GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231416Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132622382), received between Jun 22, 2018 and Aug 29, 2025 — classified as 1 death, 20 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, A REINTERVENTION OCCURRED TO TREAT A DISTAL TYPE I ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN, IMAGES ARE NOT AVAILABLE). DURING THE REINTERVENTION, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG WOULD NOT ADVANCE OVER THE GUIDEWIRE. THE DEVICE WAS NOT USED FOR THE PROCEDURE. A DIFFERENT DEVICE WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22927047 ↗
• InjuryMar 25, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE, THAT ON (B)(6), 2016, A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, A TYPE I ENDOLEAK WAS IDENTIFIED THAT WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL STENT GRAFT OF UNKNOWN BRAND. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

  Patient problems: Clinical Endoleak

  MAUDE report 21685787 ↗
• InjuryOct 9, 2024Partial Blockage; Deformation Due to Compressive Stress; Partial Blockage; Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, THE PHYSICIAN SAW THE PATIENT FOR A ROUTINE FOLLOW-UP. THE PATIENT MENTIONED THAT HE HAD DEVELOPED CLAUDICATION IN THE LEFT LEG WITHIN 48 HOURS OF THE PROCEDURE. ON (B)(6) 2024, THE PATIENT HAD A FOLLOW-UP CT SCAN. REPORTEDLY, THE IPSILATERAL LIMB WAS COMPRESSED, RESULTING IN THE LIMB BEING 80% THROMBOSED. THE PHYSICIAN HAS SCHEDULED AN OPERATION FOR WEDNESDAY, ON (B)(6), TO REMOVE THE THROMBUS AND RELINE THE GRAFT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20407221 ↗
• InjuryOct 20, 2022Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2016 WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT PRESENTED WITH COMPLETE THROMBOSIS OF THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC141200) UP TO THE INTERNAL BIFURCATION OF THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT231416) AND PARTIAL THROMBOSIS OF THE IPSILATERAL LEG OF THE RLT231416. ADDITIONALLY, SOME THROMBUS FORMATION ABOVE THE BIFURCATION OF THE RLT231416 WAS NOTED. A REINTERVENTION TO RELINE THE IPSILATERAL LEG ON THE PATIENTS RIGHT WAS PLANNED FOR (B)(6) 2022. THE PATIENTS LEFT WILL NOT BE TREATED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15640177 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 51.3 (MM) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 52MM. ON (B)(6) 2020, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED AN EXPANDING ANEURYSM SAC DUE TO A TYPE II ENDOLEAK. ON (B)(6) 2022, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 64MM. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION COIL EMBOLIZATION OF THE ANEURYSM SAC WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS.

  Patient problems: Aneurysm expansion

  MAUDE report 15459332 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT WAS LANDED LOW BELOW THE RENAL ARTERIES. AS REPORTED, THE PATIENT HAD A LONG AORTIC NECK. IN (B)(6) OF 2021 THE PATIENT UNDERWENT REINTERVENTION IN WHICH TRANSLUMBAR COILING OF THE ANEURYSM SAC AS WELL AS COILING OF THE INFERIOR MESENTERIC ARTERY (IMA) WAS PERFORMED. ON (B)(6) 2021 COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND THE ANEURYSM SAC MEASURED 6.4CMS. ON (B)(6) 2022, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED. AS REPORTED, THERE WAS A LARGE AMOUNT OF STREAK ARTIFACT DUE TO THE COILS. AS REPORTED, IT LOOKED LIKE THERE WAS A PROXIMAL TYPE I ENDOLEAK AND/OR A TYPE II ENDOLEAK POTENTIALLY COMING IN AT THE TOP OF THE GRAFT. ON (B)(6) 2022 THE ANEURYSM SAC MAX DIAMETER MEASURED AT 7.2CMS. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED IN WHICH TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDERS WERE IMPLANTED. AS REPORTED, THERE WAS NO CONFIRMED ENDOLEAK UNDER ANGIOGRAPHY WITHIN THE OPERATING ROOM.

