MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET309645

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

Patient Problem Vascular Dissection (3160)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with lot 22f033av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Artery dissection is a known potential complication associated with the use of the embotrap iii device and is listed in the instructions for use (ifu) as such.There were no alleged quality issues/malfunctions related to the device, as the device performed as intended, achieving a mtici score of 3 (complete perfusion) with one pass.The principal investigator (pi) assessed this event was unrelated to the study device, unrelated to the large bore catheter, and unrelated to the surgical procedure.However, because the event of ¿l ica [left internal carotid artery] dissection¿ occurred the day of the surgical procedure and at the location of the targeted vessel, the correlating relationship between the device and event cannot be ruled out completely.Based on this information, this event does meet us fda reporting criteria under 21 cfr 803 under the classification of ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.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.

Event Description

As reported via the excellent study (b)(6), a 51-year-old male (b)(6) with a history of previous ischemic stroke (b)(6) 2023), hyperlipidemia, hypertension, and previous smoking, presented with a witnessed stroke on (b)(6) 2023 at 09:00.The patient was presented to the treating hospital on the same day at 09:37.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was ¿large-artery disease (cervical atherosclerosis).The patient¿s baseline nihss score was 7 and a mrs score of ¿2-slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance¿.The patient underwent an endovascular mechanical thrombectomy on (b)(6) 2023 using an embotrap iii 6.5 mm x 45 mm (et309645/ 22f033av) for an occlusion at the left internal carotid artery (ica).The pre-pass mtici score was 0.The 1st pass resulted in a mtici score of 3, with no clot retrieval.During the procedure, a guidewire was used, but the brand was not specified.A 0.021 phenom microcatheter, a 0.070 sofia plus intermediate catheter, and a walrus balloon guide catheter were also used.There were no reported intraoperative study device deficiencies.The patient¿s 24-hour post-procedure nihss score was 11.On (b)(6) 2023, the patient experienced the adverse event of a ¿l ica dissection¿, which became known to the site on (b)(6) 2023 and known to the sponsor on (b)(6) 2023.The principal investigator (pi) assessed this event as not serious, mild in severity, and unrelated to the study device, unrelated to the large bore catheter and unrelated to the surgical procedure.As to whether the event was anticipated, the answer field is recorded as ¿n/a (does not meet above criteria)¿.The event required the surgical intervention of stenting and balloon angioplasty.The patient recovered and the event was resolved with an end date of (b)(6) 2023.The patient was discharged to a rehabilitation center on (b)(6) 2023 with an nihss score of 11 and a mrs score of ¿4-moderately severe disability.Unable to walk without assistance and unable to attend to own bodily needs without assistance¿.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional information was received from the excellent clinical study team on 19-nov-2023.Summary: ¿after reading the op note the dissection is suspected to be due to the patient having underlying left ica stenosis but actually developed an acute dissection causing the occlusion.There is no note of device deficiency or other issues during the procedure.After deploying the device there was recanalization of the ica but had some irregularities consistent with a distal ica dissection.Once this was noted is when multiple stents were placed to resolve the dissection.¿ per the additional information received on 19-nov-2023, the event of an artery dissection was attributed to the underlying vessel stenosis of the patient.Based on this information, the correlating relationship between the device and event can be ruled out completely.Therefore, this event no longer meets us fda reporting criteria under 21 cfr 803.The file will be re-reviewed if additional information is received at a later date.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• Type of Device: 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: 18076374
• MDR Text Key: 327485664
• Report Number: 3011370111-2023-00175
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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 Catalogue Number: ET309645
• Device Lot Number: 22F033AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/19/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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: 0.021 PHENOM MICROCATHETER; 0.070 SOFIA PLUS INTERMEDIATE CATHETER; LARGE BORE CATHETER; UNSPECIFIED GUIDEWIRE; WALRUS BALLOON GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American