Ovation Prime Adominal Stent Graft System Aortic BodyRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI M701TVAB2680E1), received between Sep 18, 2015 and Sep 28, 2023 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH CONTRAST NOTED IN THE AORTIC NECK (BEHIND THE STENT GRAFT'S SEALING RINGS) AND IN THE MID TO DISTAL PORTION OF THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) COILS IN THE AORTIC NECK (EMBOLIZATION), PLACING A NON-ENDOLOGIX FENESTRATED STENT GRAFT IN THE LEFT OVATION LIMB, AND RELINING WITH AN OVATION IX LIMB IN THE LEFT ILIAC (SEALING THE FENESTRATION). BOTH THE FENESTRATED GRAFT AND THE OVATION IX ILIAC LIMB WERE BALLOONED, AND COMPLETION ANGIOGRAM SHOWED NO CONTRAST IN THE AORTIC NECK AND NO (NON-DEVICE-RELATED) TYPE II ENDOLEAK. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. NOTE: BASED ON THE REPORTED INFORMATION, A TYPE IA ENDOLEAK WAS LIKELY PRESENT AT THE TIME OF EVENT AS THE PROXIMAL END OF THE STENT GRAFT LOST APPOSITION/SEAL WITH THE AORTIC WALL, WHICH WAS DUE TO THE CONTRAST (BLOOD FLOW) BETWEEN THE AORTIC NECK AND THE SEALING RINGS OF THE MAIN BODY.

  Patient problems: Clinical Endoleak

  MAUDE report 17831320 ↗
• InjuryOct 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SIX AND A HALF (6.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER) AND A TYPE III ENDOLEAK AT THE JUNCTURE OF THE ILIAC LIMB AND LEG TO THE MAIN BODY. IT IS UNKNOWN WHETHER THE ENDOLEAK IS A TYPE IIIA OR IIIB, OR IF THE PHYSICIAN PLANS TO RE-INTERVENE. THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Failure of Implant; Stenosis

  MAUDE report 15577601 ↗
• InjuryJun 25, 2021Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION PRIME MAIN BODY AND (2) TWO OVATION PRIME ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (5) FIVE YEARS AFTER THE POST-INITIAL PROCEDURE, AN ENDOLEAK (INDETERMINATE ORIGIN) WAS IDENTIFIED. THE PHYSICIAN BROUGHT THE PATIENT IN FOR AN ANGIOGRAM ON (B)(6) 2021 BUT UPON ANGIOGRAM IMAGINING NO 1A, 3A, OR TYPE 2 ENDOLEAK WAS FOUND. THE PATIENT WAS REPORTED TO BE DOING FINE AND IS CURRENTLY BEING MONITORED. ADDITIONAL INFORMATION: INTERNAL CLINICAL EVALUATION SHOWS REASONABLE EVIDENCE TO SUGGEST LEFT LIMB OCCLUSION WITH LOWER LEG ISCHEMIA AND AN ADDITIONAL ENDOVASCULAR PROCEDURE IMMEDIATELY POST OPERATIVELY FOLLOWING PRESSURE HELD AT THE PROCEDURE SITE.

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 12071552 ↗
• InjuryOct 15, 2018Leak/Splash; Leak/Splash

  AN OVATION PRIME ENDOVASCULAR SEALING SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING A ROUTINE FOLLOW UP, SAC GROWTH WAS DISCOVERED WITH NO ENDOLEAK PRESENT. SAC GROWTH WAS APPROXIMATELY 51MM TO 65MM EQUALING 14MM GROWTH. A CT WAS PREFORMED AND THERE WAS STILL NO ENDOLEAK PRESENT. ON (B)(6) 2018, A NON-ENDOLOGIX STENT WAS IMPLANTED TO RESOLVE THE SAC GROWTH. THE PATIENT WAS REPORTED AS DOING FINE POST-SECONDARY PROCEDURE. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 7964031 ↗
• InjuryApr 19, 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

  THE PATIENT WAS IMPLANTED WITH AN OVATION MAIN BODY AND TWO (2) ILIAC LIMBS ON 04 JUN 2015. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON 15 NOV 2016 FOR AN UNKNOWN REASON AND THE PATIENT WAS IMPLANTED WITH AN OVATION EXTENDER.

  Patient problems: Aneurysm; Failure of Implant; No Information; Stenosis

  MAUDE report 7444238 ↗
• InjuryMar 27, 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 3 YEARS POST INDEX PROCEDURE WHERE GROWTH OF THE ANEURYSM SAC WAS OBSERVED. AN ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN COULD NOT CONFIRM IF THERE WAS AN ENDOLEAK, HOWEVER, HE PLACED A CUFF TO COVER A SUSPICIOUS AREA THAT WAS OBSERVED ON THE ANGIOGRAM. ANOTHER CT WAS PERFORMED POST RE-INTERVENTION WHERE A CONTINUED ENDOLEAK, POTENTIALLY A TYPE IIIB, WAS OBSERVED. PHYSICIAN ELECTED TO RE-INTERVENE A SECOND TIME BY RELINING WITH AN AFX GRAFT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7375970 ↗
• InjuryAug 25, 2016Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE CONTRALATERAL LEG OF THE AORTICY BODY GRAFT APPEARED COMPRESSED IN THE PRESENCE OF SIGNIFICANT INFRARENAL AORTIC ANGULATION AND NARROWING. THE PHYSICIAN EXPERIENCED DIFFICULTIES TO CANNULATING THE CONTRALATERAL LEG OF THE AORTIC BODY STENT GRAFT. THE PATENT WAS CONVERTED TO AORTA-UNI ILIAC WITH A FEM-FEM BYPASS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5902778 ↗
• InjuryJul 23, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 8M FOLLOW-UP CT SHOWED A POTENTIAL ULCER OF THE AORTA AT THE LEVEL OF THE AORTIC BODY STENT GRAFT PROXIMAL STENT. A SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO EXPLANT STENT GRAFT. THE PATIENT WAS NOTED TO HAVE MULTIPLE CO-MORBIDITIES. 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

