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)
Date of Event	02/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number was not reported.Initial reporter phone: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that a (b)(6) patient underwent mechanical thrombectomy of a middle cerebral artery occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) and experienced subarachnoid hemorrhage (sah) secondary to vessel dissection during the procedure.The balloon guide catheter was inflated, and the blood flow was blocked, resulting in hemostasis of the bleeding site.The procedure was completed.The m2 superior trunk of the mca remains occluded.The patient¿s current health status is unknown.Concomitant devices included a 9f optimo balloon guide catheter (tokai medical), catalyst 6 aspiration catheter (stryker), and a phenom 21 microcatheter (medtronic).Thrombus removal was performed for cerebral infarction using the above-mentioned devices.The catalyst 6 was positioned in the internal carotid (ic) top and the phenom 21 microcatheter was regionally crossed to access the m2 superior trunk.From there, the embotrap device was positioned and deployed.The treating physician was able to capture a small amount of thrombus, but an occlusion remained at the m2 superior trunk.The occluded region was regionally crossed again, and the embotrap ii was deployed to pull the occluded region.Subsequently, subarachnoid hemorrhage was confirmed from the m2 superior trunk.The attending physician speculated that the bleeding site was dissected during the first pass.The attending physician speculated that the hemorrhage may have occurred because he/she dissected the vessel during the first pass and ¿developed embotrap ii at the same site to pull it¿.The embotrap was reportedly used in accordance with the instructions for use (ifu).Continuous flush was done.The embotrap device is not available for evaluation.No additional information is available.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Subarachnoid hemorrhage secondary to vessel dissection is a known potential complication associated with the use of the embotrap ii 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 device malfunctioned or that the event was related to a device design or manufacturing issue.The reported sah secondary to intracranial artery dissection required surgical intervention to arrest the bleeding and preclude permanent impairment.Furthermore, the relationship of the embotrap ii 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.
Event or Problem Description
It was reported by a healthcare professional that a (b)(6) patient underwent mechanical thrombectomy of a middle cerebral artery occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) and experienced subarachnoid hemorrhage (sah) secondary to vessel dissection during the procedure.The balloon guide catheter was inflated, and the blood flow was blocked, resulting in hemostasis of the bleeding site.The procedure was completed.The m2 superior trunk of the mca remains occluded.The patient¿s current health status is unknown.Concomitant devices included a 9f optimo balloon guide catheter (tokai medical), catalyst 6 aspiration catheter (stryker), and a phenom 21 microcatheter (medtronic).Thrombus removal was performed for cerebral infarction using the above-mentioned devices.The catalyst 6 was positioned in the internal carotid (ic) top and the phenom 21 microcatheter was regionally crossed to access the m2 superior trunk.From there, the embotrap device was positioned and deployed.The treating physician was able to capture a small amount of thrombus, but an occlusion remained at the m2 superior trunk.The occluded region was regionally crossed again, and the embotrap ii was deployed to pull the occluded region.Subsequently, subarachnoid hemorrhage was confirmed from the m2 superior trunk.The attending physician speculated that the bleeding site was dissected during the first pass.The attending physician speculated that the hemorrhage may have occurred because he/she dissected the vessel during the first pass and ¿developed embotrap ii at the same site to pull it¿.The embotrap was reportedly used in accordance with the instructions for use (ifu).Continuous flush was done.The embotrap device is not available for evaluation.No additional information is available.

• 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: 13769493
• Report Number: 3011370111-2022-00029
• Device Sequence Number: 5033149
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

1 Device 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: 03/02/2022
• Initial Report FDA Received Date: 03/15/2022
• 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