GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT201412Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132650996), received between May 4, 2022 and May 26, 2026 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA DATABASE: ON (B)(6) 2025, THIS 76-YEAR-OLD FEMALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. ON (B)(6) 2026, THE PATIENT DEVELOPED A TYPE 1A ENDOLEAK (ABDOMINAL AORTA), WHICH REQUIRED IN-PATIENT OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THIS EVENT WAS RELATED TO DISEASE PROGRESSION (INDEX PATHOLOGY). ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. AN ADDITIONAL STENT GRAFT (AORTIC EXTENDER DEVICE) WAS IMPLANTED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 25274515 ↗
• InjuryApr 8, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AS WELL AS GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE, A CT SCAN REVEALED A TYPE 1A ENDOLEAK ON THE CONFORMABLE TRUNK. ON (B)(6) 2026, A REINTERVENTION OCCURRED. A CONFORMABLE EXTENDER WAS PLACED PROXIMAL TO THE CXT DEVICE, AND 6 MEDTRONIC ENDOANCHORS WERE IMPLANTED. NO LEAK WAS SEEN ON PRE-INTERVENTION OR COMPLETION ANGIOGRAM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24816511 ↗
• InjuryFeb 6, 2026Patient-Device Incompatibility

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED ON A COMPUTED TOMOGRAPHY IMAGING. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. TOUCH-UP BALLOONING WAS PERFORMED USING NON-GORE BALLOON, AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24275506 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PROXIMAL TYPE I ENDOLEAK THAT OCCURRED PREVIOUSLY IMPLANTED GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. TOUCH-UP BALLOONING WAS PERFORMED USING NON-GORE BALLOON, AND THE ENDOLEAK WAS RESOLVED. HOWEVER, A RETROGRADE DISSECTION ORIGINATING NEAR THE PROXIMAL EDGE OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS IDENTIFIED. THE PHYSICIAN ELECTED TO MONITOR IT, AND NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE BALLOONING MIGHT HAVE BEEN TOO STRONG.

  Patient problems: Vascular Dissection

  MAUDE report 24275434 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR STENOSIS AT THE ANASTOMOSIS OF A Y GRAFT REPLACEMENT FOR THE ABDOMINAL AORTA USING A NON-GORE GRAFT AT THE LEFT COMMON ILIAC ARTERY (SUSPECTED PSEUDOANEURYSM). GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE USED FOR THIS EVAR PROCEDURE. A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE AND A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH FROM THE RIGHT SIDE, THEN ALL DEVICES WERE IMPLANTED. IT WAS REPORTED THAT THE 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE AFTER CLAMPING THE RIGHT FEMORAL ARTERY TO PREVENT THROMBOTIC OCCLUSION OF THE PERIPHERAL ARTERY AFTER STENT GRAFTS WERE IMPLANTED, DOPPLER EXAMINATION REVEALED POOR BLOOD FLOW IN THE RIGHT PERIPHERAL ARTERY. ANGIOGRAPHY SHOWED STENOSIS/OCCLUSION NEAR THE POPLITEAL ARTERY. THROMBECTOMY USING A FOGARTY CATHETER WAS PERFORMED. IT WAS REPORTED THAT THROMBI WERE OBSERVED FROM THE INFRARENAL AORTA TO THE PERIPHERAL ARTERIES. THE PHYSICIAN STATED THAT THE RIGHT FEMORAL ARTERY WAS CLAMPED TO PREVENT THROMBOTIC OCCLUSION OF THE PERIPH

