Model Number H601 |
Device Problems
Perivalvular Leak (1457); Insufficient Information (3190)
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Patient Problems
Regurgitation (2259); No Information (3190)
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Event Date 10/24/2017 |
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 20 years 8 months post implant of this mitral annuloplasty ring was explanted and replaced with 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 the reason for explant of this ring was due to severe mitral regurgitation.Once the device was replaced with a bioprosthetic valve post surgery transesophageal echocardiogram (tee) noted satisfactory mitral valvular function with no paravalvular leak (pvl) or regurgitation.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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