Model Number FR995 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 11/09/2017 |
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 10 years and 6 months post implant of this bioprosthetic valve, the valve was explanted and replaced with an aortic valved graft.The reason for the explant was not reported. no additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received information that the valve was explanted and replaced with a mechanical valved graft. if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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