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 Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 01/03/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not reported / available.[conclusion]: the healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (m2 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21k060av) and experienced a hemorrhage at the m2 during the procedure.The patient ultimately expired secondary to excessive bleeding.Details of the procedure is as followed: the flowgate2¿ balloon guide catheter (stryker) was advanced to the internal carotid artery (ica).Thrombus removal was attempted utilizing combined technique with the embotrap iii and an axs catalyst¿ 6 da catheter (stryker).The devices were reportedly used in accordance with the instructions for use (ifu).The embotrap iii was deployed from the distal m2 via a trevo trak 21 microcatheter (stryker) and then retrieved.However, a hemorrhage occurred at the m2.It was reported that there was no issue during deployment of the embotrap iii.The physician considered that the bleed was caused by the vessel shift when the embotrap was pulled.The physician further commented that because of the long length of the stent retriever, there is a risk of using the embotrap iii in peripheral vessels.The complaint device is not available for evaluation.On 13 feb 2022, additional information was received.The information indicated that vessel shift might be the etiology of the vessel injury.On 22 feb 2022, additional information regarding the event date was received.The event date was reported to be (b)(6) 2022.On 23-feb-2022, additional information was received.Per the information, the lot number of the device is confirmed to be 21k060av.The procedure date and the date of death was (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.Related to the etiology of the vascular injury, the information indicated that there are possibilities that vascular dissection occurred due to vessel shift.The patient suffered a subarachnoid hemorrhage (sah).It was not known whether any medical and / or surgical intervention was performed.The patient baseline and post-procedure tici / mrs / nihss scores are not known.The information indicated that there was resistance felt when the embotrap iii was being retracted.There was no unintended movement during the procedure due to the patient movement or positioning / deployment of the device.The embotrap iii was partially retracted into the suction catheter.Two passes were made with the embotrap iii device.There were no issues related to the concomitant devices used during the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21k060av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device is not available to be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Withdrawal difficulty from vessel, sah secondary to vessel dissection, and death are known potential complications associated with the use of the embotrap iii revascularization device in mechanical thrombectomy procedures.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, there are clinical and procedural factors such as vessel characteristics, clot burden/characteristics, device selection, device interaction, and mechanical manipulation of devices within the artery that may have contributed.There is no indication that the event was related to a device design or manufacturing issue.Since the withdrawal difficulty from vessel resulted in dissection/hemorrhage and ultimately led to fatal outcome, the event meets mdr reporting criteria with the classification of ¿death.¿ based on the manufacturing documentation reviews, there is no indication that the event is related to the device manufacturing process.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.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 Description

The healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (m2 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21k060av) and experienced a hemorrhage at the m2 during the procedure.The patient ultimately expired secondary to excessive bleeding.Details of the procedure is as followed: the flowgate2¿ balloon guide catheter (stryker) was advanced to the internal carotid artery (ica).Thrombus removal was attempted utilizing combined technique with the embotrap iii and an axs catalyst¿ 6 da catheter (stryker).The devices were reportedly used in accordance with the instructions for use (ifu).The embotrap iii was deployed from the distal m2 via a trevo trak 21 microcatheter (stryker) and then retrieved.However, a hemorrhage occurred at the m2.It was reported that there was no issue during deployment of the embotrap iii.The physician considered that the bleed was caused by the vessel shift when the embotrap was pulled.The physician further commented that because of the long length of the stent retriever, there is a risk of using the embotrap iii in peripheral vessels.The complaint device is not available for evaluation.On 13 feb 2022, additional information was received.The information indicated that vessel shift might be the etiology of the vessel injury.On 22 feb 2022, additional information regarding the event date was received.The event date was reported to be (b)(6) 2022.On 23-feb-2022, additional information was received.Per the information, the lot number of the device is confirmed to be 21k060av.The procedure date and the date of death was (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.Related to the etiology of the vascular injury, the information indicated that there are possibilities that vascular dissection occurred due to vessel shift.The patient suffered a subarachnoid hemorrhage (sah).It was not known whether any medical and / or surgical intervention was performed.The patient baseline and post-procedure tici / mrs / nihss scores are not known.The information indicated that there was resistance felt when the embotrap iii was being retracted.There was no unintended movement during the procedure due to the patient movement or positioning / deployment of the device.The embotrap iii was partially retracted into the suction catheter.Two passes were made with the embotrap iii device.There were no issues related to the concomitant devices used during the procedure.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13624632
• MDR Text Key: 286316106
• Report Number: 3011370111-2022-00019
• 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
• Report Date: 02/28/2022

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
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21K060AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: AXS CATALYST¿ 6 DA CATHETER (STRYKER); FLOWGATE2¿ BALLOON GUIDE CATHETER (STRYKER); TREVO TRAK 21 MICROCATHETER (STRYKER)
• Patient Outcome(s): Death