Model Number T510C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pulmonary Regurgitation (2023)
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Event Date 12/30/2013 |
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.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.From the limited information received the valve remained implanted.Without the return of the valve for analysis, a root cause of the regurgitation cannot be determined.This report is being submitted as part of a historic clinical review of events contained within the medtronic melody bpv study.
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Event Description
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Medtronic received information that 2 years 9 months post implant of this bioprosthetic valved conduit in the pulmonary position, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) due to regurgitation.No further adverse patient effects were reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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