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

Catalog Number	ENCR403912
Medical Device Problem Codes	Premature Activation (1484); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular embolization, the physician was unable to visualize the enterprise2 4mmx39mm intracranial stent (encr403912, 8294534) under x-ray after the stent was delivered to the unspecified microcatheter.The physician only retracted the stent and observed that the stent was detached from the delivery wire prematurely.It was unable to confirm when the stent was separated from the delivery wire.The physician switched a new stent to complete the surgery.The microcatheter was not replaced.No patient injury was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.E1.Initial reporter phone: (b)(4).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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional event information received on 19-dec-2024 indicated that there was no severe vascular tortuosity at the target site.There was no resistance felt within the non j&j microcatheter (mc).There was no procedural delay due to the event.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during an endovascular embolization, the physician was unable to visualize the enterprise2 4mmx39mm intracranial stent (encr403912, 8294534) under x-ray after the stent was delivered to the unspecified microcatheter.The physician only retracted the stent and observed that the stent was detached from the delivery wire prematurely.It was unable to confirm when the stent was separated from the delivery wire.The physician switched a new stent to complete the surgery.The microcatheter was not replaced.No patient injury was reported.Additional event information received on 19-dec-2024 indicated that there was no severe vascular tortuosity at the target site.There was no resistance felt within the non-j&j microcatheter (mc).There was no procedural delay due to the event.A non-sterile enterprise2 4mmx39mm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages was observed.The stent was still attached to the delivery wire and inside the introducer.Further inspection was performed under a microscope, the delivery wire was inspected along its entire length, and no damages were found.The stent was found still inside the introducer.The stent was observed in good condition, with no structural damage (i.E., no broken struts, no kinks).The stent was inspected under x-ray imaging, and the markers were properly identified and visualized.The stent was still attached to the delivery system, and the markers were correctly identified and visualized during the evaluation; based on this, the customer complaint cannot be confirmed.During the procedure there are multiple radiopaque markers present, the distal markers on the stent markers are the least visible comparatively (due to their relatively small mass).Where the stent is placed (bone density, surrounding tissue) could potentially impact visibility of the distal markers.However, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8294534.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 at this time.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.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: 20895528
• Report Number: 3008114965-2024-01200
• Device Sequence Number: 7716113
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: (01)10886704075394(17)260428(10)8294534
• 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,Followup,Followup
• Report Date (Section B): 02/07/2025

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 Expiration Date: 04/28/2026
• Device Catalogue Number: ENCR403912
• Device Lot Number: 8294534
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 01/09/2025; 02/07/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/03/2025; 01/21/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown