The device will not be returned for evaluation as it was implanted in the patient.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Mdrs related to this report: 2029214-2016-01014.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that during treatment of an aneurysm located in the left internal carotid artery (ica), two pipelines did not open.In addition, the carotid became occluded forming a cavernous carotid fistula.After further imaging and checking patency of the circle of willis the physician sacrificed the carotid artery.It was reported that the first ped-425-18 did not open proximally and the second device did not open distally as they were positioned in a bend.Proximal segment landed in a curve, slow flow was noted.A second ped-450-16 device was implanted and overlapped to extend the device into a straight segment, both pipelines remain in the patient.After deployment of the second device the carotid became occluded forming a ccf.The ccf was treated with coils and post angio showed carotid was coiled.The patient is currently doing fine.The aneurysm was unruptured and saccular, the max diameter is not known.The neck diameter was 4.5 (mm) and the distal landing zone was 4.0 mm and the proximal was 4.25 mm.The patient had moderate vessel tortuosity.
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