Catalog Number ENC452212 |
Device Problems
Premature Activation (1484); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, and weight, were not provided.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8302870.The history record indicates this product was final inspection tested at lake region 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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Event Description
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The healthcare professional reported that during an endovascular embolization procedure, the 4.5mm x 22mm enterprise® vascular reconstruction device enc452212 / 8302870) encountered slight resistance in the y-connector during its delivery process.During the advancement of the stent, the stent component became prematurely detached / separated from the delivery wire.The physician retracted the stent and replaced it to complete the procedure using the original prowler select plus microcatheter.There was no report of any negative patient impact.On 01-mar-2024, additional information was received.Per the information, the target aneurysm was located on the anterior cerebral artery.The stent / stent delivery system did not appear damaged when it was removed.The replacement stent was another 4.5mm x 22mm enterprise® vascular reconstruction device enc452212.There was no delay in the procedure as a result of the reported issue.
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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 20-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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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 4.5mm x 22mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the stent was already detached from the unit.One kink was noted on the distal portion of the delivery wire.The introducer was observed to be in good condition (i.E., no kink, no bends, no 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.The delivery wire underwent dimensional analysis.All measurements were found to be within specification, including those 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 a stent being prematurely detached was confirmed since the stent was noted as already separated from the delivery system; based on this condition, the issue reported regarding a slight resistance in the y-connector during advancement could not be evaluated through functional analysis since the stent was found already separated from the delivery system; however, this issue was able to be confirmed based on the kinked condition of the delivery wire mentioned above.It is suggested that the delivery wire got kinked and disengaged inadvertently from the stent during the retraction from the microcatheter.It is possible that the delivery wire had been pulled sufficiently to disengage it from the stent during the removal.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.However, with the limited information available no further evaluation could be conducted.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 8302870.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.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as delivery wire damage from leaving the facility.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following warnings and recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to 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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Search Alerts/Recalls
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