GORE EXCLUDER AAA Endoprosthesis PXT311413Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610334), received between Sep 4, 2018 and Jun 9, 2020 — classified as 4 injuries.

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

• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PROXIMAL PLACEMENT OF THE TRUNK IPSILATERAL LEG COMPONENT WAS LANDED APPROXIMATELY 2 CM BELOW THE LOWEST (ACCESSORY) RENAL ARTERY. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION DUE TO EXPANSION OF THE ANEURYSM SAC AND A GORE® AORTIC EXTENDER COMPONENT WAS IMPLANTED TO RELINE THE PROXIMAL END. THE CAUSE OF THE ENLARGEMENT WAS NOT DETERMINED; A TYPE II ENDOLEAK WAS SUSPECTED HOWEVER NO VISIBLE ENDOLEAK WAS DETERMINED BY CONTRAST IMAGING AT THE TIME. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10136295 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013 A TEVAR PROCEDURE WAS PERFORMED WHEREBY A GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED TO BRIDGE A PREVIOUSLY PERFORMED ELEPHANT TRUNK PROCEDURE AND A PREVIOUSLY IMPLANTED GORE® TAG® THORACIC ENDOPROSTHESIS. FOLLOWING THE TEVAR PROCEDURE, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 A THORACOABDOMINAL ANEURYSMORRHAPHY WAS PERFORMED TO PREVENT AN IMPENDING RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM DUE TO ANEURYSM ENLARGEMENT. REPORTEDLY THE AMOUNT OF ANEURYSM ENLARGEMENT IS UNAVAILABLE. NO SUSPECTED CAUSE OF ANEURYSM ENLARGEMENT WAS REPORTED. THERE WERE NO FURTHER REPORTED ISSUES IN RELATION TO THE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9826176 ↗
• InjuryNov 9, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN 44MM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, A FOLLOW-UP STUDY REVEALED THAT THE DIAMETER OF THE ANEURYSM SAC WAS 57MM. HOWEVER, NO OBVIOUS ENDOLEAK WAS OBSERVED. THE PHYSICIAN CONSIDERED A POSSIBLE TYPE III ENDOLEAK ORIGINATING FROM THE GRAFT TEAR AND PLACED ADDITIONAL STENT GRAFTS IN THE ENTIRE ORIGINAL STENT GRAFTS. THE PHYSICIAN REPORTEDLY SUSPECTS THE ISSUE MAY HAVE BEEN A TYPE II ENDOLEAK AS OPPOSED TO A TYPE III ENDOLEAK. HOWEVER, TO REMOVE THE POSSIBLE TYPE III ENDOLEAK, THE PHYSICIAN DECIDED TO PLACE ADDITIONAL STENT GRAFTS TO RELINE THE PRE-EXISTING SYSTEM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8055845 ↗
• InjurySep 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, DURING FOLLOW UP IT WAS DISCOVERED THAT, DUE TO DISEASE PROGRESSION, THE PROXIMAL NECK OF THE TRUCK-IPSILATERAL LEG COMPONENT HAD LOST WALL APPOSITION AND WAS NOW IN THE ANEURYSM SAC. ANEURYSM ENLARGEMENT WAS NOT REPORTED. ON THE SAME DAY, A REINTERVENTION OCCURRED WHEREBY THE PREVIOUSLY IMPLANTED DEVICES WERE RELINED USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IN ADDITION TWO GORE® VIABAHN ENDOPROSTHESES WERE IMPLANTED IN THE RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842856 ↗

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