GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261218Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132622436), received between Sep 18, 2018 and Jan 16, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Malposition of Device” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER ENDOPROSTHESIS IN ZONE 9 THAT HAD EXPANSION OF THE LEFT COMMON ILIAC. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT AT THE TIME OF THE (B)(6) 2022 PROCEDURE, A 27MM PLC WAS USED BUT LANDED 2 CM SHORT OF THE HYPOGASTRIC ARTERY AND ENDED UP PULLING BACK INTO THE ANEURYSM OVERTIME. ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION TO A PRIOR ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL AND CONTRALATERAL LEG) IN ZONE 10. IT WAS REPORTED THAT ANOTHER 27MM PLC WAS USED ALONG WITH TWO AORTIC CUFFS THAT ENDED UP SEALING THE COMMON ILIAC TYPE LB LEAK. THERE WERE NO FILMS AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21165141 ↗
• InjuryMar 7, 2023Partial Blockage; Malposition of Device; Partial Blockage; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, THE LEFT INTERNAL ILIAC ARTERY WAS OVERSTENTED. THE OVERSTENTING WAS UNPLANNED. THE PHYSICIAN REPORTED THAT THE OVERSTENTING WAS DUE TO INACCURATE MARKING DURING ANGIOGRAPHY. NO CLAUDICATION HAS BEEN REPORTED. NO REINTERVENTION IS PLANNED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16494377 ↗
• InjuryNov 25, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT261218) WAS PARTIALLY DEPLOYED AND PLACED AT THE INTENDED LOCATION BELOW THE RENAL ARTERIES. IT WAS STATED THAT THE PHYSICIAN PUSHED A LITTLE ON THE CATHETER WHILE THE IPSILATERAL LEG WAS STILL UNDEPLOYED. AFTER FINISHING THE DEPLOYMENT ON THE CONTRALATERAL SIDE AND BALLOONING, THE FINAL ANGIOGRAPHY SHOWED THAT THE RLT261218 LANDED UNINTENTIONALLY MORE PROXIMAL THAN INTENDED, PARTIALLY COVERING THE RIGHT RENAL ARTERY. SINCE BOTH RENAL ARTERIES FILLED RAPIDLY WITH CONTRAST DURING ANGIOGRAPHY, IT WAS DECIDED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL TREATMENT. ON OCTOBER 30, 2021, IT WAS REPORTED THAT THE FUNCTION OF THE RIGHT RENAL ARTERY WAS LESS THAN BEFORE. THEREFORE IT WAS DECIDED TO IMPLANT A COVERED BALLOON EXPENDABLE STENT IN THE RIGHT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12873566 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 A PATIENT WAS UNDERGOING TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. FOLLOWING DEPLOYMENT OF THE CEB23231010 ON THE RIGHT, ATTEMPTS WERE MADE TO ACCESS THE INTERNAL ILIAC ARTERY WITH A WIRE, HOWEVER THE WIRE KEPT LANDING SUBLIMINALLY, SO THE RIGHT SIDE WAS LEFT UNTREATED. ATTEMPTS WERE MADE TO TREAT THE LEFT SIDE WITH THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES, BUT THE INTERNAL ILIAC ARTERY WAS TOO SHORT. A DECISION WAS MADE TO USE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. FOLLOWING IMPLANTATION OF THE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS, BLOOD FLOW WAS SLUGGISH AND BY THE END OF THE PROCEDURE THIS DEVICE WAS OCCLUDED, EITHER DUE TO POOR OUTFLOW OR A DISTAL DISSECTION POSSIBLY FROM THE SHOULDERS OF THE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS BALLOON. SOME TIME FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SPINAL CORD ISCHEMIA DUE TO LACK OF PERFUSION TO THE INFERIOR MESENTERIC AND ILIAC ARTERIES. AN UNEXPLAINED STROKE WAS ALSO RECOGNIZED. THIS REPORT ADDRESS ISCHEMIC EVENTS POSSIBLY ASSOCIATED WITH THE GORE® EXCLUDER® AAA ENDOPROSTHESES.

  Patient problems: Stroke/CVA

  MAUDE report 12416120 ↗
• InjuryFeb 27, 2020Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT PRESENTED WITH BILATERAL ILIAC ANEURYSMS AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ON THE PATIENTS LEFT. ON AN UNKNOWN DATE IN (B)(6) 2019 THE PATIENT ADMITTED FOR A LEFT PSOAS ABSCESS. IN (B)(6) 2019, A PERCUTANEOUS DRAINAGE REVEALED A STAPHYLOCOCCI INFECTION. A POSITRON-EMISSION TOMOGRAPHY (PET) SHOWED INFECTION OF ALL EXCLUDER COMPONENTS. ON (B)(6) 2019, ALL COMPONENTS WERE SUCCESSFULLY EXPLANTED AND A SYNERGY ANTIMICROBIAL GRAFT WAS SUCCESSFULLY IMPLANTED. INTRAOPERATIVE SAMPLES FOUND STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS WARNERI, CORYNEBACTERIUM. IT WAS STATED THAT 6 MONTHS POST-OP, THE LEUCOCYTE COUNT AND CRP VALUES WERE NORMAL AND THAT THE RENAL FUNCTION WAS AT PRE-OP LEVEL. THE 6-MONTH ROUTINE PET-CT REVEALED NO SIGNS OF REINFECTION.

  Patient problems: Bacterial Infection; No Code Available

  MAUDE report 9763229 ↗
• InjuryFeb 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ISOLATED RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, FOLLOW UP IMAGING DETERMINED COMPRESSION OF THE IPSILATERAL LIMB ON THE LEFT SIDE AND AN UNKNOWN ENDOLEAK. NO ANEURYSM ENLARGEMENT WAS REPORTED. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO RELINE THE IPSILATERAL LEG OF THE TRUNK COMPONENT. INTRA-PROCEDURE IMAGING DETERMINED THE ENDOLEAK WAS A TYPE II ORIGINATING FROM A PATENT INFERIOR MESENTERIC ARTERY DUE TO RETROGRADE FLOW FROM THE SUPERIOR MESENTERIC ARTERY; AND A COUPLE LUMBAR ARTERIES. AT THE CONCLUSION OF THE PROCEDURE THE ENDOLEAK PERSISTED. THE PATIENT TOLERATED THE PROCEDURE AND WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Aneurysm

  MAUDE report 9703443 ↗
• InjuryJul 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BACK PAIN AND WAS DIAGNOSED WITH A TYPE II ENDOLEAK ON FOLLOW UP EVALUATION. ON (B)(6) 2019, THE PATIENT UNDERWENT PERCUTANEOUS TRANSABDOMINAL AORTIC ENDOLEAK EMBOLIZATION. THE ENDOLEAK WAS RESOLVED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8841462 ↗
• InjuryMay 16, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  A PRESENTATION WITH THE TITLE ¿BILATERAL USE OF THE GORE IBE DEVICE FOR BILATERAL CIA ANEURYSMS AND A FIRST INTERIM ANALYSIS OF THE PROSPECTIVE ICEBERG REGISTRY¿ WAS HELD BY DR. M. REIJNEN AT THE LINC CONVENTION ON JANUARY 21, 2019. THE PRESENTATION INCLUDED INITIAL RESULTS OF THE ONGOING ICEBERG STUDY THAT INCLUDED 101 PATIENTS AT EIGHT INTERNATIONAL SITES THAT WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). AMONG OTHER OCCURRENCES, THE PRESENTATION MENTIONS THAT PARTIAL COVERAGE OF A RENAL ARTERY WITH STENTING OF THE RENAL ARTERY OCCURRED DURING THE IMPLANT PROCEDURE. IT WAS NOT INDICATED THAT THE PARTIAL COVERAGE WAS UNINTENTIONAL. THE FOLLOWING ADDITIONAL INFO WAS REPORTED TO GORE APRIL 19, 2019: PATIENT (B)(6) WAS TREATED ON (B)(6) 2017. ACCORDING TO THE PHYSICIAN THE GORE® EXCLUDER® AAA TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT) WAS ACCIDENTLY PUSHED PROXIMAL DUE TO ADVANCEMENT DIFFICULTIES OF THE LEFT BRIDGING STENT ON THE LEFT SIDE. THE RLT COVERED THE LEFT RENAL ARTERY PARTIALLY (50%), WHICH WAS SUCCESSFULLY SOLVED BY IMPLANTING A 7MM BALLOON EXPANDABLE COVERED STENT IN THE RENAL ARTERY.

  Patient problems: Occlusion

  MAUDE report 8615472 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ARTERY ANEURYSM (CIAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE RIGHT HYPOGASTRIC ARTERY WAS INTENTIONALLY COVERED DURING THE PROCEDURE BY THE IPSILATERAL LEG OF THE MAIN TRUNK. THERE WAS NO ANEURYSM ENLARGEMENT REPORTED. ON (B)(6) 2018, THE PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK AND COVERAGE WAS EXTENDED ON THE RIGHT SIDE WITH A GORE® CONTRALATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 7885804 ↗

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-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis