Ovation iX Iliac Stent Graft TV-IL1410140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850007370145), received between Aug 18, 2022 and Aug 8, 2024 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryAug 8, 2024Off-Label Use; Separation Problem; Off-Label Use; Separation Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM AND AN ADDITIONAL OVATION IX ILIAC LIMB (RIGHT SIDE). REPORTEDLY, DURING THE INITIAL PROCEDURE, THE RIGHT EXTERNAL ILIAC WAS EXTENDED AS THE RIGHT INTERNAL ARTERY WAS COILED AND COVERED. ROUTINE FOLLOW-UP IDENTIFIED THAT THE RIGHT LIMBS HAD SEPARATED AND THERE IS NOW A TYPE IIIA ENDOLEAK. REINTERVENTION IS PENDING AND THE PATIENT IS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19945071 ↗
• DeathMay 17, 2023Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT PATIENT ALSO HAD AORTIC OCCLUSIVE DISEASE AND HEAVILY CALCIFIED ILIAC ARTERIES (CAUTIONARY PRODUCT USE). THE PHYSICIAN INTENDED TO USE THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM FOR AUI (AORTO-UNI ILIAC) WITH FEMORAL-FEMORAL CROSSOVER BYPASS. DURING THE INITIAL IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE ALTO STENT GRAFT PAST THE ILIAC BIFURCATION, AND THEREFORE ELECTED TO USE AN OVATION IX ILIAC LIMB TO CREATE THE AUI. THE OVATION IX DEVICE WAS IMPLANTED IN THE AORTA, EXTENDING DOWN THE RIGHT ILIAC ARTERY. NO SIGN OF COMPLICATIONS WERE NOTED AT THIS TIME OF THE PROCEDURE. THE PHYSICIAN THEN PROCEEDED BY IMPLANTING A GORE (NON-ENDOLOGIX) VBX STENT IN THE PROXIMAL AORTA ABOVE THE OVATION IX ILIAC LIMB. A COUPLE OF MINUTES LATER, THE PATIENT'S BLOOD PRESSURE DROPPED (CLASSIFIED AS HYPOTENSION) AND A HOLE IN THE AORTA WAS DIAGNOSED. SEVERAL CONTRAST INJECTIONS WERE MADE AND THE BLEEDING WAS NOTED TO BE ORIGINATING FROM THE PROXIMAL AORTA. AFTER SEVERAL ATTEMPTS TO CONTROL THE BLEEDING, THE PHYSICIAN CONVERTED THE PATIENT TO OPEN REPAIR. THE PATIENT ULTIMATELY PASSED AWAY A C

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 16947227 ↗
• InjuryApr 24, 2023Malposition of Device; Malposition of Device

  THE PATIENT WAS BEING TREATED FOR A 7.7CM ABDOMINAL AORTIC ANEURYSM (AAA) THAT HAD PREVIOUSLY RUPTURED AND WAS CONTAINED. DETAILS OF THE PREVIOUS CONTAINMENT WERE NOT PROVIDED. REPORTEDLY, THE RIGHT COMMON ILIAC WAS STENOSED; HOWEVER, THERE WAS NO DIFFICULTY GOING THROUGH IT AND IT WAS BALLOONED. THE ALTO MAIN BODY WAS DEPLOYED. UPON CANNULATION, THE WIRE WENT UP AND APPEARED TO GO THROUGH THE CONTRALATERAL LIMB. THE WIRE ALSO WENT BEHIND THE SEALING RING AND UP INTO THE PROXIMAL AORTA WITHOUT AN ISSUE. TWO 7X80 BALLOONS WERE PLACED UP INTO THE GATE, AND IT LOOKED AS IF THE DELIVERY SYSTEM WAS IN TWO SEPARATE LUMENS INSIDE THE GRAFT. THE OVATION IX ILIAC LIMBS WERE DEPLOYED. ONE WAS IN THE IPSILATERAL GATE, AND THE OTHER ONE WAS OUTSIDE OF THE AORTIC BODY. THE PHYSICIAN WAS UNABLE TO RE-ACCESS THE CONTRALATERAL GATE; THEREFORE, THE PROCEDURE WAS CONVERTED TO AN AORTO-UNI-ILIAC (AUI). THOUGH ALL STENTS DEPLOYED PROPERLY THE PHYSICIAN MISJUDGED WHERE THE WIRE WAS AND THOUGHT THE WIRE CANNULATED THE CONTRALATERAL GATE AND IT DID NOT. THE SURGERY WAS A SUCCESS. THE PATIENT IS DOING AMAZING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16803330 ↗
• InjuryAug 18, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO STENT GRAFT SYSTEM. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE A SMALL TYPE 3B ENDOLEAK WAS IDENTIFIED. THE PATIENT WILL UNDERGO A RE-INTERVENTION, THE DATE TO BE DETERMINED.

  Patient problems: Failure of Implant

  MAUDE report 15254550 ↗

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