GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA230005Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00733132650934), received between Aug 4, 2022 and Apr 13, 2026 — classified as 2 deaths, 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (6 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Malposition of Device

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. DURING DEPLOYMENT OF THE AORTIC EXTENDER, THE LEFT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY APPROXIMATELY THREE-QUARTERS, RESULTING IN NEAR LOSS OF BLOOD FLOW. A BARE METAL STENT WAS ADDITIONALLY IMPLANTED IN THE LEFT RENAL AS TREATMENT, LEADING TO IMPROVED BLOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24867454 ↗
• InjuryNov 27, 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) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2023, AN AORTIC EXTENDER (GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS) WAS ADDITIONALLY PLACED FOR A PROXIMAL TYPE I ENDOLEAK. (THIS EVENT HAS BEEN SEPARATELY REPORTED UNDER REPORT NUMBER: 3007284313-2023-02561). IN 2025, THE ANEURYSM SIZE WAS INCREASED FOR APPROXIMATELY 5 MM FROM THE FOLLOW-UP IN 2024 AND THERE WAS AN UNKNOWN ENDOLEAK ON THE DORSAL SIDE OF THE ANEURYSM. ADDITIONALLY, THROMBUS FORMATION IN THE RIGHT COMMON ILIAC ARTERY APPARENTLY PROGRESSED; THEREFORE, ANOTHER REINTERVENTION WAS INDICATED. ON (B)(6) 2025, AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED ON THE RIGHT DISTAL SIDE WITH EMBOLIZATION OF THE INTERNAL ILIAC ARTERY TO FIX THE THROMBUS ON THE PREVIOUS DEVICE AND EXTEND THE TREATMENT AREA INTO THE EXTERNAL ILIAC ARTERY. NO OBVIOUS ENDOLEAK WAS NOTED. NO TREATMENT WAS GIVEN FOR THE ANEURYSM GROWTH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23664245 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "RETROGRADE TYPE A DISSECTION AND RUPTURE OF THE AORTIC ROOT DURING ENDOVASCULAR AORTIC REPAIR" ISHIDA S, IHARA T, MORI A, YAGAMI K. J SURG CASE REP. 2025 OCT 17;2025(10): RJAF823. DOI: 10.1093/JSCR/RJAF823. AN 80-YEAR-OLD WOMAN PRESENTED WITH A PROGRESSIVELY ENLARGING INTRARENAL AAA, MEASURING UP TO 50 MM. THE PATIENT¿S PERFORMANCE STATUS WAS RELATIVELY LOW; THEREFORE, EVAR WAS SELECTED TO TREAT THE AAA INSTEAD OF OPEN SURGERY. EVAR WAS PERFORMED UNDER LOCAL ANESTHESIA, AND THE PROCEDURE WAS CONDUCTED AS USUAL. BALLOONING WAS PERFORMED AFTER IMPLANTING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS. SUBSEQUENTLY, AORTOGRAPHY WAS PERFORMED, WHICH SHOWED A PROXIMAL TYPE I ENDOLEAK. THEREFORE, BALLOONING WAS ADDED AT THE TOP OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (MAIN BODY STENT GRAFT); HOWEVER, THE ENDOLEAK PERSISTED. THUS, AN ADDITIONAL AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED AT THE UPPER END OF THE MAIN BODY STENT GRAFT. AORTOGRAPHY WAS PERFORMED AFTER BALLOONING; HOWEVER, THE FLOW WAS STAGNATING IN THE STENT GRAFT. AT THE SAME TIME, THE PULSE RATE OF THE PATIENT DECREASED SUDDENLY, AND SHE LOST CONSCIOUSNESS. SHE

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Vascular Dissection

  MAUDE report 23663344 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER AND GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDERS TO TREAT A THORACIC DISSECTION IN ZONE 2 THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON OCTOBER 22, 2025, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT SUFFERED PARALYSIS POST PROCEDURE. REPORTEDLY, THE PATIENT PRESENTED ON (B)(6) 2025, WITH CHEST PAIN AND LEG WEAKNESS, SHE DEVELOPED NEUROLOGIC CHANGES AND REQUIRED INTUBATION AND EVENTUALLY WAS FOUND TO HAVE TYPE B DISSECTIONS WITH MASSIVE MALPERFUSION, VISCERAL RENAL AND LOWER EXTREMITY MALPERFUSION AND POSSIBLY SPINAL MALPERFUSION FROM THE COMPLICATED DISSECTION. TREATMENT FOR THE PARALYSIS ON (B)(6) 2025, PERMISSIVE HYPERTENSION AND LEFT UPPER EXTREMITY SPINAL DRAIN PLACEMENT. POST REINTERVENTION ON (B)(6) 2025, THE PATIENT WAS ABLE TO MOVE THE RIGHT UPPER EXTREMITY AND NOT THE LOWER EXTREMITIES AND HAS BEEN MOVED TO A REHABILITATION FACILITY.

