Ovation iX Abdominal Stent Graft System Aortic Body (REF TV-AB2080-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI M701TVAB2080J1), received between Jun 23, 2016 and Oct 30, 2021 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (P120006); they may or may not involve this specific model.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2021Use of Device Problem; Use of Device Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 3A ENDOLEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX EXTENSION ON (B)(6) 2021 AND AT THE TIME DETERMINED THE ENDOLEAK WAS A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) COMING FROM TWO LUMBAR ARTERIES AND NOT A TYPE 3A ENDOLEAK. UPON INTERNAL CLINICAL EVALUATION IT WAS DETERMINED AN INDETERMINATE ENDOLEAK WAS CONFIRMED.

  Patient problems: Failure of Implant

  MAUDE report 12724942 ↗
• InjurySep 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, THIS PATIENT WAS TREATED FOR A TYPE 1A AND 1B ENDOLEAK. A PALMAZ (NON- ENDOLOGIX STENT) AND AN OVATION EXTENDER WERE IMPLANTED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3008011247-2018-00081. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THIS PATIENT WAS TREATED FOR ANOTHER TYPE 1A AND 1B ENDOLEAK, THE PHYSICIAN IMPLANTED AN OVATION IX ILIAC LIMB. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3008011247-2020-00011. NOW, APPROXIMATELY SEVEN (7) MONTHS POST THE LAST RE-INTERVENTION, THE PATIENT WAS PRESENT WITH A TYPE 1A ENDOLEAK. AN INTERVENTION WAS COMPLETED. A NON -ENDOLOGIX (VBX) STENT GRAFT WAS IMPLANTED AND COILING WAS PREFORMED TO RESOLVE THIS REPORTED EVENT. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 10538838 ↗
• InjuryJul 24, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AN INTRAOPERATIVE 1A ENDOLEAK WAS IDENTIFIED AT THE END OF THE PROCEDURE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AND WILL RE- EVALUATE AT THE 30 DAY FOLLOW UP. ADDITIONAL INFORMATION: IT WAS REPORTED INTRAOPERATIVE TYPE 1A ENDOLEAK APPEARS HAVE RESOLVED ON ITS OWN WITH NO INTERVENTION. THEREFORE THERE WAS NO PATIENT HARM OR DEVICE FAILURE. A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Failure of Implant; Not Applicable

  MAUDE report 10320965 ↗
• InjuryJul 1, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). SEVEN (7) DAYS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK AND 3A ENDOLEAK WERE IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO USE NON -ENDOLOGIX STENTS AND BALLOONING TO RESOLVE THESE REPORTED EVENTS. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10222335 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 2.5-YEARS POST-OP, THE PATIENT PRESENTED ON AN UNKNOWN DATE AND AN ENDOLEAK OF INDETERMINATE ORIGIN WAS IDENTIFIED. THE PATIENT CONDITION WAS NOT REPORTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9318302 ↗
• InjuryJul 5, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. AN INTRAOPERATIVE TYPE IA ENDOLEAK WAS DETECTED AND A DECISION WAS MADE TO IMPLANT A PALMAZ STENT AT THE LEVEL OF THE SEALING RINGS. THE FINAL RUN REVEALED THE TYPE IA WAS RESOLVED AND THE ANEURYSM WAS EXCLUDED. THE PATIENT WAS REPORTED STABLE AND DISCHARGED POST-OP DAY ONE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 8765579 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM AND AN ADDITIONAL OVATION IX ILIAC LIMB WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE SYSTEM DEPLOYED AS EXPECTED. THE FINAL ANGIO IDENTIFIED A POSSIBLE TYPE IA ENDOLEAK. THE PATIENT WILL BE MONITORED AND RE-SCANNED IN 30 DAYS TO DETERMINE IF THE TYPE IA ENDOLEAK RESOLVES ON ITS OWN.

  Patient problems: Failure of Implant

  MAUDE report 8628842 ↗
• InjuryApr 30, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE FINAL ANGIOGRAM CONFIRMED THE ANEURYSM WAS EXCLUDED WITH NO OBSERVATION OF AN ENDOLEAK OF ANY TYPE PRESENT. THE PROCEDURE CONCLUDED WITHOUT FURTHER INCIDENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 8566769 ↗
• InjuryJun 1, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  THE OVATION IX DEVICES WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2016. AT THE 30 DAY FOLLOW-UP VISIT, THERE WAS A NOTE OF A ENDOLEAK IN THE PROXIMAL PORTION OF THE STENT. IT WAS NOTED FROM THIS CT IMAGES, SOME ANGULATION OF THE NECK AS EXPECTED, MILD TYPE 1A ENDOLEAK BUT NO SAC GROWTH. AT THE 12 MONTH FOLLOW UP VISIT CT ON (B)(6) 2017, THERE IS EVIDENCE OF A TYPE II ENDOLEAK. THERE APPEARED TO BE 3 LOCATIONS FOR ENDOLEAK BEING OBSERVED: PROXIMAL PORTION OF THE STENT, IMA AND DISTAL PORTION. AT THE 1 YEAR FOLLOW UP CT, THE PROXIMAL ENDOLEAK STILL EXISTED. THE PATIENT CONTINUES TO BE MONITORED. NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORT.

