The previous report was submitted on 9/22/2022 and failed ack 3.This report is being resubmitted at the request of the cesub help desk due to an infrastructure issue at fda.An event of the valve breaking during rotation of the valve and patient death was reported.The investigation confirmed that the valve leaflet and orifice were fractured.Three images were received from the field, which appeared to show a valve with one leaflet dislodged and fractured, consistent with the received device.Information from the field reported that the valve breaking was unrelated to the patient's evolution.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet fracture could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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