Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028693.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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The healthcare professional reported that during a stent-assisted embolization procedure targeting a middle cerebral artery aneurysm, the complaint device, a 4mm x 23mm enterprise 2 (encr402312 / 8028693) was impeded in the distal end of the concomitant microcatheter (competitor brand) and could not pass through the microcatheter.The physician removed the stent and the microcatheter from the patient and switched to new devices to complete the procedure.There was no report of any negative patient impact.On 30-nov-2023, additional information was received.Per the information, the procedure was targeting the middle cerebral artery (mca).When the stent was removed from the patient, it was still on the delivery wire.There was no damage noted on the stent / stent delivery system.Nothing unusual was noted about the system prior to use.There were no visible kinks nor other damages observed on the microcatheter.Adequate continuous flush was maintained through the microcatheter.The replacement stent was another 4mm x 23mm enterprise 2 (encr402312).The replacement microcatheter was of the same original brand (competitor).There was no clinically significant delay in the procedure as a result of the reported issue.
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