MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number	ET009533
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (m2 segment) occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) and experienced bleeding at the m2 region.The patient has been monitored in the hospital.No further information was provided at the time of complaint initiation.
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).E.1: the initial reporter phone: (b)(6).Complaint conclusion: it was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (m2 segment) occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/ 20l150av) and experienced bleeding at the m2 region.The patient has been monitored in the hospital.No further information is available.The device was discarded; therefore, no further investigation will be performed.A review of the dhr records confirms that there were no issues with the assembly of the lot (sub and top assembly), all rejects were accounted for during the dhr review.There were no issues with sterilisation.Hemorrhage secondary to vessel trauma or injury is a well-known extensively documented potential complication associated with the embotrap ii revascularization device and is listed in the instructions for use (ifu) as such.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 hemorrhage.However, there are clinical and procedural factors such as vessel characteristics, clot burden, device selection, device interaction, and mechanical manipulation of devices within the artery that may have contributed to the reported event.There is no indication that the device malfunctioned or that it is related to the device design or manufacturing the intracranial hemorrhage is a serious injury which required prolonged hospitalization and the relationship of the device to the reported event cannot be excluded.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13051900
• Report Number: 3011370111-2021-00168
• Device Sequence Number: 3888114
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173452
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20L150AV
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown