Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1412160-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1412160J1), received between Oct 15, 2015 and Dec 16, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM AND AN ADDITIONAL LIMB EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, A COMPUTERIZED TOMOGRAPHY (CT) IMAGE REVEALED A TYPE A TYPE 1B ENDOLEAK ON THE LEFT COMMON ILIAC ARTERY. THE PATIENT IS REPORTEDLY DOING FINE AND AWAITING RE-INTERVENTION. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO IMPLANT TWO (2) ILIAC LIMBS TO RESOLVE THE TYPE 1B ENDOLEAK. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11024084 ↗
• InjuryJun 11, 2020Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) OVATION IX LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INTENDED OF USE DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX2 STENT. APPROXIMATELY SEVEN (7) MONTHS LATER, A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) HAD IDENTIFIED THAT THE OVATION IX LEFT LIMB STENT GRAFT HAD MIGRATED INTO THE ILIAC ANEURYSM CAUSING A TYPE 1B ENDOLEAK WITH ANEURYSM ENLARGEMENT OF THE LEFT ILIAC ARTERY. THE PHYSICIAN COMPLETED A SUCCESSFUL RE-INTERVENTION WITH IMPLANTING AN ADDITIONAL OVATION IX LIMB STENT GRAFT. THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 10143566 ↗
• InjuryApr 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY (CT). AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER ILIAC LIMB TO RESOLVE THIS EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION: THE TYPE IIIA ENDOLEAK (AORTIC) COMPLAINT IS CONFIRMED FROM MEDICAL RECORDS ONLY.

  Patient problems: Failure of Implant

  MAUDE report 9955747 ↗
• InjuryMay 14, 2019Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM, TWO ADDITIONAL OVATION IX ILIAC LIMBS, A NON- ENDOLOGIX HYPO STENT AND NON- ENDOLOGIX COILS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE RIGHT SIDE WAS TREATED WITH THE (NON- ENDOLOGIX) HYPO COVERED STENT IMPLANTED PARALLEL TO THE SECOND OVATION IX ILIAC LIMB (HYPO-SNORKEL PROCEDURE) WHICH WAS PLACED DISTAL OF THE FIRST OVATION IX ILIAC LIMB. THE LEFT SIDE WAS TREATED WITH THE SECOND OVATION IX ILIAC LIMB WHICH WAS PLACED TO FURTHER EXTEND IN ADDITION TO NON-ENDOLOGIX COILS. THE INITIAL PROCEDURE WAS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL). APPROXIMATELY 14 (FOURTEEN) MONTHS POST-OP, A TYPE 3A ENDOLEAK AND A TYPE 2 ENDOLEAK WITH COMPLETE COMPONENT SEPARATION ON THE RIGHT SIDE BETWEEN THE TWO OVATION IX ILIAC LIMBS AND THE NON- ENDOLOGIX HYPO COVERED STENT WAS IDENTIFIED. TWO (2) DAYS POST IDENTIFIED ADVERSE EVENT AND DEVICE MALFUNCTION, THE RIGHT ILIAC RUPTURED AND EMERGENCY RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO IMPLANT TWO ADDITIONAL OVATION IX ILIAC LIMBS ACROSS THE SEPARATED OVATION IX ILIAC LIMBS AND COILS (NON- ENDOLOGIX). THE PATIENT WAS REPORTED AS DOING WELL POST-SECONDARY PROCEDURE.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 8610102 ↗
• InjuryAug 17, 2018Partial Blockage; Partial Blockage

  ON (B)(6) 2018, AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF OCCLUSION OF THE LEFT ILIAC. ON (B)(6) 2015, THE PHYSICIAN ELECTED TO IMPLANT AN ILIAC LIMB TO RESOLVE THIS EVENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7795275 ↗
• InjuryApr 27, 2018Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR AN UNKNOWN REASON WHERE PHYSICIAN OBSERVED NARROWING OF THE SEALING RINGS AND OCCLUSION OF THE RIGHT ILIAC LIMB. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A PALMAZ STENT IN THE AORTIC BODY STENT GRAFT AND PERFORMING A THROMBECTOMY OF THE RIGHT ILIAC LIMB. STENTS WERE PLACED IN THE PROXIMAL PORTION OF THE LIMBS AS WELL. THE PROCEDURE WAS SUCCESSFUL, WITH THE FINAL ANGIO SHOWING RESTORED FLOW THROUGH THE AORTIC BODY DOWN TO THE LOWER EXTREMITIES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7468696 ↗
• InjuryMar 21, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE WITH COMPLAINTS OF BACK PAIN. A CT WAS PERFORMED WHERE PHYSICIAN OBSERVED A TYPE IB ENDOLEAK DUE TO GROWTH OF THE RIGHT COMMON ILIAC ARTERY SINCE INITIAL IMPLANT. IT WAS NOTED THAT THE INITIAL IMPLANT PROCEDURE WAS SUCCESSFUL WITH NO ENDOLEAKS. THE PATIENT WAS TRANSFERRED TO BAYLOR ST. LUKE'S IN HOUSTON WHERE PHYSICIAN THERE ELECTED TO PERFORM A RE-INTERVENTION BY PLACING COILS IN THE RIGHT HYPOGASTRIC AND EXTENDED THE RIGHT ILIAC LIMB WITH AN ADDITIONAL OVATION LIMB. THE RE-INTERVENTION WAS SUCCESSFUL AND PATIENT IS REPORTED AS DOING WELL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7357572 ↗
• InjuryOct 15, 2015Occlusion Within Device

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AND OVATION IX ILIAC STENT GRAFTS WERE IMPLANTED TO TREAT AN EMERGENT PRE-EXISTING AORTIC RUPTURE. ONE DAY FOLLOWING THE EMERGENT EVAR PROCEDURE, THE PATIENT PRESENTED WITH A COMPLETE OCCLUSION OF THE LEFT ILIAC LIMB STENT GRAFT IN THE PRESENCE OF SIGNIFICANT AORTIC ANGULATION AND TORTUOUS COMMON ILIAC ARTERIES. A FEM BYPASS PROCEDURE WAS COMPLETED ON THE SAME DAY TO SUCCESSFULLY RESTORE BLOOD FLOW TO THE OCCLUDED ILIAC ARTERY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5155173 ↗