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

Catalog Number	ENC451412
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/04/2025
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.Section e1.Initial reporter phone: (b)(6).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.Incomplete expansion is a known potential complication associated with the enterprise vascular reconstruction device.Incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.There may be clinical and procedural factors, including vessel characteristics, device selection, and mechanical manipulation of devices within the artery, that may have contributed to the reported event rather than the design or manufacture of the device.In this case, the surgical intervention of implanting a second stent inside the enterprise stent was required to fully expand the proximal markers and preclude further patient complications.It was also reported that the parent vessel was found to be occluded; it is unknown whether the enterprise stent contributed to this event.The occlusion may have been caused by thrombus formation or may have been attributed to atherosclerosis, a baseline patient condition.Further clarifying information is being requested.Currently, the correlation between this event to the used device as a contributing factor cannot be established.Based on this information, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury¿ with an awareness date of 04-aug-2025.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.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 a healthcare professional, that an eu 4.5x14mm stent 12 mm dw tip (enc451412/ 9123410) and prowler select plus 150/5cm (606s255x/ lot # unknown) were used for an endovascular embolization procedure.During the procedure, the user reported incomplete expansion of the enterprise stent.When the stent was placed and released at the target site, it was found that the distal markers expanded fully, but the proximal markers were converged.It was also found that the parent vessel was occluded.The physician removed the prowler microcatheter from the patient and used a balloon catheter (other brand) for dilation, and the blood flow of the parent vessel was restored.Since the proximal markers of the stent did not fully open or expand as intended, the physician delivered a second stent using the original microcatheter and released the second stent in the first stent and completed the surgery.The procedure was prolonged by about 30 minutes.No patient harm was reported.Additional information was received on 13-aug-2025.Summary: the temperature indicator label on the inner pouch and it was found to be within acceptable criteria.There was no resistance during the advancement of the device.The stent appeared undamaged.No vessel or aneurysm factors were identified that could have contributed to incomplete expansion.Additional intervention was performed to attempt to expand the stent reported as such ¿intervention with intracranial balloon dilatation catheter to try to expand the stent.¿ this incomplete expansion did not result in stent migration or embolization.The blood flow at the proximal end was restricted.The 30-minute procedural delay did not lead to any adverse consequences for the patient.

• 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: 22806518
• Report Number: 3008114965-2025-00875
• Device Sequence Number: 9063874
• Product Code: NJE
• UDI-Device Identifier: 10886704044017
• UDI-Public: (01)10886704044017(17)260528(10)9123410
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Catalogue Number: ENC451412
• Device Lot Number: 9123410
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown