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	11/30/2021
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.The exact timing of the event was not reported.Additional information received indicated that the bleeding was noted at the m2 segment of the mca.The complaint device was allegedly used as per the instructions for use (ifu); however, the hemorrhage was confirmed when it was used in conjunction with the aspiration catheter (brand/manufacturer unknown).Only one pass was made with the device.There was no paralysis due to the hemorrhage; the patient¿s baseline clinical symptoms were unchanged.No additional treatment was provided.After that, anticoagulation was prescribed because re-occlusion had occurred.However, the anticoagulation treatment was delayed due to the hemorrhage.There was no extension of the hospital stay as a result of the event.The physician commented that the hemorrhage must have occurred due to retraction of the stent retriever.The bleed was not considered serious because symptoms had not worsened.Additional information received indicated that anonymized procedural films/imaging is not available for review.The physician commented that the cause of the hemorrhage was pulling of the stent retriever.No medical intervention was required.Re-occlusion occurred, and the administration of anticoagulants was prescribed.However, the administration of the anticoagulants was delayed because the patient experienced hemorrhage prior to the re-occlusion.The event did not result in prolonged hospitalization, although, the patient was still in the hospital as of (b)(6) 2021.The patient did not experience any new clinical symptoms due to the hemorrhage.Baseline symptoms were unchanged.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot: the lot number 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 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.The exact timing of the event was not reported.Additional information received indicated that the bleeding was noted at the m2 segment of the mca.The complaint device was allegedly used as per the instructions for use (ifu); however, the hemorrhage was confirmed when it was used in conjunction with the aspiration catheter (brand/manufacturer unknown).Only one pass was made with the device.There was no paralysis due to the hemorrhage; the patient¿s baseline clinical symptoms were unchanged.No additional treatment was provided.After that, anticoagulation was prescribed because re-occlusion had occurred.However, the anticoagulation treatment was delayed due to the hemorrhage.There was no extension of the hospital stay as a result of the event.The physician commented that the hemorrhage must have occurred due to retraction of the stent retriever.The bleed was not considered serious because symptoms had not worsened.Additional information received indicated that anonymized procedural films/imaging is not available for review.The physician commented that the cause of the hemorrhage was pulling of the stent retriever.No medical intervention was required.Re-occlusion occurred, and the administration of anticoagulants was prescribed.However, the administration of the anticoagulants was delayed because the patient experienced hemorrhage prior to the re-occlusion.The event did not result in prolonged hospitalization, although, the patient was still in the hospital as of (b)(6) 2021.The patient did not experience any new clinical symptoms due to the hemorrhage.Baseline symptoms were unchanged.The device was discarded; therefore, no further investigation can be performed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.Hemorrhage secondary to vascular injury is a well-known potential complication associated with the use of the embotrap ii in mechanical thrombectomy procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors including vessel characteristics, clot burden/characteristics, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event.There is no indication that the device malfunctioned or that it is related to the device design or manufacturing process.The intracranial hemorrhage is considered a serious injury and the relationship of the embotrap 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.

• 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: 13176433
• Report Number: 3011370111-2022-00001
• Device Sequence Number: 4562596
• 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
• Report Date (Section B): 01/06/2022

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 Model Number: ET009533
• Device Catalogue Number: ET009533
• 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: 12/17/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNSPECIFIED ASPIRATION CATHETER
• Patient Sex: Unknown