Model Number 620BG31 |
Device Problems
Calcified (1077); Insufficient Information (3190)
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Patient Problems
Dyspnea (1816); Mitral Regurgitation (1964); No Information (3190)
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Event Date 07/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned.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 and 6 months post implant of this 31mm mitral annuloplasty band, it was explanted and replaced with a 29mm bioprosthetic valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that the reason for replacement was due to severe mitral regurgitation, extensive annular calcification extending from mid p3 through all of p2, along with exertional dyspnea.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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