  Patient problems: Vascular Dissection

  MAUDE report 23560453 ↗
• InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THIS PATIENT IS BEING BROUGHT BACK FOR A REINTERVENTION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, DURING THE REINTERVENTION, PHYSICIAN DID A REALIGNMENT OF THE TWO ORIGINAL GRAFTS (CONFORMABLE AORTIC EXTENDERS) AS THERE WAS NO BIFURCATED GRAFT IMPLANTED DURING THE ORIGINAL PROCEDURE. THE THORACIC CONFORMABLE STENT GRAFT WAS IMPLANTED TO TREAT AN UNKNOWN ENDOLEAK IN THE ANEURYSM SAC (SIZE OF GROWTH IS UNKNOWN) AS PHYSICIAN WAS NOT SURE IF ITS A TYPE 2 OR 3 ENDOLEAK BY REALIGNING FROM JUST BELOW THE SUPERIOR MESENTERIC ARTERY (SMA) TO ALMOST DOWN TO AORTIC BIFURCATION IN ORDER TO COVER THE JUNCTION BETWEEN THE TWO ORIGINAL GRAFTS, AS A RESULT, THE RENAL ARTERIES WERE OCCLUDED. PHYSICIAN THEN EXTENDED DISTALLY WITH A CONFORMABLE CUFF TO GAIN EXTRA LANDING ZONE TOWARDS THE BIFURCATION. A CTA FOLLOW-UP (DATE UNKNOWN)

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21550430 ↗
• InjuryDec 27, 2024Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON NOVEMBER 27, 2024, FROM THE IMEDIDATA STUDY DATABASE FOR THE TGR23-02AA TOGETHER AORTIC REGISTRY. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS AN ELECTIVE PROCEDURE FOR A RIGHT ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND A GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENT. THE SITES WERE ACCESSED PERCUTANEOUSLY BILATERALLY. THE DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND DEPLOYED WITH NO REPORTED ISSUES. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED. THERE WERE NO REPORTED ISSUES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON NOVEMBER 4, 2024, IT WAS REPORTED THAT THE RIGHT EXTERNAL ILIAC ARTERY HAD THROMBOSED LEADING TO OCCLUSION AND ISCHEMIA. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED WHEREBY THE PATIENT UNDERWENT A FEM-FEM BYPASS. A THROMBECTOMY WAS ALSO PERFORMED, AND THE PATIENT RECEIVED A TISSUE PLASMINOGEN ACTIVATOR (TPA) INJECTION INTO THE RIGHT POPLITEAL ARTERY. IT WAS SUSPECTED THAT THE SMALL SIZE OF THE INTERNAL ILIAC ARTERY MAY HAVE CAUSED OR CONTRIBUTED TO OVERWHELMING THE EXTERNAL ILIAC ARTERY AND ULTIMATELY COLLAPSING THE EXTERNAL ILIAC. THE

