Model Number PB1018 |
Device Problems
Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
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Patient Problems
Calcium Deposits/Calcification (1758); Stenosis (2263)
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Event Date 06/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product remains implanted therefore no product analysis can be completed.Conclusion: without return of the product, no definitive conclusions could be drawn 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 three years and four months following the implant of this transcatheter pulmonary bioprosthetic valve (tpbv) a transcatheter intervention was performed due to stenosis.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information was received that the transcatheter pulmonary bioprosthetic valve (tpbv) was replaced with a surgical valve due to calcification of the conduit.The patient was reported to be recovering well following the procedure.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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