Model Number PB1018 |
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 Known Impact Or Consequence To Patient (2692)
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Event Date 08/14/2018 |
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.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 seven years and nine days following the implant of this pulmonary transcatheter bioprosthetic valve, a valve was implanted valve-in-valve for an unknown reason.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information received that the third valve was implanted due to recurrent 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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