GORE EXCLUDER Iliac Branch Endoprosthesis HGB161207ARecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00733132635320), received between Jul 9, 2018 and Mar 30, 2026 — classified as 36 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (7 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IBE WAS IMPLANTED IN THE BILATERAL COMMON ILIAC ARTERIES. ON AN UNKNOWN DATE IN 2026, DURING A POSTOPERATIVE FOLLOW-UP EVALUATION, OCCLUSION OF THE ILIAC BRANCH COMPONENT PLACED IN THE LEFT EXTERNAL ILIAC ARTERY WAS IDENTIFIED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THROMBECTOMY WAS CONDUCTED NEAR THE BIFURCATION OF THE ILIAC BRANCH COMPONENT, FOLLOWED BY PLACEMENT OF A BARE-METAL STENT IN THE LEFT EXTERNAL ILIAC ARTERY, RESULTING IN IMPROVED ARTERIAL BLOOD FLOW. THE LEFT INTERNAL ILIAC ARTERY WAS ALSO FOUND TO BE THROMBOSED, BUT NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS CONCLUDED. BASED ON CLINICAL ASSESSMENT, IT WAS REPORTED THAT THE OCCLUSION MAY HAVE EXTENDED FROM THE LEFT EXTERNAL ILIAC ARTERY INTO THE TRUNK OF THE ILIAC BRANCH COMPONENT, WHICH MAY HAVE SUBSEQUENTLY CONTRIBUTED TO SECONDARY OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24709499 ↗
• InjuryJan 21, 2026Malposition of Device

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT RE-INTERVENTION FOR A DISCONNECT/OCCLUSION OF THE IBE DEVICES IN THE RIGHT INTERNAL ILIAC ARTERY (RIIA) FROM THE CEB IN THE RIGHT COMMON ILIAC ARTERY. WE PUT A LIMB EXTENSION INTO THE RIGHT EXTERNAL ILIAC ARTERY AND BYPASSED OVER THE FLOW DIVIDER OF THE IBE DEVICE, INTENTIONALLY COVERING THE RIIA AND LEAVING ONLY FLOW VIA THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24132480 ↗
• InjuryDec 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ANEURYSM WITH ILIAC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK WAS PRESENT FROM THE RIGHT INTERNAL ILIAC ARTERY, WHERE THE IBE DEVICE HAD BEEN IMPLANTED, AND ANEURYSM ENLARGEMENT WAS OBSERVED. ON (B)(6) 2025, AS A TREATMENT, A REINTERVENTION WAS PERFORMED. AN ADDITIONAL STENT GRAFT WAS PLACED IN THE DISTAL RIGHT INTERNAL ILIAC ARTERY, AND THE ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT THE DISTAL LANDING ZONE MIGHT HAVE BEEN SHORT AT THE INDEX PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23891363 ↗
• MalfunctionNov 14, 2025Material Separation; Malposition of Device; Difficult to Advance; Material Separation; Malposition of Device; Difficult to Advance

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE PLANNED TO BE IMPLANTED IN THE LEFT ILIAC ARTERY. WHEN DELIVERING THE INTERNAL ILIAC COMPONENT (IIC), IT COULD NOT BE ADVANCED INTO THE INTERNAL ILIAC ARTERY (IIA) DUE TO ENTANGLEMENT WITH THE PULL-THROUGH WIRE AND THE TORTUOSITY OF THE IIA. ATTEMPTS WERE MADE TO RELEASE THE WIRE WRAP BY ADJUSTING THE TENSION OF THE PULL-THROUGH WIRE, BUT IT WAS DIFFICULT. ROTATING THE DELIVERY CATHETER WITHIN THE SHEATH WAS ALSO ATTEMPTED, BUT RESISTANCE WAS STRONG AND ADVANCEMENT WAS CHALLENGING. FURTHER ATTEMPTS TO ADJUST THE WIRE TENSION AND DELIVER THE IIC WERE UNSUCCESSFUL. FINALLY, THE PULL-THROUGH WIRE WAS RELEASED AND AN ATTEMPT WAS MADE TO ADVANCE THE IIC, BUT THE LEADING OLIVE TIP OF THE IIC APPEARED TO BE CAUGHT IN THE TORTUOUS IIA AND COULD NOT PROCEED. WHEN ATTEMPTING TO WITHDRAW THE IIC, IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE LEADING OLIVE REMAINED INSIDE THE BODY AND THE IIC WAS DEPLOYED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551999 ↗
• InjuryNov 6, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE LEFT ILIAC ARTERY. BECAUSE THE ILIAC BRANCH COMPONENT WAS IMPLANTED SLIGHTLY MORE DISTALLY THAN ORIGINALLY PLANNED, BUT THIS WAS INTENTIONAL AND THERE WERE NO DEPLOYMENT ISSUES SUCH AS MIGRATION OR MALPOSITION, THE INTERNAL ILIAC COMPONENT WAS IMPLANTED APPROXIMATELY 1 CM ABOVE THE FLOW DIVIDER OF THE ILIAC BRANCH COMPONENT TO AVOID OCCLUDING THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES. THE PROCEDURE WAS CONCLUDED WITHOUT ANY ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, CTA REVEALED THE PROXIMAL OF THE INTERNAL ILIAC COMPONENT INTERFERED WITH THE EXTERNAL ILIAC SIDE OF THE ILIAC BRANCH COMPONENT, AND DUE TO THE INFLUENCE OF VESSEL ANGULATION, THE EXTERNAL ILIAC SIDE OF THE ILIAC BRANCH COMPONENT BECAME NARROWED. A BARE METAL STENT WAS IMPLANTED IN THE EXTERNAL ILIAC ARTERY SIDE OF THE ILIAC BRANCH COMPONENT. AN IMPROVEMENT IN ABI WAS OBSERVED. IT WAS REPORTED

