Ovation Prime Abominal Stent Graft System Iliac LimbRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M701TVIL1412120E1), received between Feb 7, 2016 and Mar 17, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2023Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SEVEN (7) YEARS AFTER THE POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM ORIGINATING FROM THE ILIAC ARTERY. ONE OF THE ILIAC LIMBS HAD RETRACTED BACK INTO THE SAC WHILE THE OTHER HAD MINIMAL PURCHASE IN THE ILIAC. THE PATIENT UNDERWENT A RE-INTERVENTION WHERE TWO (2) OVATION IX ILIAC LIMBS WERE IMPLANTED. THE PATIENT'S CURRENT CONDITION IS STABLE IN THE POST-EVENT PHASE.

  Patient problems: Clinical Endoleak; Rupture

  MAUDE report 16566334 ↗
• InjuryNov 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 8 MONTH POST-OPERATIVE CT SHOWED PRESENCE OF THROMBUS IN THE RIGHT ILIAC LIMB. 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: Thrombus

  MAUDE report 6082251 ↗
• InjuryFeb 7, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. THE 1 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF AN OCCLUSION OF THE LEFT ILIAC LIMB WITH A RECONSTITUTION OF FLOW IN THE LEFT INTERNAL AND EXTERNAL ILIAC ARTERIES AT THEIR ORIGIN THROUGH LUMBAR COLLATERAL VESSELS. AN ATHERECTOMY RE-INTERVENTION WAS PERFORMED TO SUCCESSFULLY RESOLVE THE OCCLUDED ILIAC LIMB. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5415350 ↗