  Patient problems: Aneurysm

  MAUDE report 15099702 ↗
• DeathJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND LEFT COMMON ILIAC ARTERY ANEURYSM >4 CM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. ADDITIONALLY, THE KIDNEY, SPLEEN, SMALL AND LARGE BOWEL; AS WELL AS THE LEFT LOWER EXTREMITY WERE EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED THE PATIENT EXPIRED AND THAT A DIAGNOSTIC LAPAROSCOPY AND EXPLORATORY LAPAROTOMY WERE PERFORMED THIS DATE. THE PHYSICIAN REPORTS THE CAUSE OF DEATH (COD) WAS DEAD GUT AND THAT THE DEATH WAS NOT DEVICE RELATED. THE PHYSICIAN STATED THERE WAS NO DEFICIENCY OF THE GORE DEVICES AND BELIEVES WIRE MANIPULATION IN THE AORTA DURING PLACEMENT OF THE GORE DEVICES MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH. NO FURTHER DETAILS WERE PROVIDED BY THE PHYSICIAN.

  Patient problems: Aneurysm

  MAUDE report 15032657 ↗
• InjuryMay 13, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT FOLLOW UP IMAGES, (COMPUTED TOMOGRAPHY DATED (B)(6) 2022), REVEALED BOTH LIMBS OF DEVICES BILATERALLY WERE COMPRESSED. THERE WAS SOME FLOW AND THE PATIENT PRESENTED NONSYMPTOMATIC. REPORTEDLY DURING THE ORIGINAL PROCEDURE, ¿THE DISTAL AORTA WAS SMALL¿. ON (B)(6) 2022, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES INSIDE EACH GORE® EXCLUDER® AAA ENDOPROSTHESES LIMB. THIS OPENED THE COMPRESSION. THE PATIENT TOLERATED THE PROCEDURE. ROOT CAUSE OF COMPRESSION- DURING THE ORIGINAL PROCEDURE, ¿THE DISTAL AORTA WAS SMALL¿.

  Patient problems: Aneurysm

  MAUDE report 14398197 ↗
• InjurySep 30, 2020Difficult or Delayed Activation; Malposition of Device; Difficult or Delayed Activation; Malposition of Device

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THERE WAS A CALCIFIED RING ABOUT 4CM DISTAL TO THE PATIENT'S RENAL ARTERIES. REPORTEDLY, WHEN THE TRUNK OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED, THE CALCIFIED RING CRUSHED THE CONTRALATERAL LEG GATE. IT WAS REPORTED THAT THE DEVICE WAS RE-CONSTRAINED TWO TO THREE TIMES TO MANEUVER AND REPOSITION THE DEVICE. DUE TO THE CALCIFIED RING, THE DEVICE WAS UNABLE TO BE MOVED SUFFICIENTLY AND THEREFORE WAS REPORTEDLY NOT MOVED AGGRESSIVELY. ON THE LAST ATTEMPT TO RE-CONSTRAIN AND MANEUVER THE DEVICE, IT WAS REPORTED THAT THE BLACK NUT OF THE CONSTRAINING MECHANISM WAS TURNED, BUT THE PROXIMAL TRUNK DID NOT RE-OPEN. WHEN THE BLACK NUT WAS TURNED, A NOISE WAS REPORTED AND RESISTANCE WAS FELT IN THE NUT. THE NUT WAS ABLE TO BE ROTATED FULLY, BUT THE TRUNK OF THE DEVICE REMAINED CONSTRAINED. IT WAS REPORTED THAT THE FAILURE OF THE PROXIMAL TRUNK TO OPEN MAY HAVE BEEN ASSOCIATED WITH THE CALCIFIED RING. THE CONSTRAINING MECHANISM WAS REMOVED. THE PHYSICIAN WAS ABLE TO ACCESS THE CONTRALATERAL LEG GATE AFTER AN UNREPORTED AMOUNT OF

  Patient problems: Occlusion

  MAUDE report 10607434 ↗
• InjuryJul 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION FOR A TYPE II ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY, ALONG WITH TWO GORE® CONTRALATERAL LEG COMPONENTS TO RELINE THE GRAFT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 10347973 ↗
• InjuryJul 24, 2020Migration; Migration