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21030858 ↗
• InjuryNov 13, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. IT WAS OBSERVED THAT BLOOD FLOW DELAY IN THE LEFT RENAL ARTERY AFTER PLACING THE AORTIC EXTENDER COMPONENT. A BARE STENT WAS PLACED IN THE LEFT RENAL ARTERY, BLOOD FLOW IMPROVEMENT WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20679618 ↗
• InjuryMar 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR INFLAMMATORY ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT¿S AORTIC NECK WAS A VERY COMPLEX ANATOMY, MAKING IT DIFFICULT TO PREDICT HOW THE DEVICES WOULD BE IMPLANTED; THEREFORE, THE SNORKEL TECHNIQUE WAS PREPARED FOR BOTH THE RENAL ARTERIES BEFORE IMPLANTING THE PROXIMAL DEVICES. THE RENAL ARTERIES WERE INTENTIONALLY PARTIAL-COVERED AND BARE-METAL STENTS (EXPRESS VASCULAR SD) WERE ADDITIONALLY IMPLANTED IN THE RENAL ARTERIES. EVENTUALLY, 6 STENT GRAFTS (CXT231412, PLL161407J, PLC161000J, PLC141000J, CXA230005, PLC121000J) WERE IMPLANTED. THE FINAL ANGIOGRAPHY SHOWED ONLY A TYPE II ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY (IMA). NO OTHER ENDOLEAK WAS FOUND, SO THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A FOLLOW-UP ENHANCED CT SCAN SHOWED A TYPE IA ENDOLEAK, TYPE II ENDOLEAK FROM THE IMA AND RAPID ANEURYSM ENLARGEMENT (SIZE UNKNOWN). ON THE SAME DAY, A SEMI-EMERGENCY OPEN CONVERSION WAS PERFORMED. DURING THE OPEN REPAIR, THE EXCLUDER LEGS WERE CUT AND THE PROXIMA

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18947621 ↗
• DeathOct 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ON AN UNKNOWN DATE APPROXIMATELY 20 YEARS AGO THIS PATIENT UNDERWENT AN OPEN AORTIC BIFURCATED REPAIR OF THE ABDOMINAL AORTA. ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEAK (UNKNOWN TYPE) AT THE ANASTOMOSIS SITE. THE TREATMENT PLAN WAS TO PLACE 2 GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS (CXA23005 X2) (AE'S) ACROSS THE ANASTOMOSIS AND ACHIEVE SEAL. THE FIRST AE WAS DEPLOYED AT THE LEVEL OF THE BIFURCATION WITH THE SECOND AE DEPLOYED AT THE LEVEL OF THE RENAL ARTERY WITH SIGNIFICANT OVERLAP OF THE AE'S. BOTH GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES DEPLOYED PROPERLY AND SUCCESSFULLY. WHEN BALLOONING WITH A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB); WE BALLOONED THE OVERLAP ZONE AND AT THE LEVEL OF THE RENAL ARTERIES, AND A LITTLE OUTSIDE THE GRAFT PROXIMALLY. THE PATIENT THEN EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE. SUBSEQUENTLY AN AORTIC RUPTURE WAS IDENTIFIED (WHICH APPEARED TO BE A TEAR LONGITUDINALLY) JUST OUTSIDE THE PROXIMAL AE. THE MOB WAS RELOCATED ABOVE THE LEVEL OF THE RENAL ARTERIES IN AN ATTEMPT TO GET SOME STABILITY OF THE BLOOD FLOW AND THE PATIENT. TWO ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS (CXA23005 AND C

  Patient problems: Rupture

  MAUDE report 17917163 ↗
• DeathOct 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN THE ASCENDING AORTA TO TREAT A PSEUDOANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER). REPORTEDLY, THE ASCENDING AORTA WAS CURVED AND THE DEVICE DID NOT TAKE THE CURVE (PROXIMAL) AND HAD NOT APPOSED THE WALL ON THE INNER CURVE WHICH LED TO A SLIGHT BIRD BEAK. PHYSICIAN BELIEVED THE DEVICE COVERED THE DEFECT (PSEUDOANEURYSM) AND IT WAS A DIFFICULT APPLICATION/ANGLE TO TREAT. THE SLIGHT BIRD BEAK DID NOT SEEM TO AFFECT THE OUTCOME OF THE PROCEDURE AND PATIENT IS DOING WELL AFTER 2 DAYS OF POST OP. ADDITIONAL INFORMATION RECEIVED FROM FSA ON 09/28/2023: LAST NIGHT ((B)(6) 2023). FSA WAS INFORMED BY A DR. (B)(6) (WHO WAS APPARENTLY ALSO AT THE INITIAL PROCEDURE) THAT THE PATIENT PASSED AWAY ON AN UNKNOWN DATE AFTER THE PROCEDURE. THE CAUSE OF DEATH WAS PERSISTENT BLEEDING. NO FURTHER INFORMATION OR DETAILS ARE AVAILABLE AS TO WHAT LED TO THE PERSISTENT BLEEDING. IT WAS ALSO REPORTED THAT THE AORTIC EXTENDER CONFORMABLE WAS INITIALLY PLACED THROUGH THE PATIENT'S NECK AND INTO THE AORTIC ARCH NEAR THE HEART. THE PATIENT ALSO HAD A PREVIOUS HEART TRAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17900860 ↗
• InjuryAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ULCERATION AND TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW-UP COMPUTED TOMOGRAPHY ON AN UNKNOWN DATE SHOWED CONTINUED FILLING OF THE ULCERATION. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED TYPE III ENDOLEAK DUE TO INSUFFICIENT OVERLAP OF THE TWO EXTENDER COMPONENTS. THE PHYSICIAN DID NOT STATE THERE WAS A DISCONNECT OF THE TWO COMPONENTS, JUST AN INSUFFICIENT OVERLAP ZONE. ADDITIONALLY, ONE OF THE DEVICES APPEARS TO SORT OF BIRD BEAK OUT INTO THE ULCERATION WHICH CONTRIBUTED TO THE PERSISTENT FILLING. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO RELINE THE GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ulcer

