(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 a lesion located in the left anterior descending coronary artery.During advancement of the xience alpine 3 x 15 mm stent delivery system (sds), mid-way up, the sds met resistance with the guiding catheter and would not advance further.While removing the sds, there was also resistance met with the guiding catheter and both were removed as a single unit.When removed, it was noticed that the guiding catheter was kinked.Another unspecified stent delivery system was used to successfully complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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