  Patient problems: Stenosis

  MAUDE report 23484172 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE INTERNAL ILIAC COMPONENT(IIC) WAS ADVANCED THROUGH THE 12FR SHEATH, BUT A STRONG RESISTANCE WAS FELT. THE CATHETER BREAKAGE WAS OBSERVED UPON REMOVING THE IIC DEVICE. AS THE BREAKAGE PART REMAINED WITHIN THE SHEATH, IT WAS REMOVED TOGETHER WITH THE SHEATH. THE PROCEDURE WAS CONTINUED USING OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070445 ↗
• MalfunctionAug 14, 2025Break; Entrapment of Device; Break; Entrapment of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE INTERNAL ILIAC COMPONENT WAS DEPLOYED SUCCESSFULLY AND WHEN PHYSICIAN WAS WITHDRAWING THE DELIVERY CATHETER BACK, THE NOSE CONE (OLIVE TIP) GOT CAUGHT ON THE 12FR DRYSEAL SHEATH. PHYSICIAN PULLED THE SHEATH BACK AND FORTH TO GET THE NOSE CONE INSIDE THE SHEATH, AT WHICH POINT, PHYSICIAN PULLED THE DELIVERY CATHETER OUT AND NOTICED THAT THE NOSE CONE CAME OUT AS IT WAS STUCK ON THE WIRE ALONG WITH THE SHEATH. AFTER REMOVING THE NOSE CONE, PHYSICIAN CONTINUED TO USE THE SAME SHEATH BY PUTTING THE DILATOR BACK IN AND REST OF THE PROCEDURE CONTINUED ON WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808933 ↗
• InjuryJun 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND A LEFT ILIAC AORTIC ANEURYSM TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT FOLLOW UP IMAGES DATED (B)(6) 2025, REVEALED THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (LEFT SIDE) HAD BECOME THROMBOSED AND NO LONGER PATENT. THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO INTERVENTION ON THE THROMBOSED DEVICE. THE RIGHT SIDE HAD DISEASE PROGRESSION (PLC201000/(B)(6) AND WAS ANEURYSMAL. THE PHYSICIAN CHOSE TO TREAT RIGHT SIDE DUE TO DISEASE PROGRESSION. A REINTERVENTION WAS PERFORMED AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® WAS IMPLANTED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Reduced Blood Flow

  MAUDE report 22332897 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES. AFTER PLACEMENT OF ILIAC BRANCH COMPONENT (IBC) IN THE RIGHT ILIAC ARTERY, CANNULATION TO THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED. AN INTERNAL ILIAC COMPONENT (IIC) WAS ADVANCED TO THE LESION, BUT INTERFERENCE WITH A PULL-THROUGH WIRE CAUSED DIFFICULTY DURING INSERTION. FOLLOWING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED AT THE OSTIUM OF THE RIGHT INTERNAL ILIAC ARTERY, SUCCESSFUL DELIVERY OF THE IIC WAS ACHIEVED, AND THE IIC WAS SUCCESSFULLY IMPLANTED. ANGIOGRAPHY AFTER BALLOON TOUCH-UP REVEALED VESSEL INJURY IN THE RIGHT INFERIOR GLUTEAL ARTERY. THE INJURED VESSEL WAS TREATED WITH COIL EMBOLIZATION. FINAL ANGIOGRAPHY SHOWED A TYPE II ENDOLEAK FROM THE RIGHT SIDE OF AAA, BUT THE PROCEDURE WAS COMPLETED. THE PHYSICIAN NOTED THAT THE TIMING OF THE INJURY TO THE RIGHT INFERIOR GLUTEAL ARTERY WAS UNKNOWN. IT IS POSSIBLE THAT TH

