Valiant Navion™ VNMF4040C103TU (UDI 00763000260507)Recalls & reported problems
Medtronic, Inc. · STENT GRAFT VNMF4040C103TU VAL NAV FF · Class 3 · Implant
All models of Valiant Navion (137)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260507), received between Sep 7, 2021 and Sep 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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
Device problems
- Leak/Splash1
Patient problems
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2021Leak/Splash; Leak/Splash
A VALIANT NAVION STENT GRAFT WAS IMPLANTED PROXIMALLY DURING INTERVENTION FOR A SUSPECTED TYPE IIIB/IA ENDOLEAK AND ANEURYSM ENLARGE MENT(50MM-70MM) ON (B)(6) -2021. DURING THE ORIGINAL INDEX PROCEDURE ON (B)(6) 2019 A NAVION STENT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM. IT WAS ALSO REPORTED THAT THERE APPEARED TO BE STENT RING ENLARGEMENT IN A DIFFERENT AREA OF THE GRAFT AND IT APPEARED LIKE THE STENT HAD COME OFF THE GRAFT. THE PATIENT HAD BEEN COMPLAINING OF CHEST PAIN. ON THE (B)(6) 2021 IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH SEVERE CHEST PAIN. THE PATIENT WAS GIVEN A HEART CATH BUT THE PATIENT WAS STILL EXPERIENCING SEVERE PAIN, A CT SHOWED A TYPE IA ENDOLEAK. *IT WAS NOTED THAT THE PATIENT HAD A 3 INTERVENTION ON AN UNKNOWN DATE (AFTER THE (B)(6) 2021 INTERVENTION) WHERE A NON MDT (GORE) STENT GRAFT WAS IMPLANTED AT SOME POINT IN THE PROXIMAL PORTION OF THE GRAFT. THE GRAFT WAS PLACED AT THE LEVEL OF THE LEFT CAROTID AND A PROXIMAL TYPE 1 ENDOLEAK WAS PRESENT.* INTERVENTION WAS PERFORMED THE SAME DAY WHERE A PROCEDURE TO DEBRANCH THE PROXIMAL AORTA WAS PERFORMED. THE PATIENT WAS TAKEN TO THE OR WHERE A GRAFT WAS PLACE
Patient problems: Chest Pain
MAUDE report 12432022 ↗
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- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
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- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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