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Model Number 200H18 |
Device Problem
Calcified (1077)
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Patient Problems
Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)
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Event Date 07/12/2018 |
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 5 years and 4 months post implant of this 18 mm pulmonary valved conduit in a (b)(6) pediatric patient, the conduit was explanted and replaced with a 22 mm valved conduit of a different model due to moderate stenosis and calcification.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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