(b)(4).The aso was not returned to sjm for analysis.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation are inconclusive because the aso was not returned for evaluation.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the embolization remains unknown.
|