The device was not returned for evaluation.Therefore, the reported event could not be confirmed and the root cause could not be determined.No evidence of the graft discoloring or failing was provided.Review of the ifu found the following information related to the closure of the device after needle puncture: anastomose the graft as perpendicular to the axillary artery as possible to minimize stress.The anastomotic angle should be as small as possible and should not exceed 25° relative to the cut edge of the graft.As stated in the complaint, a 23 gauge needle was used at an angle of 30 degrees.This exceeds the recommended angle of 25 degrees, which could have caused difficulty in the closure of the needle puncture that was reported.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Additionally, we have not received any reports of similar issues occurring for this lot.
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