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

Catalog Number	ENCR401600
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
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).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.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 a healthcare professional, during an endovascular embolization, an enterprise2 4mmx16mm no tip vascular reconstruction device (encr401600, 8907850) passed through the unspecified microcatheter tip and started to release the stent.It was found that the placement of the stent was not ideal, then the doctor only retracted the stent and tried to release it again, but the doctor observed that 3 distal markers of the stent converged and the stent did not fully open or expand as intended.The doctor only retracted the stent and then released it again, but the stent was still unable to open completely.The doctor only retracted the stent alone and switched to a new stent (other brand) to complete the surgery.The microcatheter was not replaced.The surgery was prolonged about 15 minutes.No additional information is available.
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 a healthcare professional, during an endovascular embolization, an enterprise2 4 mm x 16 mm no tip vascular reconstruction device (encr401600, 8907850) passed through the unspecified microcatheter tip and started to release the stent.It was found that the placement of the stent was not ideal, then the doctor only retracted the stent and tried to release it again, but the doctor observed that 3 distal markers of the stent converged and the stent did not fully open or expand as intended.The doctor only retracted the stent and then released it again, but the stent was still unable to open completely.The doctor only retracted the stent alone and switched to a new stent (other brand) to complete the surgery.The microcatheter was not replaced.The surgery was prolonged by about 15 minutes.No additional information is available.Since no device has been received for analysis, no product investigation can be performed, and the reported failure could not be evaluated.Incomplete stent expansion is a known potential procedural complication associated with the enterprise 2 vrd.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 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.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: 22211684
• Report Number: 3008114965-2025-00572
• Device Sequence Number: 8132619
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: (01)10886704075349(17)270228(10)8907850
• 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: 8907850
• 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: 05/25/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown