Ovation iX Iliac Stent Graft TV-EX181845-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850007370053), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 death.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P120006); 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.

• DeathJul 2, 2024Off-Label Use; Malposition of Device; Device Dislodged or Dislocated; Off-Label Use; Malposition of Device; Device Dislodged or Dislocated

  THE PATIENT WAS BEING TREATED FOR OCCLUSIVE WORK ON (B)(6) 2024. REPORTEDLY, THE PATIENT¿S DISTAL AORTA WAS FULL OF CLOTS ALL THE WAY UP TO THE RIGHT RENAL. THE RIGHT COMMON FEMORAL ACCESS WAS ACHIEVED, AND PERCLOSE (ABBOTT VASCULAR) DEVICES WERE DEPLOYED. A DISSECTION OCCURRED IN THE LEFT EXTERNAL ILIAC. THE PHYSICIAN WAS ABLE TO GO UP AND OVER FROM THE RIGHT COMMON FEMORAL AND BALLOON THE DISSECTION AND MANUAL PRESSURE WAS HELD ON THE ACCESS SITE. DUE TO THE DISSECTION IN THE LEFT COMMON ILIAC, TWO OVATION IX LIMB EXTENSIONS 18X45MM WERE IMPLANTED, OVERLAPPING FROM JUST ABOVE THE BIFURCATION UP TO THE LEFT RENAL. THESE DEVICES WERE DEPLOYED WITHOUT ANY DIFFICULTY. THE DISTAL AORTA WAS DILATED USING A Q50 (MERIT MEDICAL) BALLOON. POST ANGIOGRAM SHOWED THAT THE STENTS HAD EXPANDED, BUT THEY SQUEEZED THE CLOT OUT INTO THE DISTAL AORTA. DUE TO THIS THE PHYSICIAN ELECTED TO PERFORM A CUT DOWN LEFT GROIN AND GET ACCESS SO AN AFX2 BIFURCATED STENT GRAFT (BSG) COULD BE PLACED IN THE DISTAL AORTA AND COVER THE CLOT THAT HAD EMBOLIZED. EVEN WITH THE DIRECT CUT DOWN TO THE LEFT COMMON FEMORAL ARTERY (CFA) GETTING INTO THE TRUE LUMEN IN THE LEFT EXTERNAL ILIAC ARTERY WAS DIFFICULT. REQUIRING

  Patient problems: Hypovolemic Shock; Ischemia; Obstruction/Occlusion; Pulmonary Embolism; Renal Failure; Respiratory Failure; Vascular Dissection

  MAUDE report 19658797 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120006. One submission often covers many models, so check the product and lot details in each record.

• Z-2263-2020 · May 6, 2020 · Terminated
  Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
• Z-0125-2015 · Sep 20, 2014 · Terminated
  Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device deliver
• Z-0288-2013 · Oct 19, 2012 · Terminated
  TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The