  MAUDE report 17477153 ↗
• InjuryAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ULCERATION AND TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW-UP COMPUTED TOMOGRAPHY ON AN UNKNOWN DATE SHOWED CONTINUED FILLING OF THE ULCERATION. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED TYPE III ENDOLEAK DUE TO INSUFFICIENT OVERLAP OF THE TWO EXTENDER COMPONENTS. THE PHYSICIAN DID NOT STATE THERE WAS A DISCONNECT OF THE TWO COMPONENTS, JUST AN INSUFFICIENT OVERLAP ZONE. ADDITIONALLY, ONE OF THE DEVICES APPEARS TO SORT OF BIRD BEAK OUT INTO THE ULCERATION WHICH CONTRIBUTED TO THE PERSISTENT FILLING. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO RELINE THE GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ulcer

  MAUDE report 17476919 ↗
• MalfunctionJul 24, 2023Adverse 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) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RE-ENTRY AFTER IMPLANTATION OF COOK BARE STENT FOR DISSECTION IN ABDOMINAL AREA, USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING THE TREATMENT WHILE PULLING THE DEPLOYMENT LINE, THE DEPLOYMENT LINE WAS NOT ABLE TO BE PULLED ANY MORE. ACCESS HATCH WAS USED TO PULL THE DEPLOYMENT LINE, HOWEVER WITHOUT SUCCESS. WHILE TRYING TO PULL THE DEPLOYMENT LINE, THE DEVICE MOVED DISTALLY. SO, THE CATHETER WAS PUSHED UP TO PROXIMALLY, THEN THE DEVICE WAS DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE WOULD LIKE GORE TO DETERMINE THE CAUSE.

  Patient problems: Vascular Dissection

  MAUDE report 17376838 ↗
• InjuryMay 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. BOTH THE RIGHT AND LEFT INTERNAL ILIAC ARTERIES WERE COIL EMBOLIZED, AND THREE EXCLUDER DEVICES WERE IMPLANTED UNDER THE RENAL ARTERIES. IMMEDIATELY AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO MOVE BOTH LEGS. ON (B)(6) 2023, THE PATIENT DEVELOPED PARAPLEGIA. IT IS UNKNOWN, IF THE PATIENT RECEIVED ANY TREATMENT AND WHAT TREATMENT WAS RECEIVED. REPORTEDLY, POSSIBLE FACTORS CONTRIBUTING TO THE PARAPLEGIA WERE A TRANSIENT BILATERAL EMBOLIZATION OF BOTH INTERNAL ILIAC ARTERIES AND THE SHOWER EMBOLISM DURING THE PROCEDURE.

  Patient problems: Paralysis

  MAUDE report 16899174 ↗
• InjuryMay 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2023, THE GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESIS WAS EXPLANTED. REASON FOR EXPLANT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16870813 ↗
• InjuryFeb 9, 2023Malposition of Device; Malposition of Device

