This complaint is from a database related research activity (drra).On behalf of jennifer wood, medtech epidemiology, please see the attached drra potential complaint form, aligned to a cerenovus product, and a copy of the final study report.Lot, model, and catalog number are not available, but the suspected cerenovous devices possibly associated with reported adverse events: unknown embotrap this study dataset is a prospective clinical registry of consecutive stroke patients treated in a single center to assess embotrap¿s effectiveness, safety, and efficiency in treating acute ischemic stroke patients who have a large artery occlusion in their neurovascular.Device name: embotrap® revascularization device the following malfunction occurred 6 hours after the procedure: (b)(4) : qty 1: stent fracture.
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Product complaint #: (b)(4).The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter's contact information is not available.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Complications were assessed after recanalization, twenty-four post thrombectomy, less than six hours after the procedure, more than six hours after the procedure, and ninety days after the procedure.A fractured device could separate with the potential for vessel damage, embolization, ischemia, or infarct, and/or the need for additional intervention.Therefore, this event is usfda reportable under 21 cfr 803 with a classification of the classification of ¿malfunction¿.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
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