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

Catalog Number	ENCR401600
Medical Device Problem Codes	Component Missing (2306); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
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.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 (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
As reported by the field, during an endovascular embolization, the stent of an enterprise2 4mmx16mm no tip (encr401600, 9403134) was not visualized under the image after it was delivered to the distal end of a prowler select plus 150/5cm microcatheter (606s255x, 31471117), the stent did not pass through the microcatheter.The doctor removed the stent and microcatheter from the patient, and the stent body was noted to be absent from the stent delivery system.There was no stent body in the microcatheter.New devices were switched to complete the surgery.The surgery was prolonged about 20 minutes.Additional event information received on 10-jun-2025 indicated that it cannot be confirmed if the stent was not dislodged into patient.The stent was not prematurely detached inadvertently.There was no damage to the packaging, or any difficulty removing device from package.There was no difficulty in removing device from dispenser.The 20-minutes procedure prolongation did not result in a patient adverse consequence.There was no evidence of physical material within the devices.The microcatheter did not kink/bent.There was no excessive force used with the devices.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during an endovascular embolization, the stent of an enterprise2 4mmx16mm no tip (encr401600, 9403134) was not visualized under the image after it was delivered to the distal end of a prowler select plus 150/5cm microcatheter (606s255x, 31471117), the stent did not pass through the microcatheter.The doctor removed the stent and microcatheter from the patient, and the stent body was noted to be absent from the stent delivery system.There was no stent body in the microcatheter.New devices were switched to complete the surgery.The surgery was prolonged by about 20 minutes.Additional event information received on 10-jun-2025 indicated that it cannot be confirmed if the stent was not dislodged into patient.The stent was not prematurely detached inadvertently.There was no damage to the packaging, or any difficulty removing the device from the package.There was no difficulty in removing the device from the dispenser.The 20-minutes procedure prolongation did not result in a patient adverse consequence.There was no evidence of physical material within the devices.The microcatheter did not kink/bent.There was no excessive force used with the devices.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.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.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) do contain the following recommendation: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to 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.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: 22187801
• Report Number: 3008114965-2025-00517
• Device Sequence Number: 8588998
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: (01)10886704075349(17)271028(10)9403134
• 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
• Report Date (Section B): 07/21/2025

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: ENCR401600
• Device Lot Number: 9403134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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