The manufacturer was informed that on (b)(6) 2023, a perceval valve size 21 was implanted in a patient but, after de-clamping, pvl was noted at right coronary apex.As such, the valve was explanted, and replaced with inspiris valve size 19.No further information is available at this time.
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Manufacturer attempted to follow up with this event, but no further information was provided despite manufacturer's multiple attempts of follow up.The manufacturing and material records for the perceval heart valve, model # icv1208, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1208 perceval heart valve at the time of manufacture and release.Based on the limited information available, the definitive root cause of the reported event cannot be established.However, from the document review performed.No manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.
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