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

Catalog Number	ET309537
Medical Device Problem Codes	Difficult to Remove (1528); Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section b.3: date of event: the date of the event was not reported / known.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.The full udi is not available without the expiration date.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered later.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a mechanical thrombectomy procedure targeting the m1 segment of the right middle cerebral artery (mca) with strong vessel deviation, a total of 7 passes were made.They are documented as follows: the first pass was via an adapt (direct aspiration first pass technique) using a 0.060-inch access catheter.¿much resistance was not felt, but the physician was hesitant to insert the catheter [into the] m2, so aspiration was made after completely removing the microcatheter.¿ three passes were made via the combined technique with the 0.060-inch access catheter and the 5mm x 37mm embotrap iii revascularization device (et309537 / lot# unknown).Strong resistance was felt.The fifth pass was via the combined technique using a 0.046-inch access catheter and the 5mm x 37mm embotrap iii revascularization device.Strong resistance was felt.The sixth pass, the embotrap iii was pulled back with thrombi into the access catheter.¿at this time, deployed the embotrap iii shorter and attempted to overcome the resistance and the vessel deviation, but could not achieve recanalization.¿ on the seventh pass, the ¿embotrap iii was pulled back with thrombi into the access catheter, and both were retrieved together.Finally, recanalization was not achieved.It was not known if continuous flush was maintained.Recanalization was not achieved but there was no negative impact to the patient.On 25-nov-2025, additional information was received.Per the information, ¿strong withdrawal resistance was felt with the embotrap device.Also, curved part of the vessel became temporarily straightened during the retrieval of the embotrap device due to the withdrawal resistance.¿ based on the additional information received on 25-nov-2025, the reported event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

• 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 ; 949788-2078
• MDR Report Key: 23709846
• Report Number: 3011370111-2025-00122
• Device Sequence Number: 18814406
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• 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): 12/03/2025

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
• 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: 11/25/2025
• Initial Report FDA Received Date: 12/03/2025
• 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-INCH ASPIRATION CATHETER (UNSPECIFIED BRAND); 0.060-INCH ASPIRATION CATHETER (UNSPECIFIED BRAND); MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown