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 8028695.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.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.Additional information will be submitted within 30 days of receipt.
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The healthcare professional reported that during an endovascular embolization procedure, a microcatheter (unspecified brand) was placed in the target site.The physician started to release the stent, a 4 mm x 39 mm enterprise®2 stent (encr403912 / 8028695).It was reported that the distal markers of the stent were unable to open.After several attempts, the markers were still unable to open.The physician removed the stent from the patient¿s anatomy and ¿massaged¿ the stent then re-delivered the stent to the target site to attempt to release it again.The distal markers still could not open.The physician retracted the stent and switched to a new stent to complete the procedure.The microcatheter was not replaced.There was no report of any negative patient impact.Additional information was received from the cerenovus sales representative on (b)(6) 2023.Per the information, the procedure was a stent-assisted aneurysm embolization that was targeting an a1 segment aneurysm of the left anterior communicating artery.The target aneurysm was an unruptured, wide-necked, spindled shape of unknown size.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.There was no evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.There had been no resistance during the advancement of the stent.The microcatheter used was a prowler select plus 606s255x / (b)(6).The replacement stent was another 4 mm x 39 mm enterprise®2 stent (encr403912).The information confirmed there was no negative patient impact.There was no clinically significant delay in the procedure due to the reported issue.
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