Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1414140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVIL1414140J1), received between Jul 9, 2016 and Feb 13, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (3 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.

• InjuryFeb 13, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL PROCEDURE, THE PHYSICIAN ALSO REPAIRED THE PATIENT'S RIGHT ILIAC ARTERY (DISTAL TO THE OVATION LIMB), AND A PERFORATION WAS SEEN ON ANGIOGRAM. THEREFORE, THE PHYSICIAN IMPLANTED TWO (2) VBX (NON-ENDOLOGIX) STENTS; THIS IS AN OFF-LABEL PROCEDURE DUE TO NONCOMPATIBLE USE OF OVATION WITH A NON-ENDOLOGIX DEVICE. THIS REPORT IS TO ADDRESS THE INTRAOPERATIVE PERFORATION EVENT. A FEW HOURS POST INITIAL PROCEDURE, THE PATIENT WAS NOTED TO STILL BE BLEEDING. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB DEVICE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. REFERENCE MFR. REPORT # 3008011247-2020-00023 FOR POSTOPERATIVE BLEEDING EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 9709176 ↗
• InjuryFeb 13, 2020Use of Device Problem; Use of Device Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL PROCEDURE, THE PHYSICIAN ALSO REPAIRED THE PATIENT'S RIGHT ILIAC ARTERY (DISTAL TO THE OVATION LIMB), AND A PERFORATION WAS SEEN ON ANGIOGRAM. THEREFORE, THE PHYSICIAN IMPLANTED TWO (2) VBX (NON-ENDOLOGIX) STENTS; THIS IS AN OFF-LABEL PROCEDURE DUE TO NONCOMPATIBLE USE OF OVATION WITH A NON-ENDOLOGIX DEVICE. A FEW HOURS POST INITIAL PROCEDURE, THE PATIENT WAS NOTED TO STILL BE BLEEDING. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL OVATION IX ILIAC LIMB DEVICE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Blood Loss; Failure of Implant

  MAUDE report 9709173 ↗
• InjuryAug 21, 2018Obstruction of Flow; Obstruction of Flow

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2017. RECENTLY, ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL WITH OCCLUDED ENDOGRAFT WITH BILATERAL LIMB ISCHEMIA. RE-INTERVENTION WAS PERFORMED ON (B)(6) 2018 AT A HOSPITAL NOT AFFILIATED WITH ENDOLOGIX; THEREFORE, NO INFORMATION COULD BE OBTAINED REGARDING THE SECONDARY PROCEDURE.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7801100 ↗
• InjuryMay 30, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REPORTED THAT AT THE ROUTINE 2 MONTH FOLLOW-UP, THE PATIENT PRESENTED WITH A POTENTIAL TYPE IB ENDOLEAK. A RE-INTERVENTION WAS PERFORMED WHERE AN ADDITIONAL EXTENSION WAS PLACED TO EXTEND THE DISTAL SEAL. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 7553682 ↗
• InjuryMay 17, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  THE PATIENT WAS INITIALLY TREATED WITH OVATION IX. ENDOLOGIX WAS RECENTLY MADE AWARE FROM THE PHYSICIAN THAT THE PATIENT UNDERWENT A SECONDARY PROCEDURE FOR AN OCCLUDED LIMB. THE PATIENT WAS REPORTEDLY LOST THE PATIENT TO FOLLOW-UP HOWEVER, WAS CALLED TO THE ER FOR A LEFT LIMB OCCLUSION WHICH MAY HAVE BEEN OCCLUDED FOR AN EXTENDED LENGTH OF TIME BECAUSE THE PATIENT REVEALED THAT THERE HAD BEEN PAIN IN THE LEFT LEG SOON AFTER THE INITIAL PROCEDURE. THE RADIOLOGIST CONFIRMED SEEING THE PATIENT ON (B)(6) 2017; APPROXIMATELY 14 MONTHS POST-OP. AT THE RECENT ER VISIT, THE IMPLANTING PHYSICIAN ELECTED TO TREAT THE PATIENT BY FEM/FEM AND RELINE FLOW TO THE PATIENT'S LEFT LEG. THIS SECONDARY WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2018. THE CURRENT PATIENT CONDITION IS REPORTED AS FINE WITH NO PAIN IN EITHER LEG, NO EVIDENCE OF ANY ENDOLEAK. THE PHYSICIAN HAS SHARED THAT THE PATIENT WILL BE MONITORED UNDER HIS CARE FOR FUTURE FOLLOW-UPS.

  Patient problems: Occlusion; Pain

  MAUDE report 7523976 ↗
• InjuryFeb 13, 2018Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS ON-LABEL FOR THE OVATION IX SYSTEM. THE STENT MID-CROWN WAS DEPLOYED AND PARALLAX WAS CORRECTED; A NEW ANGIO WAS DONE TO RETRACE THE INFRARENAL ARTERY (IR) ON THE SCREEN. THE PATIENT HAD A RAPID CONICAL NECK AND NEEDED A PRECISE PLACEMENT TO OBTAIN A SEAL. IT WAS NOTED THAT THE PATIENT WAS NOT ASLEEP AND COOPERATION FROM THE PATIENT FOR A BREATH HOLD WAS REQUESTED BY THE VASCULAR SURGEON. THE PATIENT DID NOT COMPLETELY STOP BREATHING AND THERE WAS MOVEMENT EVIDENT ON THE IMAGING. THE INTERVENTIONAL RADIOLOGIST REQUESTED A SECOND ANGIO FOR MORE PRECISION AND THE VASCULAR SURGEON DECLINED AND SAID THAT THE IMAGES OBTAINED WOULD SUFFICE. THE PIG TAIL WAS REMOVED AND THE PROXIMAL CROWN WAS DEPLOYED; THE POLYMER WAS MIXED AND INJECTED. THE CONTRA GATE WAS CANNULATED AND CONTRA LIMB WAS DEPLOYED. AT 20 MINUTES POST POLYMER INJECTION A CONTROL ANGIO WAS SUGGESTED BY THE REP TO CONFIRM SEAL AND DECIDE ON THE NEED FOR A LARGE DIAMETER RING BALLOONING (SINCE THERE WAS PRESENCE OF THROMBUS IN THE SEAL ZONE); THE CONTROL ANGIO SHOWED THAT THE GRAFT WAS APPROXIMATELY 10 MM BELOW THE F

  Patient problems: Failure of Implant

  MAUDE report 7266526 ↗
• InjuryAug 4, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 5 MONTH POST-OPERATIVE ANGIOGRAPHIC IMAGING SHOWED THE PRESENCE OF AN OCCLUSION OF THE ILIAC LIMB STENT GRAFT. A THROMBECTOMY RE-INTERVENTION WAS PERFORMED FOLLOWED BY THE PLACEMENT OF A BALLOON EXPANDABLE STENT WITHIN THE ILIAC LIMB STENT GRAFT TO MAINTAIN PATENCY. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5848945 ↗
• InjuryJul 9, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE NATIVE AORTIC BIFURCATION WAS NARROW; HOWEVER, THE BILATERAL ILIAC LIMB STENT GRAFTS WERE PATENT AT THE COMPLETION OF THE INDEX PROCEDURE. LESS THAN 24 HOURS POST-OP, THE PATIENT EXPERIENCED A "COLD LEFT LEG" AND A POTENTIAL OCCLUSION OF THE LEFT ILIAC LIMB STENT GRAFT. A RE-INTERVENTION WAS PERFORMED SUCCESSFULLY RESOLVING THE OCCLUSION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5780929 ↗