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

Catalog Number	ENC452212
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref #: (b)(4).The device remains implanted; therefore, no further investigation can be performed.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 of the enterprise vascular reconstruction device (vdr) can potentially lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.There are aneurysm/vessel characteristics, device selection, and operator technique that may have contributed to the 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 and preclude patient harm, the event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury,¿ with an awareness date of 19-may-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.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 enterprise vascular reconstruction device eu 4.5x22mm stent 12 mm dw tip (enc452212/ 9550016) was used for an endovascular embolization procedure.During the procedure, the user reported incomplete expansion of the stent.The physician then used a micro- delivery wire to massage the three converged proximal markers of stent, but the proximal markers were still unable to open.Then the doctor released the second stent in the first stent and completed the surgery.No patient harm was reported.No delay to the surgical procedure was reported.The event was initially reported as such, ¿incomplete expansion.It was reported that during procedure, stent was placed and released in target site.Doctor observed that 3 proximal markers of stent were converged which could not expand as expected.The doctor used micro- delivery wire to massage the proximal markers, but the proximal markers were still unable to open.Then the doctor released the second stent in the first stent and completed the surgery.The microcatheter was not replaced.¿ no further information was made available at the time of this review.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, and h11.Section b5: additional information was received on 17-jun-2025.Summary: according to the information received, it was reported that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance observed during the advancement of the device, and the stent did not appear to be damage.Additionally, there were no vessel or aneurysm factors that may have contributed to the incomplete expansion (i.E.Tortuosity, calcification, vasospasm).Blood flow was reported to be unrestricted.Regarding the procedural elay/prolongation, it was noted that there was a delay of 12 minutes due to the event; however, this procedural delay/prolongation did not result in any adverse consequences for the patient.Patient information, including demographics and medical history, were unobtainable.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: 22175491
• Report Number: 3008114965-2025-00505
• Device Sequence Number: 12717398
• Product Code: NJE
• UDI-Device Identifier: 10886704044024
• UDI-Public: (01)10886704044024(17)261228(10)9550016
• 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,Followup
• Report Date (Section B): 06/17/2025

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: ENC452212
• Device Lot Number: 9550016
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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: GUIDEWIRE (UNSPECIFIED BRAND).; STENT (UNSPECIFIED BRAND).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown