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

Catalog Number	ENCR402312
Medical Device Problem Codes	Premature Activation (1484); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a healthcare professional, that enterprise2 4mmx23mm (encr402312/ lot: 9518157) and prowler select plus 150/5cm (606s255x/ 31351022) were used for a vascular stent placement procedure.During the procedure, the user reported incomplete expansion and premature detachment of the enterprise2 vascular reconstruction device.The event was initially reported as such, ¿unable to open & premature detachment.It was reported that during procedure, stent was delivered to m1 segment of middle cerebral artery for release, but distal markers of the stent were converged which could not be opened.Doctor retracted the stent and microcatheter, the stent was detached from the delivery wire during withdrawal, the stent remained in the c3 segment of internal carotid artery.After the doctor used the micro guidewire to massage the stent, the stent markers expanded well.The doctor raised the microcatheter to target position and delivered a second stent, then released it in the target position.The surgery was prolonged about 10 minutes.¿ no patient harm was reported.Additional information was received on 11-sep-2025.Summary: it was reported that the temperature indicator label on the inner pouch had been checked and was within acceptable criteria.There was no resistance encountered during the advancement of the device, and the stent appeared undamaged.Additionally, there were no vessel or aneurysm factors such as tortuosity, calcification, or vasospasm that could have contributed to incomplete expansion.The incomplete expansion did not result in stent migration or embolization, and blood flow was not restricted.This additional information has been reviewed, and no changes regarding reportability determination or coding were required.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The complaint was submitted with a procedural image, which is pending further analysis.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.The incomplete expansion and premature detachment are known potential complications associated with the enterprise2 vascular reconstruction device.Incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.If the stent was prematurely deployed in the patient (in an unintended site), it may lead to damage of healthy intima, possible side branch occlusion, ischemia, infarct and/or the need for additional intervention.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.Since the alleged device deficiency required additional interventions (i.E., use of a guidewire to massage the stent and implanting a second stent inside the first stent) in an effort to fully expand the stent, the event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury,¿ with an awareness date of 03-sep-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.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
Manufacturer ref#(b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.The medical imaging received was reviewed by cerenovus sr.Medical affairs director.The assessment reads as follows: ¿the description is clear and there is one image provided.There is an enterprise 2 stent visible in the ica due to inadvertent detachment, which happened upon retrieval.This may have been caused by the microcatheter coming back more than the internal stent/pusher construct, leading to a situation where the detachment point is distal to the catheter markers.From the images it is unclear what the underlying cause is.The description also lists a ¿non-opening¿ of the distal part of the stent, which led to the retrieval procedure.Upon re-entering the stent, the physician managed to open the device, which shows that there is not a malfunction in the device itself, but likely a cause due to the angle of placement, side-branches, narrowing (eg.Icad).From these images the main cause cannot be determined.¿ this additional information has been reviewed, and no changes regarding reportability determination or coding were required".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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23085881
• Report Number: 3008114965-2025-01008
• Device Sequence Number: 18767609
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)271228(10)9518157
• 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): 09/30/2025

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: ENCR402312
• Device Lot Number: 9518157
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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