Manufacturing review of the device history record for the reported lot shows that all units were quality released on 4/24/2015 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.Oem supplier reviewed the sub-lots associated with the reported lot and it was stated that, "no deviations or nonconformance's were found to be associated with the lots.The review confirms that all devices met specification." the instructions for use with the vascular product (part number 20438-032514) was reviewed.Under the section potential complication, it states: "the following complications are possible.If any of these conditions occur, the cormatrix ecm should be removed: pseudoaneurysm, thrombosis, stroke." the exact cause of the reported event cannot be conclusively determined but are known potential complications.
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