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

Catalog Number ET307645

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

Patient Problem Vascular Dissection (3160)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, race, and ethnicity were not provided.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (22j164av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.There was no device performance issue or device malfunction reported during the procedure.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As such, the investigation will be closed.Vessel dissection is a possible complication associated with the use of the embotrap iii, embovac and prowler select devices and is listed as such in the instructions for use (ifu) of these devices.Although the pi assessed this event as not related to the embotrap device or to the primary procedure but possibly related to the large bore catheter, i.E.The embovac and all the devices performed as intended with no reported malfunctions, the relationship between the event and the devices cannot be excluded given that it occurred during the procedural use of these devices.Additionally, there was the need of additional intervention by implanting a new stent to preclude patient harm.Therefore, this event meets us fda mdr reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ 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 for statistical signals and corrective / preventive action may be triggered at a later time.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.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00462, 3011370111-2023-00077, and 3008114965-2023-00463.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The event was reported via the excellent study, the 61-year-old female patient with a history of chronic obstructive pulmonary disease (copd), previous history of ischemic stroke, and a current active smoker presented with a witnessed stroke on (b)(6) 2023.Tissue plasminogen activator (tpa) was not administered at the time of the stroke presentation.The suspected origin of the embolism was cardioembolic.The patient¿s baseline nih stroke scale (nihss) score was 14.Modified rankin score (mrs) score was 2.The patient underwent an endovascular mechanical thrombectomy procedure on (b)(6) 2023 using a 6.5mm x 45mm embotrap iii revascularization device (et307645 / 22j164av) via a 160cm prowler select microcatheter (mc21160c2 / 30731168) and an embovac large bore catheter (ic71132ca / 30879725) targeting an occlusion at the right m2 segment of the middle cerebral artery (mca).The pre-pass modified treatment in cerebral infarction (mtici) score was 2a.The first pass with 1 minute incubation time resulted in an mtici score of 3 with clot retrieval.There were no reported intra-operative study device deficiencies.The 24-hour post-procedure nihss score was 8.The patient has been discharged to a rehabilitation center on (b)(6) 2023 with a nihss score of 9 and a mrs score of 3.The 90-day follow-up consultation was performed over the phone on (b)(6) 2023; the mrs score was 3.It was reported that on (b)(6) 2023, the patient experienced a ¿right internal carotid dissection.¿ the principal investigator (pi) assessed this event as moderate in severity, not serious, not related to the embotrap device or to the primary procedure but possibly related to the large bore catheter, i.E.The embovac.The event was endovascularly treated with the endovascular intervention specified in the case report form (crf) as ¿stent¿.The patient outcome has been recorded as ¿recovered/resolved¿ with an end date of (b)(6) 2023.On 21-jun-2023, modified additional information was received.The information indicated that the relationship of the reported right internal carotid dissection to the embovac large bore catheter was ¿possible.¿ the relationship of the adverse event to the embotrap iii was ¿not related.¿ the relationship to the primary study procedure was ¿not related.¿ the adverse event was deemed not serious.The outcome was reported as ¿recovered / resolved.¿.Based on the modified additional information received on 21-jun-2023, the event has been deemed usfda reportable under 21 cfr 803 with a classification ¿serious injury.¿.

• 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 ; 303552-689
• MDR Report Key: 17279864
• MDR Text Key: 318614683
• Report Number: 3011370111-2023-00077
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET307645
• Device Lot Number: 22J164AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: IC 71, 132 CM, CE, ASP. IND.; MC 21, 160 CM, OUS, 2 MARKER.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 66 KG