IPSILATERAL SIDE/LEFT EXTERNAL ILIAC ARTERY SIDE OF THE ILIAC BRANCH COMPONENT (IBC). ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. A BARE METAL STENT WAS ADDITIONALLY IMPLANTED AT THE STENOTIC AREA. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, REGARDING THE STENOTIC AREA, THE PATIENT'S VESSEL WAS ORIGINALLY BENDING/TORTUOUS AND BECAUSE OF THE CONDITION, THE AREA WAS A BIT NARROW FROM THE INITIAL PROCEDURE. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: IT IS THOUGHT THAT THE COMPRESSION/STENOSIS OCCURRED BECAUSE THE IBC IPSILATERAL LEG WAS IMPLANTED IN THE BENDING/TORTUOUS VESSEL.

  Patient problems: Stenosis

  MAUDE report 18966598 ↗
• InjuryMar 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING PUBLISHER WAS REVIEWED BY GORE: TITLE: OUTCOME OF TREATMENT USING EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (IBE) IN OUR SITE SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY 2023: 63(SUPPL.) P.S197. 8 EVAR CASES (AGE 83 ± 4.5 YEARS, 5 CASES OF MALE) USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) FOR COMMON ILIAC ARTERY ANEURYSM THAT WERE PERFORMED FROM FEBRUARY 2019 TO JANUARY 2022 AT OUR HOSPITAL WERE EVALUATED. 6 OF THESE CASES WERE WITH ABDOMINAL AORTIC ANEURYSM. 4 OF THESE CASES WERE WITH INTERNAL ILIAC ARTERY ANEURYSM. TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES, AND CONTRALATERAL INTERNAL ILIAC ARTERY EMBOLIZATION WAS REQUIRED IN 6 CASES. THE AVERAGE POSTOPERATIVE OBSERVATION PERIOD WAS 801 ± 414 DAYS, AND ALTHOUGH ONE PATIENT HAD OPEN CONVERSION DUE TO INFECTION AND ONE PATIENT HAD GRAFT OCCLUSION IN INTERNAL ILIAC ARTERY, THERE WAS NO ANEURYSM ENLARGEMENT (5 MM OR MORE), AND NO ANEURYSM-RELATED DEATH OR RUPTURE. OUTCOME USING IBE WERE GOOD. ALTHOUGH THERE ARE ANATOMICAL LIMITATIONS, THE USE OF IBE IS LIKELY TO CONTINUE TO INCREASE. ADDITIONAL INFORMATION WAS PROVIDED FOR THE INFECTION AND OPEN CONVERSION CASE AS IN BELOW. ON (B)(6) 2021, THE PATIENT U

  Patient problems: Sepsis

  MAUDE report 18822583 ↗
• InjuryJan 15, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND A RIGHT ILIAC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES, GORE® EXCLUDER® AAA ENDOPROSTHESES, AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING THE TREATMENT, AN INTERNAL ILIAC COMPONENT (IIC) WAS DIFFICULT TO BE ADVANCED INTO A RIGHT INTERNAL ILIAC ARTERY. DURING ATTEMPTS TO ADVANCE THE IIC, AN ILIAC BRANCH COMPONENT (IBC) WAS MOVED AND THE PHYSICIAN DECIDED NOT TO IMPLANT THE IIC. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. AFTER THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND A CONTRALATERAL LEG COMPONENT AS A LEFT LEG WERE IMPLANTED, A CONTRALATERAL LEG COMPONENT AS A BRIDGING DEVICE AND AN ILIAC EXTENDER COMPONENT WERE IMPLANTED TO EXTEND TO A RIGHT EXTERNAL ILIAC ARTERY. AN ANGIOGRAPHY REVEALED A DELAY FLOW WITH AN INSERTED DRYSEAL SHEATH. AN ANGIOGRAPHY USING A SURF FLOW NEEDLE REVEALED NO DELAY FLOW. NO FURTHER TREATMENT WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE. ON DECEMBER 23, 2023, THE PATIENT HAD BUTTOCK PAIN. A POSSIBLE CLAUDICATION WAS REPORTED. A POST-OPERATIVE EXAMINATION SHOWED

  Patient problems: Obstruction/Occlusion

  MAUDE report 18515219 ↗
• InjuryDec 5, 2023Insufficient Flow or Under Infusion; Patient-Device Incompatibility; Device Difficult to Maintain; Insufficient Flow or Under Infusion; Patient-Device Incompatibility; Device Difficult to Maintain

