Ovation Prime Abdominal Stent Graft System Aortic Body (REF TV-AB3480-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M701TVAB3480E1), received between Aug 21, 2015 and Aug 16, 2022 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2022Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM AND IN SHOCK. THE PATIENT WAS SUCCESSFULLY RESUSCITATED, AND A POTENTIAL TYPE I ENDOLEAK WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN AFX VELA INFRARENAL PROXIMAL EXTENSION ON (B)(6) 2022. ONE (1) DAY POST SECONDARY INTERVENTION, THE PATIENT EXPERIENCED CARDIAC ARREST, BUT WAS TREATED AND SUCCESSFULLY RETURNED TO STABLE CONDITION.

  Patient problems: Cardiac Arrest; Ruptured Aneurysm; Shock

  MAUDE report 15238119 ↗
• InjuryAug 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A GORE (NON-ENDOLOGIX) EXCLUDER LIMB WITH TWO (2) GORE (NON-ENDOLOGIX) VBX STENT GRAFTS, AND COILING THE LEFT HYPOGASTRIC ARTERY. PATIENT IS REPORTEDLY IN STABLE CONDITION AND THE ENDOLEAK WAS SUCCESSFULLY RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 12289844 ↗
• InjuryJun 15, 2020Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WITH STENT MIGRATION (7 TO 10 MM) WAS IDENTIFIED. AN INTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE WAITING FOR AN INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 10156123 ↗
• InjuryFeb 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK AND ANEURYSM SAC ENLARGEMENT (UNKNOWN DIAMETER). THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 9751716 ↗
• InjuryJun 20, 2018Occlusion Within Device; Improper or Incorrect Procedure or Method; Malposition of Device; Material Deformation; Occlusion Within Device; Improper or Incorrect Procedure or Method; Malposition of Device; Material Deformation

  OVATION DEVICES WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED FOR LOWER LIMB CLAUDICATION. THE DEVICE WAS NOTED TO HAVE BEEN IMPLANTED ABOUT 5 MM TOO LOW, AS A RESULT IN-FOLDING OF THE SECOND SEALING RING. A SECONDARY PROCEDURE IS BEING PLANNED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Ischemia; Stenosis

  MAUDE report 7623479 ↗
• InjuryMay 10, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN OVATION MAIN BODY AND TWO (2) ILIAC LIMBS ON (B)(6) 2015 BY DR. (B)(6) AT (B)(6) UNIVERSITY MED CENTER. DR. (B)(6) CONTACTED ENDOLOGIX ON (B)(6) 2018 TO REPORT THAT A TYPE 1A ENDOLEAK PER AORTOGRAM HAS DEVELOPED FOR THIS PATIENT WHOM IS ASYMPTOMATIC. THE PATIENT WAS DISCOVERED TO HAVE AN EXPANDING ANEURYSM, WHICH WAS BELIEVED TO BE FROM A TYPE 2 ENDOLEAK, BOTH DIAGNOSED BY CT SCAN. THE PATIENT WAS TREATED FOR A TYPE 2 ON (B)(6) 2018 BY HAVING THE SAC PACKED WITH COILS AND ONYX GLUE VIA A TRANSCAVAL APPROACH. WHEN DR. LOH DID A RUN TO ASSESS THE EFFECTIVENESS OF THE EMBOLIZATION BY INJECTING DYE INTO THE SAC THRU THE TRANSCAVAL CATHETER, A JET OF DYE WAS SEEN TRAVELING RETROGRADE UP THE AORTA PAST AND ABOVE THE SEALING RINGS, DEMONSTRATING A TYPE 1A ENDOLEAK. THE PHYSICIAN THEORIZES THE TYPE 2 ENDOLEAK THAT HE OBSERVED CAUSED SAC ENLARGEMENT , WHICH IN TURN CAUSED THE NECK TO DILATE AND CREATE A TYPE 1A. THE PATIENT IS DUE BACK FOR A FOLLOW-UP CT SCAN AND PENDING THE RESULTS MAY HAVE FURTHER TREATMENT. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7504280 ↗
• InjuryMar 21, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR AN UNKNOWN REASON WHERE PHYSICIAN OBSERVED A TYPE IIIA ENDOLEAK DUE TO ILIAC LIMB SEPARATION. THE PHYSICIAN HAS ELECTED TO RE-INTERVENE, HOWEVER, A DATE FOR THE RE-INTERVENTION HAS YET TO BE SCHEDULED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7357594 ↗
• InjuryOct 19, 2017Leak/Splash; Leak/Splash

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP APPROXIMATELY 3 YEARS POST-OP WHERE CT SHOWED A TYPE IA ENDOLEAK. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND QUITE UNHEALTHY, SO THE PHYSICIAN ELECTED TO NOT RE-INTERVENE AND MONITOR THE PATIENT INSTEAD. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6962505 ↗
• InjuryFeb 21, 2017Malposition 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 1.5 YEAR POST-OPERATIVE CT SHOWED EVIDENCE OF ANEURYSM ENLARGEMENT OF THE SUPRARENAL AORTA. THE PHYSICIAN ELECTED CONVERT THE PATIENT TO OPEN SURGICAL REPAIR AND EXPLANT THE OVATION DEVICE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Ischemia; Thrombosis

  MAUDE report 6344626 ↗
• InjuryJun 1, 2016Contamination; Off-Label Use; Malposition of Device; Contamination; Off-Label Use; Malposition of Device

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT WAS OUTSIDE THE INDICATIONS FOR USE AND THE PHYSICIAN ELECTED TO PROCEED WITH THE IMPLANT PROCEDURE BY PLACING THE AORTIC BODY STENT GRAFT HIGHER THAN RECOMMENDED WITH BILATERAL BALLOON EXPANDABLE STENTS IN THE RENAL ARTERIES TO MAINTAIN BLOOD FLOW. THE PATIENT PRESENTED 1 MONTH INDEX WITH A POTENTIAL RUPTURE OF THE AORTA. THE 1 MONTH POST-OPERATIVE CT SHOWED EVIDENCE OF A TYPE IA ENDOLEAK, AND INDICATIONS OF A POSSIBLE INFECTION (AORTO-DUODENAL FISTULA). THE PATIENT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND UNDERWENT A SURGICAL CONVERSION IN WHICH THE ANEURYSM SAC WAS OPENED, THE STENT GRAFT WAS LEFT IN PLACE, ANTIBIOTICS WERE INTRODUCED INTO THE ANEURYSM SAC, AND THE AORTA WAS SEWN CLOSED OVER THE STENT GRAFT. BIO GLUE WAS USED TO RESOLVE THE SMALL TYPE IA ENDOLEAK. BASED ON A FOLLOW-UP COMMUNICATION RECEIVED FROM THE SITE, CULTURES RESULTS WERE REPORTED AS STAPHYLOCOCCUS CAPTIS AND PEPTOSTREPTOCOCCUS SPECIES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Bacterial Infection; Rupture

  MAUDE report 5692771 ↗
• InjuryMar 6, 2016Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT WAS OUTSIDE THE TREATMENT SIZE RANGE FOR THE AORTIC BODY STENT GRAFT. THE PHYSICIAN ELECTED TO PROCEED WITH THE CASE BY PLACING THE PROXIMAL SEALING RING HIGHER THAN RECOMMENDED AND IMPLANTING BILATERAL STENTS IN THE RENAL ARTERIES TO MAINTAIN PATENCY. THE 2 WEEK FOLLOW-UP CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. 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 5482651 ↗
• InjuryOct 30, 2015Failure to Unfold or Unwrap

  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 IN THE PRESENCE OF SIGNIFICANT INFRARENAL ANGULATION, RESULTING IN SUBSEQUENT CANNULATION DIFFICULTIES. THE PATIENT WAS CONVERTED TO AN AORTO-UNI ILIAC (AUI), AND THE CASE WAS COMPLETED WITHOUT ADDITIONAL PATIENT SEQUELAE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 5192869 ↗
• InjurySep 16, 2015Adverse 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 5082926 ↗
• InjurySep 3, 2015Inadequacy of Device Shape and/or Size; Folded

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FOLLOWING SUCCESSFUL DEPLOYMENT AND FILL OF THE AORTIC BODY STENT GRAFT, SOME IN-FOLDING OF THE SEALING RINGS WAS OBSERVED DUE TO THE IMPLANTATION OF A STENT GRAFT SIZE WITH A LARGER DIAMETER THAN THE VESSEL TREATMENT RANGE; NO ENDOLEAKS WERE PRESENT. UPON INSERTION OF A DILATOR INTO THE VESSEL TO FACILITATE CANNULATION OF THE CONTRALATERAL LEG OF THE STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT WAS STABILIZED FOLLOWING CHEST COMPRESSIONS, AND THE ADMINISTRATION OF ADRENALINE AND BENADRYL DUE TO A SUSPECTED CONTRAST ALLERGY. THE CONTRALATERAL GATE WAS SUBSEQUENTLY CANNULATED AND THE CONTRALATERAL LIMB WAS DEPLOYED WITHOUT INCIDENT. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 5055035 ↗
• InjuryAug 21, 2015Activation, Positioning or Separation Problem

  AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE STENT GRAFT WAS INADVERTENTLY DEPLOYED ABOVE THE INTENDED LANDING ABOVE THE LEFT INFERIOR RENAL ARTERY. A BALLOON EXPANDABLE STENT WAS PLACED IN THE RENAL ARTERY MAINTAIN PATENCY. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5022179 ↗