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. THE PROXIMAL AORTIC NECK WAS 14MM IN DIAMETER AND WAS ANGULATED. A RLT231416 TRUNK-IPSILATERAL LEG COMPONENT WAS USED. AFTER IMPLANT, INFOLDING WAS NOTED DUE TO DEVICE OVER SIZING. THE CASE WAS OUTSIDE IFU DUE TO ANATOMICAL RESTRICTIONS. ON (B)(6) 2020 IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED INTO THE ANEURYSM SAC. THE PHYSICIAN COMMENTED THAT THIS WAS LIKELY DUE TO THE DEVICE OVER SIZING AND INFOLDING, AND THE CARDIAC CYCLE LIKELY PUSHED THE DEVICE FROM ITS PROXIMAL AORTIC SEAL ZONE. THEREFORE, A REINTERVENTION OCCURRED WHEREBY TWO GORE VIABAHN VBX ENDOPROSTHESES WERE IMPLANTED IN THE LEFT AND RIGHT RENAL ARTERIES, AND A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER (23MM) WAS IMPLANTED PROXIMALLY IN ORDER TO OBTAIN PROXIMAL SEAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10320419 ↗
• InjuryJul 13, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A 16.5CM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE SUCCESSFULLY PLACED. ANGIOGRAPHY WAS PERFORMED. THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG COMPONENT WAS SUCCESSFULLY ADVANCED. THE TRUNK MAIN BODY WAS DEPLOYED WITH NO REPORTED ISSUES. IT WAS REPORTED THAT CANNULATION OF THE CONTRALATERAL LEG GATE WAS DIFFICULT DUE TO PATIENT ANATOMY. THE PATIENT'S ANATOMY WAS REPORTEDLY EXTREMELY TORTUOUS, WITH A SHORT AORTIC NECK AND CALCIFICATION PRESENT. ATTEMPTS TO CANNULATE THE CONTRALATERAL LEG GATE WERE CONTINUED WITHOUT SUCCESS. REPORTEDLY THE TRUNK-IPSILATERAL LEG COMPONENT WAS FULLY DEPLOYED, WITH THE IPSILATERAL LIMB LOCATED IN THE PATIENT'S RIGHT ILIAC ARTERY. THE PHYSICIAN ADVANCED A SOFT WIRE FROM THE PATIENT'S RIGHT SIDE UP AND OVER THE DEVICE BIFURCATION IN AN ATTEMPT TO SNARE THE CONTRALATERAL LEG GATE, LOCATED ON THE PATIENT'S LEFT SIDE. THE PHYSICIAN CONTINUED ATTEMPTS TO SNARE THE CONTRALATERAL LEG GATE. REPORTEDLY DIFFICULTY WAS ENCOUNTERED DUE TO TORTUOSITY OF THE PATIENT'S ANATOMY AND THE WIRE STIFFNESS. IT WAS REPORTED THAT THERE WAS DI

  Patient problems: Blood Loss; Perforation

  MAUDE report 10268353 ↗
• InjuryApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND A LEFT INTERNAL ILIAC ANEURYSM WITH GORE® EXCLUDER® AAA AND ILIAC BRANCH ENDOPROSTHESES. THE PROCEDURE WAS COMPLETED AND FINAL ANGIO SHOWED NO PRESENCE OF LEAK. ON (B)(6) 2020 A FOLLOW-UP CTA SCAN SHOWED A LEAK INTO THE ANEURYSM. REPORTEDLY THE TRUNK-IPSILATERAL LEG COMPONENT MIGRATED DISTALLY AND/OR POTENTIALLY INFOLDED. OPTIONS INCLUDING PLACEMENT OF AN EXTENSION CUFF, RELINING AND ENDO ANCHOR PLACEMENT WERE DISCUSSED WITH THE GORE FSA. THE GORE FSA OFFERED TO SUPPORT THE REINTERVENTION, BUT THE PHYSICIAN DECLINED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 9922267 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2019, REVEALED THE PATIENT HAS AN UNKNOWN ENDOLEAK. THERE IS COMMON ILIAC ARTERY ANEURYSM SAC ENLARGEMENT REPORTED (AMOUNT OF GROWTH IS UNKNOWN). THE CAUSE FOR THE ENDOLEAK IS UNKNOWN. THE PHYSICIAN STATED ¿THE CAUSE OF THE ENDOLEAK IS UNKNOWN, COULD BE LUMBAR ARTERIES, BACK FLOW THROUGH THE COILED HYPOGASTRIC ARTERY, OR A GATE LEAK¿. NO REINTERVENTION IS PLANNED AT THIS TIME. THE PHYSICIAN HAS REFERRED PATIENT TO A DIFFERENT SURGEON.

  Patient problems: Aneurysm

  MAUDE report 9598113 ↗
• InjuryDec 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED WITH NO REPORTED ISSUES. REPORTEDLY, DUE TO A SHELF OF CALCIUM, THE PHYSICIAN WAS UNABLE TO ADVANCE A 12FR. GORE® DRYSEAL FLEX SHEATH INTO THE PATIENT'S COMMON ILIAC ARTERY TO ACCESS THE CONTRALATERAL SIDE FOR CONTRALATERAL LEG COMPONENT PLACEMENT. AFTER MULTIPLE ATTEMPTS TO ADVANCE THE SHEATH, THE PHYSICIAN DECIDED TO PERFORM AN AORTOUNIILIAC (AUI) PROCEDURE, WITH A FEM-FEM BYPASS OF THE COMMON ILIAC ARTERY. ANOTHER TRUNK-IPSILATERAL LEG COMPONENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9447719 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WITH A SMALL TYPE II IDENTIFIED AT THE CONCLUSION OF THE PROCEDURE. THE PHYSICIAN CHOSE TO MONITOR THE PATIENT. ON (B)(6) 2019, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SHOWED THE TYPE II PERSISTED. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND COIL EMBOLIZATION OF A LUMBAR ARTERY WAS PERFORMED. CONCLUSION CT SHOWED THE TYPE II PERSISTED VERY SLIGHTLY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW-UP CT SHOWED THE TYPE II SHOWED A ROBUST TYPE II ENDOLEAK, NO ENLARGEMENT OF THE ANEURYSM WAS SEEN. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND COIL EMBOLIZATION ABOVE THE AREA PREVIOUSLY COILED WAS PERFORMED. THE TYPE II ENDOLEAK AS RESOLVED AND NO ENLARGEMENT OF THE ANEURYSM WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE. IMAGES WERE PROVIDED TO GORE AND SHOWED THE FOLLOWING: IMAGES PROVIDED APPEAR TO BE POST LUMBAR EMBOLIZATION. THERE APPEARS TO BE CONTRAST OUTSIDE OF THE IMPLANTED DEVICE ON THE ARTERIAL PHASE. THERE APPEARS TO BE PATE

  Patient problems: Aneurysm

  MAUDE report 9235824 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE PATIENT HAS FOUR GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED. REPORTEDLY ON (B)(6) 2018 A CTA WAS PERFORMED AND THROMBUS WAS IDENTIFIED IN THE GRAFTS. IT WAS REPORTED THAT A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2019 DUE TO STENOSIS AND THROMBUS. TWO GRAFTS WERE IMPLANTED, ONE DISTAL TO THE CONTRA-LATERAL GATE, TO EXTEND THE GRAFT DUE WHERE STENOSIS WAS LOCATED DUE TO THE PATIENTS ANATOMY. THE SECOND WAS IMPLANTED IN THE EXTERNAL ILIAC ARTERY INSIDE OF A GRAFT TO IMPROVE BLOOD FLOW WHERE THROMBUS HAD BECOME THICK.

