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

Catalog Number	ENC452200
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an endovascular embolization procedure, a 4.5mmd 22mml enterprise2 vascular reconstruction device (product code: enc452200, lot number: 10056839) was impeded in y connector and could not be pushed into the unspecified microcatheter (mc) the stent was found detached from the delivery wire in the y connector.The doctor removed the stent and microcatheter from the patient and replaced them with new devices to complete the procedure.Additional event information received on 26-mar-2026 indicated that a guidewire was used in the microcatheter prior to using the enterprise system.There was flushing during the procedure.They were able to torque the device.It is unknown if there was evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.There was no procedure prolongation/delay due to the event.
Additional Manufacturer Narrative
Manufacturer ref # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.The device was returned to j&j medtech for further evaluation.A non-sterile 4.5mmd 22mml enterprise2 vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and as described in the event, the stent was detached from the delivery system.The stent was inspected under magnification, and the markers on one side were bent.The stent was fully expanded; both ends were completely flared.The proximal end of the positioning coil of the delivery wire was found stretched.The delivery wire was subjected to dimensional analysis and those specifications that control the attachment and delivery of the stent were found within specifications.A device history record (dhr) was performed, and no internal actions were identified.Although the detached stent prevented functional testing for the impeded condition reported, the customer complaint is confirmed based on the damaged delivery wire and bent stent.It is possible that in an effort to overcome the impeded condition reported, excessive force was inadvertently applied during the device advancement which ultimately led to the damage found in the delivery wire and stent, and detachment of the stent.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 internal action 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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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: 24715279
• Report Number: 3008114965-2026-00468
• Device Sequence Number: 5763625
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: (01)10878528009525(17)270728(10)10056839
• 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,Followup,Followup
• Report Date (Section B): 04/27/2026

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: ENC452200
• Device Lot Number: 10056839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/23/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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
• Patient Sex: Unknown