Ovation iX Iliac Stent Graft Iliac Limb (REF TV-IL1422140-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M701TVIL1422140J1), received between Sep 30, 2016 and May 14, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017, WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RIGHT COMMON ILIAC GROWTH (UNKNOWN DIAMETER), WHICH RESULTED IN THE RIGHT ILIAC LIMB DEVICE BEING PUSHED INTO THE AORTA. THE PATIENT UNDERWENT A RE-INTERVENTION ON (B)(6) 2020. THE PHYSICIAN ELECTED TO IMPLANT AN ILIAC LIMB TO TREAT THIS EVENT. THE EVENT WAS CAPTURED UNDER MANUFACTURER REPORT NUMBER 3008011247-2020-00033. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT'S RIGHT COMMON ILIAC ARTERY HAD DILATED, CAUSING THE RIGHT COMMON ILIAC TO PULL UP PROXIMALLY, RESULTING IN A TYPE 1B ENDOLEAK. THE PATIENT IS IN STABLE CONDITION PENDING A RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 19315889 ↗
• InjuryOct 16, 2023Off-Label Use; Device-Device Incompatibility; Lack of Effect; Off-Label Use; Device-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A PALMAZ (NON-ENDOLOGIX) STENT AND UTILIZING A TRUE (NON-ENDOLOGIX) BALLOON ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. INTERNAL CLINICAL ASSESSMENT IDENTIFIED THAT SIGNIFICANT ANEURYSM ENLARGEMENT WAS NOTED PER OPERATIVE REPORT AND CT (COMPUTED TOMOGRAPHY) SCAN AT FOUR (4) DAYS POST SECONDARY INTERVENTION WITH A RECURRING (NON-DEVICE-RELATED) TYPE IA ENDOLEAK (RELATED TO INADEQUATE TREATMENT WITH THE PALMAZ (NON-ENDOLOGIX) STENT AND BALLOONING ON (B)(6) 2023). THE PHYSICIAN ELECTED TO FURTHER TREAT THE PATIENT BY IMPLANTING A PMEG (PHYSICIAN MODIFIED ENDOGRAFT) COOK (NON-ENDOLOGIX) FENESTRATED AORTIC CUFF ON (B)(6) 2023; THIS TERTIARY INTERVENTION RESULTED IN OCCLUSION OF THE RIGHT RENAL ARTERY, WHICH THEN CAUSED ACUTE KIDNEY INJURY (AKI). IN RESPONSE, THE PHYSICIAN PERFORMED A PERISCOPE OF THE LEFT RENAL AND CHIMNEY OF THE SMA (SUPERIOR MESENTERIC A

