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VALIANT® Captivia VAMC3434C100TURecalls & reported problems

Medtronic, Inc. · STENT GRAFT VAMC3434C100TU 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
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 00643169347182), received between Apr 17, 2017 and Apr 17, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.

Most reported problems

Device problems

  • Activation, Positioning or Separation Problem1
  • Device Damaged by Another Device1
  • Malposition of Device1

Patient problems

  • Occlusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 17, 2017Malposition of Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Malposition of Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT HAD A HYPERTENSIVE EPISODE WHICH CAUSED THE DEVICE TO MIGRATE. THE DEVICE ORIGINALLY MEASURED 32X32X150 AND WAS LANDED AT THE LEFT COMMON CAROTID ARTERY. AFTER THE HYPERTENSIVE EPISODE, THE DEVICE WAS BEHIND THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. THERE WAS ALSO A DISSECTION THAT STARTED APPROXIMATELY 2 CM BELOW THE DISTAL EDGE OF THE STENT GRAFT. THE PHYSICIAN STATED THAT THE HYPERTENSIVE EPISODE CAUSED THE EVENT, BUT IT COULD NOT BE DETERMINED WHAT CAUSE THE HYPERTENSIVE EPISODE. FOUR DAYS LATER THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION, A 5 FRENCH SHEATH WAS PLACED USING ULTRASOUND GUIDANCE ON THE LEFT SIDE. AN 8 FRENCH SHEATH WAS ATTEMPTED TO BE PLACED ON THE RIGHT SIDE BUT WAS UNSUCCESSFUL DUE TO SCAR TISSUE. THE DECISION WAS MADE TO SWITCH THE 8 FRENCH SHEATH TO THE LEFT SIDE. IVUS WAS USED FROM THE LEFT SIDE TO ENSURE THAT THE WIRES WERE IN THE TRUE LUMEN AND THEN ONE OF THE WIRES WAS EXCHANGED FOR A LUNDERQUIST WIRE VIA THE LEFT GROIN. IVUS DETERMINED THE VESSEL DIAMETER AT THE LEFT CAROTID ARTERY MEASURED 30.9

    Patient problems: Occlusion

    MAUDE report 6498138 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

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Sources and updates

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