Model Number 200SH20 |
Device Problems
Calcified (1077); Insufficient Information (3190); Device Stenosis (4066); Central Regurgitation (4068)
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Patient Problems
Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Insufficient Information (4580)
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Event Date 02/26/2024 |
Event Type
Injury
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Event Description
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Medtronic received information that 12 years and 3 months post implant of this 20mm pulmonary valved conduit implanted in a then 11 year old pediatric patient, a 16mm transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received that reported the reason for replacement as pulmonary stenosis and severe pulmonary insufficiency.It was also reported that the conduit was calcified distally and throughout the proximal conduit.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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