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

Catalog Number	ENCR402312
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a healthcare professional, an enterprise2 4mmx23mm vascular reconstruction device ( encr402312, 9403138) was impeded in the middle of a prowler select plus 150/5cm microcatheter ( 606s255x, lot unknow) and could not advance any more.The doctor removed the stent and microcatheter (mc) from the patient and switched to new devices to complete the surgery.There was no patient injury reported.Additional event information received on 28-jul-2025 indicated that they were not able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.The procedure was prolonged within a five minutes extension due to the event resulting with no patient adverse consequence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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 enterprise2 4mmx23mm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the stent component was detached from the delivery system.A 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 impeded condition of the stent could not be evaluated due to the detachment.In order to perform a functional test, the stent component must be inside the introducer and attached to the delivery wire.Additionally, none of the returned components present damages that suggest that they were forcibly advanced.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.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.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: do not partially deploy the stent from the introducer.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Confirm the tip of the delivery wire is entirely within the introducer.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: 22700426
• Report Number: 3008114965-2025-00796
• Device Sequence Number: 9037414
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)271028(10)9403138
• 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): 08/04/2025

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 Catalogue Number: ENCR402312
• Device Lot Number: 9403138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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 PLUS 150/5CM
• Patient Sex: Unknown