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

Catalog Number	ENCR402300
Medical Device Problem Codes	Product Quality Problem (1506); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, an enterprise2 4mmx23mm no tip vascular reconstruction device (encr402300, 8997148) was not visualized under the image after it was delivered to the distal end of microcatheter (the stent did not pass through the microcatheter).The doctor only retracted the stent alone, and the stent body was noted to be absent from the stent delivery system.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 23-jul-2025 indicated that it is possible that the stent was not visible due to inadequate radiopacity.The stent did not prematurely detach 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.There was no adverse outcome to the patient as a result of the event.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Since no device has been received for analysis, no product investigation can be performed, and the reported failure could not be evaluated.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8997148.The history records indicate 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 complaints could not be confirmed.Based on the manufacturing record evaluation, 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.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.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.

• 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: 22772320
• Report Number: 3008114965-2025-00862
• Device Sequence Number: 13096878
• Product Code: NJE
• UDI-Device Identifier: 10886704075363
• UDI-Public: (01)10886704075363(17)270328(10)8997148
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: ENCR402300
• Device Lot Number: 8997148
• 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: 07/23/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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
• Patient Sex: Unknown