Model Number HC105-26 |
Device Problems
Gradient Increase (1270); Insufficient Information (3190)
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Patient Problems
Pulmonary Regurgitation (2023); No Information (3190)
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Event Date 02/13/2019 |
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 14 years and 6 months post implant of this 26mm pulmonary valved conduit, a 22mm 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 received additional information that the conduit was replaced due to high gradients (50mmhg) and moderate to severe regurgitation as a result of the patient outgrowing the conduit.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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