  Patient problems: Stenosis; Thrombosis

  MAUDE report 8396278 ↗
• InjuryMar 6, 2019Partial Blockage; Partial Blockage

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A RIGHT ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT HAD A NORMALIZED AORTA, AND THAT THE INFRARENAL AORTA WAS ANGLED (DEGREE OF ANGULATION UNKNOWN). REPORTEDLY, DUE TO THE ANGULATION OF THE PATIENT'S ANATOMY, THE CONTRALATERAL LEG COMPONENT WAS PLACED APPROXIMATELY 3MM ABOVE THE FLOW DIVIDER OF THE TRUNK-IPSILATERAL LEG COMPONENT. AS A RESULT, IT WAS NOTED THAT THE CONTRALATERAL LEG COMPONENT WAS, "SLIGHTLY COMPRESSED". THE PATIENT WAS HEPARINIZED DURING THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2019 COMPUTERIZED TOMOGRAPHY SCANS IDENTIFIED THROMBUS IN THE PROXIMAL END OF THE IPSILATERAL LIMB AT THE LEVEL OF THE FLOW DIVIDER. REPORTEDLY, THERE WAS MINIMAL PERFUSION THROUGH THE LIMB. IT WAS REPORTED THAT ON (B)(6) 2019 A THROMBECTOMY WAS PERFORMED. REPORTEDLY THE IPSILATERAL LIMB WAS RELINED, AND THE PHYSICIAN PLACED TWO BARE METAL STENTS WITHIN THE TRUNK-IPSILATERAL LEG AND CONTRALATERAL LEG COMPONENTS, CREATING A NEW FLOW DIVIDER. THE PROCEDURE WAS CONCLUDED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 8394658 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AND LEFT COMMON ILIAC ARTERY ANEURYSMS MEASURING 79.2MM ¿ABDOMINAL, 25.7MM- LEFT ILIAC WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, DURING THE INITIAL PROCEDURE THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP CTA ON (B)(6) 2016 SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 75MM. THE FOLLOW UP IMAGES FROM (B)(6) 2017 TO (B)(6) 2018 REVEALED THAT THE ANEURYSM ENLARGED IN DIAMETER FROM 78MM TO 94MM. ON (B)(6) 2018, A TYPE II ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2018, A PATIENT UNDERWENT A COIL AND GLUE EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332532 ↗
• InjuryAug 20, 2018Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE, THIS PATIENT WAS TREATED DURING AN OPEN SURGERY WITH A BIFURCATED PROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH GORE® EXCLUDER® ENDOPROSTHESES TO TREAT A PSEUDOANEURYSM OF THE RIGHT COMMON ILIAC ARTERY WHICH HAD DEVELOPED AT THE ANASTOMOSIS CONNECTING THE VESSEL AND THE RIGHT LIMB OF THE PREVIOUSLY IMPLANTED GRAFT. FOR THIS REASON, A TRUNK-IPSILATERAL LEG COMPONENT RLT231416 WAS ADVANCED THROUGH THE EXISTING GRAFT TO BE DEPLOYED AT THE INTENDED LOCATION. HOWEVER, HAVING PERFORMED INITIAL DEPLOYMENT OF THE RLT COMPONENT, IT WAS REALIZED THAT THE AORTIC NECK LENGTH HAD BEEN MISJUDGED. THE ENDOPROSTHESIS HAD BEEN PLACED TOO LOW AND IT WAS THEREFORE NOT POSSIBLE TO CANNULATE THE CONTRALATERAL GATE. AS THE POSITION COULD NOT BE CORRECTED, IT WAS DECIDED TO FULLY DEPLOY THE IPSELATERAL LEG WHICH NEVERTHELESS EXCLUDED THE PSEUDOANEURYSM IN THE RIGHT COMMON ILIAC ARTERY. TO ENSURE DISTAL BLOOD SUPPLY ON THE LEFT PATIENT SIDE, THE COMMON ILIAC ARTERY WAS PLUGGED AND THE PATIENT RECEIVED A FEMORO-FEMORAL CROSSOVER BYPASS FROM RIGHT TO LEFT. A CONVERSION TO O

  Patient problems: No Code Available

  MAUDE report 7797703 ↗
• InjuryJun 22, 2018Collapse; Collapse

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT DID NOT HAVE AN ABDOMINAL AORTIC ANEURYSM, AND THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT WAS SEATED ENTIRELY IN THE COMMON ILIAC ARTERY. A 27 MM CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGE BETWEEN THE CONTRALATERAL GATE AND THE ILIAC BRANCH COMPONENT. THE DISTAL AORTA APPEARS TO BE MEASURING APPROXIMATELY 20 MM. ON (B)(6) 2018 IT WAS RECOGNIZED THAT ONE OF THE DEVICE LIMBS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES APPEARED TO HAVE BEEN COMPRESSED. ON (B)(6) 2018 A REINTERVENTION WAS PERFORMED WHEREBY A 14 MM BEGRAFT STENT WAS PLACED WITHIN THE NON-COMPRESSED LIMB AND A 12 MM BEGRAFT STENT WAS PLACED ON THE COMPRESSED SIDE. THE PATIENT DID WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629771 ↗

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)