  Patient problems: Perforation of Vessels

  MAUDE report 22290520 ↗
• InjuryMay 24, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A BILATERAL AORTO-ILIAC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). IN LATE (B)(6) 2025, A FOLLOW-UP CT SCAN REVEALED THAT THE LEFT SIDE HGB DEVICE HAD BECOME OCCLUDED. NO TREATMENT IS PLANNED FOR THIS DEVICE. THE PHYSICIAN HAD NO OPINION ON THE CAUSE OF THE OCCLUSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22082270 ↗
• MalfunctionMay 22, 2025Loss of or Failure to Bond; Difficult to Insert; Premature Activation; Loss of or Failure to Bond; Difficult to Insert; Premature Activation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH A 12MM X 7CM GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE, HGB161207A) TO TREAT ABDOMINAL AORTIC ANEURYSM COMBINED WITH INTERNAL ILIAC ARTERY ANEURYSM. DURING THE PROCEDURE, IBE DEVICE (CEB231410A) ON THE LEFT INTERNAL ILIAC ARTERY WAS DEPLOYED FIRSTLY. A SHEATH (DSF1245) ON THE RIGHT SIDE WAS USED TO DEPLOY AND BRIDGE IEB DEVICE (HGB161407A) SUCCESSFULLY. AFTERWARDS, THE SECOND IBE DEVICE (HGB161207A) WAS INSERTED THROUGH THE SHEATH (DSF1245). RESISTANCE WAS EXPERIENCED DURING THE DELIVERY OF IBE DEVICE, AND THE RESISTANCE INCREASED AFTER IBE DEVICE WAS PUSHED OUT OF SHEATH ABOUT 3CM, MAKING IT IMPOSSIBLE TO DELIVER THE DEVICE. THEREFORE, THE SHEATH (DSF1245) WAS FIXED, AND IBE DEVICE WAS TO BE WITHDRAWN. RESISTANCE WAS VERY GREAT, CAUSING THE BREAKAGE OF DELIVERY CATHETER AND TIP LEADING END. IBE DEVICE WAS DEPLOYED IN PATIENT DURING WITHDRAWING SHEATH PROCESS. A SNARE WAS USED TO GRAB AND REMOVE THE BROKEN TIP LEADING END AND CATHETER. THE IBE DEVICE WAS LEFT IN PATIENT AT THE ABDOMINAL AORTIC ANEURYSM SITE. THE SUBSEQUENT PROCEDURE WENT SUCCESSFULLY, AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075688 ↗
• InjuryFeb 18, 2025Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE IBE WAS IMPLANTED IN THE RIGHT SIDE AND THE TRUNK-IPSILATERAL LEG WAS DEPLOYED FROM THE LEFT SIDE. DURING A FOLLOW-UP EXAMINATION, IT WAS FOUND THAT THE INTERNAL ILIAC COMPONENT (IIC) MIGRATED PROXIMALLY AND WAS DISCONNECTED FROM THE SUPERIOR GLUTEAL ARTERY (SGA) AND FELL OUT INTO THE ANEURYSMAL SAC. ADDITIONALLY, ENLARGEMENT OF THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM AND THE LEFT COMMON ILIAC ARTERY ANEURYSM WAS OBSERVED. THE LEFT COMMON ILIAC ENLARGEMENT WAS DUE TO A TYPE II ENDOLEAK. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. TWO ADDITIONAL ENDOPROSTHESES WERE IMPLANTED TO RELINE THE IIC AND THE DISTAL END WAS LANDED IN THE SGA. FOR THE TYPE II ENDOLEAK, EMBOLIZATION FOR THE MEDIAN SACRAL ARTERY AND LEFT INTERNAL ILIAC ARTERY WAS ALSO PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE LANDING ZONE OF IIC WAS QUITE SHORT DURING THE INITIAL PROCEDURE. IT WAS A PROBABLE CAUSE OF IIC PROXIMAL MI

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 21398447 ↗
• InjuryDec 13, 2024Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC AND COMMON ILIAC ANEURYSM UTILIZING MULTIPLE GORE DEVICES ALONG WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). REPORTEDLY, PHYSICIAN HAD DIFFICULTY TRACKING THE INTERNAL ILIAC COMPONENT TO THE INTENDED LOCATION DUE TO PATIENT'S VERY LONG AND TORTUOUS ANATOMY. PHYSICIAN REMOVED THE DEVICE. PHYSICIAN DID NOT PLAN ON COILING THE INTERNAL ILIAC ARTERY AS WIRES WERE IN PLACE BUT COULD NOT TRACK THE DEVICE. PHYSICIAN DID A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY THEN EXTENDED ALL THE WAY TO THE EXTERNAL ILIAC ARTERY FROM THE FLOW DIVIDER OF THE TRUNK IPSILATERAL LEG WITH A BRIDGING LIMB (CONTRALATERAL LEG) TO THE IBE FLOW DIVIDER AND PAST IT DUE TO ADDITIONAL LENGTH THAT WAS NEEDED. PROCEDURE ENDED SUCCESSFULLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20929629 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT STAGED ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). THE ILIAC BRANCH COMPONENT (IBC) WAS IMPLANTED IN THE RIGHT ILIAC ARTERY. ON (B)(6) 2024, THE STAGED SECONDARY TREATMENT WAS PERFORMED. A FINAL ANGIOGRAPHY REVEALED THAT THE IBC IN THE RIGHT INTERNAL ILIAC ARTERY HAD THROMBUS OCCLUSION AND NO FLOW. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT BLOOD FLOW IN THE RIGHT INTERNAL ILIAC ARTERY WAS ORIGINALLY POOR AND OCCLUSION WAS SUSPECTED. THE TWO-STAGED BILATERAL IBE IMPLANT WAS DONE WITH OCCLUSION IN CONSIDERATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20910179 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. DURING THE TREATMENT, A FINAL ANGIOGRAPHY REVEALED A DELAYED BLOOD FLOW OF THE INTERNAL ILIAC COMPONENT IN THE RIGHT INTERNAL ILIAC ARTERY, HOWEVER IT WAS NOT OCCLUDED. NO UNINTENTIONAL COVERAGE OF ANY BRANCH VESSEL NOR UNINTENTIONAL PLACEMENT, DEPLOYMENT WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, BUT AT THE SIX-MONTHS FOLLOW-UP, A COMPUTED TOMOGRAPHY REVEALED A LACK OF WALL APPOSITION AT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG. NO ANEURYSM ENLARGEMENT WAS OBSERVED AND THE PHYSICIAN DECIDED TO MONITOR IT. ON UNKNOWN DATE, BUT IN 2024, AT A FOLLOW-UP, A COMPRESSION OF THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG WAS OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN ANGIOGRAPHY REVEALED OCCLUSIONS FROM THE LEFT SIDE OF THE FLOW DIVIDER TO LEFT DISTAL SIDE AND IN THE RIGHT INTERNAL ILIAC ARTERY. BALLOONING AND ADDITIONAL STENT GRAFT PLACEMENT WERE PERFORMED AT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG. AN INTRAVA

  Patient problems: Obstruction/Occlusion

  MAUDE report 20841360 ↗
• InjuryNov 20, 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 TREATMENT OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE IMPLANTED IN THE RIGHT ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. ON (B)(6) 2024, THE PATIENT WAS RACED TO THE HOSPITAL. A CT REVEALED A THROMBOTIC OCCLUSION OF ENTIRE IMPLANTED DEVICES. A THROMBECTOMY TO ENTIRE DEVICES AND AN AORTA EXTENDER WAS IMPLANTED PROXIMALLY. ON (B)(6) 2024, AN ANGIOGRAPHY REVEALED THE MINOR THROMBUS REMAINS IN THE INTERNAL ILIAC COMPONENT IN THE RIGHT INTERNAL ILIAC ARTERY BUT THE PATIENT CONDITION WAS WELL AND STABLE. THE PHYSICIAN STATED THAT A BEAK WAS OBSERVED ON THE LESSER CURVATURE SIDE OF THE TRUNK IPSILATERAL LEG AND IT MIGHT HAVE LED THE OCCLUSION BUT THE CAUSE WAS NOT ONLY THIS, BUT ALSO OTHER VARIOUS FACTORS MIGHT HAVE BEEN INVOLVED WITH THE OCCLUSION. THE PHYSICIAN ALSO STATED IT MIGHT BE ALSO ONE OF CAUSE THAT THE TRUNK IPSILATERAL LEG HAD NOT IMPLANTED IN APPROPRIATE POSITION TO PRESERVE AN ACCESSORY RENAL ARTERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20732080 ↗
• InjuryJun 28, 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 TREATMENT OF THE BRACHIOCEPHALIC ARTERY USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT). IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN ARCH AORTA REPLACEMENT BEFORE THIS PROCEDURE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT AXILLARY ARTERY AND THE INTERNAL ILIAC COMPONENT WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY FROM THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY. A FINAL ANGIOGRAPHY REVEALED A DISSECTION IN THE RIGHT SUBCLAVIAN ARTERY. IT SEEMED THAT THE DISSECTION OCCURRED FROM AROUND THE DISTAL END OF THE INTERNAL ILIAC COMPONENT. THE PHYSICIAN DECIDED TO MONITOR THE DISSECTION, BECAUSE THE BLOOD FLOW OF THE RIGHT SUBCLAVIAN ARTERY WAS NORMAL AND THERE WAS NO APPROPRIATE DEVICE TO TREAT THIS DISSECTION. THE PHYSICIAN STATED THAT IT IS UNKNOWN WHY THE DISSECTION OCCURRED AND THE POSSIBILITY OF THAT THE SHEATH WAS INVOLVED TO THE DISSECTION MIGHT BE LOW BECAUSE IT WAS CONFIRMED BY AN ANGIOGRAPHY THERE WAS NO DISSECTION BEFORE THE INTERNAL ILIAC COMPONENT WAS DEPLOYED. THE PHYSICIAN ALSO SAID A TOUCH-UP USING A NON-GORE BALLOON

  Patient problems: Vascular Dissection

  MAUDE report 19631223 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. DURING THE TREATMENT, AN INTERNAL ILIAC COMPONENT WAS IMPLANTED INTO THE RIGHT INTERNAL ILIAC ARTERY. AFTER ALL STENT GRAFTS WERE IMPLANTED, AN ANGIOGRAPHY REVEALED A SLIGHT DELAYED FLOW IN THE RIGHT INTERNAL ILIAC ARTERY. A SELECTIVE ANGIOGRAPHY WAS PERFORMED FROM LEFT UPPER ARM FOR THE RIGHT INTERNAL ILIAC ARTERY AND REVEALED NO ISSUES. NO TREATMENT WAS PERFORMED FOR THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A COMPUTED TOMOGRAPHY REVEALED AN OCCLUSION OF THE INTERNAL ILIAC COMPONENT. AS THE PATIENT WAS ASYMPTOMATIC, NO TREATMENT WAS PERFORMED. THE PHYSICIAN STATED THAT THE IMAGING REVEALED NO COMPRESSION OF THE STENT GRAFT SO IT WOULD BE DUE TO POOR OUTFLOW.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19516951 ↗
• InjuryDec 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND AN ILIAC AORTIC ANEURYSM TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED ¿THE DEVICE PARTIALLY DEPLOYED¿.

  Patient problems: Aneurysm

  MAUDE report 18273768 ↗
• InjuryDec 5, 2023Adverse 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) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND AN ILIAC AORTIC ANEURYSM TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, INTERNAL ILIAC LIMB DEVICE THROMBOSED.

