MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309645

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

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 11/27/2022

Event Type  Injury  

Event Description

It was reported from a personal interaction that a patient underwent thrombectomy using a 6.5 mm x 45 mm embotrap iii revascularization device (et309645/22e052av).The lesion was in the internal carotid artery (ica) and in the m1 segment of the middle cerebral artery.Per the event description, an optimo 9f balloon-guiding catheter (tokai) was delivered to the ica, and suction was performed once with the balloon-guiding catheter.Later on, one pass was made using the embotrap iii device and vecta 71 (stryker) by the ¿arts technique¿ in the m1 segment of the mca.Reperfusion was observed, but occlusion was confirmed after a few minutes.A 3max suction catheter (penumbra) was used together and suction was performed.Eventually, percutaneous transluminal angioplasty (pta) was performed using a balloon catheter.Continuous flush was done.The procedure was completed at the end as tici2b and the patient was discharged.Per the physician, ¿intracranial atherosclerosis disease (icad) was also suspected, but when the physician looked back later, there was a possibility that dissection occurred after the pass with the complaint device.On angiography, findings showing clear dissection were not clearly understood, but there was a possibility.The physician wondered the case where dissociation occurred after passing with the et iii¿.

Manufacturer Narrative

Product complaint#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 01-feb-2023 was reviewed.Summary of the information provided: there were no device performance issues related to the event nor are there any other factors that may have contributed to the event.The patient was able to walk out of the hospital on his/her own upon discharge.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient underwent a thrombectomy using a 6.5 mm x 45 mm embotrap iii revascularization device (et309645/22e052av).The lesion was in the internal carotid artery (ica) and in the m1 segment of the middle cerebral artery.Per the event description, an optimo 9f balloon-guiding catheter (tokai) was delivered to the ica, and suction was performed once with the balloon-guiding catheter.Later on, one pass was made using the embotrap iii device and vecta 71 (stryker) by the ¿arts technique¿ in the m1 segment of the mca.Reperfusion was observed, but occlusion was confirmed after a few minutes.A 3max suction catheter (penumbra) was used together and suction was performed.Eventually, percutaneous transluminal angioplasty (pta) was performed using a balloon catheter.Continuous flush was done.The procedure was completed at the end as tici2b and the patient was discharged.Per the physician, ¿intracranial atherosclerosis disease (icad) was also suspected, but when the physician looked back later, there was a possibility that dissection occurred after the pass with the compliant device.On angiography, findings showing clear dissection were not clearly understood, but there was a possibility.The physician wondered about the case where dissociation occurred after passing with the et iii¿.Additional information was received indicating that there were no device performance issues related to the event nor are there any other factors that may have contributed to the event.The patient was able to walk out of the hospital on his/her own upon discharge.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Vessel dissection and vascular occlusion are possible complications associated with the use of the embotrap iii revascularization device and are listed as such in the instructions for use (ifu).The device performed as intended and no new patient consequences have occurred related to the use of the device.However, the relationship between the events reported and the embotrap device cannot be excluded given they occurred during the procedural use of the device.In addition, the treating physician commented that they ¿looked back later, there was a possibility that dissection occurred after the pass with the compliant device.On angiography, findings showing clear dissection were not clearly understood, but there was a possibility¿.This also resulted in the patient being treated with a percutaneous transluminal angioplasty (pta).Therefore, this does meet mdr reporting criteria as a ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 III 6.5 MM X 45 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 16129943
• MDR Text Key: 306985799
• Report Number: 3011370111-2023-00003
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (y/n): N
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: ET309645
• Device Catalogue Number: ET309645
• Device Lot Number: 22E052AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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: 3MAX SUCTION CATHETER (PENUMBRA); OPTIMO 9F BALLOON-GUIDING CATHETER (TOKAI); VECTA 71 (STRYKER)
• Patient Outcome(s): Required Intervention