Catalog Number ENC453712 |
Device Problems
Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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Event Description
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As reported by the field, during a stent assist coil embolization, an unspecified microcatheter (mc) arrived at parent artery.The package of an eu 4.5x28mm stent 12 mm dw tip intracranial stent (enc452812, 6948542) was inspected to be intact.The physician opened the packaging, then held introducer sheath and delivery wire tightly to prevent the stent from being released during the removal process.The stent was pushed into the microcatheter, but the stent was impeded in y connector and could not advance anymore.The doctor retracted the stent and found introducer sheath tip and stent body were deformed.Then another eu 4.5x37mm stent 12 mm dw tip intracranial stent (enc453712, 7044263), but it was with the same issue.The third stent was changed to complete the surgery.There was no patient injury reported.Additional information received indicated that it is unknown if other devices were able to be advanced through the same microcatheter.It was further clarified that the head end of the stent is slightly bent.The events did not result in a loss of cerebral target position.There was nothing noted to be obstructing the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.There was no excessive force applied to the device.There were no procedural delays due to the event.
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Manufacturer Narrative
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(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(4).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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 is 3008114965-2022-00712.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, g3, g6, h2, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization, an unspecified microcatheter (mc) arrived at parent artery.The package of an eu 4.5x28mm stent 12 mm dw tip intracranial stent (enc452812, 6948542) was inspected to be intact.The physician opened the packaging, then held introducer sheath and delivery wire tightly to prevent the stent from being released during the removal process.The stent was pushed into the microcatheter, but the stent was impeded in y connector and could not advance anymore.The doctor retracted the stent and found introducer sheath tip and stent body were deformed.Then another eu 4.5x37mm stent 12 mm dw tip intracranial stent (enc453712, 7044263), but it was with the same issue.The third stent was changed to complete the surgery.There was no patient injury reported.Additional information received indicated that it is unknown if other devices were able to be advanced through the same microcatheter.It was further clarified that the head end of the stent is slightly bent.The events did not result in a loss of cerebral target position.There was nothing noted to be obstructing the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.There was no excessive force applied to the device.There were no procedural delays due to the event.The device was discarded; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 7044263.The history records indicate 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 complaints 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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