MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; CERENOVUS ENTERPRISE

Catalog Number	ENCR402312
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that prior to use, the doctor opened the device packaging of an enterprise2 4mmx23mm vascular reconstruction device (encr402312, 9061888) and removed the device from dispenser hoop.It was found that the stent was released automatically.The stent was detached from the delivery wire.The device was not used in the patient.The doctor switched to a new stent to complete the surgery.Additional event information received on 24-jul-2025 indicated that there was no other physical damage to the device besides the reported premature detachment.The replacement stent was another enterprise2 4mmx23mm® vascular reconstruction device.The event did not result in a clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).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.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: ENTERPRISE2 4MMX23MM
• Common Device Name: CERENOVUS ENTERPRISE
• 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: 22737199
• Report Number: 3008114965-2025-00840
• Device Sequence Number: 9240216
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)270528(10)9061888
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: 9061888
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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