(b)(4).Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.The product code listed and the pma # are based on the predicate device (xience v stent system) that is determined to be same and similar to the delivery system of this device.Evaluation summary: the device was returned for analysis.The kinked tip was unable to be confirmed; however the tip was torn which is likely the damage reported by the account.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other incidents for tip damage (kinks/tears) reported from this lot.Based on the reviewed information, no product deficiency was identified.
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