Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008114965-2020-00210, 3008114965-2020-00211, and 3008114965-2020-00212 are related to the same incident.
|
This complaint is from a literature source.As reported in the literature publication entitled,¿ stent retrievers in acute ischemic stroke: complications and failures during the perioperative period.¿ 1 patient with ischemic stroke and large-vessel occlusion who underwent stent retriever¿assisted thrombectomy experienced an arterial perforation and died subsequently.Purpose: stent retriever¿assisted thrombectomy promotes high recanalization rates in acute ischemic stroke.Nevertheless, complications and failures occur in more than 10% of procedures; hence, there is a need for further investigation.Method: a total of 144 patients with ischemic stroke presenting with large-vessel occlusion were prospectively included.Patients were treated with stent retriever¿assisted thrombectomy_iv fibrinolysis.
|