Model Number 200H12 |
Device Problems
Calcified (1077); Insufficient Information (3190)
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Patient Problems
Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024); No Information (3190)
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Event Date 10/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 12 years and 3 months post implant of this 12mm pulmonary valved conduit in a 6 month old pediatric patient, an 18mm transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for intervention was not reported.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information that this 12mm pulmonary valved conduit was replaced valve-in-valve with a 22mm transcatheter pulmonary bioprosthetic valve (tpbv) due to severe calcification, severe insufficiency, and mild-moderate stenosis.Cardiac magnetic resonance imaging (mri) showed gradual right ventricle (rv) enlargement with diminished rv systolic function (rv ejection fraction = 33%).The patient was reported to be stable after a successful valve implant.Patient weight added.Patient and device codes updated.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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