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

Model Number ET009533

Device Problem Difficult to Remove (1528)

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 01/27/2021

Event Type  Injury  

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 lot number 20k134av presented no issues during the manufacturing or inspection process that can be related to the reported event.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A report from the field indicated that a patient underwent a mechanical thrombectomy procedure using a 5 x 33mm embotrap ii ((b)(4)/20k134av) revascularization device to remove a thrombus at a major artery occlusion site and experienced withdrawal difficulty and cerebral hemorrhage.It was reported that the embotrap ii was used as per the instructions for use (ifu).The m2 was relatively thick with a long and large thrombus in the middle cerebral artery (m1 ¿ m2) and a considerable amount of thrombus in the ¿svs¿.As a result, the physician attempted to retrieve the clot with an embotrap ii and react 71 suction catheter.There was resistance ( not too strong) felt when retracting the embotrap which occurred more from the m2 cortical branch of the middle cerebral artery.It was reported that hemorrhage occurred from the m2 cortical branch of the middle cerebral artery.The procedure was completed with an end mtici score of 2a.Inflation was performed with a balloon guide catheter and heparin reverse was used to stop the bleeding.Initially the alberta stroke program early ct score (aspects) was low and therefore the symptoms did not change.As per the doctor¿s comment, ¿it may have been bad that the deployment of the et ii was slightly bent at the distal m2.¿ additional information received from the sales rep on 17-feb-2021 indicated that the doctor believes that the degree of seriousness for the reported event is not serious because the cortical branch hemorrhage was successfully treated with a balloon guiding catheter for five minutes dilatation and disappeared the next day.The patient was asymptomatic.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 09 mar 2021 indicated that vessel injury occurred at the m2 segment of the middle cerebral artery (mca) which resulted in the subarachnoid hemorrhage.It was reported that excessive force had not been applied to the complaint device.The resistance reported was ¿not so strong¿.The current condition of the patient is unknown.Svs stands for susceptibility vessel sign.No further details could be obtained.Section e1: initial reporter phone: (b)(6).Section h6: health effect - clinical code: perforation of vessels (e0511).Section h6: health effect - impact code: change in therapeutic response (f01) and inadequate/inappropriate treatment or diagnostic exposure (f10).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 a patient underwent a mechanical thrombectomy procedure using a 5 x 33mm embotrap ii (et009533/20k134av) revascularization device to remove a thrombus at a major artery occlusion site and experienced withdrawal difficulty and cerebral hemorrhage.It was reported that the embotrap ii was used as per the instructions for use (ifu).The m2 was relatively thick with a long and large thrombus in the middle cerebral artery (m1 ¿ m2) and a considerable amount of thrombus in the susceptibility vessel sign (svs).As a result, the physician attempted to retrieve the clot with an embotrap ii and react 71 suction catheter.There was resistance ( not too strong) felt when retracting the embotrap which occurred more from the m2 cortical branch of the middle cerebral artery.It was reported that hemorrhage occurred from the m2 cortical branch of the middle cerebral artery.The procedure was completed with an end mtici score of 2a.Inflation was performed with a balloon guide catheter and heparin reverse was used to stop the bleeding.Initially the alberta stroke program early ct score (aspects) was low and therefore the symptoms did not change.As per the doctor¿s comment, ¿it may have been bad that the deployment of the et ii was slightly bent at the distal m2¿.Additional information received from the sales rep on 17-feb-2021 indicated that the doctor believes that the degree of seriousness for the reported event is not serious because the cortical branch hemorrhage was successfully treated with a balloon guiding catheter for five minutes dilatation and disappeared the next day.The patient was asymptomatic.Additional information received on 09 mar 2021 indicated that vessel injury occurred at the m2 segment of the middle cerebral artery (mca) which resulted in the subarachnoid hemorrhage.It was reported that excessive force had not been applied to the complaint device.The resistance reported was ¿not so strong¿.The current condition of the patient is unknown.No further details could be obtained.The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with lot number 20k134av presented no issues during the manufacturing or inspection process that can be related to the reported event.Withdrawal difficulty from the vessel, vessel injury, and hemorrhage are well-known potential complications associated with the use of the embotrap ii device in endovascular mechanical thrombectomy.The embotrap ii instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical and procedural factors, including clot burden/characteristics, vessel characteristics, device selection, and operator technique, that may have contributed to the event rather than the design or manufacture of the device.The alleged withdrawal difficulty from vessel appears to have led to vessel injury with consequent hemorrhage, and the hemorrhage required surgical intervention to achieve hemostasis.Furthermore, the index procedure had to be aborted due to the event with final tici score of 2a.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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
• MDR Report Key: 11365091
• MDR Text Key: 241788086
• Report Number: 3011370111-2021-00019
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20K134AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON GUIDING CATHETER; REACT71 SUCTION CATHETER ().
• Patient Outcome(s): Required Intervention