Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1422120-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M701TVIL1422120J1), received between Dec 20, 2017 and Dec 5, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2020Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM AND TWO (2) OVATION IX ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, AT IMPLANT, THE LIMBS WERE CROSSED. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE THE RIGHT OVATION IX ILIAC LIMB HAD SLIPPED OUT OF THE OVATION IX MAIN BODY. SUCCESSFUL REINTERVENTION WAS COMPLETED WITH CANNULATION OF THE MAIN BODY BY IMPLANTING AN OVATION IX ILIAC LIMB BRIDGING THE MAIN BODY TO THE ILIAC LIMB THAT SLIPPED OUT. FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED ON DAY POST RE-INTERVENTION AND FINE. PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10950380 ↗
• InjuryAug 12, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, A RIGHT-SIDE TYPE IB ENDOLEAK WAS DETECTED BY CT (COMPUTED TOPOGRAPHY) DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EMBOLIZING THE HYPOGASTRIC ARTERY AND IMPLANTING AN ADDITIONAL ILIAC LIMB OVATION IX DEVICE ON (B)(6) 2019. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY DOING WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THE INITIAL IMPLANT WAS AN OFF-LABEL CASE DUE TO RIGHT CORONARY ILIAC ARTERY MEASURING AT 50.6MM (IFU STATES THE MEASUREMENT SHOULD BE BETWEEN 8- 25MM) AND THE SAC SIZE WAS 70.2MM.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8885913 ↗
• InjuryFeb 5, 2019Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 30 DAY POST OP CTA IDENTIFIED A BILATERAL TYPE 1B ENDOLEAK. RE-INTERVENTION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2019, WITH IMPLANT OF TWO OVATION IX ILIAC LIMB EXTENSIONS.

  Patient problems: Aneurysm; Failure of Implant; Occlusion

  MAUDE report 8307533 ↗
• InjuryOct 5, 2018Leak/Splash; Leak/Splash

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON 09/05/2018 FOR A PERVIOUS REPORT EVENT (3008011247-2018-00168), CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDINGS OF A TYPE 1A ENDOLEAK OF THE MAIN BODY. THIS REPORT IS FOR THE TYPE 1A ENDOLEAK OF THE MAIN BODY ONLY

  Patient problems: Failure of Implant

  MAUDE report 7939064 ↗
• InjuryAug 1, 2018Leak/Splash; Unintended Movement; Leak/Splash; Unintended Movement

  AT THE COMPLETION OF THE CLINICAL ASSESSMENT ON (B)(6) 2018, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING ADDITIONAL FINDINGS OF A TYPE 1A ENDOLEAK OF THE MAIN BODY. A SEPARATE REPORT WILL BE FILED FOR THIS ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 7741541 ↗
• InjuryJul 18, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2017, THE OVATION SEALING SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 1B ENDOLEAK WITH SAC GROWTH. A SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2018. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) ILIAC LIMBS. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7698574 ↗
• InjuryMay 2, 2018Leak/Splash; Leak/Splash

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR AN UNKNOWN REASON WHERE A POTENTIAL TYPE IB ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT SINCE THE PATIENT IS CURRENTLY UNDERGOING CHEMOTHERAPY AND WILL PERFORM A FOLLOW-UP CT AT AN UNSCHEDULED DATE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7479725 ↗
• InjuryJan 8, 2018Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE INITIAL PROCEDURE CONCLUDED WITHOUT ISSUE. PATIENT RETURNED ONE WEEK POST INDEX PROCEDURE WITH LEFT LIMB OCCLUSION AND HAD A BALLOON EXPANDABLE STENT IMPLANTED IN THE LEFT LIMB. THIS DID NOT RESOLVE THE OCCLUSION AND ANOTHER PHYSICIAN PERFORMED A FEM-FEM ON THE PATIENT, WHICH WAS UNSUCCESSFUL. A THIRD PHYSICIAN ATTEMPTED ANOTHER FEM-FEM, WHICH WAS ALSO UNSUCCESSFUL. THE IMPLANTING PHYSICIAN RE-INTERVENED A THIRD TIME WHERE BRACHIAL ACCESS WAS USED TO BALLOON THE LEFT LIMB, SUCCESSFULLY RESOLVING THE OCCLUSION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Claudication; Failure of Implant; Occlusion; Thrombosis

  MAUDE report 7173565 ↗
• InjuryDec 20, 2017Malposition of Device; Malposition of Device

  UPON THE CLINICAL ASSESSMENT OF THIS EVENT, IT WAS DISCOVERED THAT THE RIGHT OVATION LIMB WAS THE POTENTIAL CAUSE FOR THE RIGHT HYPOGASTRIC OCCLUSION.

  Patient problems: Not Applicable

  MAUDE report 7134128 ↗