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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified anatomy resulting in the reported failure to advance.Interaction with the heavily calcified anatomy and/or manipulation of the device resulted in the reported stent dislodgement.The treatment appears to be related to the operational context of the procedure as a snare was used to successfully retrieve the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the procedure was performed to treat a lesion in the heavily calcified right circumflex coronary artery.Pre-dilatation was performed, and a 4x15mm xience pro a stent delivery system (sds) failed to cross due to the anatomy.During removal of the entire system, the stent dislodged, so a snare was used to successfully retrieve the stent.An unspecified sds was used to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
|