Ovation iX Iliac Stent Graft TV-IL1418140-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850007370305), received between May 19, 2022 and Apr 29, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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.

• InjuryApr 29, 2026Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED FOR A FUSIFORM ANEURYSM WITH A LONG NECK AND NARROW ACCESS VESSELS. THE ALTO MAIN BODY WAS DEPLOYED VIA LEFT ACCESS. THE CONTRALATERAL LEG OF THE ALTO MAIN BODY WAS ORIENTED TO THE ANTERIOR/POSTERIOR DIRECTION, RESULTING IN A CROSS-LEGGED (BALLERINA) CONFIGURATION. THE CUSTOMSEAL POLYMER FILL WAS DELIVERED WITHOUT ANY ISSUES. CONTRALATERAL CANNULATION WAS ACHIEVED SUCCESSFULLY IN APPROXIMATELY FOUR MINUTES. THE OVATION IX ILIAC LIMB STENT GRAFT WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY (CIA), FOLLOWED BY TOUCH-UP USING THE INTEGRATED BALLOON 14 MINUTES LATER. NEXT THE OTHER OVATION IX ILIAC LIMB STENT GRAFT WAS DEPLOYED IN THE LEFT CIA, FOLLOWED BY BALLOON TOUCH-UP. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS OR FLOW DELAYS CONFIRMED. ROUTINE FOLLOW-UP APPROXIMATELY THREE MONTHS LATER ON (B)(6) 2026 CONDUCTED A COMPUTED TOMOGRAPHY (CT) SCAN THAT REVEALED THROMBOTIC OCCLUSION OF THE RIGHT CIA LIMB (FROM THE PROXIMAL TO THE DISTAL END) AS WELL AS OCCLUSION OF THE PROXIMAL SECTION OF THE

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25034415 ↗
• InjuryAug 13, 2025Positioning Failure; Off-Label Use; Positioning Failure; Off-Label Use

  THE PATIENT WAS TREATED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, TWO OVATION IX ILIAC LIMBS, AND AN OVATION IX EXTENDER ON (B)(6) 2022. APPROXIMATELY TWO YEARS AFTER THE INITIAL PROCEDURE, INTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF AN AFX2 BSG AN AFX VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB TO TREAT ANEURYSM ENLARGEMENT, A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC (RCI) ARTERY, TYPE IIIB ENDOLEAK OF THE DISTAL MAIN BODY, AND LOSS OF OVERLAP OF THE LEFT OVATION IX ILIAC LIMB FROM THE AFX2 BSG. (REPORTED UNDER MFR# 3011063223-2024-00120). APPROXIMATELY ONE YEAR POST INTERVENTION, DURING A PROCEDURE TO TREAT AN UNRELATED HEART ISSUE, THE CATHETER PUSHED THE AFX2 BSG UP AND THE OVATION IX EXTENDER IN THE RCI SLIPPED OUT OF THE AFX2 BSG CAUSING A TYPE IB ENDOLEAK. REINTERVENTION OCCURRED ON (B)(6) 2025. REPORTEDLY, THE ILIAC WAS TORTUOUS. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO KEEP THE RIGHT ILIAC OPEN BUT FAILED AND WAS UNABLE TO PLACE A NEW, RIGHT COMMON ILIAC ARTERY GRAFT. THE PROCEDURE CONVERTED TO AN AORTO-UNI-I LIAC (AUI) WITH A LEFT TO RIGHT FEMORAL BYPASS. THE PATIENT WAS REPORTED AS HAVING NO ABDOMINAL PAIN AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797424 ↗
• InjuryMay 29, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT 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). BOTH LIMBS WERE 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. (REPORTED TO THE FDA ON MDR# 3008011247-2023-00067). ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED THAT THE RIGHT COMMON IS NOW ANEURYSMAL AND THE OVATION IX ILIAC LIMB NO LONGER HAS PURCHASE RESULTING IN A TYPE IB ENDOLEAK. REPORTEDLY, THE PATIENT HAD A SHORT ECTATIC COMMON ILIAC AND ON THE INITIAL ANGIOGRAM IT WAS DETERMINED THAT THE INTERNAL ILIAC ON THE RIGHT SIDE WAS NOT PATENT. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB STENT GRAFT. THE PROXIMAL PLACEMENT WAS AT

