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

Catalog Number	ENC452800
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular embolization, a 4.5mmd 28mml vascular reconstruction device (enc452800, 9493885) was impeded at the proximal end of an unspecified microcatheter (mc) and could not advance any more.The doctor only retracted the stent alone and switched to a new one to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 25-jun-2025 indicated that the event did not result in any undue procedural delay that could be considered clinically significant.The device did not appear to be damaged at any time.Continuous flush was maintained.Nothing was noted to be obstructing the microcatheter.Based on the product analysis of the device received, the stent is found broken.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) the purpose of this mdr submission is to report the findings of the device investigation.The stent is found broken; the findings meet us fda regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was returned to j&j medtech for further evaluation.A non-sterile eu ent4.5mmd 28mml wno dstl tp was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the stent was detached from the delivery unit.No damages were noted on the returned components.Microscopic inspection was performed on the stent component, and one (1) strut was broken.Although the broken strut, the stent was noted to be fully expanded, and both ends can be noted as completely flared.No damages were noted on the delivery wire.The issue reported regarding the stent becoming impeded in the proximal end of the microcatheter could not be evaluated due to the detached condition of the stent.In order to perform a functional test, the stent must be attached to the delivery wire and inside the introducer.However, based on the broken condition of the stent, the customer complaint is confirmed, as the damaged condition of the stent suggests that the device was subjected to certain manipulation that could resulted in the stent breakage.It is also suggested that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The stent detachment was not originally reported, and the exact time of occurrence cannot be determined; therefore, this is not considered related to the issue reported.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 9493885.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the 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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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.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.

• 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: 22776495
• Report Number: 3008114965-2025-00868
• Device Sequence Number: 15824512
• Product Code: NJE
• UDI-Device Identifier: 10886704071785
• UDI-Public: (01)10886704071785(17)261228(10)9493885
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: ENC452800
• Device Lot Number: 9493885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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