Ovation Prime Abdominal Stent Graft SystemRecalls & reported problems across all models
Trivascular, Inc. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 3
- Injuries reported
- 39
- Recalls
- 0
We found 11 models of Ovation Prime Abdominal Stent Graft System by Trivascular, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2015 and Feb 11, 2025 — classified as 3 deaths, 39 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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
Reports received per month, all models
Most reported Ovation Prime Abdominal Stent Graft System problems
Device problems
- Insufficient Device Problem Information12
- Adverse Event Without Identified Device or Use Problem9
- Leak/Splash8
- Malposition of Device5
- Improper or Incorrect Procedure or Method4
- Failure To Adhere Or Bond3
- Off-Label Use3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Aneurysm17
- Failure of Implant16
- Death3
- Ischemia3
- Occlusion3
- Unspecified Infection3
- Bacterial Infection2
- No Consequences Or Impact To Patient2
Ovation Prime Abdominal Stent Graft System models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ovation Prime Abdominal Stent Graft System Aortic BodySystem, Endovascular Graft, Aortic Aneurysm Treatment15 reports
- Ovation Prime Abdominal Stent Graft System Aortic BodySystem, Endovascular Graft, Aortic Aneurysm Treatment1 death10 reports
- Ovation Prime Abdominal Stent Graft System Aortic BodySystem, Endovascular Graft, Aortic Aneurysm Treatment1 death7 reports
- Ovation Prime Abdominal Stent Graft System Aortic BodySystem, Endovascular Graft, Aortic Aneurysm Treatment1 death2 reports
- Ovation Prime Abdominal Stent Graft System Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation Prime Abdominal Stent Graft System Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation Prime Abdominal Stent Graft System Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation Prime Abdominal Stent Graft System Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation Prime Abdominal Stent Graft System Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation Prime Abdominal Stent Graft System Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation Prime Abdominal Stent Graft System Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
Recent Ovation Prime 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.
InjuryFeb 11, 2025Obstruction of Flow; Obstruction of Flow
THE PATIENT WAS IMPLANTED WITH THE OVATION PRIME STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015. APPROXIMATELY NINE AND A HALF (9.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN OCCLUSION IN THE LEFT LIMB OF THE GRAFT. ON (B)(6) 2025, THE PHYSICIAN PERFORMED A THROMBECTOMY USING A PENUMBRA (NON-ENDOLOGIX DEVICE) AND RELINE THE AFFECTED LIMB WITH TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS. THE PATIENT WAS REPORTED TO BE RECOVERING WELL AND WAS DISCHARGED THE FOLLOWING DAY.
Patient problems: Obstruction/Occlusion
MAUDE report 21360391 ↗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 3, 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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) OVATION IX EXTENDER ON (B)(6). THE FINAL PATIENT STATUS POST SECONDARY INTERVENTION IS UNKNOWN.
Patient problems: Clinical Endoleak
MAUDE report 16665100 ↗InjuryAug 30, 2022Complete Blockage; Off-Label Use; Complete Blockage; Off-Label Use
THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION PRIME STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED AT THE DOCTOR'S OFFICE IN A WHEELCHAIR AND WAS SENT TO THE HOSPITAL TO BE ADMITTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP AND HAD STOPPED TAKING THEIR MEDICATION (XARALTO). THE GRAFT WAS FOUND TO HAVE THROMBOSED AND THE CLOT LOOKED CHRONIC. THE PHYSICIAN ELECTED TO PERFORM AN OPEN THROMBECTOMY FOLLOWED BY IMPLANT OF AN OVATION IX 12X120 ILIAC LIMB IN THE RIGHT COMMON ILIAC ARTERY / EXTERNAL ILIAC ARTERY (CIA/EIA), WITH RIGHT TO LEFT FEM/FEM BYPASS TO RESOLVE THIS EVENT. THE PATIENT WAS DISCHARGED TWO (2) DAYS LATER.
Patient problems: Failure of Implant; Thrombosis/Thrombus
MAUDE report 15324291 ↗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 ↗DeathJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE OVATION PRIME ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN IN THE FLANK AND ILIAC FOSSA. THE PATIENT HAD AN EXPLANT OF THE DEVICE DUE TO AN INFECTION POSSIBLY CAUSED BY THE PATIENT CONTRACTING MALARIA. THE FINAL PATIENT STATUS WAS REPORTED AS BEING ALIVE AND WELL.
Patient problems: Unspecified Infection
MAUDE report 14918337 ↗InjuryApr 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 WITH A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO SUCCESSFULLY TREAT THE PATIENT BY IMPLANTING AN OVATION IX ILIAC LIMB ON (B)(6) 2022. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION AND DISCHARGED HOME.
Patient problems: Failure of Implant
MAUDE report 14074415 ↗InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (6) SIX YEARS AFTER THE POST-INITIAL PROCEDURE, A TYPE 2 ENDOLEAK AND A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IS PLANNING TO RE-INTERVENE, BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENTS CURRENT CONDITION IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 12350573 ↗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 ↗InjurySep 28, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, FIVE (5) OVATION PRIME ILIAC LIMBS, AND ONE (1) OVATION PRIME EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). ADDITIONALLY, A GENISIS L (NON-ENDOLOGIX) STENT WAS IMPLANTED. APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, PATIENT EXPERIENCED LEFT LOWER EXTREMITY CLAUDICATION. LEFT LIMB OCCLUSION WAS IDENTIFIED. PATIENT WAS TREATED WITH STENTING OF THE RIGHT EXTERNAL ILIAC ARTERY (TYPE OF STENT NOT REPORTED) AND FEM-FEM BYPASS GRAFT. THE FINAL PATIENT STATUS WAS NOT REPORTED.
Patient problems: Failure of Implant; Thrombus
MAUDE report 10596715 ↗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 ↗InjurySep 25, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY 5.5 YEARS POST-OP, ANEURYSM SAC GROWTH OF APPROXIMATELY 1.5CM WAS OBSERVED WITHOUT THE PRESENCE OF ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE IMPLANTING TWO (2) ADDITIONAL OVATION IX ILIAC LIMBS. THE PATIENT TOLERATED THE PROCEDURE AND WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: THE REPORTED NO PRESENCE OF ENDOLEAK WAS REFUTED AS THERE WAS A TYPE 2 ENDOLEAK IDENTIFIED DURING CLINICAL ASSESSMENT. THIS IS A NON- DEVICE RELATED FAILURE.
Patient problems: Aneurysm
MAUDE report 9120912 ↗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 ↗
Other Trivascular, Inc. products
All Trivascular, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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