Manufacturer was informed of the following event through device tracking department.Reportedly, on 14 jan 2012, a carboseal valsalva valve cp-029 was implanted in a patient.The device was explanted and replaced with a perceval valve pvs27 on (b)(6)
2017.No allegation of any device dysfunction or serious injury on the patient has yet been reported from the site.
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A complete manufacturing and material records review for the carboseal valsalva cp-027 has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Manufacturer attempted to follow up with field, but no further information has yet been received despite manufacturer's multiple attempts of follow up.Based on the limited information available, the definitive root cause of the reported event cannot be established at this time.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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