The issue was identified during pre-implant preparation, the leaking tributary was sutured, and the graft was successfully implanted.As a result, there was no reported adverse event associated with this complaint.Based on the documentation and complaint history review, we do not believe there is a systemic issue with this device.Manufacturing records and necessary logs were reviewed and no deviations or non-confomances were found.This is the second event related to a tributary leak within the past two years, but only represents <0.0001% of the grafts that have been released over the same time period.All available information has been provided.This and similar complaints will continue to be monitored and investigated.Additional actions will be performed as deemed necessary.
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