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

Catalog Number	ENF401600
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3 ¿ date of event: the date of the event was not reported.The event year is 2025.The complaint was submitted with photographs of the device, which is pending further analysis.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.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 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.
Event or Problem Description
A healthcare professional reported that an enterprise2 4mmx16mm no tip vascular reconstruction device (enf401600, 9493904) was detached inside the sheath.There was no patient injury reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.Complaint conclusion: a healthcare professional reported that an enterprise2 4mmx16mm no tip vascular reconstruction device (enf401600, 9493904) was detached inside the sheath.There was no patient injury reported.No additional information was provided.One photo accompanied the complaint file.In said photo a stent component can be seen detached from a delivery system; this can be noted still inside of the proximal portion of the introducer.A slightly kinked condition was noted on the distal portion of the delivery wire.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 customer complaint was confirmed.This investigation was performed based only on the photo provided.As part of j&j medtech 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.The instructions for use (ifu) 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.

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22698960
• Report Number: 3008114965-2025-00792
• Device Sequence Number: 13014521
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: (01)10886704075349(17)271128(10)9493904
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 Catalogue Number: ENF401600
• Device Lot Number: 9493904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2024
• 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
• Patient Sex: Unknown