MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP; EMBOTRAP III REVASCULARIZATION DEVICE

Catalog Number	ET309537
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that this was a mechanical thrombectomy of the middle cerebral artery with segment m2 occlusion was initiated.Carotid artery stenting of common carotid artery was also performed concomitantly.When the aspiration catheter was inserted, it was unable to pass beyond the protage stent deployed in the common carotid artery.Then, an embotrap iii 5 mm x 37 mm (et309537, 24f016av) was delivered to the m2 occlusion site and deployed.After retrieving the thrombus and withdrawing it with the embotrap iii, the embotrap iii stent became caught on the protage in the common carotid artery and could not be removed.A 6fr inner catheter was inserted to retrieve the embotrap iii stent.The embotrap iii was pulled from the patient¿s body, and the procedure was successfully completed.There was no negative impact to the patient.A continuous flush was unknown.Other concomitant devices were optimo 8fr guiding catheter and a phenom microcatheter.
Additional Manufacturer Narrative
Manufacturer ref # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h4: the device manufacture date is is not available at the time of reporting.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h4, h6 and h11.Complaint conclusion: a healthcare professional reported that this was a mechanical thrombectomy of the middle cerebral artery with segment m2 occlusion was initiated.Carotid artery stenting of the common carotid artery was also performed concomitantly.When the aspiration catheter was inserted, it was unable to pass beyond the protage stent deployed in the common carotid artery.Then, an embotrap iii 5 mm x 37 mm (et309537, 24f016av) was delivered to the m2 occlusion site and deployed.After retrieving the thrombus and withdrawing it with the embotrap iii, the embotrap iii stent became caught on the protage in the common carotid artery and could not be removed.A 6fr inner catheter was inserted to retrieve the embotrap iii stent.The embotrap iii was pulled from the patient¿s body, and the procedure was successfully completed.There was no negative impact to the patient.A continuous flush was unknown.Other concomitant devices were optimo 8fr guiding catheter and a phenom microcatheter.Additional event information received on 12-aug-2025 indicated that there was no damage to the device due to the entanglement.There was no evidence of vessel damage or thromboembolism.The device was not used for additional passes after the entanglement.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 review (dhr) associated with this lot 24f016av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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: EMBOTRAP
• Common Device Name: EMBOTRAP III REVASCULARIZATION DEVICE
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22770380
• Report Number: 3011370111-2025-00091
• Device Sequence Number: 9341999
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: (01)10886704084570(17)270524(10)24F016AV
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193063
• 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): 08/26/2025

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: ET309537
• Device Lot Number: 24F016AV
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: ASPIRATION CATHETER (UNSPECIFIED BRAND); OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); PHENOM¿ MICROCATHETER (MEDTRONIC); PROTÉGÉ¿ STENT (MEDTRONIC)
• Patient Sex: Unknown