  Patient problems: Thromboembolism

  MAUDE report 18267679 ↗
• InjuryOct 17, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). THE PATIENT¿S AORTA WAS NOT SUITABLE FOR STENT GRAFT TREATMENT; THUS, THE PHYSICIAN DECIDED TO IMPLANT THE IBE ALONE. AN AORTIC EXTENDER COMPONENT OF GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS ADDED PROXIMAL TO THE IBE DEVICE IN ORDER TO EXTEND THE SEALING ZONE. NO ENDOLEAK WAS FOUND. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED DUE TO A TYPE IB ENDOLEAK FROM THE LEFT INTERNAL ILIAC ARTERY AND COMMON ILIAC ANEURYSM EXPANSION. THE LEFT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED. A CONTRALATERAL LEG COMPONENT (PLC271000J) WAS ADDITIONALLY IMPLANTED UPSIDE DOWN TO RELINE THE ILIAC BRANCH COMPONENT. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. NO OPINION REGARDING THE CAUSE OF ENDOLEAK WAS OBTAINED FROM THE PHYSICIAN.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17954361 ↗
• InjurySep 5, 2023Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH TO TREAT THE RIGHT COMMON ILIAC ARTERY ANEURYSM AND THE LEFT COMMON ILIAC ARTERY ANEURYSM THAT WAS SUSPECTED BUT NOT DETERMINED, PREOPERATIVELY, IF THE LEFT ANEURYSM SHOULD ALSO BE TREATED AT THE SAME TIME. THE PATIENT HAD PREVIOUSLY UNDERGONE AN ABDOMINAL AORTIC GRAFT REPLACEMENT USING J GRAFT (JAPAN LIFELINE CO., LTD) ON (B)(6), 2016. DURING THE PROCEDURE, A SHEATH WAS DELIVERED FROM PATIENT¿S RIGHT LIMB AND A PULL-THROUGH WIRE WAS FORMED. AN ILIAC BRANCH COMPONENT (IBC, (B)(4)) WAS THEN DELIVERED FROM THE RIGHT LIMB, AND ITS PROXIMAL PORTION WAS DEPLOYED AT THE RIGHT COMMON ILIAC ARTERY. THE PROXIMAL END OF THE IBC WAS PLACED WITHIN THE J GRAFT. A 12FR 45CM SHEATH WAS THEN DELIVERED FROM PATIENT¿S LEFT LIMB, HOWEVER, THE SHEATH ADVANCEMENT WAS REPORTEDLY DIFFICULT BECAUSE IT WAS DELIVERED WITHIN THE J GRAFT, NOT THE NATIVE VESSEL. BECAUSE OF THE J GRAFT, THE VESSEL WALL WAS LESS SMOOTH THAN THE NATIVE VESSEL AND THE SHEATH WAS MORE PRONE TO GET STU

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 17685887 ↗
• 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 (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 17599987 ↗
• InjuryMay 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM AND LEFT ILIAC ANEURYSM. THE LEFT INFERIOR GLUTEAL ARTERY WAS EMBOLIZED, AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS PLACED TO LAND ON THE LEFT INFERIOR GLUTEAL ARTERY. THE INTERNAL ILIAC COMPONENT WAS PLACED SO THAT THEY OVERLAPPED BY ABOUT 3 CM. ON (B)(6) 2023, DURING FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) CONFIRMED OCCLUSION OF THE LEFT INTERNAL ILIAC ARTERY. LEFT BUTTOCK CLAUDICATION, LEFT BUTTOCK PAIN AND POSSIBLE COMPRESSION OF STENT GRAFTS WERE ALSO REPORTED. THE PHYSICIAN STATED AS FOLLOWS: AN ANTIPLATELET AGENT (CILOSTAZOL) WAS ALSO ADMINISTERED IMMEDIATELY AFTER PROCEDURE. NO HISTORY OF PAD. IT WAS CONFIGURED TO STACK THE IIC AFTER PLACING THE VIABAHN DISTALLY. THE END OF THE IIC WAS JUST LOCATED AT THE TORTUOUS POINT. A 12 MM DEVICE LANDED IN A 7 MM BLOOD VESSEL, WHICH MAY HAVE HINDERED THE BLOOD FLOW. WE EXPECT GRADUAL IMPROVEMENT IN BUTTOCK CLAUDICATION OVER NEXT 6 TO 12 MONTHS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17019566 ↗
• InjuryDec 5, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). THE IBE DEVICES WERE IMPLANTED ON THE RIGHT SIDE USING AN UP-AND-OVER TECHNIQUE. A NON-GORE MANUFACTURED DEVICE HAD BEEN PREVIOUSLY IMPLANTED IN THE ABDOMINAL AORTA. ON (B)(6) 2022, AN ENDOLEAK (TYPE UNKNOWN) WAS REPORTEDLY OBSERVED DURING PATIENT FOLLOW-UP. IMAGING EXAMINATION REPORTEDLY SHOWED THAT THE INTERNAL ILIAC COMPONENT (HGB161207A) WAS PLACED OUTSIDE OF THE INTERNAL ILIAC GATE OF THE ILIAC BRANCH COMPONENT (CEB231210A). A REINTERVENTION PROCEDURE HAS BEEN PLANNED BY THE PHYSICIAN. NO COMMENT WAS OBTAINED FROM THE PHYSICIAN REGARDING THE ROOT CAUSE.

  Patient problems: Clinical Endoleak

  MAUDE report 15915370 ↗

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)