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

Model Number ET309537

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that a male patient underwent mechanical thrombectomy of a middle cerebral artery (proximal m2 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537/21k060av) and experienced vessel dissection during the procedure.There was slight bleeding, but the patient's condition was ¿good¿ with tici score of 3.It was last reported that the patient remains hospitalized but is doing well.The condition of the infarct area is unchanged and did not worsen with the procedure.¿there seems to be almost no infarction.¿ direct aspiration first pass technique (adapt) was initially performed with a cat6 aspiration catheter (penumbra), but this was unsuccessful.Therefore, the trak 21 microcatheter (stryker) was advanced to the superior m2, and the embotrap iii was deployed at the target occlusion.The device was then removed.The procedure was thrombus removal for ais with using a combine technique.¿although it was thought to be tici3 in the angiography of immediate, it was almost occluded after a while¿, and dissection was suspected on angiography.A 9f optimo balloon catheter (tokai medical) was used, and the procedure was completed.Concomitant devices also included a chikai 14 black soft guidewire (asahi intecc) and a cat6 y-connector.Additional information received on 01-feb-2022 indicated that the balloon catheter was used to treat the dissected vessel.There were no device malfunctions or performance issues associated with the embotrap.Anonymized procedural films/imaging is not available for review.No further information could be obtained.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: it was reported by a healthcare professional that a male patient underwent mechanical thrombectomy of a middle cerebral artery (proximal m2 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537/21k060av) and experienced vessel dissection during the procedure.There was slight bleeding, but the patient's condition was ¿good¿ with tici score of 3.It was last reported that the patient remains hospitalized but is doing well.The condition of the infarct area is unchanged and did not worsen with the procedure.¿there seems to be almost no infarction.¿ direct aspiration first pass technique (adapt) was initially performed with a cat6 aspiration catheter (penumbra), but this was unsuccessful.Therefore, the trak 21 microcatheter (stryker) was advanced to the superior m2, and the embotrap iii was deployed at the target occlusion.The device was then removed.The procedure was thrombus removal for ais with using a combine technique.¿although it was thought to be tici3 in the angiography of immediate, it was almost occluded after a while¿, and dissection was suspected on angiography.A 9f optimo balloon catheter (tokai medical) was used, and the procedure was completed.Concomitant devices also included a chikai 14 black soft guidewire (asahi intecc) and a cat6 y-connector.Additional information received indicated that the balloon catheter was used to treat the dissected vessel.There were no device malfunctions or performance issues associated with the embotrap.Anonymized procedural films/imaging is not available for review.No further information could be obtained.The device was discarded, therefore, no further investigation can be performed.A review of the dhr records for lot 21k060av confirms that there were no issues with the assembly of the lot.Hemorrhage secondary to vessel dissection is a known potential adverse event associated with the use of the embotrap iii in endovascular mechanical thrombectomy.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 device malfunctioned or that the event was related to the device design or manufacturing process.The intracranial artery dissection with bleed occurred during procedural use of the device and required surgical intervention to preclude further damage.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.

• 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 ; 9497898687
• MDR Report Key: 13445105
• MDR Text Key: 288395720
• Report Number: 3011370111-2022-00017
• 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
• Report Date: 02/03/2022

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
• 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: 01/19/2022
• Initial Date FDA Received: 02/03/2022
• 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: 9F OPTIMO BALLOON CATHETER (TOKAI MEDICAL); CAT6 ASPIRATION CATHETER (PENUMBRA); CAT6 Y-CONNECTOR; CHIKAI 14 BLACK SOFT GUIDEWIRE (ASAHI INTECC); TRAK 21 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male