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 was unable to determine a conclusive cause for the reported difficulties.Factors which may contribute to difficulty advancing/removing the device in the guiding catheter include, but are not limited to, manufacturing defects, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).In this case, it is possible that the device was not properly supported or coaxially aligned, which may have contributed to the reported difficult to advance/position and difficult to remove (guide catheter resistance); however, without the device to examine, this cannot be confirmed.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 in the left anterior descending (lad) artery with 90% stenosis and moderate calcification.Pre-dilatation was performed using a 2.5x20mm balloon.The 2.5x38mm xience alpine stent delivery system (sds) had resistance with the guide catheter during advancement and failed to cross.The guide catheter was attempted to be removed but was not possible so the complete system, which was the guide wire, guide catheter and xience alpine sds, was removed.Another 2.5x38mm stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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