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

Catalog Number	ENC453712
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during endovascular embolization, a 4.5x37mm enterprise vascular reconstruction device 12 mm dw tip (enc453712, 8945944) was impeded in introducer and could not be pushed into a prowler select plus microcatheter.The doctor only removed the stent alone and switched a new one to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information states that the event did not result in any undue procedural delay that could be considered clinically significant.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.The introducer was successfully flushed prior to the event.Based on the product analysis of the device received, the delivery wire was separated.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The delivery wire of the device received was separated, 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 4.5x37mm stent 12 mm dw tip was received contained in the decontamination pouch.A concomitant prowler select plus microcatheter was included in the return.Upon receiving the device, visual inspection was performed and it was noted that the distal tip segment of the delivery wire is separated.The distal tip and stent body are contained within the introducer sheath, separate from the rest of the system.The delivery wire separation was not originally reported in the complaint, therefore, the exact time when this condition occurred cannot be determined.This condition is not considered related to the reported issue.The issue regarding a stent being impeded in the introducer sheat cannot be evaluated through functional testing.The stent must be inside the introducer tube to perform the functional analysis and still engaged to the rest of the delivery system.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot: 8945944.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 at this time.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.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.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: 22963848
• Report Number: 3008114965-2025-00958
• Device Sequence Number: 9113816
• Product Code: NJE
• UDI-Device Identifier: 10886704044048
• UDI-Public: (01)10886704044048(17)260228(10)8945944
• 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): 09/04/2025

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: 02/28/2026
• Device Catalogue Number: ENC453712
• Device Lot Number: 8945944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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: PROWLER SELECT MICROCATHETER.
• Patient Sex: Unknown