GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT231212Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132651009), received between Jan 17, 2023 and Aug 15, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (CEXC). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION TO TREAT A THROMBOSED LEFT LIMB OF THE CEXC DEVICE. THE PHYSICIAN CHOSE TO MAKE THE CEXC INTO AN AORTO-UNI-ILIAC (AUI) BY PLACING A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT (PLC231200) INVERTED WITH THE 23MM END AT THE RENAL ARTERIES WITH THE 16MM DIAMETER DISTAL END IN THE RIGHT LIMB. THE PHYSICIAN THEN DID A FEM-FEM BYPASS TO PROVIDE FLOW FROM THE RIGHT COMMON FEMORAL TO THE LEFT COMMON FEMORAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22822307 ↗
• InjuryMar 4, 2024Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2024, THE PATIENT HAD THROMBUS. BOTH OF THEIR EXTERNAL ILIACS THROMBOSED AND A CLOT WENT NORTH. THEIR SYSTEM WAS OCCLUDED. THE PHYSICIAN HAS NOT RE-INTERVENED; HOWEVER, THEY ARE PLANNING NEXT STEPS. THEY WILL POSSIBLY PERFORM AN AXILLA-FEMORAL BYPASS. AS OF NOW, THE PATIENT IS STABLE. THE PHYSICIAN SUSPECTED THAT THE PATIENT HAD A CLOTTING DISORDER AND CLOTTED THE LEFT EXTERNAL ILIAC AND IT CONTINUED PROXIMAL INTO THE EXCLUDER.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18827184 ↗
• InjuryJan 17, 2023Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT HAD AN OCCLUDED LEFT LIMB. THIS WAS OCCLUDED FROM THE TOP OF THE BIFURCATION TO THE LEFT HYPOGASTRIC ARTERY. THERE WAS A NARROWING IN THE VBX DEVICE WHICH WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (CIA). THE INITIAL IMPLANT ON DEC. 16 WAS WITH A PLL161007 ABOVE THE LCIA AND HAD AN EXTENSION OF A 8L X79. THROMBECTOMY CATHETER WAS USED AND OPENED VESSEL AND THAN WE USED KISSING 8L STENTS JUST ABOVE FLOW DIVIDER TO RESTORE FLOW. PATIENT DOING WELL.

  Patient problems: Inflammation; Pain

  MAUDE report 16184324 ↗