GORE EXCLUDER AAA Endoprosthesis PXT311417Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132610358), received between Nov 8, 2018 and May 22, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON APRIL 26, 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN OF THE FOLLOWING EVENT IN REGARDS TO AN EXCLUDER MIGRATION WITH A MASSIVE ANEURYSM GROWTH AND TYPE I ENDOLEAK. NO FURTHER INFORMATION IS KNOWN ON THIS EVENT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22073652 ↗
• InjuryMar 27, 2025Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT WAS BROUGHT IN A FOR REINTERVENTION ON THE RIGHT SIDE WHERE THE CONTRALATERAL LEG (PXC141000) WAS IMPLANTED FOR A TYPE 1B ENDOLEAK WHICH WAS COIL EMBOLIZED THEN EXTENDED DISTALLY WITH A FLARED LIMB. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN COMMON AND INTERNAL ILIAC ANEURYSM UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, THE MAIN BODY TRUNK IPSILATERAL GRAFT HAD MIGRATED DOWN BY 5CM FROM THE RENALS LEADING TO A TYPE 1B ENDOLEAK ON THE LEFT CONTRALATERAL (PXC201400) WITH ANEURYSM GROWTH IN THE COMMON ILIAC ARTERY (SIZE UNKNOWN). REINTERVENTION WAS DONE TO TREAT THE ENDOLEAK WITH IPSILATERAL IBE AND TO PRESERVE THE INTERNAL ILIAC ARTERY. DURING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE, A CONTRALATERAL SIDE UP AND OVER THE FLOW DIVIDER OF THE IBE DEVICE WAS DONE BY BASICALLY DELIVERING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE DISTAL PART OF THE INTERNAL ILIAC ARTERY. THE D

  Patient problems: Aneurysm expansion

  MAUDE report 21714535 ↗
• InjuryJul 25, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: BONARDELLI, S., VERZINI, F., RIVOLTA, N., PAGLIARICCIO, G., ZANOTTI, C., BOERO, M., FRANCHIN, M., CARBONARI, L., BAGGI, P., GIBELLO, L., PARLANI, G., CAVI, R. AND PIFFARETTI, G. (2022). 'LONG-TERM OUTCOMES OF ENDOVASCULAR AORTIC REPAIR WITH FLARED ILIAC LIMB ENDOGRAFTS IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM AND ANEURYSMAL COMMON ILIAC ARTERIES', J CARDIOVASC SURG (TORINO), 63(4), PP. 464-470. THE AIM OF THIS STUDY WAS TO EVALUATE MID-TO-LONG-TERM OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR USING FLARED ILIAC LIMB GRAFTS IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM (AAA) AND ANEURYSMAL COMMON ILIAC ARTERIES (CIAS). THIS IS A MULTICENTER, RETROSPECTIVE, OBSERVATIONAL COHORT STUDY THAT INVOLVES FOUR TERTIARY REFERRAL HOSPITALS BETWEEN MAY 1, 2005 AND APRIL 30, 2019. 995 ANEURYSMAL ILIAC LIMBS IN 795 PATIENTS WHO MET THE INCLUSION CRITERIA WERE INVOLVED IN THE STUDY. OUT OF THESE 795 PATIENTS, 471 PATIENTS WERE TREATED WITH ZENITH ALPHA¿ (COOK), 180 PATIENTS WITH ENDURANT¿ (MEDTRONIC), AND 144 PATIENTS WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS ADDITIONALLY REPORTED BY THE CORRESPONDING AUTHOR, THAT A TOTAL OF 90 PATIENTS

  Patient problems: Aneurysm; Aneurysm expansion; Clinical Endoleak

  MAUDE report 15091768 ↗
• InjuryJul 1, 2022Migration or Expulsion of Device; Migration; Migration

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF A RUPTURED ANEURYSM. AS REPORTED, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ¿ STENT GRAFT IPSILATERAL LEG HAD MIGRATED DISTALLY FROM THE ORIGINAL IMPLANTATION LOCATION BY AT LEAST 5-6CM.

  Patient problems: Failure of Implant; Ruptured Aneurysm

  MAUDE report 14893480 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. ONE DEBRANCH BYPASS, A LEFT COMMON CAROTID ARTERY - LEFT SUBCLAVIAN ARTERY BYPASS, PROCEDURE WAS PERFORMED. THE TGMR404020J WAS IMPLANTED PROXIMALLY TO COVER THE LEFT SUBCLAVIAN ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS EMBOLIZED BY PLUG (AVP2 14MM). COMPUTED TOMOGRAPHY ANGIOGRAPHY VERIFIED THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. (THIS WAS REPORTED ON MFR REPORT # 2017233-2021-02123). ON AN UNKNOWN DATE, THE PATIENT WAS CONVERTED TO OPEN SURGERY AND REPLACED WITH A BIFURCATED GRAFT DUE TO AN ANEURYSM ENLARGEMENT. NO OTHER ISSUES AND DETAILS WERE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 12100021 ↗
• InjuryNov 8, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, IMAGING IDENTIFIED A SUSPECTED TYPE II ENDOLEAK ORIGINATING FROM MULTIPLE LUMBAR ARTERIES. IT IS UNKNOWN HOW MUCH GROWTH HAS OCCURRED. ON (B)(6) 2018, INTRAOPERATIVE IMAGES CONFIRMED A TYPE II ENDOLEAK. THE PATIENT REPORTEDLY UNDERWENT AN ADDITIONAL PROCEDURE, WHEREBY MULTIPLE LUMBAR ARTERIES AND AN INTERNAL ILIAC ARTERY WERE COIL EMBOLIZED. REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8051896 ↗

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)