Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1418140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1418140J1), received between Apr 8, 2017 and Sep 14, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

• InjurySep 14, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM AND (2) TWO OVATION IX ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) FOUR MONTHS POST INITIAL PROCEDURE, A RIGHT COMMON ILIAC OCCLUSION THAT CAUSED THE GRAFT TO SHUT DOWN ON THE RIGHT WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP. A RE-INTERVENTION WAS PERFORMED, THE PHYSICIAN ELECTED TO BALLOON THE BILATERAL LIMBS AT THE DIVIDER TO EXTENDED BOTH LIMBS PROXIMALLY TO THE RINGS. THE PHYSICIAN ALSO IMPLANTED (2) TWO OVATION IX ILIAC LIMBS. THE FINAL PATIENT STATUS WAS REPORTED AS BEING GOOD. (REPORTED UNDER MFR # 3008011247-2021-00071). APPROXIMATELY TWO (2) MONTHS POST REINTERVENTION, IT WAS IDENTIFIED AT ROUTINE FOLLOW-UP THAT THE RIGHT COMMON ILIAC HAD BECOME OCCLUDED ONCE MORE. THE PHYSICIAN ELECTED TO ASPIRATE USING A PENUMBRA LIGHTNING 12 (NON-ENDOLOGIX). ADDITIONALLY, TWO (2) ATRIUM (NON-ENDOLOGIX) BALLOON EXPANDABLE PTFE COVERED STENTS WERE PLACED TO THE RING AND A EXTENDING THE LIMB. THE RESULTS WERE GOOD AND THE PATIENT WAS REPORTED TO BE WELL.

  Patient problems: Failure of Implant

  MAUDE report 12469125 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A POSSIBLE LIMB OCCLUSION. THE PHYSICIAN ELECTED TO EXTEND BOTH LIMBS WITH TWO (2) OVATION IX EXTENDER DEVICES ON (B)(6) 2020.

  Patient problems: Occlusion; Thrombosis

  MAUDE report 9814316 ↗
• InjuryJan 21, 2020Migration; Migration

  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 (EXACT DATE WAS NOT PROVIDED), THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK DUE TO MIGRATION OF THE LEFT LIMB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB ON (B)(6) 2019. RE-INTERVENTION WAS SUCCESSFUL AND THE ENDOLEAK WAS CONFIRMED RESOLVED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9613326 ↗
• InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, A LIMB OCCLUSION WAS IDENTIFIED ON UNKNOWN DATE. THE PATIENT WAS TREATED; LYSED AND RELINED WITH VBX (NON-ENDOLOGIX) ON AN UNKNOWN DATE AND REPORTED AS DOING WELL.

  Patient problems: Occlusion

  MAUDE report 9119187 ↗
• InjuryJul 30, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, A TYPE IB ENDOLEAK WAS DETECTED DURING ROUTINE FOLLOW-UP. THE PATIENT'S ANEURYSM RUPTURED THE FOLLOWING MORNING ON (B)(6) 2019 AND THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) ADDITIONAL ILIAC LIMB OVATION IX DEVICES. THE PATIENT IS REPORTEDLY DOING WELL POST RE-INTERVENTION, AND THE RUPTURE AND ENDOLEAK WERE SUCCESSFULLY RESOLVED.

  Patient problems: Rupture

  MAUDE report 8843142 ↗
• InjuryDec 14, 2018Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT REFUTING THE REPORTED TYPE IB ENDOLEAK AND RATHER, A TYPE IA AND TYPE II ENDOLEAKS WITH ANEURYSM ENLARGEMENT WERE CONFIRMED PRESENT AT THE TIME OF THE EVENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8166980 ↗
• InjuryFeb 28, 2018Malposition of Device; Malposition of Device

  AN OVATION IX ILIAC LIMB STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING PLACEMENT OF THE IPSILATERAL LIMB, THE PHYSICIAN MISTAKENLY PLACED THE LIMB ABOVE THE CELIAC ARTERY AND SMA. ANOTHER 18 MM LIMB WAS PLACED UP THE IPSILATERAL LIMB TO EXTEND IT TO THE LEVEL OF THE 2ND SEALING RING OF THE MAIN BODY. THE CONTRALATERAL LIMB WAS PLACED WITHOUT ISSUE AND THE FINAL ANGIO REVEALED ADEQUATE SEAL OF THE ANEURYSM. THE PATIENT IS REPORTED TO BE IN EXCELLENT CONDITION, HOWEVER, THE PHYSICIAN IS CONCERNED ABOUT THE LONG TERM DURABILITY OF THE AORTIC FLOW DUE TO THE ISPI LIMB BEING EXTENDED INTO THE SUPRARENAL AORTA. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Stenosis

  MAUDE report 7304147 ↗
• InjuryApr 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A ROUTINE FOLLOW-UP ANGIO WAS COMPLETED APPROXIMATELY 1 MONTH POST-OP SHOWING A POSSIBLE TYPE IB ENDOLEAK. THE PHYSICIAN ELECTED TO COMPLETE A RE-INTERVENTION IMPLANTING AN OVATION LIMB; PATIENT'S RIGHT, WHICH SUCCESSFULLY RESOLVED THE REPORTED ENDOLEAK. THE PATIENT WAS REPORTED AS WELL AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6474434 ↗