(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided.It should be noted that the omni elite instructions for use states: when treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the stent.The investigation determined the reported difficulties to be related to user error as a deviation to the ifu contributed to the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other omnilink elite referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch report number.
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