MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Difficult to Remove (1528)

Patient Problem Intracranial Hemorrhage (1891)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Date of event: the date of the event was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device manufacture date: not available at time of report.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported from a personal interaction that a patient with an acute cerebral infarction underwent a thrombectomy procedure for an occlusion at the m1-m2 segment of the middle cerebral artery (mca) with a 5mm x 37mm embotrap iii (et309537/22g037av) revascularization device.Per details of the procedure, a 9fr sheath used to punctured the right femoral artery and a balloon guiding catheter was advanced to the internal carotid artery (ica).A ¿red¿ suction catheter (unknown manufacturer) was advanced to the m1 of the mca and a microcatheter (unknown device details) crossed the lesion.The complaint embotrap iii was deployed, and it was stated that although the complaint device was retracted together with thrombus, there was an intense resistance felt while the complaint device was being retracted.It was reported that an asymptomatic subarachnoid hemorrhage as occurred upon thrombus removal.It was stated that the patient was observed for a while, and it was confirmed that hemostasis was achieved without any additional medical treatment and that the procedure was deemed completed.Although the subarachnoid hemorrhage was judged by the physician as non-serious because it was asymptomatic, he thinks that the adverse event might have been related with the complaint device.It is not known if a continuous flush was done.Other concomitant device used: optimo 9fr (tokai medical) balloon catheter.

Manufacturer Narrative

Product complaint #(b)(4).Section e1: initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient with an acute cerebral infarction underwent a thrombectomy procedure for an occlusion at the m1-m2 segment of the middle cerebral artery (mca) with a 5mm x 37mm embotrap iii (et309537/22g037av) revascularization device.Per details of the procedure, a 9fr sheath used to puncture the right femoral artery and a balloon guiding catheter was advanced to the internal carotid artery (ica).A ¿red¿ suction catheter (unknown manufacturer) was advanced to the m1 of the mca and a microcatheter (unknown device details) crossed the lesion.The complaint embotrap iii was deployed, and it was stated that although the complaint device was retracted together with thrombus, there was an intense resistance felt while the complaint device was being retracted.It was reported that an asymptomatic subarachnoid hemorrhage as occurred upon thrombus removal.It was stated that the patient was observed for a while, and it was confirmed that hemostasis was achieved without any additional medical treatment and that the procedure was deemed completed.Although the subarachnoid hemorrhage was judged by the physician as non-serious because it was asymptomatic, he thinks that the adverse event might have been related with the complaint device.It is not known if a continuous flush was done.Other concomitant device used: optimo 9fr (tokai medical) balloon catheter.The device was discarded; therefore, no further investigation can be performed.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.Withdrawal difficulty from vessel 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.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 mdr reportable.The complaint will be reassessed if additional information becomes available.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.

Manufacturer Narrative

Product complaint # (b)(4).The device was discarded; therefore, no further investigation can be performed.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16303427
• MDR Text Key: 308841162
• Report Number: 3011370111-2023-00018
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• 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
• Device Lot Number: 22G037AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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: "RED¿ SUCTION CATHETER (UNKNOWN MANUFACTURER); 9FR SHEATH; OPTIMO 9FR (TOKAI MEDICAL) BALLOON CATHETER; UNSPECIFIED MICROCATHETER
• Patient Outcome(s): Life Threatening