(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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.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 manufacture, design or labeling.
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It was reported that the procedure was to treat the left anterior descending artery that did not have tortuosity or calcification.Before use, a 3.5 x 23 mm xience sierra stent delivery system (sds) was being advanced over an unspecified guide wire.However, the proximal part of the guide wire perforated the sds nose-cone and possibly the balloon as well.Therefore, the device was replaced with another 3.5 x 23 mm xience sierra (sds) to successfully complete the procedure.There was no patient involvement.No additional information was provided.
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