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

Catalog Number	ENCR402312
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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.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 the stent component was found still attached to the delivery wire; however, the proximal end of the proximal coil was found severely stretched.Microscopic inspection was performed, and no additional damage besides the stretched condition of the delivery wire were found.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 premature detachment of the stent cannot be confirmed since the stent was found still attached to the delivery system; however, the damaged condition of the delivery wire suggest that excessive force could had been inadvertently applied during the attempts to overcome the impeded condition reported, resulting in the damages of the delivery wire.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.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.
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, an enterprise2 4mmx23mm vascular reconstruction device (encr402312, 9392925) was impeded in the middle of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not advance any more.The doctor only retracted the stent alone, it was found that the stent was detached from the delivery wire in the microcatheter (mc) and the delivery wire of the stent was unraveled/stretched.The doctor removed the stent and microcatheter from the patient and switched new devices to complete the surgery.There was no patient injury reported.Additional event information received on 24-jul-2025 indicated that 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 five minutes with no result in a patient adverse consequence.

• 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: 22714106
• Report Number: 3008114965-2025-00795
• Device Sequence Number: 9611809
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)271028(10)9392925
• 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): 08/05/2025

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: 9392925
• 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: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM
• Patient Sex: Unknown