Catalog Number ENC452212 |
Device Problems
Premature Activation (1484); Failure to Advance (2524)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/25/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.The product analysis lab team reviewed the photo included in the complaint.The review is documented below.[photo review]: the photo shows the enterprise system inside the hoop dispenser, and the detached stent was noted, inside the pouch.No structural damage was noted, in the detached stent, (i.E., no broken struts, no kinks).Also, it was noted, fully expanded, both ends can be noted, as completely flared.(b)(6) medical performed, a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7682980.The history record indicates, this product was final inspection tested at (b)(6) medical.And was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue regarding a stent being prematurely detached was confirmed, based on the detachment condition of the stent.However, the issue regarding an impeded condition cannot be evaluated, since a functional analysis needs to be performed.This investigation was performed, based only on the photo provided.If the product is received after this investigation, an assessment will be performed, as per the conditions of the device returned.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.
|
|
Event Description
|
The healthcare professional reported that, during an endovascular embolization procedure, the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 7682980), was impeded in the y-connector and could not be pushed through into the microcatheter.The physician retracted the stent and observed, that the stent component had been released in the y-connector.The stent body was prematurely separated from the delivery wire.The physician switched to a new stent to complete the procedure, using the original microcatheter (unspecified brand).There was no report of any negative patient impact.A photo of the device was included in the complaint.On (b)(6) 2024, additional information was received.The information indicated, that the target vessel of the procedure was the middle cerebral artery (mca).Adequate continuous flush was maintained through the concomitant microcatheter.A prowler select plus microcatheter.The replacement stent was another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212).The information confirmed, there was no negative patient impact.There was no clinically significant delay in the procedure as a result of the reported issue.
|
|
Manufacturer Narrative
|
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 19-jan-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.
|
|
Manufacturer Narrative
|
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 4.5mm x 22mm enterprise® vascular reconstruction device 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, bends, or elongations).Microscopic inspection was performed on the stent component.It was observed to be in good condition and as seen in the photo that was included in the complaint, 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.The retraction bump and marker distance were subjected to dimensional analyses, and all measurements were found to be within specifications.Since the distance between the delivery wire tip and reference marker was found to be within specifications, manufacturing or design defects are not suspected.The reported issue documented in the complaint regarding a stent being prematurely separated was confirmed since the stent was noted as already separated from the delivery system; based on this condition, the issue regarding a stent being impeded 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 7682980.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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.
|
|
Search Alerts/Recalls
|
|