Reportable based on device analysis completed on (b)(4) 2016.It was reported that crossing difficulties were encountered.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex (lcx) artery.After performing plain old balloon angioplasty (poba) and ablation, a 2.25 x 12 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a 8mm non-bsc stent.No patient complications were reported and the patient's status was good.However, returned device analysis revealed distal stent damaged.
|