Model Number 310C33 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Thrombus (2101)
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Event Date 12/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that an unknown duration post implant of this bioprosthetic valve, the valve was explanted and replaced with a mechanical valve due to thrombus of the bioprosthetic valve.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that the valve was explanted 8 months post implant.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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