Model Number T50525H |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problem
Aortic Valve Stenosis (1717)
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Event Date 11/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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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 15 years and 3 months post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to severe aortic stenosis of the bioprosthetic valve.No adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that 15 years and 4 months post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to severe aortic stenosis of the bioprosthetic valve.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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