GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132610600), received between Oct 23, 2018 and Oct 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND NO ENDOLEAK WAS REPORTED AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. THE PRE-IMPLANT MAXIMUM ANEURYSM DIAMETER WAS REPORTED TO BE 52MM. ON (B)(6) 2018, FOLLOW-UP CAT SCAN DETERMINED A TYPE IA AND A TYPE IB ENDOLEAK ON THE LEFT SITE ALONG WITH SIGNIFICANT ANEURYSM GROWTH TO 70MM. A PREVIOUSLY SEEN AND UNTREATED TYPE II ENDOLEAK WAS NOT VISIBLE. A REINTERVENTION WAS PERFORMED ON (B)(6) 2018. TWO AORTIC EXTENDERS WERE IMPLANTED PROXIMAL AT THE EDGE OF THE LEFT RENAL ARTERY TO TREAT THE TYPE IA ENDOLEAK. ADDITIONALLY THE RIGHT LIMB WAS EXTENDED WITH THE IMPLANTATION OF A CONTRALATERAL LEG ENDOPROSTHESIS TO TREAT THE TYPE IB ENDOLEAK. THE PROCEDURE WAS COMPLETED WITH FAVORABLE RESULTS.

  Patient problems: No Code Available

  MAUDE report 7994947 ↗

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