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The healthcare professional reported that during a stent-assisted endovascular embolization procedure targeting a right wide-necked posterior communicating artery (pcoa) aneurysm, after the microcatheter was placed in the distal end of the vessel, the complaint stent, a 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 7497509) was delivered into the microcatheter.The physician encountered a lot of resistance when the stent was at the middle section of the microcatheter.The physician tried to withdraw the stent, but the stent was impeded and was not able to be retracted.Therefore, the physician delivered the stent to pass through the microcatheter tip and withdrew the microcatheter to release the stent; it was reported that the physician also encountered significant resistance.The physician attempted to retract the stent, but it was prematurely released in the patient.The stent was not released in the desired location and the target lesion was not covered.It was reported that a second stent was implanted to complete the procedure.The procedure was prolonged by approximately half an hour.There was no report of any adverse patient event.One procedure medical image was included in the complaint and is pending independent physician review.On (b)(6) 2023, additional information was received.The information indicated that the target was a 4mm ruptured aneurysm was on the posterior communicating artery.The enterprise stent length selected was at least 10mm longer than the aneurysm neck to maintain a minimum of 5mm on either side of the aneurysm neck.There was no evidence of obstructed blood flow due to the reported event.It was not known if there were vessel or aneurysm factors that may have contributed to the issue related to resistance and prematurely deployment.The microcatheter use was a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown).A continuous flush was maintained through the microcatheter.There were no visible kinks or damages observed on the microcatheter; the same microcatheter was used to deliver the second stent, which was a 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812).There was no allegation of patient injury due to the reported issue.The physician did not consider the half hour procedure extension to be significant.Based on the additional event information received on (b)(6) 2023, the prowler select plus microcatheter was used with the complaint stent when resistance was encountered in the middle section.The stent was also impeded and could not be retracted.The issue resulted in the premature deployment of the stent in a location other than the desired location and the target location was not covered.A second stent was implanted to complete the procedure.This meets reportability criteria under 21 cfr 803 with a classification of ¿serious injury.¿.
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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 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 7497509.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 in the complaint cannot be confirmed.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.Stent deployment difficulty is a known complication associated with the use of the enterprise vascular reconstruction device and is listed in the instructions for use (ifu) as such.Premature deployment of the stent in the patient may have led to damage to healthy intima, possible side branch occlusion, ischemia, infarct, and/or the need for additional intervention.Additionally, since the reported stent was prematurely deployed in the patient as well as with an inaccurate placement and this required additional intervention, i.E., the use of a second stent device to conclude the procedure, the event meets us fda mdr reporting criteria under 21 cfr 803 with the classification of ¿serious injury¿ and ¿malfunction.¿ the file will be re-reviewed if additional information is received at a later date.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 is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00279.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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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the medical image review completed on (b)(6) 2023.The procedure images included in the complaint underwent independent physician review.The assessment is documented below.The case described involves stent placement with unexpected friction and lack of control.There is one image supplied, which does not highlight the problem encountered nor does it show what approach was taken.There is a distal access catheter present as support and a microcatheter with a wire that seems to belooped in the region of the pcom aneurysm.It is not clear from the image whether the stent was already deployed.The stent, according to the description, was placed despite serious friction.Removal of the stent from the microcatheter was not possible and from what is described removal of the microcatheter was not attempted but the stent was pushed forward with significant resistance.The fact that the stent is in the patient precludes analysis of the stent itself, however, analysis of the microcatheter can be attempted if available.From the provided information and image, it is not possible to speculate on possible etiologies for the difficulties encountered during this procedure.Physician name and date reviewed: (b)(6) 2023.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00274 and 3008114965-2023-00279.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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