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

Catalog Number	ENC453712
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, a 4.5x37mm enterprise vascular reconstruction device (enc453712, 8645715) was impeded in the proximal end of a prowler select plus 150/5cm microcatheter (606s255x, 31359810) and could not advance any more.The doctor removed the stent and microcatheter (mc) from the patient and switched to new devices to complete the procedure.The surgery was prolonged by about 15 minutes.There was no patient injury reported.Additional event information received on 25-jul-2025 indicated that no torque was applied.There was no excessive force used with the devices.The 15 minutes procedure delay did not result in a patient adverse consequence.
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.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Complaint conclusion: a healthcare professional reported that during an endovascular embolization, a 4.5x37mm enterprise vascular reconstruction device (enc453712, 8645715) was impeded in the proximal end of a prowler select plus 150/5cm microcatheter (606s255x, 31359810) and could not advance any more.The doctor removed the stent and microcatheter (mc) from the patient and switched to new devices to complete the procedure.The surgery was prolonged by about 15 minutes.There was no patient injury reported.Additional event information received on 25-jul-2025 indicated that no torque was applied.There was no excessive force used with the devices.The 15-minute delay did not result in a patient adverse consequence.The device was returned to j&j medtech for further evaluation.A non-sterile 4.5x37mm enterprise vascular reconstruction device inner pouch was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and only the inner pouch was returned for analysis.The enterprise device (stent and delivery system) were missing.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8645715.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported regarding a impeded stent cannot be evaluated as only the inner pouch of the device was returned.This investigation is considered complete at this time; if additional information is received at a later time, this investigation will be updated, and further actions can be taken as needed.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since no product defect was identified, no capa activity is required.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: 22717358
• Report Number: 3008114965-2025-00808
• Device Sequence Number: 18434198
• Product Code: NJE
• UDI-Device Identifier: 10886704044048
• UDI-Public: (01)10886704044048(17)250928(10)8645715
• 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): 08/21/2025

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 Expiration Date: 09/28/2025
• Device Catalogue Number: ENC453712
• Device Lot Number: 8645715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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