Model Number H607M |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Mitral Valve Stenosis (1965); No Information (3190)
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Event Date 12/22/2017 |
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 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The reason for the 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 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve due to stenosis.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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