Skip to content

Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1410140-J)Recalls & reported problems

Endologix LLC · The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector. · Class 3 · Implant

All models of Ovation iX Iliac Stent Graft (66)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M701TVIL1410140J1), received between Oct 7, 2017 and Oct 19, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (2 reports).

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

Device problems

  • Occlusion Within Device2
  • Complete Blockage1
  • Insufficient Device Problem Information1

Patient problems

  • Occlusion4
  • Failure of Implant3
  • Ischemia2
  • Pain1
  • Stenosis1
  • Thrombosis1
  • Thrombus1

Recent adverse event reports

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

  • InjuryOct 19, 2020Complete Blockage; Complete Blockage

    THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM (ONE (1) MAIN BODY AND TWO (2) LIMB EXTENSIONS) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ELEVEN (11) MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED AT THE ER WITH A SORE LEG, PROXIMAL LIMB OCCLUSION WAS IDENTIFIED. REPORTEDLY, THE PHYSICIAN TREATED THE PATIENT WITH PLACEMENT OF BILATERAL BALLOON EXPANDABLE STENTS SUCCESSFULLY REGAINING FLOW. PATIENT TOLERATED PROCEDURE WELL AND WAS RELEASED HOME ONE DAY POST INTERVENTION.

    Patient problems: Failure of Implant; Ischemia; Occlusion; Pain

    MAUDE report 10702111 ↗
  • InjuryMay 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5 YEARS POST INITIAL PROCEDURE, OCCLUSION OF THE RIGHT LIMB GRAFT AND THROMBUS AND STENOSIS OF THE LEFT LIMB GRAFT WAS IDENTIFIED BY A CT (COMPUTED TOMOGRAPHY) DURING A ROUTINE FOLLOW UP. THE PATIENT WAS REPORTED AS DOING GOOD AND IS CURRENTLY BE MONITORED.

    Patient problems: Occlusion; Stenosis; Thrombus

    MAUDE report 10027166 ↗
  • InjuryMar 13, 2018Occlusion Within Device; Occlusion Within Device

    AN OVATION IX ILIAC LIMB STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY WITH A COLD RIGHT FOOT. THERE WAS NO DIAGNOSTIC PROCEDURE DONE AND THE PHYSICIAN ELECTED TO PERFORM A FEM-FEM BYPASS, SUCCESSFULLY RESTORING BLOOD FLOW TO THE RIGHT FOOT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Patient problems: Failure of Implant; Ischemia; Occlusion; Thrombosis

    MAUDE report 7334639 ↗
  • InjuryOct 7, 2017Occlusion Within Device; Occlusion Within Device

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY SEVEN MONTHS POST-OP, PATIENT RETURNED WITH REPORTED LEFT LIMB OCCLUSION. THE PHYSICIAN ELECTED TO PERFORM AN OPEN THROMBECTOMY WITH NON-ENDOLOGIX DEVICES. THE CLOT WAS REMOVED AND SENT FOR TESTING FOR POSSIBLE ATRIAL SEPTIC DEFECT. THE PATIENT WAS REPORTED AS STABLE POST-PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Patient problems: Failure of Implant; Occlusion

    MAUDE report 6926534 ↗

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page