Model Number 700FC31 |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/02/2017 |
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.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 during the implant of this 31mm mitral annuloplasty band, the band was explanted and replaced with a 29mm mitral bioprosthetic valve for unknown reasons.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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Manufacturer Narrative
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Medtronic received additional information that this 31 mm mitral annuloplasty band was implanted and explanted on the same day and replaced with a 29 mm mitral bioprosthetic valve due to mild central leak.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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