It was reported that during preparation, the sealed packaging of a 6.0mmx19mmx135cm omni elite 35 balloon-expandable stent system (bess) was opened for use when it was noted that there was no dispenser coil and no stent implant on the delivery system balloon.Another same size omni elite was used successfully for the procedure.After the procedure, the physician inflated the system balloon in vitro to conclude there was no stent on the balloon.There was no patient involvement and no clinically significant delays in the procedure.No additional information was provided.
|
A visual inspection was performed on the returned device.The reported missing component (stent dislodgement) was confirmed.The analysis found crimp marks on the returned device indicating that there was a stent on the device at some point which dislodged.The reported missing component (missing coil) was not confirmed, as the coil was returned.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.The investigation was unable to determine a conclusive cause for the reported missing components (coil and stent).There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|