The device was not returned for evaluation.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 of the reported lot 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 respects to the design, manufacture, or labeling of the device.
|
It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, heavily tortuous, 90% stenosed left circumflex coronary artery.Pre-dilatation was performed with a 2.5x15 non-abbott balloon, and a 2.5x28mm xience skypoint stent was implanted.A 3x8mm nc trek balloon dilatation catheter (bdc) experienced resistance with the anatomy during advancement, and the balloon ruptured during the first inflation at 8 atmospheres.A 3x8mm non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|