Ovation iX Iliac Stent Graft TV-IL1422120-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850007370336), received between Jan 7, 2022 and Jul 23, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM, TWO ADDITIONAL OVATION IX ILIAC LIMBS AND AN OVATION IX EXTENDER. IT WAS REPORTED TO ENDOLOGIX ON (B)(6) 2024, THAT A POSSIBLE TYPE IIIA ENDOLEAK OR TYPE II ENDOLEAK WAS IDENTIFIED. AN ANGIOGRAM WAS PERFORMED ON (B)(6) 2024. REINTERVENTION WAS COMPLETED THE SAME DAY CONFIRMING THE TYPE IIIA ENDOLEAK BETWEEN THE BOTTOM OF OVATION IX ILIAC LIMB AND THE OVATION IX EXTENDER ON THE RIGHT SIDE. THIS WAS SEALED SUCCESSFULLY WITH THE IMPLANT OF AN ADDITIONAL OVATION IX ILIAC LIMB. IT WAS CONFIRMED THAT THERE WAS NO TYPE II ENDOLEAK. THE PATIENT WAS REPORTED TO BE STABLE POST-REINTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19812837 ↗
• InjuryJul 1, 2024Separation Problem; Separation Problem

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. DURING ROUTINE SURVEILLANCE ON (B)(6) 2024, A TYPE 3A ENDOLEAK AND SUSPECTED COMPONENT SEPARATION ON THE LEFT ILIAC LIMBS WERE DETECTED. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 19652090 ↗
• InjuryJul 19, 2023Lack of Effect; Lack of Effect

  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, ANGIOGRAPHY IDENTIFIED BILATERAL TYPE IB ENDOLEAKS. ADDITIONAL BALLOON TOUCH-UP WAS PERFORMED, HOWEVER THE ENDOLEAK REMAINED UNRESOLVED. IN RESPONSE, THE PHYSICIAN OCCLUDED THE RIGHT INTERNAL ILIAC ARTERY AND AN ADDITIONAL LIMB WAS ADDED ON THE RIGHT-SIDE. BALLOON TOUCH-UP WAS PERFORMED AGAIN, AND ANGIOGRAPHY SHOWED A TYPE IIIA ENDOLEAK BETWEEN THE TWO RIGHT LIMBS AND THE PERSISTENT TYPE IB ENDOLEAK FROM THE LEFT LIMB. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND WILL CONTINUE TO MONITOR THE PATIENT. ADDITIONAL TREATMENT IS BEING DISCUSSED, BUT AN ADDITIONAL SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Clinical Endoleak

  MAUDE report 17352785 ↗
• InjuryMay 24, 2023Deformation Due to Compressive Stress; Unintended Movement; Deformation Due to Compressive Stress; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A PROXIMAL RIGHT ILIAC STENT COMPRESSION (GREATER THAN 50 PERCENT), BILATERAL TYPE IB ENDOLEAKS AND OUTFLOW TO THE LUMBAR ARTERIES (CLASSIFIED AS A NON-DEVICE-RELATED TYPE II ENDOLEAK). THE PATIENT WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: BOTH LIMBS ARE PULLED UP PROXIMALLY BEYOND THE MARGINS OF THE VERY SHORT COMMON ILIACS RESULTING IN THE BILATERAL TYPE 1B ENDOLEAKS. THE PHYSICIAN ELECTED TO RE-INTERVENE AND EXTENDED BILATERALLY WITH OVATION IX ILIAC LIMBS ON (B)(6) 2023 TO RESOLVE THIS EVENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16996793 ↗
• InjuryJun 13, 2022Off-Label Use; Migration; Off-Label Use; Migration

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN OVATION IX EXTENDER, AND TWO (2) OVATION IX ILIAC LIMBS. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY FOUR (4) MONTHS POST-INITIAL PROCEDURE, IT WAS IDENTIFIED THAT THE LIMB HAD PULLED BACK OUT OF THE ILIAC. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT REPORTED TO BE DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14676029 ↗
• InjuryJan 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT WHILE THE PATIENT WAS STILL HOSPITALIZED EIGHT (8) DAYS FOLLOWING THE INITIAL PROCEDURE, THE ANKLE-BRACHIAL INDEX REVEALED THAT THE BLOOD PRESSURE IN THE RIGHT LOWER LIMB DECREASED; HOWEVER, THERE WAS NO LIMB OCCLUSION. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THAT THE RIGHT ILIAC LIMB WAS KINKED NEAR THE AORTIC BIFURCATION. DECREASE IN BLOOD FLOW AND THE BLOOD PRESSURE WERE ALSO CONFIRMED. THE PHYSICIAN ELECTED TO IMPLANT SMART (NON-ENDOLOGIX) BARE METAL STENTS ON EACH SIDE. ADDITIONALLY, AN EXPRESS (NON-ENDOLOGIX) BALLOON-EXPANDABLE STENT WAS DEPLOYED IN THE AREA OF THE KINK ON THE RIGHT SIDE. THE EVENT WAS RESOLVED, AND BOTH THE BLOOD PRESSURE AND BLOOD FLOW IMPROVED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 13229508 ↗
• InjuryJan 7, 2022Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM. REPORTEDLY, DURING INDEX PROCEDURE THE PHYSICIAN COVERED THE LEFT HYPOGASTRIC ARTERY WITH A LIMB. AT THE FINAL ANGIOGRAM IT WAS IDENTIFIED THAT THE RIGHT LIMB WAS NO LONGER IN THE COMMON ILIAC AND THERE WAS A TYPE IB ENDOLEAK COMING FROM THE RIGHT SIDE. ADDITIONALLY, IT WAS OBSERVED THAT THE LEFT HYPOGASTRIC ARTERY WHICH WAS COVERED BY THE LIMB WAS STILL FILLING. THE PHYSICIAN ELECTED TO END THE PROCEDURE TO SEND PATIENT OUT TO LARGER CENTER TO HAVE THE LEFT HYPOGASTRIC ARTERY COILED USING ACCESS UP AND OVER THE AORTIC BIFURCATION COMING FROM THE RIGHT SIDE AND DID NOT WANT TO EXTEND RIGHT LIMB RESOLVING THE TYPE IB ENDOLEAK UNTIL THE COILING WAS COMPLETED. ONE DAY POST INITIAL IMPLANT, COILING OF THE LEFT HYPOGASTRIC WAS COMPLETED AND IMPLANT OF TWO OVATION IX ILIAC LIMBS ON THE RIGHT SIDE RESOLVED THE TYPE IB ENDOLEAK. THE PATIENT IS REPORTED TO BE WELL POST REINTERVENTION.

  Patient problems: Failure of Implant; Vascular Dissection

  MAUDE report 13192467 ↗

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