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

Catalog Number	ENCR403000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2, and h11.Additional information was received on 15-jul-2025.Summary: according to the information received, it was reported that there was no evidence of fragments remaining in the patient, and no additional intervention was planned.The distal tip of the enterprise was not reshaped prior to use.Excessive force was not applied to the device.The target vessel being treated was the m1 segment of the middle cerebral artery (mca).The relevant anatomical characteristic noted was the tortuosity of the vessel.Patient information, including demographics and medical history, was unobtainable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was not received for analysis; therefore, 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.Fracture/separation is a known potential complications associated with the enterprise2 vascular reconstruction device.If a fracture/separation occur at the distal tip of the delivery wire for the enterprise2 stent while in patient, this can potentially embolize, resulting in ischemia or infarct.There are clinical and procedural factors, including vessel characteristics, device interaction, and operator technique, that may have contributed to the reported event, rather than the design or manufacture of the device.The physician was required to use a second stent (other brand) to capture the fractured delivery wire and then removed it from patient.Based on the surgical intervention this event does 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.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.
Event or Problem Description
It was reported, via a healthcare professional, that an enterprise2 4mmx30mm no tip (encr403000/ 8994894) was used for an endovascular embolization procedure.During the procedure, the stent was placed at the target site, but during the release attempt, the tip of the delivery wire broke into two separate pieces.The doctor retracted only the stent alone and switched to a second stent from another brand to capture the fractured delivery wire and removing it from the patient.The second stent was then delivered and released at the target site, and the microcatheter from another brand was not replaced.The event was initially reported as such, ¿fractured/separated-during use.It was reported that before procedure, device package and device were inspected and found in good condition.During the procedure, stent was placed in target site and tried to release.It was found that the tip of the delivery wire broke into two separate pieces.The doctor only retracted the stent alone and switched a second stent (other brand) to capture the fractured delivery wire and then removed it from patient.Then the second stent was delivered and released in target site.The microcatheter (other brand) was not replaced.¿ no further information was made available at the time of this review.

• 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: 22359344
• Report Number: 3008114965-2025-00660
• Device Sequence Number: 7998043
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: (01)10886704075387(17)270428(10)8994894
• 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): 07/15/2025

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 Catalogue Number: ENCR403000
• Device Lot Number: 8994894
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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: MICROCATHETER (UNSPECIFIED BRAND).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown