GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281416Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132610723), received between Jul 3, 2018 and Jul 6, 2023 — classified as 1 death, 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathJul 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2014, COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED A MAXIMUM AORTIC ANEURYSM DIAMETER OF 72.2 MM. ON (B)(6) 2022, THE LAST DATE WHEN IMAGING WAS AVAILABLE, CT IMAGING SHOWED A MAXIMUM AORTIC ANEURYSM DIAMETER OF 103 MM. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ISCHEMIC COLITIS. THE PHYSICIAN STATED THAT THE DEVICE OR PROCEDURE CONTRIBUTED TO THE CONDITION. NO TREATMENT WAS DOCUMENTED. THE PATIENT DIED DUE TO THE SAME CONDITION ON (B)(6) 2022.

  Patient problems: Aneurysm expansion; Ischemia; Unspecified Gastrointestinal Problem

  MAUDE report 17272906 ↗
• InjuryJun 9, 2023Complete Blockage; Device Stenosis; Complete Blockage; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014, A PATIENT PRESENTING WITH ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2023, THE PATIENT PRESENTED WITH THROMBOSIS OF THE CONTRALATERAL LEG OF THE ENDOPROSTHESIS. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH A FEMORAL LEFT TO RIGHT CROSS OVER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17101763 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, COILING WAS PERFORMED TO TREAT A TYPE II ENDOLEAK AT AN UNKNOWN FACILITY. ON (B)(6), 2023, FOLLOW-UP CT IMAGING REVEALED AN ENDOLEAK OF UNKNOWN ORIGIN. THE GORE REPRESENTATIVE BECAME AWARE OF THE ENDOLEAK ON FEBRUARY 6, 2023. AFTER REVIEW OF THE CT IMAGING BY THE GORE IMAGING SCIENCES TEAM, IT WAS OBSERVED ON COMPARISON AXIAL IMAGING THAT THE ANEURYSM HAD ENLARGED FROM 69.3MM X 68.4MM IN APRIL, 2021 TO 74.3MM X 75.4MM ON THE FEBRUARY, 2023 SCANS. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED. THE ORIGIN OF THE ENDOLEAK REMAINS UNKNOWN. REPORTEDLY A ONE MONTH FOLLOW-UP CT WILL BE PERFORMED TO MONITOR ANEURYSM GROWTH. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 16492512 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE BEEN IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. ON (B)(6) 2019, A POSSIBLE PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS REPORTED. THE PHYSICIAN PLANS A REINTERVENTION TO RELINE WITH AORTIC CUFFS AND LINKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166803 ↗
• InjurySep 26, 2019Deformation Due to Compressive Stress; Migration; Deformation Due to Compressive Stress; Migration

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, THE PATIENT HAD A RE-INTERVENTION DUE TO GRAFT MIGRATION AND A LOSS OF SEAL IN THE PROXIMAL NECK. IT WAS ALSO REPORTED THAT DEVICE WAS NEAR OCCLUSIVE KINKING OF THE LEFT ILIAC LIMB AND THERE WAS REPORTED PERINEAL AORTIC ENLARGEMENT. DISTANCE OF THE MIGRATION IS UNKNOWN BUT A CT SCAN TAKEN (B)(6) 2017 MEASURED THE ANEURYSM SAC AT 36CM AND ANOTHER CT SCAN TAKEN (B)(6) 2019 MEASURED THE SAC AT 43MM (7CM GROWTH). THE PHYSICIAN REPORTEDLY RE-LINED THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS AND THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS SEEN FOR A 1 WEEK POST OP AND IS REPORTEDLY DOING WELL AND BLOOD FLOW THROUGH THE DEVICE IS GOOD. ON AUGUST 31ST, 2019 THE PRODUCT SURVEILLANCE U.S. REGIONAL LEADER WAS ATTENDING A SEMINAR WHEN THE COMPLAINANT NOTIFIED HER OF A POSSIBLE ADVERSE EVENT. THE PHYSICIAN STATED HE HAD TO RELINE AND PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 9124537 ↗
• InjuryAug 15, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6) 2019, THE PATIENT WAS ADMINISTERED TO HOSPITAL FOR FOLLOW-UP IMAGING TO BE CONDUCTED THE NEXT DAY. ON (B)(6) 2019, A TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY AT THE LEVEL OF VERTEBRAE L3/L4 WAS DIAGNOSED WITH THE ANEURYSM MEASURING 80 MM. ON (B)(6) 2019, ANGIOGRAPHY WAS PERFORMED AND THE ENDOLEAK WAS EMBOLIZED. FOLLOW-UP CTA IMAGING ON (B)(6) 2019, FOUND AN ANEURYSM DIAMETER OF 83 MM. ACCORDING TO THE PHYSICIAN, THIS INCREASE IS NOT CONSIDERED AN ANEURYSM ENLARGEMENT AS THE PATIENT WAS GIVEN AN EMBOLIZATE AND THERE IS A TOLERANCE OF MEASUREMENT. THE ENDOLEAK IS BELIEVED TO HAVE BEEN REPAIRED.

  Patient problems: No Information

  MAUDE report 8895894 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2019, REVEALED THE ANEURYSM SAC HAS INCREASED IN SIZE MEASURING 7.9 X 7.5 CM. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND PRE-OP IMAGES AND REVEALED A PROXIMAL TYPE I ENDOLEAK AND IMPLANTED A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8756332 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 52 MM IN DIAMETER AND WAS THEREFORE IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2012, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING IDENTIFIED AN ANEURYSM DIAMETER OF 45 MM. ON (B)(6) 2017, FOLLOW-UP ULTRASOUND EXAMINATION REVEALED AN ANEURYSM DIAMETER OF 38 MM. ON (B)(6) 2018, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING CONFIRMED AN ANEURYSM DIAMETER OF 50 MM. THE CAUSE FOR THE ENLARGEMENT WAS STATED TO BE UNKNOWN. THERE IS NO RE-INTERVENTION PLANNED AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8188777 ↗
• MalfunctionSep 5, 2018Premature Activation; Premature Activation

  ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN 18FR DRYSEAL SHEATH COMPATIBLE TO THE MAIN BODY WAS USED IN THE FEMORAL ARTERY, WHICH MEASURED 10.8MM IN DIAMETER. THE DEVICE WAS PREPARED AS REQUESTED BY IFU. THE SHEATH WAS POSITIONED IN THE LEFT COMMON ILIAC ARTERY UNDER FLUOROSCOPY OVER AN EXTRA STIFF GUIDEWIRE. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS ADVANCED TO THE INTENDED POSITION UNDER FLUOROSCOPY, HOWEVER, THE LEFT RENAL ARTERY WAS PARTIALLY COVERED. THE PHYSICIAN TRIED TO MOVE THE DEVICE BACK, HOWEVER, REPORTEDLY, THE DISTAL PART OF THE IPSILATERAL LEG PREMATURELY RELEASED. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND THE SHEATH TOGETHER. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 7848772 ↗
• InjuryJul 3, 2018Human-Device Interface Problem; Human-Device Interface Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (DIAMETER 55MM) THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING PERFORMED ON (B)(6) 2015, SHOWED ANEURYSM GROWTH (DIAMETER 58MM). ON (B)(6) 2015, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH THE IMPLANTATION OF AN AORTIC EXTENDER ENDOPROSTHESIS ON (B)(6) 2015. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7657685 ↗

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