Catalog Number ENCR402312 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Event Description
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As reported by the filed, during a stent assist coil embolization, an enterprise2 intracranila stent 4mmx23mm (encr402312, 8294533) was placed in target position and started to release, but the distal markers of the stent were converged which could not be opened.The physician withdrew the stent and attempted to release it again, but the markers still failed to open.The doctor retracted the stent and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional information received on 29-dec-2023 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.The stent did not appear damaged.There was no vessel dissection and tortuosity that may have contributed to the incomplete expansion.There was no additional intervention performed to attempt to expand the stent.The stent was recaptured into the mc and removed.There were no procedural delays due to the event.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (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.The company is seeking this information through the event investigation.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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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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Manufacturer Narrative
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Product complaint (b)(4).Complaint conclusion: as reported by the filed, during a stent assist coil embolization, an enterprise2 intracranila stent 4mmx23mm (encr402312, 8294533) was placed in target position and started to release, but the distal markers of the stent were converged which could not be opened.The physician withdrew the stent and attempted to release it again, but the markers still failed to open.The doctor retracted the stent and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional information received on 29-dec-2023 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.The stent did not appear damaged.There was no vessel dissection and tortuosity that may have contributed to the incomplete expansion.There was no additional intervention performed to attempt to expand the stent.The stent was recaptured into the mc and removed.There were no procedural delays due to the event.A non-sterile 4mm x 23mm 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 only the detached stent was returned for evaluation.The stent component was inspected under a microscope and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.No other damages were found.The customer complaint regarding a stent not being fully open or expanded was not confirmed since the stent was noted as already expanded on both ends.It is possible that the marker bands may have converged together but apposed to the vessel wall during the procedure.The stent detachment was not originally documented in the complaint, and the exact time when this condition occurred cannot be determined; however, this finding is not a contributing factor to the stent's inability to open during the procedure.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8294533.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: maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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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