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. DURING THE PROCEDURE, AN AORTIC EXTENDER ENDOPROSTHESIS WAS REPORTEDLY DEPLOYED MORE PROXIMALLY THAN INTENDED, AND THE RIGHT RENAL AND SUPERIOR MESENTERIC ARTERIES WERE PARTIALLY AND UNINTENTIONALLY COVERED BY THE ENDOPROSTHESIS. AS TREATMENT, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (6 MM X 25 MM) AND A STENT (PALMAZ GENESIS® 6X18MM) WERE IMPLANTED IN THE RIGHT RENAL ARTERY, AND A STENT (S.M.A.R.T.®) WAS IMPLANTED IN THE SUPERIOR MESENTERIC ARTERY VIA ACCESS FROM THE RIGHT UPPER ARM. FINAL INTRA-PROCEDURAL IMAGING REPORTEDLY REVEALED A TYPE II ENDOLEAK, BUT NO FURTHER TREATMENT WAS GIVEN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16337360 ↗
• InjuryDec 19, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DISTAL STENT GRAFT-INDUCED NEW ENTRY TEAR CAUSED BY A NON-GORE MANUFACTURED STENT GRAFT USING TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESES. DURING THE PROCEDURE, TWO AORTIC EXTENDER DEVICES WERE DEPLOYED, AND THE DISTAL DEVICE WAS PLACED JUST ABOVE THE LUMBAR ARTERY THAT WAS TO BE PRESERVED. HOWEVER, THE TWO AORTIC EXTENDER DEVICES REPORTEDLY MIGRATED APPROXIMATELY 5MM DISTALLY WHILE BALLOONING, AND THE LUMBAR ARTERY WAS UNINTENTIONALLY COVERED BY THE DISTAL AORTIC EXTENDER DEVICE. THE PHYSICIAN ELECTED TO MONITOR THE VESSEL COVERAGE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE DEVICE MIGRATED DUE TO THE BALLOON BEING PUSHED BY THE BLOOD FLOW.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16010341 ↗
• InjuryOct 12, 2022Malposition of Device; Migration; Malposition of Device; Migration

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. WHILE ATTEMPTING TO REPOSITION THE TRUNK-IPSILATERAL LEG COMPONENT, THE DEVICE WAS PUSHED BY THE BLOOD FLOW AND FELL OUT INTO THE ANEURYSM. ATTEMPT WAS MADE TO PUSH UP THE DEVICE BUT IT WAS NOT SUCCESSFUL DUE TO THE NECK ANGULATION, HENCE, THE CONFORMABLE AORTIC EXTENDER COMPONENT (CUFF) WAS DEPLOYED PROXIMALLY. BECAUSE OF THE SHORT LENGTH OF THE OVERLAP, THE PHYSICIAN ATTEMPTED TO PLACE ADDITIONAL STENT GRAFT. IN DOING SO, THE GORE® DRYSEAL FLEX INTRODUCER SHEATH PUSHED THE CUFF DEVICE UP. THE CUFF DEVICE MIGRATED PROXIMALLY AND THE LEFT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY THE CUFF DEVICE. NO FURTHER TREATMENT WAS PERFORMED BECAUSE BLOOD FLOW WAS OBSERVED ON THE ANGIOGRAPHY, AND ALSO THE PATIENT HAD HYDRONEPHROSIS AND POOR RENAL ARTERY FUNCTION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE DEVICE WAS PUSHED UP INADVERTENTLY.

  Patient problems: Aneurysm

  MAUDE report 15587178 ↗
• InjuryOct 5, 2022Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM REPAIR. IT WAS REPORTED THAT THE PATIENT'S PROXIMAL NECK WAS HIGHLY TORTUOUS. TRUNK - IPSILATERAL LEG ENDOPROSTHESIS AND BILATERAL LIMB WERE DEPLOYED. IN ORDER TO OBTAIN STRONGER SEALING ON THE PROXIMAL SIDE, AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED. THEN, BILATERAL RENAL ARTERIES WERE COVERED UNINTENTIONALLY. REPORTEDLY, BLOOD FLOW TO BOTH RENAL ARTERIES WAS CONFIRMED, BUT IT WAS DETERMINED THAT FLOW TO THE LEFT RENAL ARTERY WAS SLIGHTLY DELAYED. A BARE METAL STENT WAS PLACED. THE DELAY WAS RESOLVED, AND IT WAS DETERMINED THAT THERE WAS NO PROBLEM WITH BLOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED AS FOLLOWS: THE DEGREE OF THE AORTA NECK WAS OUTSIDE THE IFU.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 15543287 ↗
• 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. 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 OF MULTIPLE COLLATERAL FLOWS. IT WAS REPORT

  Patient problems: Unspecified Vascular Problem

  MAUDE report 15164006 ↗