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

Catalog Number	ET309537
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference #: (b)(4).Updated sections on this medwatch: a3a, a4, a5, a6, b4, g3, g6, h2 and h11.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
(b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was discarded; therefore, no further investigation can be performed.A device history review (dhr) associated with lot 23k200av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Embotrap- withdrawal difficulty into the microcatheter (inability) could result in damage to the basket with the potential for release of emboli and subsequent ischemia or infarct and/or the need for additional intervention.There are clinical and procedural factors including clot burden (i.E., hard clot), vessel characteristics (i.E., tortuosity), and mechanical manipulation of devices that may have contributed to the event, rather than a device design or manufacturing issue.In this case, there were no reports of patient injury; however, recanalization was not achieved prior to the termination of the procedure.This decision was made at the discretion of the treating physician based on the high risk for bleeding complications since retrieving the hard thrombus would require excessive force.The alleged device deficiency did not contribute to this decision.Any patient outcome resulting from the absence of treatment would be attributed to the progression of the patient¿s underlying disease process (index stroke).Based on this information and the assessment of the treating physician, this event does not meet us fda reporting criteria as a serious injury.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.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 personal interaction, that an embotrap iii 5 mm x 37 mm (et309537/ 23k200av) was used for a mechanical thrombectomy procedure to treat an occlusion from the internal carotid artery (ica) to the m1 segment of the middle cerebral artery (mca) for an acute ischemic stroke.During the procedure, the user experienced withdrawal difficulty into the microcatheter (inability).As a result, the physician withdrew the embotrap iii into the cat6 intermediate catheter (penumbra).The whole system was removed from the patient's body as a single unit.The physician opted to cancel the procedure without removing the thrombus since the vessel was extremely tortuous, and the thrombus was very hard; he considered forcibly retrieving a very hard thrombus would pose a high risk for bleeding complications.There was no negative impact to the patient.A continuous flush was done.Other concomitant devices were trak microcatheter (stryker) and a cat6 intermediate catheter.The event was reported as such, ¿the procedure was a mechanical thrombectomy of internal carotid artery - middle cerebral artery m1 occlusion to treat acute cerebral infarction.The device was used according to ifu.The lesion was extremely tortuous, and the thrombus was so hard.The procedure was performed by combined technique.When tried to re-sheath the embotrap iii, the stent could not be moved and could not be retracted into microcatheter due to severe resistance.So, cat6 was inserted up to the stent, and the embotrap iii was drawn into the cat 6, the whole system was removed from the patient's body as a single unit.Though recanalization was not achieved, considering the risks involved, the procedure was cancelled.The physician commented that while recanalization was not achieved in this case, it was determined that forcibly retrieving a very hard thrombus would likely pose a higher risk of complications such as bleeding.Therefore, in this situation, the failure to achieve recanalization contributed to risk management regarding potential complications.Post-procedure changes in the patient: there was no negative impact to the patient.Continuous flush was done.The lesion was internal carotid artery - middle cerebral artery.Other concomitant devices were trak microcatheter, cat6 intermediate catheter.¿ no further information was made available at the time of this review.

• 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: 21918474
• Report Number: 3011370111-2025-00036
• Device Sequence Number: 9031265
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: (01)10886704084570(17)261019(10)23K200AV
• 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): 05/01/2025

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: 23K200AV
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2023
• 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: CAT6¿ INTERMEDIATE CATHETER (PENUMBRA); TRAK¿ MICROCATHETER (STRYKER)
• Patient Sex: Female
• Patient Weight: 31 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian