Ovation iX Iliac Stent Graft TV-IL1412140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850007370183), received between Sep 12, 2022 and Oct 31, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

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

• InjuryOct 31, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2022, WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED ON 24 OCTOBER 2024, THAT A TYPE II ENDOLEAK (NON-DEVICE RELATED) WAS IDENTIFIED ON (B)(6) 2022. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE ROUTINE FOLLOW-UP ON (B)(6) 2024, IDENTIFIED THAT THE TYPE II ENDOLEAK (NON-DEVICE RELATED) CONTINUED TO FILL THE ANEURYSM SAC WHICH CREATED A TYPE IB ENDOLEAK. REINTERVENTION WAS PERFORMED ON (B)(6) 2024 WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB TO TREAT THE ANEURYSM ENLARGEMENT AND TYPE IB ENDOLEAK. AFTER DEPLOYMENT THERE APPEARED TO STILL BE A SMALL LEAK; HOWEVER, THE PHYSICIAN THINKS IT WILL SEAL ONCE PATIENT CAME OF HEPARIN. THE PATIENT WAS IN GOOD CONDITION POST-REINTERVENTION. THE TYPE II ENDOLEAK (NON-DEVICE RELATED) IS REPORTEDLY GOING TO BE TREATED BY INTERVENTION RADIOLOGY IN NOVEMBER.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 20578581 ↗
• InjuryAug 26, 2024Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM ON (B)(6) 2023. ON (B)(6) 2024, IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2024, WITH THIGH AND CALF CLAUDICATION SYMPTOMS, WHICH HAD BEEN ONGOING FOR THREE MONTHS. THESE SYMPTOMS WERE REPORTED TO BE SIGNIFICANTLY LIMITING, AS THE PATIENT COULD BARELY AMBULATE. A COMPUTED TOMOGRAPHY (CT) SCAN INDICATED AN OCCLUSION OF THE LEFT LIMB. A RE-INTERVENTION WAS PERFORMED AT AN UNKNOWN TIME AND DATE. THE FINAL PATIENT STATUS REMAINS UNKNOWN, AS IT WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20072274 ↗
• InjuryDec 19, 2023Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN, SHOWED THE PATIENT WAS FOUND TO HAVE AN OCCLUDED LEFT LIMB. IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD SMALL ACCESS VESSELS AND PREVIOUSLY IMPLANTED (NON-ENDOLOGIX) STENTS IN BOTH COMMON ILIAC ARTERIES. THE PHYSICIAN ELECTED TO PERFORM A TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP OVERNIGHT AND THE NEXT DAY EXTENDED THE IPSILATERAL LIMB WITH AN OVATION IX ILIAC EXTENDER TO MATCH THE CONTRALATERAL LIMB. THIS SUCCESSFULLY RESOLVED THE EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18353980 ↗
• InjurySep 12, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. APPROXIMATELY THIRTY-EIGHT (38) DAYS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED STENOSIS IN THE LEFT ILIAC LIMB >50% DUE TO BOTH THROMBUS AND STENT KINK. THE NATIVE ANEURYSM SAC MEASURED AT 49MM. THERE WAS NO EVIDENCE OF AN ENDOLEAK. ADDITIONALLY, THERE WAS CRITICAL LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY. THE PATIENT IS BEING MONITORED.

  Patient problems: Ischemia; Stenosis; Thrombosis/Thrombus

  MAUDE report 15403501 ↗

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