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

Catalog Number	ENC451412
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
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 e1.Initial reporter phone: (b)(6).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.Incomplete stent expansion is a known potential procedural complication associated with the enterprise 2 vrd.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.The instructions for use (ifu) do contain the following recommendations: do not partially deploy the stent from the introducer.Maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Select a stent length that is at least 10 mm longer than the aneurysm neck to maintain a minimum of 5 mm on either side of the aneurysm neck.A large differential in diameter between the proximal and distal segments of the parent vessel may increase the risk of stent migration.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.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
A healthcare professional reported that during an endovascular embolization, a 4.5x14mm 12mm dw tip enterprise vascular reconstruction device (enc451412, 8997141) was placed in target position and started to release.It was found that 2 distal markers of the stent were converged which could not be opened or expanded as intended.The doctor removed the stent and the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) from the patient and found the stent body was kinked/bent.Then the doctor switched to a new stent to complete the surgery with the original microcatheter.There was no patient injury reported.Additional event information received on 01-sep-2025 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no significant resistance during advancement of the device.The stent appeared damaged, kinking at the tip.It was noted that the vessel was tortuous.The stent was tried to ¿twist¿ in the attempt to expand the stent.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.The procedure was not delayed/prolonged due to the event.There was no excessive force used with the enterprise.There was no alleged product malfunction with the prowler select.

• 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: 23017058
• Report Number: 3008114965-2025-00977
• Device Sequence Number: 9741643
• Product Code: NJE
• UDI-Device Identifier: 10886704044017
• UDI-Public: (01)10886704044017(17)260328(10)8997141
• 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): 09/10/2025

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 Expiration Date: 03/28/2026
• Device Catalogue Number: ENC451412
• Device Lot Number: 8997141
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EU 4.5X14MM STENT 12 MM DW TIP
• Patient Sex: Unknown