Ovation iX Iliac Stent Graft TV-IL1416140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850007370268), received between Mar 21, 2024 and Feb 11, 2025 — classified as 1 death, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathFeb 11, 2025Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. ON (B)(6) 2025, A CLINICAL STUDY REPORTED THAT THE RIGHT LIMB OF THE PATIENT'S ENDOGRAFT WAS ACUTELY OCCLUDED, PROMPTING AN OPEN THROMBECTOMY OF THE RIGHT LOWER EXTREMITY (RLE), A FEMORAL-FEMORAL BYPASS, AND A MECHANICAL THROMBECTOMY DUE TO ACUTE THROMBUS. THE PATIENT, DIAGNOSED WITH LUNG CANCER AND BRAIN METASTASES, IS LIKELY HYPERCOAGULABLE. ACUTE THROMBUS WAS NOTED IN THE RIGHT COMMON FEMORAL ARTERY (CFA), DISTAL ABOVE-KNEE POPLITEAL ARTERY, AND TIBIAL VESSELS, WITH CHRONIC OCCLUSION OBSERVED IN THE EXTERNAL ILIAC ARTERY (EIA). DESPITE REVASCULARIZATION ON (B)(6) 2025, RE-OCCLUSION OCCURRED. DUE TO SEVERE PERIPHERAL VASCULAR DISEASE (PVD) IN SMALL VESSELS AND UNDERLYING MEDICAL COMORBIDITIES, A RIGHT ABOVE-KNEE AMPUTATION (AKA) WAS REQUIRED. THE PATIENT REMAINS HOSPITALIZED AND IN STABLE CONDITION AS OF (B)(6) 2025.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 21360694 ↗
• InjuryDec 31, 2024Malposition of Device; Migration; Device Stenosis; Malposition of Device; Migration; Device Stenosis

  THE PATIENT WAS INITIALLY TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) 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 DURING THE INDEX PROCEDURE, ONE LIMB WAS DEPLOYED LOWER THAN THE OTHER, RESULTING IN DEFORMATION AND PROXIMAL STENOSIS. THIS WAS IDENTIFIED ON A 1-MONTH CTA BUT WAS DEEMED INSIGNIFICANT AT THE TIME. HOWEVER, A 1-YEAR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED WORSENING STENOSIS AND THROMBUS FORMATION, RAISING CONCERNS ABOUT LIMB THROMBOSIS. ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION, DURING WHICH THE ISSUE WAS RESOLVED BY IMPLANTING KISSING STENTS.

  Patient problems: Aneurysm; Stenosis

  MAUDE report 21048334 ↗
• InjurySep 23, 2024Unintended Movement; Lack of Effect; Unintended Movement; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024, WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2024, IDENTIFIED A TYPE IB ENDOLEAK OF THE RIGHT LIMB. REPORTEDLY, THE VESSEL HAS GROWN AND CONTRAST IS LEAKING BEHIND THE OVATION IX ILIAC LIMB. REINTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF AN OVATION IX (RIGHT) ILIAC LIMB EXTENSION (14X100) INTO THE COMMON ILIAC ARTERY AND AN OVATION IX ILIAC LIMB (12X100) INTO THE EXTERNAL ILIAC ARTERY. THE TYPE IB WAS SUCCESSFULLY SEALED. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 20279525 ↗
• InjuryAug 28, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS IMPLANTED WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM AND ONE ADDITIONAL OVATION IX ILIAC LIMB IN THE LEFT ILIAC ARTERY TO TREAT AN 8.5 CM ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. DURING THE INDEX PROCEDURE THERE WAS AN INTRAOPERATIVE TYPE IA ENDOLEAK THAT WAS TREATED WITH A PALMAZ STENT (NON-ENDOLOGIX), THERE WAS A MINIMAL ENDOLEAK AT END OF PROCEDURE. THE CLINICAL ASSESSMENT OF MEDICAL RECORDS AND COMPUTED TOMOGRAPHY (CT) ON 08/08/2024 FOR PREVIOUSLY REPORTED MFR# 3008011247-2024-00074, IDENTIFIED ADDITIONAL INFORMATION NOT PREVIOUSLY REPORTED. THE CLINICAL ASSESSMENT REVEALED THAT ONE DAY POST INDEX PROCEDURE ON (B)(6) 2023, THERE WAS LACK OF LOWER LEFT LIMB EXTENSION PULSES. A COMPUTED TOMOGRAPHY ARTERIOGRAM (CTA) REVEALED THAT INFRARENAL ANGULATION WAS 55 DEGREES, AND THE PROXIMAL END OF THE LEFT ILIAC OVATION IX STENT GRAFT WAS STENOTIC AND BUCKLED. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) COVERED STENTS (NON ENDOLOGIX) BILATERALLY IN A KISSING STENT TECHNIQUE AT THE LEVEL OF THE OVATION IX ILIAC LIMB AND RESTORED FLOW TO THE LOWER LEFT LIMB EXTENSION. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 20086101 ↗
• InjuryJun 28, 2024Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE YEAR POST INITIAL PROCEDURE A ROUTINE FOLLOW-UP REVEALED AN OCCLUSION OF THE LEFT ILIAC LIMB. THE PHYSICIAN BELIEVES IT IS DUE TO THE PATIENT¿S TORTUOUS ANATOMY. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19639598 ↗
• InjuryMar 21, 2024Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THE CONTRALATERAL LEG TO THE ALTO MAIN BODY DID NOT COMPLETELY FILL WITH POLYMER. THE PHYSICIAN SUCCESSFULLY UTILIZED THE CROSS-OVER CHANNEL FOR GATE ACCESS AND THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3008011247-2022-00104. NOW, APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP THE ILIAC LIMB STENT GRAFT WAS FOUND TO HAVE OCCLUDED ON AN UNKNOWN DATE. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT A PRE ANGIOGRAM NOTED A STENOTIC AREA AT THE PROXIMAL RIGHT PORTION OF THE RIGHT ALTO LIMB. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB STENT GRAFT ON THE RIGHT SIDE FOLLOWED BY TWO (2) I-CAST (NON-ENDOLOGIX) BALLOON EXPANDABLE STENTS ON EACH SIDE OF THE ALTO MAIN BODY TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY REPAIR.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18953800 ↗

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