Model Number PB1016 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pulmonary Valve Stenosis (2024); No Information (3190)
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Event Date 08/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned.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 approximately five years, five months and sixteen days following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was surgically explanted and replaced with a medtronic surgical valve.The reason for explant and replacement was not reported.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information was received that the valve was explanted due to stenosis.No additional adverse patient effects were reported. product analysis: the device was discarded, therefore no product analysis can be performed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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