VALIANT® Captivia VAMC4242C100TURecalls & reported problems
Medtronic, Inc. · STENT GRAFT VAMC4242C100TU VALCAP CLOSE · Class 3 · Implant
All models of VALIANT Captivia (95)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347144), received between Feb 16, 2017 and Feb 16, 2017 — classified as 1 death.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Death1
- Pain1
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH PAIN AND AN ENLARGED ANEURYSM WITH A RUPTURE. IT WAS NOTED THAT THERE WAS NO VISIBLE ENDOLEAK. THE PATIENT EXPIRED AS A RESULT OF THE RUPTURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.
Patient problems: Aneurysm; Death; Pain; Rupture
MAUDE report 6337341 ↗
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page