MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENCR403900
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, an enterprise2 4mmx39mm no tip vascular reconstruction device (encr403900, 9185298) was placed in target position and started to release, it was found that distal markers of the stent could not be opened or expanded completely as intended.The doctor retracted the stent and delivered the stent to release it again, but the distal stent markers still failed to open completely.The doctor only retracted the stent alone, then switched to a new stent to complete the surgery.There was no patient injury reported.Additional event information received on 25-jul-2025 indicated that there was no resistance during advancement of the device.The stent did not appear damaged.There was calcification noted.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.The procedure was delayed/prolonged due to the event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Complaint conclusion: a healthcare professional reported that during an endovascular embolization, an enterprise2 4mmx39mm no tip vascular reconstruction device (encr403900, 9185298) was placed in target position and started to release, it was found that distal markers of the stent could not be opened or expanded completely as intended.The doctor retracted the stent and delivered the stent to release it again, but the distal stent markers still failed to open completely.The doctor only retracted the stent alone, then switched to a new stent to complete the surgery.There was no patient injury reported.Additional event information received on 25-jul-2025 indicated that there was no resistance during advancement of the device.The stent did not appear damaged.There was calcification noted.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.The procedure was delayed/prolonged due to the event.The device was returned to j&j medtech for further evaluation.A non-sterile enterprise2 4mmx39mm no tip was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the stent was still attached to the delivery wire inside the introducer.No appearance of damages were observed.Microscopical inspection was performed, and the stent component was disengaged from the delivery wire.A functional test was attempted; however, the stent could not be advanced due to the disengaged condition.The customer complaint regarding stent marker bands converging cannot be evaluated since due to the disengaged condition of the stent this cannot be exposed.However, it is possible that the marker bands may have converged together but opposed to the vessel wall during the procedure.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 9185298.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues were encountered, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.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: ENTERPRISE2 4MMX39MM NO TIP
• 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: 22742076
• Report Number: 3008114965-2025-00845
• Device Sequence Number: 20683838
• Product Code: NJE
• UDI-Device Identifier: 10886704075400
• UDI-Public: (01)10886704075400(17)270728(10)9185298
• 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): 08/25/2025

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: ENCR403900
• Device Lot Number: 9185298
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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).
• Patient Sex: Unknown