MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP; CATHETER, THROMBUS RETRIEVER

Catalog Number	ET309537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a personal interaction, that an embotrap iii 5 mm x 37 mm (et309537/ 25l363av) was used for a mechanical thrombectomy of the middle cerebral artery m2 (with two occlusion sites) to treat cerebral infarction, which was performed by combined technique.It was reported that the patient had suffered a stroke ¿some time ago.¿ during the procedure, successful recanalization (tici 3) was achieved with two passes; however, a postoperative hemorrhagic complication was observed.The patient was left with residual neurological deficits.The physician commented that it was considered unlikely that there was a causal relationship with the embotrap iii device.Potential causes other than the embotrap iii was reported as ¿prolonged time from symptom onset and the patient¿s advanced age.¿ continuous flush was not done.Other devices used during the procedure are unknown.The event was initially reported as such, ¿the procedure was a mechanical thrombectomy of middle cerebral artery m2 occlusion to treat cerebral infarction, which was performed by combined technique.The devices were used according to ifu.The target was an m2 occlusion, with two occlusion sites identified.The patient had suffered a stroke some time ago, and also exhibited significant vascular tortuosity.Using the embotrap iii with a combined technique, successful recanalization (tici 3) was achieved after 2 passes.A postoperative hemorrhagic complication was observed.The patient was left with residual neurological deficits.Physician¿s comment on the relationship between this event and the product: it was considered unlikely that there was a causal relationship with the embotrap iii.Possible causes other than the embotrap iii include the prolonged time from symptom onset and the patient¿s advanced age.Neurological deficits remained.Continuous flush was not done.The lesion was middle cerebral artery m2.Other concomitant devices were unknown.¿.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Us fda determination: cerebral hemorrhage is a known potential complication associated with the use of the embotrap iii device and is mentioned in the instructions for use (ifu) as such.There was no alleged quality issue related to the used device, as the device performed as intended.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.It was reported that alternative factors, such as delayed reperfusion and the patient¿s advanced age, may have contributed to the hemorrhagic event; however, the exact cause remains unknown.Based on the information provided, the event is more likely associated with patient or procedural-related factors, rather than a device-related cause.However, given that the serious adverse event (hemorrhage with associated neurological deficits) occurred in temporal association with device use, and in absence of a confirmed alternative cause, a device-related cause cannot be ruled out entirely.Therefore, this event does meet us fda reporting criteria reporting criteria under 21 cfr 803 with a classification of a ¿serious injury,¿ with an awareness date of (b)(6) 2026.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.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.

• Brand Name: EMBOTRAP
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: 24939558
• Report Number: 3011370111-2026-00044
• Device Sequence Number: 10671281
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: (01)10886704084570(17)281110(10)25L363AV
• 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
• Report Date (Section B): 04/21/2026

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: ET309537
• Device Lot Number: 25L363AV
• 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: 04/02/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown