Model Number 31003101 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Calcium Deposits/Calcification (1758); No Information (3190)
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Event Date 11/16/2017 |
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 14 years and 8 months post implant of this bioprosthetic valve, the valve was explanted and replaced with a valve of the same model. 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 additional information that this bioprosthetic valve, the valve was explanted and replaced due to calcification.No further adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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