(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties 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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It was reported that the procedure was to treat a heavily calcified mid circumflex artery.A 2.5 x 15 mm xience sierra stent delivery system (sds) was used; however, the device met resistance with a guideliner during advancement.The stent then dislodged in the lesion.Therefore, the stent was crushed against the vessel wall in the lesion and a 3.0 x 12 mm xience sierra stent was implanted to successfully complete the procedure.No additional information was provided.
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