Catalog Number ENC452212 |
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 10/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # :(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(4).Section h3 - 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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
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Event Description
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As reported by the field, during the use of an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8129995), the device became impeded in y connector and could not advance any more.After several attempts, the stent was still impeded in y connector.The physician retracted the stent and it was released without intention.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The 0.021 inch headway 21 microcatheter (mc) was not replaced.There was no patient injury report.Additional information received on (b)(6) 2023 indicated that they were able to move the device and torque it.The mc did not kink or bent.There were no procedural delays due to the event.The tip of the introducer did sit correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.
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Manufacturer Narrative
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Product complaint # (b)(4) complaint conclusion: as reported by the field, during the use of an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8129995), the device became impeded in y connector and could not advance any more.After several attempts, the stent was still impeded in y connector.The physician retracted the stent and it was released without intention.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The 0.021 inch headway 21 microcatheter (mc) was not replaced.There was no patient injury report.Additional information received on 06-nov-2023 indicated that they were able to move the device and torque it.The mc did not kink or bent.There were no procedural delays due to the event.The tip of the introducer did sit correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.A non-sterile 4.5mm x 22mm enterprise® 12mm tip vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit and this was not returned for evaluation.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).The distance between the delivery wire tip and the reference marker was measured, and it was confirmed to be within specifications.The customer 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 regarding a stent being impeded in the y connector 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 did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8129995.The history records indicate 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.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do 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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Manufacturer Narrative
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Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Search Alerts/Recalls
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