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

Catalog Number	ENC452200
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, an enterprise vascular reconstruction device (enc452200, 9353564) was impeded in the middle section of a prowler select plus microcatheter (606s255x, lot unknown) and could not advance any more.The doctor removed the microcatheter (mc) and stent from the patient for inspection, no issues were found.The doctor delivered the stent and microcatheter again, but the stent was still impeded in the middle section of the microcatheter, and the stent was detached from the delivery wire in the microcatheter.The doctor removed the microcatheter and stent from the patient and switched new devices to complete the surgery.The surgery was prolonged about 20 minutes.No patient injury was reported.
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).One picture was included with the complaint report.The pictures show the distal segment of delivery wire, apparently being broken; however, due to the distance in which the picture was taken this cannot be confirmed.The stent is no visible.No other relevant details can be observed.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.The reported complaint regarding a stent being detached and the issue regarding an impeded condition cannot be evaluated with the provided pictures since a functional test needs to be performed.There is not enough information to determine any contributing factors to the issue experienced.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.This investigation was performed based only on the video provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.As part of johnson & johnson medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.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.The company is seeking this information through the event investigation.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: 22195204
• Report Number: 3008114965-2025-00534
• Device Sequence Number: 13196500
• Product Code: NJE
• UDI-Device Identifier: 10886704071761
• UDI-Public: (01)10886704071761(17)260928(10)9353564
• 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): 06/12/2025

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: 09/28/2026
• Device Catalogue Number: ENC452200
• Device Lot Number: 9353564
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• 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