Catalog Number ENCR401612 |
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 11/23/2023 |
Event Type
malfunction
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Event Description
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As reported by the field, during a stent assist coil embolization to the right middle cerebral artery (mca, an enterprise2 4mmx16mm intracranial stent (encr401612, 8254492) became impeded in middle section of a prowler select plus 150/5cm microcatheter (606s255x, 31113002) and could not advance or withdraw.The physician removed the microcatheter and stent from patient and observed that the middle section of the microcatheter (mc) was kinked/bent and the stent could not be removed from the microcatheter.The doctor switched to a new microcatheter and stent to complete the surgery.There was no patient injury reported.Additional information received on 05-dec-2023 indicated that there was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.No excessive force was applied to the device.The procedure was delayed by three minutes due to the event and it was not clinically significant.There was severe tortuosity of the cavernous sinus segment of the internal carotid artery.
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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)(6).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 3008114965-2023-00924 and 3008114965-2023-00925.
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Manufacturer Narrative
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Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization to the right middle cerebral artery (mca, an enterprise2 4mmx16mm intracranial stent ((b)(4)) became impeded in middle section of a prowler select plus 150/5cm microcatheter ((b)(4)) and could not advance or withdraw.The physician removed the microcatheter and stent from patient and observed that the middle section of the microcatheter (mc) was kinked/bent and the stent could not be removed from the microcatheter.The doctor switched to a new microcatheter and stent to complete the surgery.There was no patient injury reported.Additional information received on 05-dec-2023 indicated that there was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.No excessive force was applied to the device.The procedure was delayed by three minutes due to the event and it was not clinically significant.There was severe tortuosity of the cavernous sinus segment of the internal carotid artery.The device was discarded; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) do contain the following 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.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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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Search Alerts/Recalls
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