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

Catalog Number	ENC451400
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	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref.No: (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 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.
Event or Problem Description
As reported by the field, during an endovascular embolization to the posterior communicating segment of internal carotid artery, a 4.5mmd 14mml enterprise intracranial stent (enc451400, 8779771) became impeded in the introducer and could not be pushed into the unspecified microcatheter (mc).The stent was found detached from the delivery wire introducer.The doctor removed the introducer and delivery wire as a whole.A new stent was used to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 06-mar-2025 indicated that the microcatheter was not damaged during manipulation of the device or noticed to be damaged upon removal from the patient.It was noted that the enterprise appeared damage prior to infusion into the microcatheter.A continuous flush was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.
Additional Manufacturer Narrative
Manufacturer complaint # (b)(4).Updated sections on this medwatch: section b5: additional event information received on 17-mar-2025 clarified that the embolic coil was not unraveled/stretched or kink/bent.No further information is available.Complaint conclusion: as reported by the field, during an endovascular embolization to the posterior communicating segment of internal carotid artery, a 4.5mmd 14mml enterprise intracranial stent (enc451400, 8779771) became impeded in the introducer and could not be pushed into the unspecified microcatheter (mc).The stent was found detached from the delivery wire introducer.The doctor removed the introducer and delivery wire as a whole.A new stent was used to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 06-mar-2025 indicated that the microcatheter was not damaged during manipulation of the device or noticed to be damaged upon removal from the patient.It was noted that the enterprise appeared damage prior to infusion into the microcatheter.A continuous flush was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.Additional event information received on 17-mar-2025 clarified that the embolic coil was not unraveled/stretched or kink/bent.No further information is available.The device was returned to j&j medtech for further evaluation.A non-sterile 4.5mmd 14mml enterprise intracranial stent was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit and this remained inside of the introducer.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The customer complaint regarding a stent being detached was confirmed due to the detached condition of the stent, however, based on this condition the issue regarding a stent being impeded in the introducer be evaluated through functional testing.The stent must be still attached to the delivery system to perform the functional analysis.However, since the stent was found on the proximal portion of the introducer it is suggested that the stent was pushed and retracted with the enough force to disengage the stent from the system and based on this the complaint can be confirmed.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.(b)(6) did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8779771.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do 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.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: 21619655
• Report Number: 3008114965-2025-00226
• Device Sequence Number: 18276791
• Product Code: NJE
• UDI-Device Identifier: 10886704071747
• UDI-Public: (01)10886704071747(17)251128(10)8779771
• 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): 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 Expiration Date: 11/28/2025
• Device Catalogue Number: ENC451400
• Device Lot Number: 8779771
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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