  Patient problems: Failure of Implant

  MAUDE report 7563296 ↗
• InjuryMay 2, 2018Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility; Failure To Adhere Or Bond; Leak/Splash; Patient-Device Incompatibility

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR AN UNKNOWN REASON WHERE A TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING A PALMAZ STENT WITHIN THE DEVICE AND BALLOONING. ANOTHER OVATION LIMB WAS PLACED AS WELL TO EXTEND THE SEAL ZONE. A SMALL ENDOLEAK WAS STILL PRESENT AT THE CONCLUSION OF THE PROCEDURE AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT IS REPORTED TO BE DOING WELL AND AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7479676 ↗
• InjuryApr 27, 2018Fluid/Blood Leak; Device Dislodged or Dislocated; Material Integrity Problem; Fluid/Blood Leak; Device Dislodged or Dislocated; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT UPON POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE EMPTIED INDICATIVE OF AN INTRAVASCULAR LEAK OF POLYMER. THE PATIENT EXPERIENCED HYPOTENSION AND WAS QUICKLY TREATED AND STABILIZED PER THE DEVICE IFU. THE REMAINING DEVICE COMPONENTS WERE NOT IMPLANTED (ILIAC LIMBS) AND THEREFORE THE ANEURYSM WAS NOT EXCLUDED. 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: Failure of Implant; Low Blood Pressure/ Hypotension; Stenosis

  MAUDE report 7470865 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A FOLLOW UP APPROXIMATELY 8 MONTHS POST-INDEX PROCEDURE WHERE PHYSICIAN OBSERVED THE PRESENCE OF A TYPE II ENDOLEAK. THE PHYSICIAN HAS ELECTED TO PERFORM A RE-INTERVENTION; HOWEVER, THE DATE OF THE RE-INTERVENTION HAS NOT BEEN REPORTED/CONFIRMED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Not Applicable

  MAUDE report 7285631 ↗
• InjuryNov 15, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED. 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: Failure of Implant

  MAUDE report 7035632 ↗
• InjuryNov 13, 2017Leak/Splash; Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PATIENT RETURNED FOR 3 MONTH FOLLOW UP WHERE A CT REVEALED A LATE TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PLACING COILS AS WELL AS ONYX GLUE IN THE ANEURYSM SACK. AFTER, A PALMAZ STENT WAS PLACED AT THE LEVEL OF THE LOWEST RENAL ARTERY, SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEE NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7026595 ↗
• InjuryNov 2, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE INDEX PROCEDURE WENT AS EXPECTED. PATIENT RETURNED APPROXIMATELY 2 MONTHS LATER WITH AN OCCLUDED LEFT LIMB AND A LATE TYPE IA ENDOLEAK. PHYSICIAN ELECTED TO RE-INTERVENE AND PLACE ICAST STENTS INTO THE OCCLUDED LEFT LIMB TO OPEN THE VESSEL. COILS AND A PALMAZ STENT WERE ALSO PLACED AT THE LEVEL OF THE SEALING RINGS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION AND THE TYPE IA ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6998063 ↗
• InjurySep 22, 2017Occlusion Within Device; Off-Label Use; Occlusion Within Device; Off-Label Use

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP APPROXIMATELY 6 MONTHS POST-OP WHERE A CT REVEALED A COMPLETE OCCLUSION OF THE AORTA. THE PHYSICIAN ELECTED TO RE-INTERVENE BY PERFORMING AXILLOFEMORAL BYPASS, WHICH SUCCESSFULLY RESOLVED THE OCCLUSION. HE PATIENT CONDITION POST SECONDARY IS REPORTED AS STABLE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Claudication; Failure of Implant; Occlusion

  MAUDE report 6887855 ↗
• MalfunctionFeb 7, 2017Adverse 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 IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A POTENTIAL TYPE IA ENDOLEAK IN THE PRESENCE OF SIGNIFICANT CALCIUM WITHIN THE AORTA THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING AND THE PLACEMENT OF A BALLOON EXPANDABLE STENT. 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; Failure of Implant

  MAUDE report 6309439 ↗
• InjuryAug 30, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED APPROXIMATELY 2 MONTHS POST-OPERATIVE WITH EVIDENCE OF A POTENTIAL INFECTION. THE PATIENT UNDERWENT A SURGICAL CONVERSION AND THE STENT GRAFT WAS EXPLANTED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 5915654 ↗
• InjuryJul 29, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A POTENTIAL TYPE IA ENDOLEAK; HOWEVER, IT COULD NOT BE DEFINITIVELY DETERMINED TO BE A TYPE IA ENDOLEAK AND/OR A TYPE II 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 5835407 ↗
• InjuryJun 23, 2016Occlusion Within Device; Occlusion Within Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE 1 MONTH POST-OPERATIVE CT SHOWED COMPRESSION OF THE ILIAC LIMB STENT GRAFT IN THE PRESENCE OF SIGNIFICANT NARROWING AT THE LOCATION OF THE AORTIC GRAFT BIFURCATION, RESULTING IN A OCCLUSION FROM THE AORTIC BODY SEALING RINGS DOWN TO THE BILATERAL ILIAC LIMB STENT GRAFTS WITH RETROGRADE FLOW TO THE LOWER EXTREMITIES. AS OF THE DATE OF THIS REPORT, THE PATIENT HAS NOT RETURNED FOR ADDITIONAL FOLLOW-UP AND THERE HAS BEEN NO REPORTED RE-INTERVENTION. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 5746885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120006. One submission often covers many models, so check the product and lot details in each record.

• Z-2263-2020 · May 6, 2020 · Terminated
  Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
• Z-0125-2015 · Sep 20, 2014 · Terminated
  Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device deliver
• Z-0288-2013 · Oct 19, 2012 · Terminated
  TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The