Model Number PVC216S |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Aneurysm (1708); Pulmonary Valve Stenosis (2024)
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Event Date 03/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.The device serial number has not been reported.Without the serial number, the device manufacturing and expiration date may not be obtained.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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Event Description
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Medtronic received information that one year, five months post implant of this pulmonic bioprosthetic valved conduit in a pediatric patient, this patient developed peripheral pulmonary stenosis and elevated right ventricular pressure leading to significant aneurysm formation at the valve.Four months later, the device was explanted and replaced with a "blood vessel prosthesis." no further adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received which included the serial number.This event was previously reported see report # (2025587-2015-01002).
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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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