Catalog Number ENCR403912 |
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 01/29/2024 |
Event Type
malfunction
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Event Description
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As reported by the field, during a stent-assist embolization of aneurysm, an enterprise2 4mmx39mm intracranial stent (encr403912, 8302865) became impeded in the tip of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not be released.The physician removed the microcatheter (mc) and stent from the patient, then switched new devices to complete the surgery.There was no patient injury reported.Additional event information received on 04-feb-2024 indicated that there were no procedural delays.
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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: (b)(6).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00206.
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Manufacturer Narrative
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Product complaint # (b)(4).Complaint conclusions: as reported by the field, during a stent-assist embolization of aneurysm, an enterprise2 4mmx39mm intracranial stent (encr403912, 8302865) became impeded in the tip of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not be released.The physician removed the microcatheter (mc) and stent from the patient, then switched new devices to complete the surgery.There was no patient injury reported.Additional event information received on 04-feb-2024 indicated that there were no procedural delays.No additional information is available.A non-sterile 4mm x 39mm enterprise 2 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.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or 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 issue regarding a stent being impeded in the tip of the microcatheter cannot be evaluated through functional testing.The stent must be inside the introducer tube to perform the functional analysis.The stent detachment was not originally reported in the complaint, therefore, the exact time when this condition occurred cannot be determined.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 8302865.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).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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