Ovation Prime Abdominal Stent Graft System Aortic Body (REF TV-AB2380-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M701TVAB2380E1), received between Aug 28, 2015 and Aug 30, 2022 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2022Complete Blockage; Off-Label Use; Complete Blockage; Off-Label Use

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION PRIME STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED AT THE DOCTOR'S OFFICE IN A WHEELCHAIR AND WAS SENT TO THE HOSPITAL TO BE ADMITTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP AND HAD STOPPED TAKING THEIR MEDICATION (XARALTO). THE GRAFT WAS FOUND TO HAVE THROMBOSED AND THE CLOT LOOKED CHRONIC. THE PHYSICIAN ELECTED TO PERFORM AN OPEN THROMBECTOMY FOLLOWED BY IMPLANT OF AN OVATION IX 12X120 ILIAC LIMB IN THE RIGHT COMMON ILIAC ARTERY / EXTERNAL ILIAC ARTERY (CIA/EIA), WITH RIGHT TO LEFT FEM/FEM BYPASS TO RESOLVE THIS EVENT. THE PATIENT WAS DISCHARGED TWO (2) DAYS LATER.

  Patient problems: Failure of Implant; Thrombosis/Thrombus

  MAUDE report 15324291 ↗
• InjurySep 25, 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 PRIME ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY 5.5 YEARS POST-OP, ANEURYSM SAC GROWTH OF APPROXIMATELY 1.5CM WAS OBSERVED WITHOUT THE PRESENCE OF ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE IMPLANTING TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS. THE PATIENT TOLERATED THE PROCEDURE AND WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: THE REPORTED NO PRESENCE OF ENDOLEAK WAS REFUTED AS THERE WAS A TYPE 2 ENDOLEAK IDENTIFIED DURING CLINICAL ASSESSMENT. THIS IS A NON- DEVICE RELATED FAILURE.

  Patient problems: Aneurysm

  MAUDE report 9120912 ↗
• InjuryJun 11, 2018Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2015. ENDOLOGIX WAS MADE AWARE OF AN ENLARGED AAA ON A PATIENT DURING A ROUTINE FOLLOW UP CT. IT WAS NOTED THAT THE AAA HAS GROWN 1CM SINCE THE INITIAL IMPLANT. PHYSICIAN ALSO OBSERVED IN THE CT A SLIGHT BLUSH OF CONTRAST AROUND THE AORTIC BODY INDICATING A LEAK OF UNKNOWN ORIGIN. PATIENT CONTINUES TO BE MONITORED, THERE WERE NO DISCUSSION ON A REINTERVENTION, PATIENT WILL BE MONITORED. PATIENT CONDITION IS GOOD OTHERWISE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7589553 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY ONE MONTH POST INDEX PROCEDURE WITH ABDOMINAL PAIN AND FEVER. THE PATIENT'S LAB REPORT DID NOT SHOW ANY SIGN OF INFECTION OR INFLAMMATION, HOWEVER, THE PHYSICIAN RE-INTERVENED BY DRAINING THE ANEURYSM SAC. AFTER THE DRAINING WAS COMPLETED, THE PATIENT'S FEVER AND PAIN RESOLVED. THE PATIENT IS REPORT TO BE DOING WELL AND AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7479689 ↗
• InjuryMar 12, 2018Leak/Splash; Leak/Splash

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY 4 YEARS POST INDEX PROCEDURE WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A NON-ENDOLOGIX CUFF AT THE LEVEL OF THE SEALING RINGS, SUCCESSFULLY RESOLVING THE ENDOLEAK. IT WAS ALSO NOTED DURING THE RE-INTERVENTION THAT THERE WAS NARROWING OF THE AORTIC NECK AT THE LEVEL OF THE SEALING RINGS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 7331142 ↗
• InjuryMar 16, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING. AS OF THE DATE OF THIS REPORT, THE PATIENT WILL CONTINUE TO BE MONITORED AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; No Consequences Or Impact To Patient

  MAUDE report 5506261 ↗
• DeathAug 28, 2015Leak/Splash; Improper or Incorrect Procedure or Method; Malposition of Device; Device Dislodged or Dislocated

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC BODY DELIVERY SYSTEM WAS INADVERTENTLY RETRACTED PRIOR TO REMOVAL OF THE 3RD RELEASE WIRE KNOB, RESULTING IN DISPLACEMENT OF THE STENT GRAFT AND A TYPE IA ENDOLEAK, WHICH WAS SUCCESSFULLY RESOLVED FOLLOWING THE PLACEMENT OF A BALLOON EXPANDABLE STENT AND TWO AORTIC CUFFS IN THE SEAL ZONE, AND BILATERAL COVERED STENTS IN THE RENAL AND SUPERIOR MESENTERIC ARTERIES. BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN, THE PATIENT EXPIRED TWELVE DAYS POST-OP DUE TO MESENTERIC ISCHEMIA AND BOWEL INFARCTION. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE BUT RATHER A POST-OPERATIVE COMPLICATION FROM THROMBUS DISPLACEMENT DURING THE EVAR PROCEDURE.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Ischemia; Occlusion; Tissue Damage

  MAUDE report 5038937 ↗