MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Catalog Number ET007533

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The inner channel was fractured, meeting regulatory reporting criteria.Information regarding patient race and ethnicity was 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that the (b)(6) male patient underwent endovascular mechanical thrombectomy of a left middle cerebral artery (mca) (m1-m2) occlusion with a 5mm x 33mm embotrap ii revascularization device (et007533/20m084av).During the procedure, three passes were made with the embotrap via a prowler select plus microcatheter (product code & lot number unknown).However, the clot was not able to be retrieved.Therefore, the physician replaced the embotrap device with a 6mm x 40mm solitaire stent retriever (medtronic) and the clot was able to be retrieved in one pass.The procedure was completed successfully.The surgery was delayed 20 minutes due to the event.There was no report of patient injury.The initial examination of the returned embotrap device identified fractures present on the distal section of the inner channel.Fractures were present on the inner channel spring feature and one of the inner channel expanded struts.There was also deformation present on the inner channel spring feature consistent with a tensile force.No evidence of any further damage or deformation was present on the device.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device failed to fully retract through a 0.0195¿ id tube, indicating that the fractures present on the inner channel have affected the collapsing profile of the returned device.The ptfe insertion tool was dimensionally inspected and found to be within specification for the inner and outer diameter.Clot retrieval attempts were carried out with the returned device.The returned device was successfully delivered and deployed in a sample prowler select plus microcatheter.Clot engagement was achieved, where the device successfully deployed within the clot, flow restoration was visually observed and the returned embotrap device successfully retrieved the clot (with aspiration) to the aspiration catheter tip.This indicates that the returned embotrap device is capable of correct clot engagement and clot retrieval.It is probable that other patient or procedure specific factors may have impacted clot retrieval performance of the returned device during the complaint event.The damage noted during visual inspection (i.E.Deformation of the spring feature and fractures of the inner channel expanded struts and spring feature) is consistent with a material failure under tension.Sem analysis of the appearance of the fracture faces on the inner channel of the returned device also indicates the fractures are consistent with a material failure under tension.A review of the manufacturing documentation associated with s lot 20m084av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Although no device damage was reported in the complaint, the returned embotrap device has fractures and deformation present on the distal section of the inner channel.It is unknown when the damage noted occurred but as the damage is very obvious it is unlikely that it occurred prior to or during the use by the physician.The device was returned in packaging similar to the embotrap protective packaging but the ability to insert and remove the device from the packaging used to return the device without damage to the device is not proven.No further damage was observed on the returned device.Despite the damage to the device the returned embotrap was successfully delivered through a sample prowler select plus microcatheter, successfully engaged with clot and successfully retrieved clot when used with aspiration.This demonstrates that the damage noted does not impact the ability of the device to retrieve a blood clot and it is concluded that the damage is therefore not a contributor to the event reported and likely to have been caused after the event reported.The damage and deformation present on the device are consistent with damage as a result of application of a tensile force.No high forces or difficulty during use during the complaint event were reported as part of the complaint.As the returned device successfully retrieved the clot under test conditions it can be concluded that the most likely causes of the failure to retrieve the clot in the event reported are procedural and/or patient specific factors such as vessel tortuosity.As concluded, the device damage occurred post its use in the procedure, the performance of the undamaged device in delivery, clot engagement and withdrawal would be improved over the performance demonstrated in this investigation.Treatment failure is a known potential outcome associated with endovascular mechanical thrombectomy.The embotrap ii revascularization device is intended to be used to restore blood flow in patients experiencing an acute ischemic stroke due to a large vessel neurovascular occlusion.The root cause of the inability to achieve a mtici score of =2b with three embotrap passes cannot be determined.However, there are clinical and procedural factors including clot burden/ characteristics, vessel characteristics, anatomical challenges, device interaction, and operator technique that may have contributed.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 Description

A report from the field indicated that the (b)(6) male patient underwent endovascular mechanical thrombectomy of a left middle cerebral artery (mca) (m1-m2) occlusion with a 5mm x 33mm embotrap ii revascularization device (et007533/20m084av).During the procedure, three passes were made with the embotrap via a prowler select plus microcatheter (product code & lot number unknown).However, the clot was not able to be retrieved.Therefore, the physician replaced the embotrap device with a 6mm x 40mm solitaire stent retriever (medtronic) and the clot was able to be retrieved in one pass.The procedure was completed successfully.The surgery was delayed 20 minutes due to the event.There was no report of patient injury.Based on the analysis of the device received, the inner channel was fractured.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13211127
• MDR Text Key: 290282899
• Report Number: 3011370111-2022-00004
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Catalogue Number: ET007533
• Device Lot Number: 20M084AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 6MM X 40MM SOLITAIRE STENT RETRIEVER (MEDTRONIC).; PROWLER SELECT PLUS MICROCATHETER.
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 78 KG