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

Catalog Number	ENCR402312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Since no device has been received for analysis, no product investigation can be performed, and the reported failure could not be evaluated.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.Thromboembolism is a known procedural complication associated with the use of enterprise2 vascular reconstruction device and is listed as such in the instruction for use (ifu).There was no alleged quality issues related to the used device, as the device performed as intended.There may be patient, procedural, and pharmacological factors that may have contributed to the event with no indication of a device malfunction or defect.Since the event occurred shortly after the procedure, device involvement cannot be ruled out.Additionally, the event resulted in neurological symptoms (i.E., slurred and right limb weakness), cerebral edema, and required further diagnostic tests and medicinal treatment.Based on this information the events meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.Per the additional information received on 25-jul-2025, it was disclosed that the procedure was attributed to a partial pontine occlusion, secondary to dilatation of the basilar artery with a stent, which led to involvement of the pontine perforator artery, likely due to thrombosis.The event remains reportable to the us fda.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
It was reported, via health authority, that an enterprise2 4mmx23mm (encr402312/ 9095777) was used for an angioplasty procedure for a patient with severe stenosis of the v4 segment of the left vertebral artery.Approximately six hours after the procedure, on the same day, the patient developed slurred speech and right limb weakness.A reexamination with head ct showed no evidence of a hemorrhage.However, a thrombus, involving the pons perforator artery, was suspected.Systemic heparinization and intensive antithrombotic therapy with teicoplanin were recommended, and after discussing with the affected party, the patient consented to this treatment.However, the patient's right limb weakness gradually worsened.Subsequently, cranial mri was performed, and teicoplanin was discontinued.Bedside rehabilitation was initiated, low-dose steroids were administered to reduce edema, and close observation was maintained.The event was initially reported as such, ¿post-op thrombus.This case is from the health authority.The patient had the surgery of implanting the stent.The operation ended at 10:00.At about 16:00 of the surgery day, the patient had slurred speech and weakness of right limbs.Reexamination of head ct showed no hemorrhage.The patient communicated with the consultant, and was considered to have involvement of pons perforator artery and thrombosis.It was recommended to receive systemic heparinization and tensive antithrombotic therapy with teicoplanin.The patient agreed to use it after communicating with the affected party.However, the patient's right limb weakness gradually worsened.Subsequent reexamination of cranial mri was performed; teicoplanin was suspended and bedside rehabilitation was performed; low-dose steroids were given to relieve edema; close observation was performed.¿ it was further noted that, ¿the patient suffered from severe stenosis of v4 segment of left vertebral artery.¿ additional information was received on 25-jul-2025.Summary: the physician believes that the events were caused or contributed to by ¿partial pontine occlusion due to dilatation of basilar artery with stent.¿ the patient's baseline neurological status included ¿slurred speech, muscle strength of right limbs: upper and lower limbs grade 1; right hemiparesis.¿ as for the current health status, the patient is currently in rehabilitation.

• 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: 22771976
• Report Number: 3008114965-2025-00861
• Device Sequence Number: 15775223
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)270528(10)9095777
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 9095777
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown