Catalog Number ENCR403012 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/13/2023 |
Event Type
malfunction
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Event Description
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The healthcare professional reported that during an endovascular embolization procedure, the complaint stent, a 4mm x 30mm enterprise 2 stent (encr403012 / 7469243) was impeded in the distal end of the concomitant microcatheter, a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) and could not pass through the microcatheter.The physician removed the microcatheter and the stent from the patient for inspection and observed that the microcatheter was in good condition; the physician switched to a new stent and completed the procedure using the original microcatheter.The procedure was prolonged by approximately 30 minutes.There was no negative patient impact reported.On 20-nov-2023, additional information was received.Per the information, when the stent was removed, it was still on the delivery wire.The stent / stent delivery system did not appear damaged.A continuous flush was maintained through the microcatheter.The information confirmed that the 30-minute procedure extension was not clinically significant and confirmed there was no negative patient impact.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).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 7469243.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00850.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.(b)(4) the purpose of this mdr submission is to report that the product was received in the product analysis lab on (b)(6)2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00849 and 3008114965-2023-00850.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 30mm enterprise 2 stent 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, 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).It was also noted to be fully expanded, both ends can be noted as completely flared.The reported issue in the complaint regarding a stent being impeded in the distal end of the concomitant microcatheter cannot be evaluated.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 7469243.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00849 and 3008114965-2023-00850.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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