  Patient problems: Embolism/Embolus

  MAUDE report 23663171 ↗
• MalfunctionNov 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WAS AT THE FINAL DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WHEN A ¿STRING¿ LINE BROKE (1600-E:-CATHETER EVENTS - OTHER/UNKNOWN). ¼ OF THE OF THIS STRING LINE WAS HANGING OUT OF THE DEPLOYMENT KNOB. IT WAS ABLE TO BE REMOVED, AND FULL DEPLOYMENT WAS ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE. THE CONSTRAINING MECHANISM OF THE DEVICE WAS USED ONCE DURING THE PROCEDURE. THE FIELD SALES ASSOCIATE DOES NOT KNOW WHAT THE ¿STRING¿ WAS OR WHERE IT CAME FROM. REPORTEDLY WHEN ¿THE RED LOCK PIN WAS PULLED, SHE ASSUMED ONE OF THE STRINGS MUST OF BROKEN¿.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23622003 ↗
• MalfunctionJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS 72-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED PROCEDURE FOR AN ABDOMINAL AORTIC AND ILIAC PSEUDOANEURYSM. THE PATIENT WAS TREATED WITH THREE GORE® EXCLUDER® ENDOPROSTHESIS DEVICES IN THE INFRARENAL ABDOMINAL AORTA AND BILATERAL COMMON ILIAC ARTERIES. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WERE NO ADJUNCTIVE PROCEDURES. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A CTA FOLLOW UP. IT IS NOTED THAT THE PATIENT HAD COMPRESSION OR INFOLDING OF THE GORE® EXCLUDER® CONFORMABLE AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS DEVICE. THERE WAS NO LOSS OF PATENCY. NO FURTHER INFORMATION IS PROVIDED AT THIS TIME. DESCRIPTION SUMMARY THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND FOR AN ABDOMINAL AND ILIAC ARTERY AORTIC ANEURYSM(S) AND WAS IMPLANTED WITH GORE® EXCLUDER® EXCLUDER CONFORMABLE AAA ENDOPROSTHESES. ON (B)(6) 2025, THE PATIENT UNDERW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292789 ↗
• InjuryMay 7, 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 USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER®AAA ENDOPROSTHESES. A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) WAS USED AS AN ACCESSORY. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS PLACED BELOW THE LEFT RENAL ARTERY. A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) WAS USED FOR BALLOON MOLDING. FINAL ANGIOGRAPHY REVEALED A RETROGRADE DISSECTION FROM JUST ABOVE THE RENAL ARTERY/PROXIMAL END OF THE DEVICE TO THE DIAPHRAGM AREA. THE PATIENT WAS DECIDED TO BE MONITORED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN MENTIONED THAT THE PATIENT PROXIMAL NECK WAS NARROW, AND THE BALLOON MOLDING MAY HAVE BEEN TOO FORCEFUL.

  Patient problems: Vascular Dissection

  MAUDE report 21981671 ↗
• InjuryApr 28, 2025Malposition of Device; Malposition of Device

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A IGHT COMMON ILIAC ANEURYSM UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) IN ZONE 9. THERE WAS NOT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE CXT WAS INITIALLY WELL PLACED JUST BELOW THE RENAL ARTERIES. WHEN PLACING THE BRIDGE LIMB FOR THE IBE DEVICE, FORWARD PRESSURE WAS APPLIED IN ORDER TO SHORTEN THE LENGTH NEEDED. THE BRIDGE LIMB WAS SUCCESSFULLY PLACED. FINAL ANGIOGRAMS SHOWED ABOUT 5 MM OF PROXIMAL MOVEMENT OF THE CXT COVERING THE MAJORITY OF THE RENAL ARTERIES. THIS WAS FELT TO BE DUE TO THE FORWARD PRESSURE EXERTED WHEN SHORTENING THE BRIDGE LIMB. THE FLOW INTO THE RENAL ARTERIES DID NOT APPEAR TO BE AFFECTED. ON (B)(6) 2025, THE PATIENT WAS BROUGHT BACK AND UNDERWENT SUCCESSFUL BILATERAL RENAL ARTERY STENTING TO PREVENT ANY POTENTIAL COMPLICATIONS IN THE FUTURE. A 6 MM X 18 MM EXPRESS SD STENT (NON-GORE DEVICE) WAS USED IN EACH VESSEL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918498 ↗
• InjuryApr 25, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE TO TREAT A DISSECTION IN THE LEFT DISTAL COMMON ILIAC ARTERY UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS, TWO GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN® DEVICE) AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT). REPORTEDLY, PATIENT HAD A TORTUOUS AORTIC NECK AND DURING INITIAL WIRE ACCESS THERE WAS A DISSECTION NOTED IN THE VISCERAL SEGMENT, THIS WAS RESOLVED AND COVERED WITH THE CONFORMABLE MAIN BODY GRAFT. THE PROCEDURE WENT WELL WITH ALL DEVICES IMPLANTED. AT THE END OF THE PROCEDURE, IT WAS UNCERTAIN BUT THERE WAS A POSSIBLE TYPE 3 ENDOLEAK FROM THE PARALLEL VBX STENTS THAT WERE INSERTED IN THE HYPOGASTRIC AND EXTERNAL ILIAC ARTERIES ON THE PATIENT'S LEFT SIDE. PHYSICIAN DECIDED TO WAIT AND SEE IF THE ENDOLEAK RESOLVED ON ITS OWN, OR REVIEW ON THE CT AT NEXT FOLLOW UP TO CONFIRM EXACT LOCATION OF THE LEAK. ON (B)(6) 2025, THE PATIENT WAS BROUGHT BACK FOR AN EMERGENT PROCEDURE TO TREAT THE RETROGRADE DISSECTION FROM ABOVE THE TRUNK IPSILATERAL LEG CONFORM

