The device lot number is unknown; therefore, a search for non-conformances associated with the reported part/lot number combination could not be performed.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided.Therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies hemorrhage, vascular thrombosis as potential complications associated with use of the device.
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As reported through the article titled, "web device for treatment of posterior communicating artery aneurysms", during the procedure and post deployment of the web device to treat the patient's ruptured aneurysm, a thrombus formed at the level of the web device with subarachnoid hemorrhage.There was complete resolution of this thrombotic event with the use of a glycoprotein iib/iiia receptor antagonist without any clinical repercussion.
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