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

Catalog Number	ENF401600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
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 d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Section h4: the device manufacture date is not known as the device lot number is not available / not reported.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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, lot unknown) migrated from the distal internal carotid artery (ica) to the proximal ica, where it had been initially deployed successfully.At 1 year follow up, imaging demonstrated the migration of the stent.The patient remains asymptomatic.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.Procedural photos were reviewed by an independent physician, concluding the following: "the description and images are clear.There are subtracted images and images with contrast that show both the coil mesh and the stent positions.The stent is objectively moved proximally in comparison to the original delivery position.This can be due to several reasons but has almost certainly occurred in the early stages after implantation.If the stent is too large, compared to the vessel diameter, this may be a reason for it to slide proximal due to continued opening to the nominal diameter.However, if the patient experienced vasospasm in the post-implantation period, the stent will move even more due to the incongruence between the stent size and the size of the spastic vessel.The exact cause cannot be determined in hind-sight".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: 23477158
• Report Number: 3008114965-2025-01189
• Device Sequence Number: 16001404
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: (01)10886704075349
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/30/2025

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
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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