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The healthcare professional reported that during an angioplasty procedure with stent implantation, the 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device ((b)(4)) was released and implanted in the target site, it was observed that the stent body was shorter than intended.After measurement the stent length was only about 17mm while the label has the length of 23mm.Two procedure images were included in the complaint.No negative patient impact was reported.On 07-feb-2024, additional information was received.Per the information, the target vessel of the cerebral angioplasty procedure was the right middle cerebral artery (mca).A response to the question of whether the enterprise stent length selected was at least 10mm longer than the target lesion to maintain a minimum of 5mm on either side is as follows: ¿the patient was suffering from intracranial stenosis and the length of target lesion was about 15mm.The patient also had vessel dissection.¿ the delivery wire of the 4mm x 23mm enterprise 2 was not reshaped prior to use.Nothing unusual was noted about the 4mm x 23mm enterprise 2 system prior to use.The reported issue with the length of the stent did not prompt the use of a second stent to make up for the 5mm difference.The concomitant microcatheter used was a prowler (catalog / lot# not provided).There was no evidence of obstructed blood flow due to the reported issue.The information confirmed there was no negative patient impact and no delay in the procedure.Additional information was provided by the cerenovus sales representative on 17-feb-2024.Information whether the vessel dissection was part of the patient¿s presentation or it if it was associated with the procedure could not be obtained.The information indicated that there was no patient harm as a result of the reported stent length issue.
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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.Section e.1: initial reporter facility name: (b)(6) hospital.The two procedure images included in the complaint underwent independent physician review on (b)(6) 2024.The review is documented below.¿the description is clear and supported by the images provided.There are two images (both subtracted) of a right sided mca with a stent in position.The length of the stent as measured by the physician on the images provided does not correlate to the expected length.It should be noted that in plane measurements there is an expected degree of error since the artery does not necessarily run in the plane.If measurement in two planes is performed, this should correct for the actual length.Foreshortening after deployment may be due to unconstrained opening of the device, leading to further foreshortening, but this should be no more than 2 millimeter.A cause of the further foreshortening in this cannot be assessed from the images and description, provided that the measurements are accurate.¿ physician name and date reviewed: (b)(6) md, (b)(6) 2024.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 8639210.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.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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