It was reported that the procedure was to treat a lesion in the mildly calcified, mildly tortuous proximal left anterior descending artery (lad) with 90% stenosis.After implanting a 4.5x23mm xience skypoint stent, a 5.0x15mm xience skypoint stent delivery system (sds) was attempted to be advanced through a non-abbott guide catheter; however, became stuck in the guiding catheter and could not be removed.Therefore, the xience skypoint and guiding catheter were removed together as one unit.A 4.5x15mm xience skypoint was implanted, and the procedure was completed.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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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 did not indicate a lot specific quality issue.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.Na.
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