  Patient problems: Clinical Endoleak

  MAUDE report 22107334 ↗
• InjuryMar 11, 2025Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. APPROXIMATELY THREE (3) MONTHS AFTER THE INITIAL PROCEDURE, A LIMB OCCLUSION WAS DETECTED, REQUIRING AN ADDITIONAL FEMORAL-FEMORAL BYPASS SURGICAL PROCEDURE TO RESTORE BLOOD FLOW. THE FINAL PATIENT STATUS REMAINS UNKNOWN, AS IT WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21574169 ↗
• InjuryMay 3, 2024Improper or Incorrect Procedure or Method; Obstruction of Flow; Malposition of Device; Improper or Incorrect Procedure or Method; Obstruction of Flow; Malposition of Device

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. IT WAS REPORTED THAT THE PROCEDURE WAS CHALLENGING DUE TO ANGULATION AND A SHORT NECK. DESPITE THESE OBSTACLES, THE PHYSICIAN MANAGED TO IMPLANT THE ALTO STENT GRAFT AND PERFORM BALLOON DILATION 16 MINUTES AFTER POLYMER MIXING. BOTH LIMBS WERE POSITIONED WITHOUT DIFFICULTY. FOLLOWING THE IMPLANTATION, THERE WAS A NOTABLE AGGRESSIVE TYPE IA ENDOLEAK. TO ADDRESS THIS, A (NON-ENDOLOGIX) PALMAZ P4010 WITH A NEW CODA BALLOON WAS INTRODUCED, BUT THE IA ENDOLEAK PERSISTED AT A REDUCED RATE. ADDITIONAL ATTEMPTS WITH A Q50 BALLOON AND ZMED 25X40 BALLOON WERE UNSUCCESSFUL IN COMPLETELY HALTING THE IA ENDOLEAK. AS A FINAL MEASURE, A (NON-ENDOLOGIX) GORE EXCLUDER EXTENSION WAS DEPLOYED, RESULTING IN A SIGNIFICANT REDUCTION IN THE IA ENDOLEAK REPORTED UNDER MFR# 3008011247-2024-00018. ON FEBRUARY 27, 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BILATERAL LEG PAIN. IT WAS REPORTED THAT THE LEFT LOWER EXTREMITY APPEARED COLD, PALE, AND MOTTLED FROM THE KNEE DOWNWARDS WITH AN ABSENT DISTAL PULSE. THE LEFT COMMON ILIAC ARTERY (LCIA) WAS OCCLUDED, AND THERE WAS PARTIAL OCC

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 19241824 ↗
• InjuryDec 12, 2023Device Stenosis; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA WAS INTENTIONALLY OCCLUDED. AFTER IMPLANT OF THE ALTO MAIN BODY THERE WAS NO TYPE 1A ENDOLEAK NOTED. THE CONTRALATERAL LIMB WAS IMPLANTED ON THE RIGHT SIDE. DURING INSERTION OF THE IPSILATERAL ILIAC LIMB ON THE LEFT SIDE, THE ALTO MAIN BODY MOVED SLIGHTLY; HOWEVER, THE PHYSICIAN CONTINUED THE IMPLANT OF THE LIMB FOLLOWED BY AN ILIAC EXTENSION ON THE RIGHT SIDE. AN INDETERMINATE ENDOLEAK WAS OBSERVED AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT NOT TO PERFORM ANY FURTHER TREATMENT AT THAT TIME. REFERENCE MFR # 3008011247-2023-00198 FOR THIS EVENT. APPROXIMATELY THREE OR FOUR DAYS POST INITIAL PROCEDURE A CONTRAST COMPUTED TOMOGRAPHY (CT) WAS TAKEN PRIOR TO PATIENT DISCHARGE AND SHOWED LEFT LIMB STENOSIS AROUND THE TERMINAL AORTA. AN EMERGENCY INTERVENTION WAS PERFORMED AT THAT TIME AND A BARE STENT WAS IMPLANTED ON THE LEFT LIMB. IT WAS REPORTED THAT THE SIX (6) MONTH FOLLOW-UP CONTRAST CT SHOWED A POSSIBLE TYPE 1A ENDOLEAK. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 FOR ADDITIONAL EVALUATION AND T

  Patient problems: Stenosis

  MAUDE report 18312848 ↗
• InjuryMay 19, 2022Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM (ONE (1) ALTO MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS). APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, OCCLUSION OF THE LIMB WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THREE (3) OVATION IX ILIAC LIMBS. THE PATIENT WAS REPORTED TO BE DOING WELL POST REINTERVENTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14435373 ↗

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