  Patient problems: Clinical Endoleak

  MAUDE report 17946406 ↗
• InjuryJul 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX INFRARENAL AORTIC EXTENSION. APPROXIMATELY SIX (6) YEARS AFTER THE POST-INITIAL PROCEDURE, ENDOLOGIX WAS MADE AWARE OF A TYPE 3B ENDOLEAK. A SECONDARY PROCEDURE WAS COMPLETED ON (B)(6) 2018 TO RESOLVE THE REPORTED TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT ONE (1) OVATION IX MAIN BODY, TWO (2) OVATION IX ILIAC LIMB GRAFT EXTENSIONS AND OVATION PRIME FILL POLYMER. REFERENCE MFR. REPORT # 2031527-2018-00588 FOR THIS PREVIOUS EVENT. APPROXIMATELY FOUR (4) YEARS POST-SECONDARY PROCEDURE ENDOLOGIX WAS NOTIFIED OF A TYPE 1B ENDOLEAK IN THE RIGHT ILIAC REGION. A RE-INTERVENTION WAS UNDERTAKEN, AND THE PHYSICIAN DECIDED TO IMPLANT AN ADDITIONAL OVATION IX ILIAC LIMB, AND COILED THE RIGHT HYPOGASTRIC ARTERY AND EXTENDED INTO THE EXTERNAL. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE.ADDITIONAL INFORMATION:A CLINICAL EVALUATION SHOWS REASONABLE EVIDENCE TO SUGGEST THAT SAC GROWTH OF 14MM ALSO OCCURRED. THE SAC GROWTH WAS DISCOVERED ON 08/17/2023, DURING A REVIEW OF THE COMPUTERIZED TOMOGRAPHY (CT) SCAN DATED 06/01/2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17330062 ↗
• InjuryJul 10, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2020. REPORTEDLY, DURING A ROUTINE FOLLOW-UP VISIT IN (B)(6) 2023, A TYPE II ENDOLEAK (NON-DEVICE RELATED) WAS IDENTIFIED; HOWEVER, NOT REPORTED TO ENDOLOGIX AT THE TIME. ON (B)(6) 2023, A PROCEDURE WAS PERFORMED TO COIL EMBOLIZE THE COLLATERAL VESSELS. DURING THE PROCEDURE ANGIOGRAM IDENTIFIED A TYPE IB ENDOLEAK. AN OVATION IX ILIAC LIMB WAS IMPLANTED AND SUCCESSFULLY SEALED THE TYPE IB ENDOLEAK. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 17289713 ↗
• InjuryApr 7, 2021Insufficient 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 (4) FOUR YEARS POST INITIAL IMPLANT THE PATIENT WAS IDENTIFIED WITH A TYPE 1B ENDOLEAK ON THE RIGHT SIDE. THE PHYSICIAN ELECTED TO IMPLANT THREE (3) ILIAC LIMB STENT GRAFTS TO RESOLVE THE REPORTED EVENT. THE PATIENT IS DOING WELL POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 11628688 ↗
• InjuryDec 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM (ONE (1) MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS) WITH AN ADDITIONAL OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH LEG AND ABDOMINAL PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED THE RIGHT ILIAC LIMB HAD RETRACTED OUT OF THE RIGHT ILIAC (NOT THE SOURCE OF ABDOMINAL PAIN). SUCCESSFUL RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN OVATION IX ILIAC LIMB. FINAL PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10997142 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PATIENT WAS DIAGNOSED WITH RENAL INSUFFICIENCY PRIOR TO THE INITIAL OVATION IMPLANT (PRE-EXISTING AND NON-AAA-RELATED). THE OVATION STENT GRAFT SYSTEM LANDED AND DEPLOYED AS EXPECTED DURING THE INITIAL PROCEDURE. APPROXIMATELY THREE (3) YEARS POST OP, THE ROUTINE FOLLOW-UP NON-CON CT IDENTIFIED AAA SAC GROWTH FROM 6CM TO 7CM COMPARED TO THE PREVIOUS YEAR IN ADDITION TO A POSSIBLE TYPE 1B OR TYPE II ENDOLEAK. THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8537501 ↗
• InjuryDec 27, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH THE OVATION IX SEALING SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE DURING S ROUTING FOLLOW UP, A TYPE 1B ENDOLEAK IN LEFT ILIAC WAS DISCOVERED BY A CT SCAN. RE-INTERVENTION WAS COMPLETED WHERE A 14X160 OVATION LIMB WAS PLACED WITH COILING OF THE HYPO GASTRIC ARTERY SUCCESSFULLY RESOLVING THE LEAK. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8201510 ↗
• InjuryOct 17, 2018Obstruction of Flow; Obstruction of Flow

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS DISCOVERED DURING A ROUTINE FOLLOW-UP CT THAT THE PATIENT HAS A RIGHT SIDE OVATION LIMB THAT IS OCCLUDED. THE PATIENT REPORTED EXPERIENCING CLAUDATION AT THE FOLLOW-UP VISIT. PATIENT IS CURRENTLY STABLE. REPORTEDLY, THERE ARE PLANS TO TREAT THE OCCLUSION WITH THROMBECTOMY/EMBOLECTOMY AND KISSING STENTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Claudication; Failure of Implant; Occlusion

  MAUDE report 7974790 ↗
• InjuryMar 12, 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 8 MONTH FOLLOW-UP SHOWED THE PRESENCE OF A TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT. A RE-INTERVENTION IS PLANNED AT A LATER DATE TO TREAT THE ENDOLEAK WITH THE PLACEMENT OF AN ILIAC LIMB EXTENSION 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: Aneurysm; Failure of Implant

  MAUDE report 7331177 ↗
• InjuryNov 2, 2017Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A 6 MONTH FOLLOW-UP WHERE CT REVEALED POSSIBLE LEFT LIMB THROMBOSIS. THERE ARE CURRENTLY NO PLANS FOR RE-INTERVENTION. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion; Thrombosis

  MAUDE report 6998119 ↗
• InjurySep 30, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MON TH FOLLOW-UP CT SHOWED THE PRESENCE OF A POTENTIAL TYPE IB ENDOLEAK. A RE-INTERVENTION WAS PERFORMED TO PLACE AN ADDITIONAL ILIAC LIMB STENT GRAFT TO EXTEND THE DISTAL SEAL SUCCESSFULLY RESOLVING THE TYPE IB ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5991913 ↗