MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP; CATHETER, THROMBUS RETRIEVER

Catalog Number	ET309645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, via a personal interaction, that an embotrap iii 6.5 mm x 45 mm (et309645/ 24f121av) and a 132cm cereglide 71 catheter (nic71132c/ 31294255) were used for a mechanical thrombectomy procedure to treat an occlusion at the m1 segment of the middle cerebral artery (mca).A total of four passes were made.Details of the procedure are as follows, ¿the 1st and the 2nd pass were made to m1 occlusion site by combined technique with using the embotrap iii, phenom27, the cereglide 71 and optimo but recanalization was not achieved.The 3rd pass was made by adapt with using the cereglide 71 and optimo, as crossing the clot by microcatheter was not feasible at this time.During the thrombus retrieval, the proximal part of the thrombus was torn off and removed, but the distal residual of thrombus was left in m1.The 4th pass was made by using double stent retrievers.Two microcatheters (phenom21 and trevo trak 21) were inserted.The embotrap iii and a solitaire 4*40 were delivered and deployed parallel at the m1 occlusion site and retracted.¿ after the fourth pass was done using double stent retriever technique, angiography confirmed an intracranial hemorrhage.The patient was treated medically, and homeostasis was achieved.The patient is still being hospitalized.The physician commented that the main cause was thought to be the strong vascular shift caused by the two stent retrievers (the embotrap iii and solitaire 4*40) being placed and deployed in parallel in m1 vessel.The devices were not used according to ifu, as it is not recommended to deploy two stent retrievers in parallel.The event was reported as such, ¿the procedure was a mechanical thrombectomy of middle cerebral artery m1 occlusion.After the preparation, the procedure was initiated (at about 9:15 am).The 1st and the 2nd pass were made to m1 occlusion site by combined technique with using the embotrap iii, phenom27, the cereglide 71 and optimo but recanalization was not achieved.The 3rd pass was made by adapt with using the cereglide 71 and optimo, as crossing the clot by microcatheter was not feasible at this time.During the thrombus retrieval, the proximal part of the thrombus was torn off and removed, but the distal residual of thrombus was left in m1.The 4th pass was made by using double stent retrievers.Two microcatheters (phenom21 and trevo trak 21) were inserted.The embotrap iii and a solitaire 4*40 were delivered and deployed parallel at the m1 occlusion site and retracted.When the stent retrievers were pulled, a strong vascular shift occurred, but the procedure was continued.Angiography confirmed intracranial hemorrhage from ic-top.Stopped the hemorrhage, and the patient was treated medically.Post-procedure changes in the patient: the patient was in the hospital.Continuous flush was done.Other concomitant device was phenom microcatheter, optimo balloon catheter.The physician commented that the main cause was thought to be the strong vascular shift caused by the two stent retrievers (the embotrap iii and solitaire 4*40) being placed and deployed in parallel in m1 vessel.The devices were not used according to ifu, as it is not recommended to deploy two stent retrievers in parallel.The physician had questions about the recommended number of the embotrap iii use, the location of the proximal marker on the embotrap iii, and the recommended number of the cereglide use, and the sales representative has already answered them.
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.Intracranial hemorrhage is a known potential complication associated with the use of the embotrap iii device and is mentioned in the instructions for use (ifu) as such.There was no alleged quality issues related to the used device, as the device performed as intended.The physician felt the hemorrhage resulted from a strong vascular shift caused by the two stent retrievers being placed and deployed in parallel.As explained in the referenced medical literature, double stent-retriever technique presents high risk for hemorrhagic complications due to the substantial displacement of blood vessels by the two stent retrievers.In comparison to single stent-retriever technique, the use of parallel stent-retrievers causes more damage to the vascular endothelium and stronger forces being applied to the vessel, which increases the risk for subsequent intracranial hemorrhage.It is important to note, the embotrap iii device was not used according to the ifu, as the device should only be used in conjunction with the compatible devices listed, which includes a neurovascular guide or sheath, a balloon guide catheter, an intermediate catheter, a microcatheter, and a rotating hemostasis valve (rhv); it is not recommended to deploy two stent retrievers in parallel.Nevertheless, the correlating relationship between the event of an intracranial hemorrhage to the used embotrap iii device as a contributing factor cannot be ruled out.Further, the severity of the event is unknown.Based on this information and the assessment of the treating physician, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ 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.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.

• Brand Name: EMBOTRAP
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 20887010
• Report Number: 3011370111-2024-00116
• Device Sequence Number: 9043478
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: (01)10886704082859(17)270613(10)24F121AV
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211338
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 24F121AV
• 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: 12/02/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 132CM CEREGLIDE 71 CATHETER; OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); PHENOM¿ MICROCATHETER (MEDTRONIC); SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC); TREVO TRAK¿ MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown