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

Catalog Number	ENCR401600
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.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
As reported by the field, during an endovascular embolization, an enterprise2 4mmx16mm no tip intracranial stent (encr401600, 8945947) became impeded in the middle section of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not advance any more.The doctor removed the stent and microcatheter from the patient for inspection.Then the same stent was delivered with the same microcatheter again, but the same issue occurred.The doctor only retracted the stent alone and switched to a new stent to complete the procedure with the same microcatheter (mc).No patient injury was reported.Additional event information was received on 18-feb-2025 indicating that they were able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.There were no procedural delays due to the event.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4) updated sections on this medwatch.Complaint conclusion: as reported by the field, during an endovascular embolization, an enterprise2 4mmx16mm no tip intracranial stent (encr401600, 8945947) became impeded in the middle section of a prowler select plus 150/5cm microcatheter (606s255x, lot unknow) and could not advance any more.The doctor removed the stent and microcatheter from the patient for inspection.Then the same stent was delivered with the same microcatheter again, but the same issue occurred.The doctor only retracted the stent alone and switched to a new stent to complete the procedure with the same microcatheter (mc).No patient injury was reported.Additional event information was received on 18-feb-2025 indicating that they were able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.There were no procedural delays due to the event.The device was returned to j&j medtech for further evaluation.A non-sterile enterprise2 4mmx16mm no tip vascular reconstruction device was received contained in the decontamination pouch.Device was returned contained within the plastic hoop, the stent body and delivery wire are lodged with the introducer sheath.Functional test was performed by advancing the device through a sample prowler select plus microcatheter.The device was successfully advanced through the entire length of the microcatheter with little to no resistance.The stent was inspected under a microscope, and no damages were found (i.E., no kinks, no bents, or broken struts).Both distal ends can be noted completely flared.The delivery wire was also inspected under the microscope and no defects or anomalies were observed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of lot 8945947.The historical record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported regarding the stent component being impeded in the microcatheter could not be confirmed.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.As part of the j&j 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 at this time.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21458406
• Report Number: 3008114965-2025-00160
• Device Sequence Number: 20743676
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: (01)10886704075349(17)270228(10)8945947
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 8945947
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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 SELECT PLUS 150/5CM.
• Patient Sex: Unknown