MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERENOVUS ENTERPRISE; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENC451400
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.
Event or Problem Description
As reported by the field, during an endovascular embolization, an eu ent4.5mmd 14mml wno dstl tp intracranial stent (enc451400, 8878743) was placed in the target site and tried to release.The 3 distal markers of the stent did not fully open or expand as intended.The physician only retracted the stent and delivered it again to release, but the 3 distal stent markers were still failed to open.Micro-guidewire was used to massage the stent, but the markers were still unable to open.The physician only retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.Additional event information was received on 21-nov-2024 indicating 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.It was noted that the release site at the head end is straight blood vessel.Massage was applied to the head end guide wire.There was no stent migration or embolization of the stent.The procedure was delayed by 5 minutes due to the event but was not clinically significant.Additional event information was received on 29-nov-2024 clarifying that there was no blood flow restriction.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Updated sections on this med watch report: b4, d9, g3, g6, h2, h3, and h11.Complaint conclusion: as reported by the field, during an endovascular embolization, an eu ent4.5mmd 14mml wno dstl tp intracranial stent (enc451400, 8878743) was placed in the target site and tried to release.The 3 distal markers of the stent did not fully open or expand as intended.The physician only retracted the stent and delivered it again to release, but the 3 distal stent markers were still failed to open.Micro-guidewire was used to massage the stent, but the markers were still unable to open.The physician only retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.Additional event information was received on 21-nov-2024 indicating 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.It was noted that the release site at the head end is straight blood vessel.Massage was applied to the head end guide wire.There was no stent migration or embolization of the stent.The procedure was delayed by 5 minutes due to the event but was not clinically significant.Additional event information was received on 29-nov-2024 clarifying that there was no blood flow restriction.A non-sterile eu ent4.5mmd 14mml wno dstl tp intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the stent was detached from the delivery system.No appearance of damages was observed.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.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.The issue reported regarding the distal markers of stent being converged is not confirmed, as the stent did not have any structural damage.It is possible that the marker bands may have converged together but apposed to the vessel wall.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.There is no indication that the issues reported in the complaint are a result of a defect inherently related to the enterprise device.The stent detachment was not originally reported, and the exact time of occurrence cannot be determined; therefore, this condition is not considered related to the issue reported.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues were encountered, 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.¿ position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.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.

• Brand Name: CERENOVUS ENTERPRISE
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20821097
• Report Number: 3008114965-2024-01168
• Device Sequence Number: 21011758
• Product Code: NJE
• UDI-Device Identifier: 10878528009457
• UDI-Public: (01)10878528009457(17)260128(10)8878743
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2026
• Device Catalogue Number: ENC451400
• Device Lot Number: 8878743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNSPECIFIED BRAND).
• Patient Sex: Unknown