A complete manufacturing and material records review for the perceval valve (model pvs25, sn (b)(4)) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information available on the database, there is no indication of valve re-intervention.As such, since the device is not available for return, no further investigation is possible at this time.Based on the information available, the root cause cannot be definitively stated.It is possible that the patient's risk factors (diabetes; obesity) contributed to the reported structural valve deterioration.However, since no device inspection could be performed, this cannot be ultimately confirmed.Structural valve deterioration is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.The manufacturer is following up to gather additional information on this event and will provide a follow-up report if new information will be received.
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The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2014 a patient received a perceval pvs25 in aortic position.Good device functionality is recorded at discharge and in the yearly follow-up visits up to (b)(6)2017.The manufacturer was informed on the following adverse event, which occurred on (b)(6) 2018: structural valve deterioration described as leaflet stiffening (calcified) and leading to stenosis.The patient is asymptomatic as a result of the reported event and no indication of a re-intervention is present on the database.Per additional information received, the stenosis detected in (b)(6) 2018 was defined as "moderate" although the evolution compared to the previous year was pejorative.In feb 2019, the patient was monitored for cardiac decompensation with multifactorial origin.The patient is euvolemic and well compensated clinically.
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