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

Catalog Number	ENCR403912
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
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).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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
As reported by a healthcare professional, during an endovascular embolization, an enterprise2 4mmx16mm no tip vascular reconstruction device (encr403912, 8848366) was placed in target position and started to release, but distal markers of the stent were converged which could not be opened.The doctor only retracted the stent alone and switched to a new one to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.Additional event information received on 11-jun-2025 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.The stent did not appear damaged.There was no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.No additional information is available.
Additional Manufacturer Narrative
Manufacturer ref#:(b)(4) updated sections on this medwatch: b4, b5, g3, g6, h2, h3, h6 and h11.Section b5: additioanl event information received on 19-jun-2025 indicated that the type of procedure performed was an angioplasty.Complaint conclusion: as reported by a healthcare professional, during an angioplasty procedure, an enterprise2 4mmx16mm no tip vascular reconstruction device (encr403912, 8848366) was placed in target position and started to release, but distal markers of the stent were converged which could not be opened.The doctor only retracted the stent alone and switched to a new one to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.Additional event information received on 11-jun-2025 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.The stent did not appear damaged.There was no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.No additional information is available.The device was returned to j&j medtech for further evaluation.A non-sterile enterprise2 4mmx39mm was returned for analysis contained in decontamination pouch.The pouch contains the device inserted within the dispenser hoop.Device was inspected under magnification.Biological residue was observed within the introducer sheath.No damage to stent, delivery wire or distal tip was present.Delivery wire was advanced without significant resistance.Device was advanced until stent started to deploy out of introducer, and the distal portion of the stent was noted to flare outward as expected.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 customer complaint regarding an incomplete expansion was not confirmed, as the stent flared distally as expected.A root cause of the issue described by customer cannot be determined.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.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.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: 22211858
• Report Number: 3008114965-2025-00573
• Device Sequence Number: 12948849
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: (01)10886704075394(17)270128(10)8848366
• 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): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENCR403912
• Device Lot Number: 8848366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sex: Unknown