The devices were not returned for analysis, as they were successfully implanted in the patients.Hemorrhages and thrombosis events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related event.Linked: 2029214-2018-00324.If information is provided in the future, a supplemental report will be issued.
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Medtronic received the following report through literature review of ¿the role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms¿.One patient presented with a retroperitoneal hematoma, and 1 experienced a thromboembolic complication (ipsilateral cerebellar stroke after stent placement and coiling of a giant partially thrombosed vertebral dissecting aneurysm), both with complete recovery.Residual deficits were related to neurologic conditions preceding treatment.Two patients died from late complications of sah.There was no sign of aneurysm rupture following treatment with ped in this series.
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