  MAUDE report 5818141 ↗
• InjuryMar 22, 2016Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING BALLOONING OF THE AORTIC BODY STENT GRAFT IN AN ATTEMPT TO REPOSITION A MALPOSITIONED ILIAC LIMB STENT GRAFT, THE AORTIC BODY POTENTIALLY DISPLACED DISTALLY. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING 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 5516041 ↗
• InjuryFeb 24, 2016Occlusion Within Device; Improper or Incorrect Procedure or Method; Occlusion Within Device; Improper or Incorrect Procedure or Method

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MONTH POST-OPERATIVE CT SHOWED UNEVEN PLACEMENT OF THE PROXIMAL ASPECT OF THE ILIAC LIMB STENT GRAFTS, RESULTING IN A BILATERAL ILIAC LIMB OCCLUSION. A TISSUE PLASMINOGEN RE-INTERVENTION WAS PERFORMED FOLLOWED BY THE PLACEMENT OF TWO STENTS SUCCESSFULLY RESOLVING THE AORTIC OCCLUSION. 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: Occlusion

  MAUDE report 5458327 ↗
• InjuryFeb 12, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED 6 MONTHS POST-OP WITH AN AORTIC BODY STENOSIS IN THE PRESENCE OF THROMBUS IN THE SEAL ZONE AND SIGNIFICANT AORTIC ANGULATION. A RE-INTERVENTION WAS PERFORMED IN WHICH THE SEAL ZONE WAS BALLOONED AND TWO (2) BALLOON EXPANDABLE STENTS WERE IMPLANTED TO SUCCESSFULLY RESOLVE THE STENOSIS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Stenosis

  MAUDE report 5435579 ↗
• InjuryDec 10, 2015Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 3 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK IN THE PRESENCE OF SIGNIFICANT CALCIFICATION. A RE-INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK WITH COIL EMBOLIZATION WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5287734 ↗
• InjuryNov 29, 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 WAS NOT RESOLVED FOLLOWING BALLOONING. 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

  MAUDE report 5253720 ↗
• InjuryOct 29, 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 POTENTIAL TYPE IA ENDOLEAK. ANALYSIS OF THE PRE-OPERATIVE IMAGING INDICATED THE PRESENCE OF A PATENT LUMBAR VESSEL AT THE LEVEL OF THE AORTIC BODY STENT GRAFT SEALING RING. 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 5189892 ↗
• InjuryOct 27, 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 POTENTIAL TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING 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 5180760 ↗
• InjuryOct 24, 2015Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 7 MONTH POST-OPERATIVE CT SHOWED THE PRESENCE OF A POTENTIAL TYPE IA ENDOLEAK IN THE PRESENCE OF SIGNIFICANT ANGULATION. 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

  MAUDE report 5173700 ↗
• InjurySep 24, 2015Difficult to Open or Close; Material Deformation

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FOLLOWING SUCCESSFUL DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE CONTRALATERAL LEG OF THE GRAFT WAS REPORTED TO BE COMPRESSED AND/OR INCOMPLETELY OPEN, RESULTING IN SUBSEQUENT CANNULATION DIFFICULTIES AND PROLONGED PROCEDURE TIME. A BRACHIAL ACCESS APPROACH WAS USED TO SUCCESSFULLY CANNULATE THE CONTRALATERAL LEG OF THE STENT GRAFT AND THE CASE WAS COMPLETED WITHOUT PATIENT SEQUELAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5102513 ↗
• InjurySep 18, 2015Off-Label Use; Improper or Incorrect Procedure or Method; 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'S AORTIC DIAMETER WAS OUTSIDE THE TREATMENT RANGE FOR THE DEVICE. TO OBTAIN PROXIMAL SEAL, THE PHYSICIAN PLACED THE AORTIC BODY STENT GRAFT PROXIMAL TO THE RECOMMENDED LOCATION AND IMPLANTED BILATERAL STENTSIN THE RENAL ARTERIES VIA BRACHIAL ACCESS. UPON DEPLOYMENT OF THE RENAL STENTS, THE INTRODUCER SHEATH WAS INADVERTENTLY ADVANCED OVER ONE OF THE STENT CROWNS OF THE AORTIC BODY STENT GRAFT CAUSING THE ANCHORS TO ENGAGE INTO THE INTRODUCER SHEATH AND PREVENT ITS REMOVAL. THE PATIENT WAS CONVERTED TO OPEN SURGERY AND THE STENT GRAFT WAS EXPLANTED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5089588 ↗