Model Number 505DA |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 07/27/2017 |
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.A good faith effort will be made to obtain the applicable information relevant to the report.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 3 years 3 months post implant of this aortic mechanical valve, the device was explanted and replaced with a mechanical valve of the same size and model for unknown reasons.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information received indicated that an echocardiogram showed moderate to severe paravalvular leak (pvl).The patient experienced increasing symptoms of congestive heart failure (chf) and volume overload.Added patient weight.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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