It was reported that during the procedure the physician used a micro catheter to deliver and deploy the subject coil as a second coil into the aneurysm in mca.While the physician was readjusting the subject coil in an attempt to have it better confirm to the aneurysm wall, it prematurely detached partially inside the aneurysm and partially in the parent vessel.A stent was used as a snare/additional device to tack up the tail of the subject coil which was in the parent vessel.It was reported that this attempt shut down the mca vessel and the procedure was completed without treating the occluded mca.A follow-up ct (computed tomography scan) was conducted post procedure and it was reported that the occlusion appeared to be open and was no longer occluded.It was reported that the patient is suffering from other co-morbidities unrelated to the procedure and subject device.According to physician, patient is doing well.No other clinical consequences were reported to the patient due to this event.
|
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the coil was not advanced or retracted with force, and the coil prematurely detached half in the aneurysm and half in the parent vessel (mca) while readjusting the coil to better conform to the aneurysm wall.It was noted that there was no allegation against the micro catheter and the stent was used to tack the coil.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
|
It was reported that during the procedure the physician used a micro catheter to deliver and deploy the subject coil as a second coil into the aneurysm in mca.While the physician was readjusting the subject coil in an attempt to have it better confirm to the aneurysm wall, it prematurely detached partially inside the aneurysm and partially in the parent vessel.A stent was used as a snare/additional device to tack up the tail of the subject coil which was in the parent vessel.It was reported that this attempt shut down the mca vessel and the procedure was completed without treating the occluded mca.A follow-up ct (computed tomography scan) was conducted post procedure and it was reported that the occlusion appeared to be open and was no longer occluded.It was reported that the patient is suffering from other co-morbidities unrelated to the procedure and subject device.According to physician, patient is doing well.No other clinical consequences were reported to the patient due to this event.
|