The device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.Related mdrs for this event: 2029214-2019-00569, 2029214-2019-00570, 2029214-2019-00571.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that increased friction lead to more manipulations, which, in turn, lead to 2 thromboembolic events of the middle cerebral artery (mca) branches.The patient was undergoing double catheter technique coiling treatment for a small aneurysm on the m1-m2 junction of the right middle cerebral artery (mca).The vessel was observed moderately tortuous.Prior the event, it was reported that the physician decided to use double catheter technique.He used one echelon 10 and one echelon 10 45-degree microcatheters and were placed both in the aneurysm.The microcatheters were prepared in accordance to the ifu and were under continuous saline drip.The physician delivered coils through one microcatheter without problems.During the placement of the first coil in the second microcatheter, the physician noticed increased friction in one of the microcatheters.He decided to continue with the delivery of the coil, despite the increased friction, and he delivered and detached the coil.The second coil he decided to use through this microcatheter was the apb-2-3-hx-ss.Again, he noticed increased friction which lead to ¿snaking¿ of the coil inside the microcatheter.He retrieved the microcatheter and it was placed aside for return and further evaluation.The aneurysm was treated with coils delivered from the first microcatheter.It is the physician¿s view that the increased friction lead to more manipulations, which, in turn, lead to 2 thromboembolic events of the mca branches.The physician did super selective catheterization of mca branches and administered iib iiia inhibitor to resolve the thrombi.The superior and front opercular branches of the mca remained occluded but the patient had good collaterals and slight neurological symptoms were noticed because of this event.According to the physician she is doing well but she has some slight neurological problems (headaches and minor memory disorders).
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