  Patient problems: Vascular Dissection

  MAUDE report 21913661 ↗
• InjuryApr 1, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE STENT GRAFT. AFTER THE PROCEDURE, A CT SCAN REVEALED THAT THE LEFT RENAL ARTERY WAS COVERED BY THE PROXIMAL END OF THE MAIN TRUNK. NO SPECIFIC TREATMENT WAS PERFORMED AND THE PATIENT WAS PLACED UNDER OBSERVATION. THE PHYSICIAN REPORTED THAT THE LEFT RENAL SEEMED NOT TO BE COVERED DURING THE PROCEDURE, BUT IT WAS COVERED ACCORDING TO THE CT. DUE TO THE SHORT TREATMENT SITE, THE MAIN TRUNK WAS PUSHED UP FORCEFULLY, AND IT POSSIBLY MOVED MORE PROXIMALLY THAN EXPECTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21736116 ↗
• InjuryMar 2, 2025Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6)2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC PSEUDOANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. INTRAOPERATIVELY, AFTER DEPLOYING A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS TRUNK PART AND A CONTRALATERAL LEG ENDOPROSTHESIS IN THE CONTRALATERAL SIDE, WHILE THE IPSILATERAL LEG OF TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS BEING DEPLOYED WITH PUSHING UP, THE UNDEPLOYED (CONSTRAINED) PART OF THE IPSILATERAL LEG MOVED DISTALLY ON THE DELIVERY CATHETER BEFORE THE DEPLOYMENT LINE (DISTAL DEPLOYMENT KNOB) WAS FULLY PULLED. AS THE IPSILATERAL LEG WAS NO LONGER FIXED TO THE DELIVERY CATHETER, THE IPSILATERAL LEG COULD NOT BE PUSHED UP ANY FURTHER, AND THE IPSILATERAL LEG WAS UNAVOIDABLY DEPLOYED IN A POSITION THAT COVER THE LEFT INTERNAL ILIAC ARTERY. AN ATTEMPT TO PUSH UP THE IPSILATERAL LEG BY DILATING IT WITH A MOB GORE® MOLDING & OCCLUSION BALLOON IN THE ANEURYSM WAS UNSUCCESSFUL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21501318 ↗
• InjurySep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER®AAA ENDOPROSTHESES. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) WERE USED AS CHIMNEY STENTGRAFTS AND PLACED IN EACH OF THE LEFT AND RIGHT RENAL ARTERIES, THEN AN ADDITIONAL NON-GORE STENT GRAFT WAS IMPLANTED IN PROXIMAL SIDE. THE ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED. THIS EVENT WAS CAPTURED IN MEDWATCH REPORT NUMBER 3007284313-2024-03449, 3007284313-2024-03450. ON (B)(6) 2024, POSTOPERATIVE THROMBOTIC OCCLUSION WAS CONFIRMED FROM THE LEFT FEMORAL ARTERY TO THOSE TWO CONTRALATERAL LEG ENDOPROSTHESES (PLC121200J, PLC141400J) AND THE FLOW-DIVIDER OF TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. THROMBECTOMY WITH FOGARTY CATHETER WAS PERFORMED. REPORTEDLY THAT THE THROMBOSIS IS RELATED TO THE PUNCTURE TREATMENT. ON (B)(6) 2024, THE PATIENT WAS TRANSPORTED EMERGENCY WITH ANEURYSM RUPTURE. IT WAS CONFIRMED THAT THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC141400J/24704243) IMPLANTED ON (B)(6) 2022 HAD MIGRATED ABOU

