During coil embolization of an aneurysm at the right internal carotid artery the surgeon suspected the deltaplush coil (cpl10020330/c24291) may have been stretched while it was being retrieved and possibly pulled another coil out of the aneurysm into the microcatheter.The other coils already in the aneurysm were a presidio (pc410041230/c18185) deltaplush (cpl10025630/c23275), and another deltaplush (cpl10020630/c24227).The surgeon tried to retrieve the deltaplush into the excelsior sl 10 microcatheter (details unknown) because it was too large for the aneurysm.The surgeon noticed on the angiography monitor that one part of the coil was visible, then there was a gap and then a piece of the coil stuck in the microcatheter.The surgeon is not sure, whether the coil was stretched while it was retrieved or whether he pulled another coil out of the aneurysm into the microcatheter when he retrieved the coil that didn¿t fit.This piece of the coil couldn¿t be repositioned into the aneurysm so it emerged out of the aneurysm and protruded into the artery.The loose piece of the coil was pinned to the artery wall with a solitaire ab 5-20 stent (details unknown).Although the delay to the procedure was noted as significant, the issue did not cause any further injury to the patient.Despite being pinned to the wall of the vessel, the coil was retrieved for investigation.It is unknown if there were any other parts of the coil delivery system that were damaged.There was some resistance when advancing the coil through the microcatheter however there was no kink in the microcatheter.A one to one relationship between the coil & delivery tube verified with fluoro prior to repositioning.
|
Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).
|