Model Number 680R |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Aortic Regurgitation (1716)
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Event Date 02/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for analysis.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 immediately post implant of this annuloplasty ring in the mitral position, this device was replaced with a bioprosthetic valve due to regurgitation following the repair.No other adverse patient effects were reported.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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