Model Number 620RG31 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 11/27/2019 |
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 immediately post implant of this 31mm mitral annuloplasty ring, it was explanted and replaced with a 25mm 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 31mm annuloplasty ring was implanted in the tricuspid position and the 25mm bioprosthetic valve was implanted in the mitral position.Both devices remain implanted and active, and there was no allegation against either device.No 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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