  Patient problems: Clinical Endoleak; Ruptured Aneurysm; Thrombosis/Thrombus

  MAUDE report 20318164 ↗
• InjuryAug 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER®AAA ENDOPROSTHESES. ANGIOGRAPHY AFTER STENTGRAFTS PLACEMENT CONFIRMED A PROXIMAL TYPE I ENDOLEAK AT THE OUTER CURVATURE OF THE AORTA. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DECIDED TO BE MONITORED. ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PROXIMAL TYPE I ENDOLEAK STILL REMAINED AT THE POSTOPERATIVE FOLLOW-UP EXAMINATION. THE DECISION WAS MADE TO PERFORM ADDITIONAL INTERVENTION. IT IS UNKNOWN IF THE ANEURYSM HAD ENLARGED OR NOT. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. A CHIMNEY STENTGRAFT WAS PLACED IN EACH OF THE LEFT AND RIGHT RENAL ARTERIES, AND AN ADDITIONAL STENT GRAFT (ENDURANT CUFF 32MM X 49MM) WAS IMPLANTED TO THE MOST PROXIMAL SIDE. THE ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Clinical Endoleak

  MAUDE report 20045035 ↗
• InjuryJun 2, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. FINAL CONTRAST IMAGING AFTER STENT-GRAFT DEPLOYMENT REVEALED THE COVERAGE OF THE LEFT RENAL ARTERY. IT WAS CONSIDERED THAT THE PLACEMENT POSITION ON THE PROXIMAL SIDE OF TRUNK IPSILATERAL LEG ENDOPROSTHESIS MIGHT HAVE MOVED WHEN THE DISTAL LEG WAS DEPLOYED USING PUSHING UP. THERE WERE NO PROBLEMS WITH BLOOD FLOW TO THE RENAL ARTERY. BECAUSE THE FACILITY DID NOT HAVE A RENAL ARTERY STENT AVAILABLE, IT WAS DETERMINED TO TAKE WAIT-AND-SEE APPROACH. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT'S RENAL FUNCTION HAD SLIGHTLY WORSENED. THE CREATININE LEVEL WAS 1.3. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION. A BARE STENT WAS PLACED IN THE RENAL ARTERY. BLOOD FLOW TO THE RENAL ARTERY IMPROVED. THE PHYSICIAN STATED THE FOLLOWING. AT THE TIME OF INITIAL DEPLOYMENT, IT WAS SUCCESSFULLY JUST BELOW THE LEFT RENAL ARTERY. I THINK A RENAL ARTERY STENT SHOULD BE PLACED, BUT SINCE I DIDN'T HAVE ANY PREPARATIONS, I'LL CONSIDER THAT AT A LATER DATE. AFTER EVAR, PCI (PERCUTANEOUS CORONARY INTER

