Ovation Prime Abdominal Stent Graft System Aortic Body (REF TV-AB2980-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M701TVAB2980E1), received between Aug 28, 2015 and Sep 27, 2024 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION PRIME STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT AND HALF (8.5) YEARS POST INITIAL PROCEDURE, THE AAA WAS FOUND TO HAVE STILL BEEN GROWING. ONLY COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED TO DETECT THE ANEURYSM GROWTH AND NO ANGIOGRAM WAS DONE; HOWEVER, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS IN (B)(6) 2024 (EXACT DATE IS UNKNOWN). THE GRAFT WAS FULLY INTACT WHEN EXPLANTED BUT IT WAS COVERED IN BILE AND PUS. THE PROXIMAL FIXATION STENT OF THE OVATION PRIME WAS NOT EXPLANTED AND REMAINED IN THE PATIENT. THE EXPLANTED STENT GRAFTS WERE NOT RETURNED AND THE FINAL PATIENT STATUS AT THE TIME WAS NOT REPORTED TO ENDOLOGIX.

  Patient problems: Aneurysm

  MAUDE report 20325324 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST OP, ON AN UNKNOWN DATE IN (B)(6) 2018, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND A SUSPECTED TYPE 1A ENDOLEAK. THE PHYSICIAN TREATED THE PATIENT BY IMPLANTING A NON-ENDOLOGIX (COOK MEDICAL) ZFEN GRAFT ATTEMPTING TO RESOLVE THE TYPE 1A ENDOLEAK. APPROXIMATELY FOUR (4) MONTHS POST RE-INTERVENTION, THE PATIENT PRESENTED TO A SCHEDULED VISIT WITH SEVERE LIFESTYLE LIMITING CLAUDICATION AND NONPALPABLE BILATERAL FEMORAL PULSES. ANGIOGRAM IDENTIFIED SEVERE HIGH GRADE STENOSIS 2CM ABOVE THE FLOW DIVIDER. BALLOONING WAS PERFORMED TO INCREASE BLOOD FLOW. REPORTEDLY, THE EVENT OF STENOSIS WAS DUE TO ENFOLDING OF THE NON-ENDOLOGIX (ZFEN) STENT WITHIN THE OVATION PRIME RINGS AND WAS NOT RELATED TO THE ENDOLOGIX DEVICE. PATIENT HAD PALPABLE FEMORAL PULSES POST ADDITIONAL RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8525438 ↗
• InjuryOct 31, 2018Leak/Splash; Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A TYPE 1A ENDOLEAK WAS IDENTIFIED AT A ROUTINE FOLLOW-UP VISIT. PATIENT IS REPORTED TO BE STABLE. THE TREATMENT PLAN IS TO BALLOON WITH NON-COMPLIANT BALLOON TO TRY TO GAIN A FEW MM'S OF DIAMETER TO OPPOSE WALL. SECONDARY TREATMENT HAS NOT YET BEEN SCHEDULED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 8025038 ↗
• InjuryNov 30, 2017Human-Device Interface Problem; Human-Device Interface Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED APPROXIMATELY 3 YEARS POST INDEX PROCEDURE WITH AN INFECTED GRAFT, AND THE PHYSICIAN DECIDED TO EXPLANT THE GRAFT. THE EXPLANT PROCEDURE WENT AS EXPECTED, HOWEVER, COMPLICATIONS FROM THE SURGERY LED TO PATIENT EXPIRATION ONE DAY POST INTERVENTION.

