Model Number PB1018 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Mitral Insufficiency (1963)
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Event Date 04/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.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 approximately four years and five months following the implant of this transcatheter pulmonary bioprosthetic valve, implanted in the mitral position, decreased exercise capacity was reported at the follow-up visit.An echocardiogram showed severe central mitral regurgitation of the implanted valve.Subsequently, a non-medtronic valve was successfully implanted valve-in-valve without complication.No 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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Search Alerts/Recalls
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