The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported leak.The reported difficulties of difficult or delayed activation, stent dislodgement and the patient effects of serious illness/injury/impairment and foreign body in patient appear to be related to operational context of the procedure.The investigation was unable to determine a conclusive cause for the reported leak as the device was not returned for analysis.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.The reported delayed activation appears to be related to operational context of the procedure as it is likely the reported device leak caused/contributed to the reported difficult or delayed activation.The device was removed; however, upon removal the stent was noted to be dislodged.The stent was found via cine and fluoroscopy partially deployed in the small branch of the ulnar artery.It is likely the partially expanded stent interacted with artery during removal causing the stent to dislodgement from the delivery system.The stent remains in the patient as no intervention was performed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to a lesion in the left circumflex (lcx) artery.The 3.00x15mm xience skypoint stent delivery system (sds) was advanced to the target lesion; however, when attempting to deploy the stent the balloon was thought to have leak and may have ruptured.Pressure was increased; however, no atmospheres (atm) were reached to inflate the balloon and blood was noted to come back into the indeflator.The sds was removed from the patient; however, the stent was noted to not be the balloon.The guide catheter and guidewire were then removed from the patient.The stent was not in the guide catheter.Cine and fluoroscopy were performed up and down the radial access site to look for the dislodged stent and the xience stent was found to be partially deployed as both ends of the stent were noted to have expanded slightly in the small branch of the ulnar artery.No intervention was performed in the remove the dislodged stent.There was no adverse patient sequela.No additional information was provided.
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