It was reported that during a mildly tortuous, eccentric, 90% stenosed, distal right coronary artery procedure, the 5.0 x 8 mm nc trek had successfully post-dilated the xience xpedition stent but after deflation, the balloon refold was noted to be poor and would not pull into the guiding catheter.The guiding catheter and the balloon dilatation catheter were removed as a single unit.As the stent was noted to be well apposed to the vessel wall, there was no further treatment performed.There were no adverse patient effects or a clinically significant delay reported.There was no additional information provided.
|
(b)(4).Concomitant products: guide wire: sion, guide cath: heartrail 6f al10.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.
|