MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309537

Device Problem Difficult to Remove (1528)

Patient Problems Intracranial Hemorrhage (1891); Thromboembolism (2654)

Event Type  Injury  

Event Description

The healthcare professional reported that the patient underwent a thrombectomy procedure targeting an occlusion in the middle cerebral artery (mca) after intravenous tissue plasminogen activator (tpa), a 5mm x 37mm embotrap iii revascularization device (et309537 / lot # unknown) was delivered via a trevo trak 21 microcatheter (stryker).It was reported that a continuous flush was maintained.Recanalization was achieved after the first pass, but occlusion at the m2 segment was confirm by angiography.The physician speculated that distal migration had occurred and a second pass was made.There was slight resistance felt when the complaint device was retracted, and bleeding was confirmed by angiography.Limited information including additional treatment and concomitant devices were not available at the time of the complaint initiation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(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.Withdrawal difficulty from vessel, embolization of thrombus and hemorrhage secondary to vascular injury are well-known potential complications associated with the use of the embotrap iii in mechanical thrombectomy procedures and are listed in the instructions for use (ifu) as such.The ifu also warns the user to not withdraw the device against significant resistance.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.There are vessel characteristics, clot burden/characteristics, device selection, operator technique, device interaction, and mechanical manipulation of devices within the artery that may have contributed to the event.There is no indication of a device design or manufacturing issue.Withdrawal difficulty from the vessel is considered an mdr reportable malfunction as it could result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli and subsequent ischemia or infarct and/or the need for additional intervention.Therefore, this event is considered serious and usfda mdr reportable.The complaint will be reassessed if additional information becomes available.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.The lot number of the device is not known; therefore, manufacturing documentation review 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 at a later time.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.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 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on (b)(6) 2023.[additional information]: on (b)(6) 2023, limited additional information was received.The information indicated that the lot number of the embotrap iii device is not known.The event / procedure date is not known.The reported bleed was observed after the second pass was made when the slight resistance was felt.E.1: initial reporter phone: (b)(6).Updated sections: b.4, e.1, e.3, g.3, g.6, h.2, and h.10.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.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: 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 ; 303552-689
• MDR Report Key: 16444369
• MDR Text Key: 310261936
• Report Number: 3011370111-2023-00023
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TREVO TRAK 21 MICROCATHETER (STRYKER).
• Patient Outcome(s): Life Threatening