  Patient problems: Obstruction/Occlusion

  MAUDE report 19444904 ↗
• InjuryMar 11, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THE LEFT RENAL ARTERY WAS UNINTENTIONALLY PARTIALLY COVERED BY THE DEVICE, AN ADDITIONAL BARE STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IT MIGHT HAVE CAUSED BY PUSHING UP TO MUCH WHILE DEPLOYING THE IPSILATERAL LEG.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18872981 ↗
• InjuryMar 1, 2024Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRALATERAL LEG ENDOPROSTHESES). ON (B)(6) 2024, ABI OF THE RIGHT LIMB WAS GETTING WORSE. ON (B)(6) 2024, AN ANGIOGRAPHY REVEALED THE IPSILATERAL LEG OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WHICH WAS IMPLANTED IN THE RIGHT SIDE WAS ALMOST COMPRESSED. A KISSING BALLOONING WAS PERFORMED TO AROUND A FLOW DIVIDER. THE COMPRESSION WAS IMPROVED, BUT A STENT WAS IMPLANTED TO RELINE, JUST IN CASE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED IT SEEMED THAT A FINAL ANGIOGRAPHY AND PRESSURE GAP BETWEEN THE RIGHT LIMB AND THE LEFT LIMB AT THE INITIAL PROCEDURE DIDN¿T SHOW ANY ISSUES, BUT THE THEY WERE PERFORMED WITH A STIFF WIRE INSERTED, THEREFORE WHEN THE WIRE WAS REMOVED, THE ARTERY RUN WAS CHANGED AND THE TORTUOUS OF THE PROXIMAL NECK MIGHT HAVE AFFECT TO THE COMPRESSION OF THE IPSILATERAL LEG.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18814356 ↗
• InjuryFeb 18, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE:ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER ENDOPROSTHESIS).IT WAS CONSIDERED THE IPSILATERAL LEG ENDOPROSTHESIS WOULD BE NECESSARY TO PUSH UP ABOUT 1CM WHEN THE IPSILATERAL LEG OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED. THEN, THE IPSILATERAL LEG WAS DEPLOYED WITH PUSHING UP. DURING THE DEPLOYMENT OF THE IPSILATERAL LEG, THE PHYSICIAN THOUGHT THAT THERE WAS A RISK THAT THE ENTIRE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WOULD BE MOVED IF THE IPSILATERAL LEG DEPLOYED WITH PUSHING UP. THEREFORE, THE IPSILATERAL WAS DEPLOYED WITH STOPPED PUSHING UP AND IT WAS LANDED IN THE LEFT EXTERNAL ILIAC ARTERY.THE RIGHT INTERNAL ILIAC ARTERY WAS PATENT, SO THE PHYSICIAN DECIDED THAT THE OBSTRUCTION OF THE LEFT INTERNAL ILIAC ARTERY BY THE IPSILATERAL LEG WAS MONITORED.THE PATIENT TOLERATED THE PROCEDURE.THE PHYSICIAN STATED THAT THE AORTA WAS SHORT BECAUSE THE PATIENT HAD A SMALL BUILD AND THE PROXIMAL NECK WAS TORTUOUS, THEREFORE IT HAD NO OTHER CHOICES

  Patient problems: Obstruction/Occlusion

  MAUDE report 18728614 ↗
• InjuryJul 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG) AND GORE® EXCLUDER® AAA ENDOPROSTHESES (TWO CONTRALATERAL LEGS). PTA BALLOONING WAS PERFORMED TO A STENOSIS SITE OF THE LEFT EXTERNAL ILIAC ARTERY BEFORE DEVICES IMPLANTED. THEN, A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE AND THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG) WAS IMPLANTED. A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE AND THE CONTRALATERAL LEG (PLC201200J) WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. THEN, THE IPSILATERAL LEG OF THE TRUNK WAS DEPLOYED IN THE RIGHT LIMB AND THE CONTRALATERAL LEG (PLC141000J) WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY TO EXTEND THE IPSILATERAL LEG. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY WAS PERFORMED AND IT REVEALED THAT A PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK. TOUCH-UP BALLOONING WAS PERFORMED TO THE PROXIMAL OF THE TRUNK AND THE PHYSICIAN DETERMINED IT IS HIGH POSSIBILITY THIS ENDOLEAK MIGHT BE THE TYPE II ENDOLEAK. THE PHYSICIAN DECIDED TO MONITOR T

  Patient problems: Aneurysm

  MAUDE report 17304951 ↗
• MalfunctionFeb 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TRUNK IPSILATERAL LEG COMPONENT THE PROXIMAL END OF THE STENT UPON DEPLOYMENT DIDN'T SEEM TO FULLY/100% OPEN AS IT IS SUPPOSED TO. OPENING MAYBE ONLY 50%. AS THE CASE WAS FINISHED UP AND BALLOONING WAS PERFORMED IT DID FULLY OPEN AND EVERYTHING WAS FINE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 16294988 ↗
• InjuryNov 29, 2022Difficult or Delayed Activation; Patient-Device Incompatibility; Material Deformation; Activation Failure; Difficult or Delayed Activation; Patient-Device Incompatibility; Material Deformation; Activation Failure

