The manufacturer was informed of this event through the device tracking department: based on the information reported on the patient implant form, a perceval valve pvs27 was implanted and explanted on the same day, (b)(6) 2019.No further information is presently available.
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The manufacturing and material records for the perceval heart valve, model# icv1211, serial# (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model# icv1211 (pvs27) perceval heart valve at the time of manufacture and release.The manufacturer made several attempts to follow-up for further information, however, at this time no further information has been received.If further information is received the manufacturer will reassess the investigation.At this time because no further information is available and the device is not available for analysis the root cause cannot be established as no event modes have been identified.
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