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Model Number 505 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.
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Event Description
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Medtronic received information that prior to the implant of this mechanical valve, the valve was inspected and no abnormalities were noticed.During the implant of this valve, echocardiogram revealed that one of the valve leaflets would not flap normally.This valve was explanted and a new mechanical valve was implanted in its place.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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