Ovation iX Iliac Stent Graft TV-IL1410160-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850007370114), received between Aug 24, 2022 and Jun 16, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Complete Blockage; Unintended Movement; Complete Blockage; Unintended Movement

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY THIRTY-ONE (31) DAYS POST INITIAL PROCEDURE AT ROUTINE FOLLOW-UP, IT WAS IDENTIFIED THAT THE LEFT LIMB OF THE STENT GRAFT HAD MIGRATED DOWNWARDS IN THE PATIENT'S BODY. THE PATIENT IS IN STABLE CONDITION. A RE-INTERVENTION IS PLANNED TO ADDRESS THE ISSUE, BUT SURGERY HAS NOT BEEN SCHEDULED. ADDITIONAL INFORMATION: THE INITIAL REPORT INDICATED A "LIMB WENT DOWN - MIGRATION" SCENARIO. HOWEVER, UPON A COMPREHENSIVE REVIEW OF THE COMPUTERIZED TOMOGRAPHY (CT) SCAN RESULTS, IT BECAME EVIDENT THAT THE INTENDED INTERPRETATION WAS THAT THE "LIMB WENT DOWN" IN THE CONTEXT OF OCCLUSION, RATHER THAN SIGNIFYING MIGRATION. THE OBJECTIVE FINDINGS FROM THE COMPUTERIZED TOMOGRAPHY (CT) SCAN CONDUCTED ON (B)(6), 2023, SHOW THE COMPLETE OCCLUSION OF THE LEFT LIMB. THIS CONCLUSION ALIGNS WITH THE CLINICAL SUMMARY, WHICH ALSO CONFIRMS THE OCCLUSION OF THE LEFT LIMB. THE IDENTIFIED CONTRIBUTING FACTORS SUGGEST THAT THE OCCURRENCE OF ANGULATION UPON AB'S LANDING LED TO THE OCCLUSION OF THE LEFT LIMB. THE PATIENT UNDERWENT A SECONDARY PROCEDURE DURING WHICH THE PHYSICIAN CHOSE TO PERFORM THE

  Patient problems: Clinical Endoleak; Failure of Implant; Obstruction/Occlusion

  MAUDE report 17144835 ↗
• InjuryMar 9, 2023Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT HAD AN OCCLUSION OF THE RIGHT OVATION ILIAC LIMB DUE TO THE LIMB BEING IN A BEND IN THE ILIAC ARTERY AND THIS SHUT FLOW DOWN TO LIMB. IT WAS ALSO NOTED THAT THE LEFT SIDE HAD BECOME ANEURYSMAL. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXTENDING BOTH LIMBS TO SUCCESSFULLY RESOLVE THESE EVENTS. THE FINAL PATIENT STATUS WAS REPORTED AS DOING GOOD AND WAS RELEASED HOME.

  Patient problems: Aneurysm; Obstruction/Occlusion

  MAUDE report 16519001 ↗
• InjuryAug 24, 2022Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. REPORTEDLY, THE AORTIC NECK WAS 11MM, THERE WAS AN EXISTING UNDERSIZED SELF-EXPANDING STENT IN THE COMMON ILIAC ARTERY (CIA) AND LEFT EXTERNAL ILIAC ARTERY (EIA)/CIA WAS COMPLETELY OCCLUDED. PER THE SIZING SHEET THE LEFT CIA WAS OFF LABEL AS IT MEASURED AT 7MM AND SHOULD BE = 8MM & = 25MM. THE PHYSICIAN WAS ABLE TO CROSS THE LEFT ILIAC OCCLUSION WITH WIRES AND CATHETERS AND A RE-ENTRY DEVICE. THE GRAFT WAS PLACED AND WHEN POST BALLOONING THE LEFT LIMB THE CIA HYPO JUNCTION OF THE VESSEL RUPTURED. AN ADDITIONAL OVATION IX ILIAC LIMB WAS IMPLANTED TO COVER THE RUPTURED VESSEL; HOWEVER, THE RUPTURE WAS BEING FED RETROGRADE VIA COLLATERALS FROM THE RIGHT ILIAC SYSTEM CAUSING A SLOW LEAK. THE PHYSICIAN OPENED THE PATIENTS LEFT RETROPERITONEAL CAVITY TO EVACUATE THE HEMATOMA, SEWED AND CLIP THE LEFT HYPO. THIS WAS SUCCESSFUL. THE PATIENT HAD PALPABLE DISTAL PULSES, BOTH ILIACS SYSTEMS ARE PATENT AND THE ANEURYSM IS EXCLUDED. THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE AND WAS EXPECTED TO BE DISCHARGED ONE DAY POST PROCEDURE.

  Patient problems: Rupture

  MAUDE report 15287429 ↗

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