Catalog Number ENCR402312 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
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, and weight 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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028668.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 4mm x 23mm enterprise 2 (encr402312 / 8028668) passed through the microcatheter tip, the physician attempted to release the stent.It was observed that the distal markers of the stent were converged and the stent did not fully open or expand as intended.The physician retracted the stent and then delivered the stent and attempted to release it again; however, the stent was still unable to open completely.The physician retracted the stent and replaced it with a new device to complete the procedure using the original concomitant microcatheter (unspecified brand).There was no report of any negative patient impact.On 22-mar-2024, additional information was received.Per the information, the target vessel of the procedure was the left posterior communicating artery.The aneurysm was an irregular unruptured aneurysm with origin in the left posterior communicating artery.There were no vessel nor aneurysm factors that may have contributed to the incomplete expansion of the stent.There was no evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch was checked and confirmed to be within acceptable criteria.The concomitant microcatheter use was a prowler select plus (606s255x / 31108275).There was no resistance during the advancement of the stent.The replacement stent was a 4mm x 16mm enterprise 2 vascular reconstruction device (encr401612).There was no delay in the procedure and the information confirmed there was no negative patient impact.
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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 22-apr-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 4mm x 23mm enterprise 2 was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the was already detached from the unit and this together with the introducer component were not returned for evaluation.The delivery wire was in good condition (i.E., no kinks, no bends, no elongations).The reported issue documented in the complaint regarding stent not being able to fully open was not able to be evaluated since the stent was not returned for inspection.With the limited information available, the root cause of the reported failure remains inconclusive; however, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.The detached condition of the stent was not originally reported in the complaint and is considered secondary to the manipulation required during the stent removal.It is suggested that the stent may have gotten lost during the post-operative handling.This finding is not a contributing factor to the stent's inability to open experienced during the procedure.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028668.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 recommendation: ¿ 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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