  Patient problems: Bacterial Infection; Death; Renal Failure; Respiratory Failure; Sepsis

  MAUDE report 7070822 ↗
• InjuryJan 13, 2016Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF AN UNRESOLVED TYPE IA ENDOLEAK DUE TO THE AORTIC BODY STENT GRAFT SEALING RINGS BEING LOCATED IN AN AORTIC DIAMETER OUTSIDE THE TREATMENT RANGE FOR THE IMPLANTED STENT GRAFT. A RE-INTERVENTION WAS PERFORMED 5 DAYS POST-OP TO PLACE AN AORTIC CUFF AT THE LEVEL OF THE SEALING RINGS WHICH SUCCESSFULLY RESOLVED THE TYPE IA ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5365629 ↗
• InjuryDec 4, 2015Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE IMPLANTING PHYSICIAN REPORTED HE WAS INFORMED VIA ANOTHER PHYSICIAN THAT THE PATIENT HAD PRESENTED ON AN UNKNOWN DATE POST-OP TO A DIFFERENT HOSPITAL WITH AN ABSENT FEMORAL PULSE AND POSSIBLE DISENGAGEMENT OF THE ILIAC LIMB FROM THE AORTIC BODY STENT GRAFT WITH PLANS FOR A RE-INTERVENTION AT A LATER DATE; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO CONFIRM PATIENT STATUS AND/OR WHETHER ANY RE-INTERVENTION PROCEDURES HAVE BEEN COMPLETED.

  Patient problems: Aneurysm

  MAUDE report 5267585 ↗
• InjuryNov 15, 2015Improper or Incorrect Procedure or Method

  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. UPON RE-POSITIONING THE BALLOON AND BALLOONING THE SEAL ZONE MORE AGGRESSIVELY, THE PATIENT'S BLOOD PRESSURE WAS OBSERVED TO HAVE DROPPED AND EXTRAVASATION OF THE VESSEL WAS OBSERVED NEAR THE LEVEL OF THE AORTIC BODY GRAFT COLLAR INDICATIVE OF AN AORTIC RUPTURE. AN ILIAC LIMB EXTENSION STENT GRAFT AND AN AORTIC CUFF WERE IMPLANTED AT THE LEVEL OF THE SEAL ZONE FOLLOWED BY THE PLACEMENT OF A BALLOON EXPANDABLE STENT, SUCCESSFULLY RESOLVING THE TYPE IA ENDOLEAK AND AORTIC RUPTURE AND EXCLUDING THE ANEURYSM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Rupture

  MAUDE report 5223823 ↗
• InjuryOct 10, 2015Insufficient 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 AND THE PLACEMENT OF A BALLOON EXPANDABLE STENT. 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

  MAUDE report 5142559 ↗
• InjurySep 18, 2015Product Quality Problem; Device Misassembled During Manufacturing /Shipping; Incorrect Device Or Component Shipped

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE PHYSICIAN NOTED UNDER FLUOROSCOPY THAT THE SEALING RINGS WERE NOT IN APPOSITION TO THE VESSEL WALL. THE DIAMETER OF THE PRIMARY SEALING RING WAS MEASURED INTRAOPERATIVELY, AND CONFIRMED TO BE WITHIN THE RANGE OF A SMALLER DIAMETER AORTIC BODY STENT GRAFT. A TYPE IA ENDOLEAK WAS PRESENT THAT COULD NOT BE RESOLVED FOLLOWING THE PLACEMENT OF COVERED STENTS IN THE RENAL ARTERIES AND SUPERIOR MESENTERIC ARTERY, AND TWO AORTIC CUFFS. 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

  MAUDE report 5087332 ↗
• DeathAug 28, 2015Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FOLLOWING THE SUCCESSFUL IMPLANTATION OF THE DEVICE AND ANEURYSM EXCLUSION, THE PATIENT'S LEFT FOOT HAD NO PULSE, BELIEVED TO BE DUE TO A POTENTIAL BLOOD CLOT. BECAUSE MULTIPLE ATTEMPTS TO RESOLVE THE BLOOD CLOT WERE UNSUCCESSFUL AND RESULTED IN PROLONGED PATIENT ANESTHESIA TIME (9 HOURS), THE PHYSICIAN ELECTED TO PERFORM A SURGICAL BYPASS. BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE PHYSICIAN, THE PATIENT LATER EXPIRED THAT NIGHT FOLLOWING THE BYPASS PROCEDURE. AS OF THE DATE OF THIS REPORT, THE EXACT CAUSE OF DEATH HAS NOT BEEN CONFIRMED.

  Patient problems: Death; Loss Of Pulse; Occlusion; Thrombosis

  MAUDE report 5038953 ↗