Model Number 690R |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 04/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Without the receipt 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 immediately post implant of this annuloplasty ring in the tricuspid position, this device was explanted and replaced with a bioprosthetic valve due to residual moderate mitral regurgitation.Prior to the replacement procedure, the patient presented with severe mitral regurgitation and shortness of breath.These symptoms resolved post-operatively.No other adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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