(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 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: 3008680601-2020-00002, 3008680601-2020-00003, 3008680601-2020-00004, 3008680601-2020-00005, 3008680601-2020-00007, 3008680601-2020-00008.Are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled, ¿early postmarket results with pulserider for treatment of wide-necked intracranial aneurysms: a multicenter experience¿ (pmid:31703202).1 patient with intracranial aneurysm who was treated with pulserider experienced intraprocedural aneurysm rupture leading to death.The complication resulted from the perforation of the left pca by the pulserider arch during deployment.Objective: traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies.Pulserider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling.The objective of this study was to report early postmarket results with the pulserider device.Methods: this study was a prospective registry of patients treated with pulserider at 13 american neurointerventional centers following fda approval of this device.Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events.Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.Cerenovus devices were used in this study.No device specific information (including catalog and lot number) were provided in the article.
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