(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.
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(b)(4).A visual inspection was performed on the returned device.The reported detachment of the device was confirmed.The reported difficult to remove could not be tested as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use states (ifu) that the device is indicated for improving coronary luminal diameter in native coronary artery lesions.It is unknown the ifu deviation contributed to the reported event.The investigation determined the reported detachment of the device, difficult to remove, device embedded in vessel or plaque and the subsequent treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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