Ovation iX Iliac Stent Graft TV-IL1412120-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850007370176), received between Aug 30, 2021 and Jul 22, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Complete Blockage; Complete Blockage

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM (ONE (1) ALTO MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS). POST-DEPLOYMENT, WHILE ATTEMPTING TO ADVANCE THE Q50 MERIT MEDICAL BALLOON TO MOLD THE RINGS, THE NOSE CONE OF THE BALLOON BECAME CAUGHT ON THE DISTAL SUPRARENAL PORTION OF THE ALTO MAIN BODY, PUSHING THE ALTO MAIN BODY PROXIMALLY ABOUT 1 CM AND PARTIALLY COVERING LEFT RENAL. ARM ACCESS WAS OBTAINED, AND THE LEFT RENAL WAS SUCCESSFULLY STENTED. THERE SEEMED TO BE SEAL IN THE NECK AT THE SECOND RING HOWEVER A TYPE 2 ENDOLEAK CONFIRMED TO STILL BE PRESENT. THIS EVENT HAS BEEN REPORTED UNDER MRN 3008011247-2022-00047. SEVERAL HOURS POST-PROCEDURE THE PATIENT DEVELOPED A COLD LEG AND WAS BROUGHT BACK INTO THE OPERATING ROOM. THE RIGHT LIMB WAS NOT GETTING FLOW DO TO THE ALTO MAIN BODY LEGS BECOMING A LITTLE TWISTED AND OCCLUDING ON THE RIGHT SIDE. TWO (2) NON-ENDOLOGIX BALLOON-EXPANDABLE STENTS WERE IMPLANTED AT THE LEVEL OF THE SECOND SEALING RING AND INTO THE LEGS OF THE MAIN BODY. NORMAL FLOW WAS ACHIEVED. THE FINAL ANGIOGRAM LOOKED PERFECT. THE PATIENT WAS REPORTED TO BE DOING WELL. THIS EVENT HAS BEEN REPORTED UNDER MR

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 15089208 ↗
• InjuryAug 30, 2021Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) WEEKS POST INITIAL PROCEDURE THERE WAS STENOSIS WITHIN THE LEFT STENT GRAFT LIMB AND THE ILIAC LIMB WAS FOUND TO BE OCCLUDED. THE PATIENT UNDERWENT A LYSIS PROCEDURE FOLLOWING BY IMPLANT OF LUMINEXX (NON-ENDOLOGIX) BARE METAL STENTS TO OPEN THE LIMBS AT THE BIFURCATION OF THE GRAFT. THE PATIENT WAS REPORTED AS DISCHARGED POST THIS SECONDARY PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 12388891 ↗

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