MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number	ET309645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a personal interaction, that an embotrap iii 6.5 mm x 45 mm (et309645/ lot # unknown) was used for a mechanical thrombectomy procedure to treat an occlusion at the left internal carotid artery (ica).During the procedure, the user reported recanalization of left internal carotid artery was achieved after the first retrieval attempt, but embolization occurred to the anterior cerebral artery (aca).A second and third pass was made at the aca site, but recanalization was not achieved.The procedure was then terminated ¿because it had been about an hour since the start of the procedure, and there were insurance restrictions because three devices had been used.¿ there were no clinical symptoms to the patient.Continuous flush was unknown.Other concomitant devices were unknown.The event was reported as such, ¿the procedure was a mechanical thrombectomy of left internal carotid artery occlusion.9fr balloon guiding catheter, 0.071-inch and 0.046-inch access catheter, the embotrap 6.5mmx45mm were used for the procedure.Angiography after 1 pass showed recanalization of left internal carotid artery but embolization in the aca.For the 2nd and 3rd pass to aca, aspiration by adapt were attempted using a 0.046-inch ac, but recanalization was not achieved.The procedure was terminated because it had been about an hour since the start of the procedure, and there were insurance restrictions because three devices had been used.There were no clinical symptoms to the patient.Continuous flush was unknown.The lesion was left internal carotid artery.Other concomitant devices were unknown.¿ no further information was made available at the time of this review.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3 ¿ date of event: the date of the event was not reported.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.A thromboembolism is a known potential complication associated with the use of the embotrap iii device and is listed in the instructions for use (ifu) as such.There were no alleged quality issues related to the used device, as the device performed as intended.Clinical and procedural factors, including vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery, are all factors that may have contributed to the reported event rather than the design or manufacture of the device.Since the device was in use when the event occurred, the correlating relationship between the event to the used device as a contributing factor cannot be ruled out.In this case, the procedure was terminated after the retrieval of the first thrombus, due to time and insurance restrictions.The severity of the event is unknown.Since a thromboembolism is considered to be a serious injury, this event does meet us fda reporting criteria under 21 cfr 803 with the classification of ¿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.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20033513
• Report Number: 3011370111-2024-00073
• Device Sequence Number: 6404877
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211338
• 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
• Report Date (Section B): 08/21/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ET309645
• 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: 08/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 0.046 IN ACCESS CATHETER (UNSPECIFIED BRAND).; 9F BALLOON GUIDE CATHETER (UNSPECIFIED BRAND).
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown