The case was from the china health authority.It was reported that angiography revealed severe stenosis of the basilar artery requiring stent placement.The 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) was used and it became kinked / bent.The stent (unspecified brand) encountered resistance during advancement in the microcatheter.The stent became prematurely released in the proximal section of the microcatheter.After replacing the microcatheter and the stent, the replacement stent (unspecified brand) was safely released and well formed in the target location.The patient reportedly had no discomfort after the procedure.There was no negative patient impact reported.On 27-nov-2023, additional information was received.Per the information, the lot number of the prowler select plus microcatheter is 31028212.The stent used was a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600 / 8302861).The replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter.
|
Manufacturer¿s ref.No:(b)(4).Information regarding patient identifier, date of birth, age, 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.A review of manufacturing documentation associated with this lot (31028212) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00879.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.
|
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 11-dec-2023.[additional information]: on 11-dec-2023, additional information was received, the information documented a change / correction in the health professional contact.Section e.1: the initial reporter phone was updated from 18653450282 to 18678381566.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00869 and 3008114965-2023-00879.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.The name of the initial reporter was changed from (b)(6).The initial reporter phone was updated from (b)(6).
|