GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231216Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132622344), received between Jul 18, 2018 and May 15, 2024 — classified as 2 deaths, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC AND ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). AFTER THE PROCEDURE, THE PHYSICIAN NOTED THAT THE IPSILATERAL LEG OF THE MAIN BODY APPEARED OCCLUDED, AND A REINTERVENTION WAS PLANNED FOR A POSSIBLE FEM-FEM BYPASS. ADDITIONAL INFORMATION PROVIDED BY THE FIELD SALES ASSOCIATE ON APRIL 30, 2024 REGARDING THE REINTERVENTION: ON (B)(6) 2024, THE PHYSICIAN DID A REINTERVENTION TO TREAT THE OCCLUSION/THROMBOSED LIMB WITH FEM-FEM BYPASS, WHICH RE-ESTABLISHED THE FLOW TO THE LEG. THE CAUSE OF OCCLUSION IS NOT DETERMINED BUT PHYSICIAN THINKS IT MIGHT HAVE BEEN DUE TO TOO MUCH RADIAL FORCE. PROCEDURE WAS SUCCESSFUL AND PATIENT TOLERATED PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19324326 ↗
• MalfunctionDec 2, 2022Difficult or Delayed Positioning; Difficult to Remove; Material Separation; Difficult to Remove

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC TO LEFT ILIAC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. AS REPORTED, POST DEPLOYMENT OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT2312160) WHILE TAKING THE DELIVERY CATHETER OUT, THE NOSE CONE ON THE LEADING END OF THE CATHETER SHEARED OFF PARTIALLY AND WAS STILL ATTACHED ON THE WIRE. AS REPORTED, THE PHYSICIAN WAS ABLE TO BACK IT OFF AND PULL IT OUT WITH NO IMPACT TO THE PATIENT. AS REPORTED, THE POSITIONING OF THE SHEATH WHEN REMOVING THE CATHETER WAS NOT OPTIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904664 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN PLANNED FOR A 2 PIECE CASE VIA PEVAR. ALL NORMAL STEPS WERE TAKEN DURING THE PROCEDURE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WAS INSERTED THROUGH GORE® DRYSEAL FLEX SHEATH ON THE RIGHT SIDE. A PIGTAIL WAS ADVANCED THROUGH A GORE® DRYSEAL FLEX SHEATH. AN INITIAL ANGIOGRAM WAS OBTAINED. RENALS ARTERIES WERE MARKED. THE GRAFT WAS ~1.5-2CM LOW. GRAFT ADVANCED AND DEPLOYED AT THE LINE. THE CONSTRAINING MECHANISM DEPLOYED. ANGIO WAS REPEATED AND IT WAS NOTICED THE GRAFT WAS TOO HIGH, COVERING THE RENAL ARTERIES. PATIENT WAS CONVERTED TO OPEN SURGERY. AFTER SURGERY, THE SURGEONS TALKED ABOUT POSSIBLE CAUSES OF THE ERRONEOUS DEPLOYMENT. IT IS CONCLUDED THAT SOMETHING HAPPENED WITH THE MAGNIFICATION LEVEL BETWEEN ANGIOS AND DEPLOYMENT. THE INSTITUTION IS INVESTIGATING WHAT HAPPENED.

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

  MAUDE report 14743772 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, A REINTERVENTION OCCURRED TO TREAT A TYPE I PROXIMAL ENDOLEAK WHEREBY A AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO EXTEND THE ORIGINALLY IMPLANTED TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. ANEURYSM ENLARGEMENT WAS NOT REPORTED. THE CAUSE OF THE ENDOLEAK WAS NOT REPORTED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 12143638 ↗
• InjurySep 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, FOLLOW-UP IMAGING SHOWED NO EVIDENCE OF A TYPE I ENDOLEAK, HOWEVER A TYPE II ENDOLEAK ORIGINATING FROM THE RIGHT INTERNAL ILIAC ARTERY WAS IDENTIFIED. THAT SAME DAY, AN ADDITIONAL PROCEDURE WAS PERFORMED, WHEREBY THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND INTENTIONALLY COVERED WITH THE IMPLANTATION OF AN ILIAC EXTENDER COMPONENT (PLL161207) INTO THE RIGHT EXTERNAL ILIAC ARTERY. ADDITIONALLY, AN AORTIC EXTENDER COMPONENT (PLA230300) WAS IMPLANTED FOR PROXIMAL EXTENSION ON THE PREVIOUSLY IMPLANTED TRUNK-IPSILATERAL COMPONENT (RLT231216) AS A PRECAUTIONARY MEASURE. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF THE ENDOLEAK, AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10610867 ↗
• InjuryJun 24, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT AFTER MULTIPLE ATTEMPTS, THE CONTRALATERAL GATE WAS UNABLE TO BE CANNULATED. IT WAS DECIDED THAT AN AORTO-UNI-ILIAC STENT GRAFT PROCEDURE WOULD BE PERFORMED WITH A FEMORAL-FEMORAL BYPASS, WHICH WAS SUCCESSFUL. THE PHYSICIAN OR FIELD SALES ASSOCIATE COULD NOT FIND A REASON FOR THE CONTRALATERAL GATE BEING UNABLE TO BE CANNULATED, HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD A REVERSE TAPERED AORTIC NECK WITH A DIAMETER RANGE OF 15MM-20MM, AND THAT THE GRAFT HAD THE APPEARANCE OF LOOKING CRIMPED. NO FURTHER ISSUES WERE REPORTED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10192269 ↗
• DeathApr 23, 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 ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. AT THE END OF THE PROCEDURE THE PATIENT'S BLOOD PRESSURE WAS NOTED TO BE LOW. THE PATIENT TOLERATED THE PROCEDURE WITH NO DEVICE RELATED INCIDENTS REPORTED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2019, THE PATIENT EXPIRED, A CAUSE OF DEATH WAS NOT KNOWN.

  Patient problems: Aneurysm

  MAUDE report 8542223 ↗
• InjuryApr 12, 2019Adverse 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 UNKNOWN ETIOLOGY AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW-UP IMAGING WAS PERFORMED AND A DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE WAS REPORTED. NO ANEURYSM ENLARGEMENT WAS REPORTED. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL ENDOPROSTHESIS WAS PLACED ON THE LEFT SIDE TO EXTEND COVERAGE TO THE LEFT EXTERNAL ILIAC ARTERY AND SUCCESSFULLY EXCLUDE THE ANEURYSM.

  Patient problems: No Information

  MAUDE report 8509274 ↗
• DeathNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED IN A PATIENT WITH A RUPTURED AORTA DUE TO AN ABDOMINAL ULCER WHICH OCCURRED DURING A PREVIOUS FLUOROSCOPIC PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITHIN THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), WITHOUT ANY COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ONE MONTH AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT HAD BLEEDING DUE TO A FAILED PERCUTANEOUS ACCESS SITE AND UNDERWENT A PROCEDURE TO TREAT THE BLEEDING. INFECTION WAS FOUND IN THE SITE OF THE PERCUTANEOUS ACCESS AFTER THE BLEEDING WAS TREATED. ACCORDING TO THE PHYSICIAN, INFECTION WAS NOT RELATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND AFTER THE TREATMENT, IT APPEARED THAT THE INFECTION DID NOT SPREAD. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH CONTINUED INFECTION WITH THE PAIN IN THE ZONE THAT WAS NOT COVERED BY THE GORE DEVICE IMPLANTS. ALSO, IT WAS NOTICED A NEW ANEURYSM DEVELOPED (A ZONE OF 3-4MM) AND IT RUPTURED. ON (B)(6) 2018, THE PHYSICIAN PLANNED TO TREAT THE NEW RUPTURE WITH A DACRON GRAFT. THERE WAS NO PROBLEM WITH THE GRAFT ANASTOMOSES; HOWEVER, SINCE IT

  Patient problems: Death; Post Operative Wound Infection

  MAUDE report 8040336 ↗
• InjurySep 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY THE PATIENT HAD FRIABLE ANATOMY. IT WAS REPORTED THERE WAS A SHELF OF CALCIUM IN THE ARTERY WHERE THE CONTRALATERAL GATE WAS GOING TO OPEN. THE PHYSICIAN ATTEMPTED TO LAND AND OPEN THE CONTRALATERAL GATE ON THE SHORT SIDE OF THE SHELF OF CALCIUM. WHEN THE DEVICE WAS DEPLOYED, THE CONTRALATERAL GATE WAS PINCHED. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO FULLY OPEN THE CONTRALATERAL GATE, BUT COULD NOT GET THE GATE TO FULLY OPEN, DUE TO THE SHELF OF CALCIUM. THE PHYSICIAN DECIDED TO PERFORM AN UNPLANNED AUI AND A FEM-TO-FEM BYPASS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7840469 ↗
• InjuryJul 18, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED COMPUTED TOMOGRAPHY IMAGES (DATED (B)(6) 2018), REVEALED THERE IS ANEURYSM SAC ENLARGEMENT, THE AMOUNT IS UNKNOWN. THE CAUSE OF THE ENLARGEMENT IS UNKNOWN. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 7700581 ↗

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