(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It was reported that force was applied to the stent delivery system during advancement.It should be noted that the xience skypoint instructions for use states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.In this case, it is unknown the ifu deviation contributed to the reported event.The investigation determined the reported difficulties are related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|
It was reported that the procedure was to treat a greater than 80% stenosed, heavily calcified and heavily tortuous vessel in the left anterior descending (lad) artery.The 2.25x23mm xience skypoint stent delivery system (sds) was attempted to be advanced through the guiding catheter however, it would not advance even when force was applied and there was resistance during removal.The sds and the guiding catheter were retrieved together as one unit.It was not until the device was on the table and the stent was pulled from the guiding catheter that the shaft was noted to be kinked.Another xience skypoint was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
|