Ovation iX Abdominal Stent Graft SystemRecalls & reported problems across all models

We found 5 models of Ovation iX Abdominal Stent Graft System by Trivascular, Inc. in the FDA's device registry (GUDID). Together they are named in 338 adverse event reports in the FDA's MAUDE database, received between Oct 28, 2015 and Sep 25, 2026 — classified as 21 deaths, 312 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (74 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ovation iX Abdominal Stent Graft System problems

Ovation iX Abdominal Stent Graft System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ovation iX Abdominal Stent Graft System Aortic Body

  System, Endovascular Graft, Aortic Aneurysm Treatment
  11 deaths105 reports
• Ovation iX Abdominal Stent Graft System Aortic Body

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths87 reports
• Ovation iX Abdominal Stent Graft System Aortic Body

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths72 reports
• Ovation iX Abdominal Stent Graft System Aortic Body

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths54 reports
• Ovation iX Abdominal Stent Graft System Aortic Body

  System, Endovascular Graft, Aortic Aneurysm Treatment
  20 reports

Recent Ovation iX Abdominal Stent Graft System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Lack of Effect

  The patient was initially treated for an Abdominal Aortic Aneurysm (AAA) on (b)(6) 2019 with the implant of an Alto Abdominal Stent Graft System. Routine follow-up conducted on approximately on (b)(6) 2026 identified a Type IA Endoleak. Patient currently has no symptoms and was being monitored with a re-intervention scheduled; however, the re-intervention procedure was cancelled as the patient¿s family decided not to do anything.

  Patient problems: Clinical Endoleak

  MAUDE report 50899768 ↗
• InjuryDec 9, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH AN ANEURYSM THAT IS STILL GROWING. THE PATIENT IS ASYMPTOMATIC BUT AAA IS NOW OVER 5CM. THE PATIENT IS BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONALLY, AN INTERNAL CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 1A ENDOLEAK OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 1A ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN DATED ON (B)(6) 2025.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23758470 ↗
• InjuryJun 26, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON 25 SEPTEMBER 2017 WITH THE IMPLANT OF AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM. A PREVIOUS TYPE II ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY ANGIOGRAM DATED (B)(6) 2018 AND DEFERRED TO VASCULAR SURGERY FOR MANAGEMENT. THE TYPE II ENDOLEAK WAS PREVIOUSLY TREATED WITH THE ADDITION OF COILING IN THE SAC AT UNKNOWN TIME AFTER CONSULT WITH VASCULAR SURGERY APPROXIMATELY (B)(6) 2021. AT AN UNKNOWN TIME IN 2023 THERE WAS AN ANEURYSM RUPTURE AND TYPE IIIA ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY. PATIENT UNDERWENT RELINING WITH (NON-ENDOLOGIX) BILATERAL COMMON ILIAC STENTS AT SOME TIME IN 2023.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22336603 ↗
• InjuryJan 20, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A PALMAZ (NON-ENDOLOGIX) STENT AND ALSO EMBOLIZED THE 1A ENDOLEAK WITH COOK (NON-ENDOLOGIX) COILS ON (B)(6) 2025. THE PATIENT IS REPORTED AS RECOVERING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 21193157 ↗
• InjuryNov 22, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN ALTO STENT GRAFT SYSTEM FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017. APPROXIMATELY SEVEN (7) YEARS AFTER THE INITIAL PROCEDURE, NON-SYMPTOMATIC SAC ENLARGEMENT, WITH A SUSPECTED TYPE II ENDOLEAK WAS IDENTIFIED. THE SAC MEASURED AT 9CM IN 2017, IN 2023 IT MEASURED AT 5.3CM, AND THE MOST RECENT COMPUTED TOMOGRAPHY MEASURED IT AT 6.3CM. ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2024, CONFIRMING THE TYPE II ENDOLEAKS AT THE INFERIOR MESENTERIC ARTERY (IMA) AND LUMBARS. REPORTEDLY, THE OVATION IX MAIN BODY RINGS WERE MISSHAPED. A PALMAZ (NON-ENDOLOGIX) STENT WAS IMPLANTED TO ENSURE PROPER WALL APPOSITION AND ADEQUATE INTERNAL RING LUMEN. HE ALSO DECIDED TO EXTEND THE LEFT COMMON ILIAC ARTERY LIMB TO THE LEFT HYPO BECAUSE THE LIMB HAD LANDED IN THROMBUS DURING THE INITIAL IMPLANT. THE PATIENT WAS REPORTED TO BE DISCHARGED ONE DAY POST-REINTERVENTION AND IS TO BE REFERRED TO INTERVENTIONAL RADIOLOGIST TO EMBOLIZE THE IMA.

  Patient problems: Aneurysm

  MAUDE report 20759080 ↗
• InjuryMay 24, 2024Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM ON (B)(6) 2017. ROUTINE FOLLOW-UP ON (B)(6) 2024 IDENTIFIED TYPE IA ENDOLEAK AND SAC GROWTH. REINTERVENTION HAS NOT YET BEEN PLANNED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19394614 ↗
• InjuryMay 8, 2024Unintended Movement; Unintended Movement

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE WITH THE OVATION IX STENT GRAFT SYSTEM AND AN OVATION IX EXTENDER ON (B)(6) 2017. ON (B)(6)2024, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A CONTAINED RUPTURE. EXAMINATION REVEALED BOTH COMMON ILIAC ARTERIES WERE NOW ANEURYSMAL. BOTH LIMBS MOVED PROXIMALLY AND WERE IN THE INFRARENAL SAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY COILING BOTH HYPOGASTRIC ARTERIES AND IMPLANTING FOUR (4) OVATION IX ILIAC LIMBS.

  Patient problems: Clinical Endoleak; Rupture

  MAUDE report 19272163 ↗
• InjuryApr 5, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WAS REPORTED. A REVIEW OF COMPUTED TOMOGRAPHY (CT) SCANS SHOWED A SLIGHT ENDOLEAK OUTSIDE THE SEAL LOCATION. ADDITIONALLY, THE CT SHOWED THERE IS CONTRAST AROUND THE LEFT LIMB; HOWEVER, THE SOURCE CANNOT BE LOCATED. THERE IS ALSO A PATENT INFERIOR MESENTERIC ARTERY (IMA). THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19048912 ↗
• InjuryJan 9, 2024Deformation Due to Compressive Stress; Insufficient Device Problem Information; Device Stenosis; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW UP THE PHYSICIAN SCHEDULED A REINTERVENTION ON (B)(6) 2024 FOR AN UNKNOWN REASON. THE PATIENT IS CURRENTLY BEING MONITORED. ADDITIONAL INFORMATION: INTERVENTION HAS BEEN COMPLETED. TWO OVATION IX ILIAC EXTENDERS HAVE BEEN IMPLANTED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18475980 ↗
• DeathDec 6, 2023Device-Device Incompatibility; Lack of Effect; Device-Device Incompatibility; Lack of Effect

  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. AT THE CONCLUSION OF THE PROCEDURE THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 300811247-2019-00166. NOW, APPROXIMATELY FOUR (4) YEARS POST IMPLANT THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS. THE PHYSICIAN STATED THE SEALING RINGS WERE WELL OPPOSED TO THE AORTIC WALL. THERE WAS NO TYPE 1A OR TYPE 2 ENDOLEAK AND NO UNORGANIZED OR FRESH BLOOD IN THE ANEURYSM SAC; HOWEVER, THE COMMON ILIAC ARTERIES (CIA) WERE ANEURYSMAL AND THE PATIENT HAD A GORE (NON-ENDOLOGIX) ILIAC BRANCH ENDOPROSTHESIS (IBE) PLACED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. THE PHYSICIAN ATTRIBUTED THE SAC ENLARGEMENT TO SAC WALL DETERIORATION. AFTER THIS EXPLANT PROCEDURE, THE PATIENT WAS DISCHARGED OUT OF THE INTENSIVE CARE UNIT (ICU) AND IS RECOVERING. THE EXPLANTED STENT GRAFT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Aneurysm

  MAUDE report 18276290 ↗
• InjuryAug 10, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A PATENT PAIR OF LUMBARS (NON-DEVICE-RELATED TYPE II ENDOLEAKS) FEEDING THE ANEURYSM SAC, EVENTUALLY CREATING A SHORTER AORTIC NECK. THIS LED TO A TYPE IA ENDOLEAK.THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A 28X45 OVATION IX EXTENSION AT THE RENAL SITE TO IMPROVE THE DURABILITY OF THE PROXIMAL SEAL, ALONG WITH A 14X80 OVATION IX ILIAC LIMB ON THE DISTAL LEFT LIMB. A SEAL WAS ESTABLISHED UP TO THE HYPOGASTRIC REGION DUE TO THE SLIGHTLY ECTATIC AND CHALLENGING-TO-ACCESS NATURE OF THE LEFT COMMON ILIAC. IT WAS NOTED THAT THERE WAS NOT INDICATION OF A TYPE IA ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED TO HOME ON POSTOPERATIVE DAY ONE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17505242 ↗
• InjuryJul 28, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A PALMAZ (NON-ENDOLOGIX) STENT AND UTILIZING A TRUE (NON-ENDOLOGIX) BALLOON ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. ADDITIONAL INFORMATION: INTERNAL CLINICAL ASSESSMENT IDENTIFIED THAT SIGNIFICANT ANEURYSM ENLARGEMENT WAS NOTED PER OPERATIVE REPORT AND CT (COMPUTED TOMOGRAPHY) SCAN AT FOUR (4) DAYS POST SECONDARY INTERVENTION WITH A RECURRING TYPE IA ENDOLEAK (RELATED TO INADEQUATE TREATMENT WITH THE PALMAZ (NON-ENDOLOGIX) STENT AND BALLOONING ON (B)(6) 2023). THE PHYSICIAN ELECTED TO FURTHER TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX FENESTRATED GRAFT ON (B)(6) 2023; THIS TERTIARY INTERVENTION RESULTED IN OCCLUSION OF THE RIGHT RENAL ARTERY, WHICH THEN CAUSED ACUTE KIDNEY INJURY (AKI). THE PATIENT WAS READMITTED ON (B)(6) 2023 FOR TREATMENT OF CONGESTIVE HEART FAILURE (CHF) RELATED TO THE ACUTE KIDNEY FAILURE WHICH STEMMED FROM THE (B)(6) 20

  Patient problems: Aneurysm; Clinical Endoleak; Renal Failure

  MAUDE report 17416125 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM ON (B)(6) 2019. ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2023, IDENTIFIED SAC EXPANSION (SIZE OF GROWTH NOT REPORTED) AND POSSIBLE NECK DILATION. REINTERVENTION HAS NOT YET BEEN PLANNED. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT THE PATIENT WAS SENT TO CLEVELAND CLINIC AND IT IS UNKNOWN IF TREATMENT WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 17213641 ↗
• InjuryFeb 16, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AND (NON-DEVICE-RELATED) TYPE II ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT IS REPORTEDLY IN GOOD CONDITION. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Clinical Endoleak

  MAUDE report 16391089 ↗
• InjuryJan 5, 2023Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT IS REPORTEDLY IN GOOD CONDITION, AND THE PHYSICIAN IS EXPLORING TREATMENT OPTIONS.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 16101464 ↗

Other Trivascular, Inc. products

• Ovation Prime Abdominal Stent Graft System11 models · 42 reports