The manufacturing records for the packaging of valve onxae-27/29 serial number (b)(4).Were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.Onxae-27/29 sn (b)(4) was implanted october 7th, 2016.The patient experienced a stroke on april 9th, 2019.The patient's inr is reported to have been 1.6 at the time and had been consistently taking 81mg aspirin.The patient¿s documented historical inr¿s were in the 1.6 ¿ 2.0 range.An inr of 1.8 (range 1.5 ¿ 2.0) plus 75-100mg aspirin daily for the isolated on-x aortic valve is the current recommendation [ifu, nishimura 2017].Stroke is a recognized potential adverse event [ifu] and for rigid heart valve replacement, the rate of occurrence is 3.0 %/valve-year [iso 5840:2005].Thromboembolism is a recognized potential adverse event for any mechanical aortic heart valve recipient.With the information provided, as the patient was on anticoagulation due to a mechanical prosthesis, the first consideration for a source is the valve.No further action is required at this time.Should additional information become available, it will be evaluated and the complaint will be reopened.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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