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT A SUCCESSFUL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH RIGHT IBE PLACEMENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS). ON (B)(6) 2023, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) COMPLAINING OF RIGHT LOWER EXTREMITY CLAUDICATION INCREASING IN SEVERITY OVER THE PAST WEEK OR TWO. THE FOOT WAS WARM AND THERE WAS NO REST PAIN. A CTA REVEALED AN OCCLUDED RIGHT EXTERNAL ILIAC LIMB OF THE IBE DEVICE. REPORTEDLY, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL FOR TREATMENT. ON (B)(6) 2023, FIELD SALES ASSOCIATE (FSA) WAS INFORMED OF THE PROCEDURE DETAILS WHERE A RIGHT FEMORAL CUTDOWN WAS PERFORMED WITH THROMBECTOMY USING A FOGARTY CATHETER FOLLOWED BY GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) STENTING OF THE RIGHT IBE LIMB AND EXTERNAL ILIAC ARTERY. THIS REESTABLISHED THE ANTEGRADE FLOW. THE PATIENT¿S SYMPTOMS HAVE RESOLVED AND IS DOING WELL AT THIS POINT. AFTER REVIEW OF THE IMAGES, IT IS FELT THE IPSILATERAL LIMB OF THE IBE DEVICE ENDED IN A SEVERE BEND OF THE RIGHT EXTERNAL ILIAC ARTERY. THIS CREATED A KINK IN THE VESSEL, COMPROMISING FLOW.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 18266679 ↗
• InjurySep 29, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (HGB161007A & CEB231010A), GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261218 & PLC271000). SOMETIME DURING A FOLLOW UP IN (B)(6) 2023 (DATE UNKNOWN), CTA SCANS SHOWED THE SEPARATION OF THE CONTRALATERAL LIMB AND THE IBE DEVICE AND THERE IS A LARGE COMMON ILIAC ANEURYSM (SIZE UNKNOWN). IT IS A TYPE 3 ENDOLEAK (COMPONENT DISCONNECTION) ON (B)(6), 2023, THE PATIENT WAS SCHEDULED TO UNDERGO A REINTERVENTION ON A SEPARATION BETWEEN THE IBE DEVICE AND THE 27MM BRIDGE PIECE (CONTRALATERAL) INTO THE COMMON ILIAC ANEURYSM FROM THE INITIAL IMPLANT. HOWEVER, ON THE DAY OF THE PROCEDURE, THE PATIENT HAD COVID DUE TO WHICH THE PHYSICIAN DELAYED THE REINTERVENTION BY 2-WEEKS AND IF PATIENT CONDITION WAS BETTER THEN THEY WILL INTERVENE. ON (B)(6), 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT A ZONE 10- COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG) AND DOING A REVISION TO THE PRIOR EVAR. REPORTEDLY, THE CONTRALATERAL DEVICE (SN#(B)(6)) WAS

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17847670 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A REINTERVENTION ON (B)(6) 2023, AN ADDITIONAL DEVICE (27MMX12CM SN (B)(6) LIMB) WAS USED TO RESOLVE THE LEAK. THE PROCEDURE WENT WELL, AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17827997 ↗
• InjuryAug 22, 2023Positioning Problem; Positioning Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN EXPANDING RIGHT ILIAC AORTIC ANEURYSM AND TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS UTILIZING THE CROSS OVER METHOD TO CANNULATE THE GATE OF THE INTERNAL ILIAC ARTERY, THE DILATOR OF THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (16FR, LOT/SERIAL NUMBER IS UNK) BECAME CAUGHT UP ON THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ENDOPROSTHESES (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT, CEB231010A/20686548 AND HGB161207A/26853406) DEVICES. THIS PUSHED BOTH THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES INTO THE AORTA. THE PHYSICIAN CHOSE TO LEAVE AS ¿ENDO TRASH¿ AND DEPLOYED AN ADDITIONAL GORE® EXCLUDER® TRUNK-IPSILATERAL AAA ENDOPROSTHESIS TO CONTAIN THE ¿ENDO TRASH¿ IN THE AORTA. A DIFFERENT GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT) WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17600029 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. WHILE IMPLANTING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE TIP OF THE GREEN WIRE BROKE OFF. THIS WASN'T NOTICED UNTIL THE PHYSICIAN REMOVED THE DELIVERY CATHETER. WHEN THE SHEATH WAS REMOVED, THE REMAINING PIECE WAS STILL INSIDE THE SHEATH. THE DELIVERY CATHETER WILL BE RETURNED FOR EVALUATION. WHEN ADDING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AS A BRIDGING PIECE, THE FINAL 3CM OF THE GRAFT PREMATURELY DEPLOYED, LEAVING THE DEVICE IN AN UNDESIRED LOCATION. USING A BALLOON AND MOVING THE SHEATH, THE PHYSICIAN WAS ABLE TO BRING THE DEVICE TO THE PROPER POSITION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144117 ↗

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)