Model Number 700FC27 |
Device Problem
Gradient Increase (1270)
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Patient Problems
Mitral Valve Stenosis (1965); Stenosis (2263)
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Event Date 07/03/2018 |
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 1 year 6 months post implant of this 27mm mitral annuloplasty band, it was explanted and replaced with a 25mm mitral bioprosthetic valve for severe mitral stenosis along with increased gradients.No additional 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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