Catalog Number ENCR402312 |
Device Problems
Premature Activation (1484); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Event Description
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The healthcare professional reported during an endovascular embolization procedure, the 4mm x 23mm enterprise 2 (encr402312 / 7369551) was impeded in the y-connector and could not advance further.The physician retracted the stent and it was already automatically released; the stent component became prematurely separated from the delivery wire.The physician replaced the stent to complete the procedure using the same microcatheter.There was no report of any negative patient impact.The cerenovus sales representative provided the additional information via phone on 19-feb-2024.Per the information, the location of the targeted aneurysm was the left ophthalmic artery.The microcatheter was a ricoton microcatheter.A continuous flush had been maintained through the microcatheter.The stent / stent delivery system did not appear damaged.Nothing unusual was noted about the system prior to use.The replacement stent was another 4mm x 23mm enterprise 2 (encr402312).The reported issue did not result in any clinically significant delay in the procedure.
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Manufacturer Narrative
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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 h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.(b)(6) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7369551.The history record indicates this product was final inspection tested at (b)(6) medical and was determined to be acceptable.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 Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 23mm enterprise 2 was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was already detached from the unit.The delivery wire and the introducer were in good condition (i.E., no kinks, no bends, nor elongations).Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.Dimensional analysis was performed on the delivery wire.All measurements were found to be within specifications, including the specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The reported issue documented in the complaint regarding the stent automatically released was confirmed since the stent was noted as already separated from the delivery system; based on this condition, the issue regarding some resistance in the y-connector cannot be evaluated through functional testing.The stent must be inside the introducer tube to perform the functional analysis.Additionally, none of the returned components present damages that suggest that they were forcibly advanced.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7369551.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ if resistance is met during manipulation, determine the cause of resistance before proceeding.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 11-mar-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.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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Search Alerts/Recalls
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