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER IT WAS NOT POSSIBLE TO CANNULATE TO THE CONTRALATERAL GATE, AN ANGIOGRAPHY REVEALED THE OCCLUSION OF THE CONTRALATERAL SIDE OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS). IT SEEMED THAT THE CONTRALATERAL GATE WAS COMPRESSED AT THE ROOT, BUT REPORTEDLY, IT WAS UNKNOWN IF THE CONTRALATERAL GATE WAS COMPRESSED AFTER THE DEPLOYMENT OF THE GATE OR THE GATE FAILED TO DEPLOY. THE IPSILATERAL LEG OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS DEPLOYED. THE ANGIOGRAPHY WAS PERFORMED AGAIN AND IT SHOWED THE CONTRALATERAL SIDE OF GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS COMPLETELY OCCLUDED. THE CANNULATION OF THE GATE WAS ABANDONED AND THE PROCEDURE WAS CHANGED TO AUI. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, THE FEMORAL-FEMORAL BYPASS WAS CREATED AND THE AORTA EXTENDER ENDOPROSTHESIS WAS IMPLANTED INSIDE THE TRUNK IPSILATERAL ENDOPROSTHESIS TO COVER THE CONTRALATERAL SIDE. THE PHYSICIAN STATED THAT IT WAS NOT POSSIBLE TO CANNULA

  Patient problems: Obstruction/Occlusion

  MAUDE report 15877442 ↗
• InjuryAug 4, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE PROXIMAL TRUNK AT JUST DISTAL TO THE RENAL ARTERIES, IT MOVED DISTALLY FOR APPROXIMATELY 5 MM. THUS, HE ATTEMPTED TO PUSH IT UP USING THE CONSTRAINING MECHANISM, BUT HE COULD NOT AND THE DEVICE FURTHER MOVED DISTALLY. HE GAVE UP TO CORRECT THE POSITION, AND FULLY DEPLOYED THE DEVICE. THEN AN AORTIC EXTENDER WAS ADDITIONALLY PLACED PROXIMAL TO THE TRUNK-IPSILATERAL LEG. THE FINAL ANGIOGRAPHY DURING THE PROCEDURE SHOWED A LOCALIZED DISSECTION IN THE SUPRARENAL AREA OF THE AORTA. NO ADDITIONAL TREATMENT WAS GIVEN AND A WAIT-AND-SEE APPROACH WOULD BE TAKEN. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: A GUIDEWIRE (EGOIST) OR THE LEADING TIP OF C-EXCLUDER DELIVERY CATHETER PROBABLY CAUSED THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 15171795 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AAA). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO CANNULATE THE AAA DEVICES CONTRALATERAL GATE SO THE CASE WAS CONVERTED TO AN AUI. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE OUTCOMES. THE ENDOPROSTESIS REMAINS IMPLANTED IN THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579165 ↗
• InjuryMay 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 5.5 CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2022, THE PHYSICIAN REPORTED THAT THE PATIENT HAD A PERSISTENT TYPE II ENDOLEAK AND THE ANEURYSM MEASURED APPROXIMATELY 6.2 CM IN DIAMETER. THE PHYSICIAN REPORTED THE DEVICE LOOKED GOOD. THE PHYSICIAN BASED ON THE PATIENT¿S AGE IS PLANNING TO EITHER OPEN THE PATIENT AND EITHER REMOVE THE DEVICE OFF THE LUMBAR'S OR REMOVE THE DEVICE AND SEW OFF THE LUMBAR'S AND PLACE AN OPEN GRAFT. THE PHYSICIAN REPORTED THIS IS IN DESPITE OF NOTHING BEING WRONG WITH THE DEVICE, IT HASN'T MOVED. THERE IS NO TYPE 1 ENDOLEAK TYPE 3, NO TYPE 4. SO NOT COMPLETELY CLEAR, THERE IS NO FAILURE POINT THE PHYSICIAN CAN SEE. PHYSICIAN REPORTS THE PATIENT HAS A VERY ANGLED NECK EXCEEDING; OR RIGHT AT A 60 DEGREE ANGLE.

  Patient problems: Aneurysm

  MAUDE report 14278177 ↗