Model Number 680R |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 12/19/2017 |
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 immediately post implant of this annuloplasty ring, the ring was explanted and replaced with an unknown device.The reason for explant 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 mitral annuloplasty ring was explanted and replaced with a non-medtronic valve due to mild paravalvular leak (pvl).The patient was reported to be stable after a successful valve implant.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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