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

Catalog Number	ENF403000
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a vascular stent placement procedure on (b)(6) 2025, the 4.0mm x 30mm with no tip enterprise®2 (enf403000 / 9320829) became impeded in the concomitant 150cm x5cm prowler select plus / 45 tip (606s255fx / 31471103) when the physician tried to advance the stent in the midpoint of the microcatheter.The devices were replaced with another 4.0mm x 30mm with no tip enterprise®2 (enf403000) and another 150cm x5cm prowler select plus / 45 tip (606s255fx) and the procedure was successfully completed.There was no negative impact to the patient.The devices were reported as available to be returned for evaluation and analyses.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone is not available / reported.Section h.3: 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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 9320829.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 26-aug-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.11.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.0mm x 30mm with no tip enterprise®2 was received contained in the decontamination pouch.Visual inspection was performed.The stent component was detached inside the hub of the microcatheter.The distal end of the delivery wire was observed bent.The stent component was retrieved and inspected under the microscope.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks).It was also noted to be fully expanded with both ends completely flared.The delivery wire was observed stretched at the area that was observed to be bent during the visual inspection.In order to perform the functional test, for the reported impeded condition of the stent, the stent must be attached to the delivery wire and inside the introducer, the impeded condition reported is confirmed.The detached condition of the stent suggests that the introducer of the enterprise system was not fully seated in the hub of the microcatheter, causing the stent to expand in the microcatheter's hub, causing the resistance and resulting in the stent component being unable to advance further, where push/pull force was applied sufficiently to disengage the stent from the delivery wire and resulting in the damaged delivery wire.However, with the amount of information available this only remains speculative.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 9320829.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instruction for use (ifu) does contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Based on the manufacturing documentation 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 for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 949788-2078
• MDR Report Key: 22537925
• Report Number: 3008114965-2025-00718
• Device Sequence Number: 20840290
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: (01)10886704075387(17)270828(10)9320829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/07/2025

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: ENF403000
• Device Lot Number: 9320829
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/07/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: PROWLER SEL PLUS 150/5CM 45TIP.
• Patient Sex: Unknown