GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132622498), received between Aug 26, 2020 and Mar 19, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION AND EMBOLIZATION OF THE ANEURYSM SAC WITH SHAPEMEDICAL PLUGS WAS PERFORMED. THE PHYSICIAN REPORTS SOME SAC ENLARGEMENT (AMOUNT UNKNOWN AND DATE OF ONSET OF TYPE II ENDOLEAK DETERMINED IS UNKNOWN) THE PATIENT TOLERATED THE PROCEDURE, ENDOLEAK RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932175 ↗
• InjurySep 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, IMAGING REVEALED A TYPE IA AND TYPE IB ENDOLEAK, AS WELL AS A TYPE II ENDOLEAK. THE FSA BELIEVES THAT THE TYPE II ENDOLEAK CAUSED NECK DILATATION, RESULTING IN THE TWO TYPE I ENDOLEAKS. REINTERVENTION IS PLANNED. IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 17769649 ↗
• InjurySep 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE GORE REPRESENTATIVE BECAME AWARE OF A PROXIMAL TYPE I ENDOLEAK WITHOUT DEVICE MIGRATION. NECK DEGRADATION WAS REPORTED AS THE CAUSE OF THE ENDOLEAK. IT IS REPORTEDLY UNKNOWN IF ANEURYSM ENLARGEMENT WAS PRESENT. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED WHEREBY A GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15385490 ↗
• MalfunctionAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281214/21448982) WAS ADVANCED OVER THE .035 MEIER¿ GUIDEWIRE THROUGH THE 18FR DRYSEAL SHEATH. AFTER A FULL DEPLOYMENT WHEN THE EXCLUDER® DEVICE WAS TAKEN OUT, THE OLIVE TIP REMAINED ON THE WIRE AT THE TIP OF THE SHEATH. THIS WAS AN AREA OF ACUTE ANGLE IN THE ILIAC ARTERY. A FOGARTY® BALLOON WAS ADVANCED ABOVE THE OLIVE TIP AND INFLATED. IT WAS THEN PULLED BACK AND THE OLIVE TIP WAS CAPTURED IN THE DRY SEAL SHEATH. ALL OF THE COMPONENTS WERE RETRIEVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10457830 ↗

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