Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, 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 remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8302876.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 product 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 device; 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 endovascular embolization procedure, the physician released the 4mm x 23mm enterprise 2 (encr402312 / 8302876).The distal markers of the stent opened well, but the three proximal markers of the stent were converged and could not expand as intended.The physician used the micro delivery wire to massage the proximal markers but the markers still were not able to open.Information related on how the procedure was completed was not provided at the time of the complaint initiation.It was reported that the patient is in stable condition.On 27-mar-2024, additional information was received.Per the information, the target was an unruptured wide-necked aneurysm with the following dimensions: 3mm x 2mm neck: 2mm on the posterior communicating segment of the left internal carotid artery.The information indicated that there was no evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch was checked and confirmed to be within acceptable criteria.The microcatheter used was a prowler select plus (606s255x / 31138753).There had been no resistance during the advancement of the stent.The stent and microcatheter was not replaced.The procedure was completed when ¿angiography showed no abnormal blood flow, and the patient was normal.¿ the information confirmed there was no negative patient impact and there was no delay in the procedure as a result of the reported issue.On 31-mar-2024, additional information was received.The information indicated that the 4mm x 23mm enterprise 2 (encr402312 / 8302876) was implanted.
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