(b)(4).A review of manufacturing and qc records confirmed that device has been manufactured to specification.Vascutek did not receive complaints for any other units from the complaint batches or any other units that were impregnated and sterilised at the same time as the complaint device.Endotoxin results for the complaint device were reviewed and they were within the limit.As the event was reported as fever and seroma 5-year similar events review covered all infection, seroma and fever complaints for all gelweave family product types which gave a low occurrence rate of 0.002% (complaints v sales).During review of vascutek's clinical evaluation report and relevant clinical papers for polyester vascular grafts, it was noted that seroma formation is a known and expected complication of this type of procedure.As a complaint device was not available no further investigation can be carried out.Vascutek now consider this event closed; however, the event type will continue to be tracked and trended through the complaint's monitoring system.If negative trend arises corrective actions may be considered at the time.
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