Model Number FR995-29 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Calcium Deposits/Calcification (1758); Pseudoaneurysm (2605)
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Event Date 04/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 9 years and 11 months post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with a bioprosthetic valve of a different model due to a pseudoaneurysm and calcified leaflets.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Added expiration date.Added device manufacture date.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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