It was reported that during deployment of the fred stent, the stent did not deploy "properly" approximately 10 to 15mm from the distal end of the stent.An attempt was made to resheath the stent, but the resistance was too high and the stent could not be retrieved into the microcatheter.The stent was withdrawn using the intermediate catheter and successfully removed from the patient.There was no reported patient injury.The current condition of the patient was reported to be "no health damage.".
|
The stent was returned for evaluation.Upon initial inspection, the stent was found damaged.The stent was too damaged to be loaded onto a new pusher, and therefore further investigation into the stent's ability to deploy could not be conducted.The root cause of the complaint may have been due to the friction and resistance felt when attempting to resheath, and pulling the stent back may have damaged the stent during the procedure.The microcatheter used in the procedure was not available to be evaluated, so the investigation could not determine if it had caused or contributed to the reported complaint.
|