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

Model Number ET009533

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

Patient Problem Vascular Dissection (3160)

Event Date 12/22/2020

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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The device was discarded; therefore, no product investigation can be performed.A review of the manufacturing documentation associated with lot number 20c089av presented no issues during the manufacturing or inspection process that can be related to the reported event.

Event Description

A report from the field indicated that a patient underwent a mechanical thrombectomy procedure using 5 x 33mm embotrap ii (et009533/ 20c089av) revascularization device at the target lesion of the m1 segment of the middle cerebral artery (mca) and experienced a vascular dissection.As per the doctor¿s comment, the vascular dissection is not related to the embotrap device.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 01 mar 2021 indicated that thrombus was successfully retrieved using the embotrap device, but the vessel dissection was noted after the procedure.No information regarding the location of the dissection, intervention required, or patient outcome could be obtained.There were no device malfunctions or performance issues associated with the embotrap device.Anonymized images/angiographs of the procedure are not available for review.Section h6: the health impact code was updated to ¿recognized procedural complication¿.Complaint conclusion: a report from the field indicated that a patient underwent a mechanical thrombectomy procedure using 5 x 33mm embotrap ii (et009533/ 20c089av) revascularization device at the target lesion of the m1 segment of the middle cerebral artery (mca) and experienced a vascular dissection.As per the doctor¿s comment, the vascular dissection is not related to the embotrap device.Additional information received on 01 mar 2021 indicated that thrombus was successfully retrieved using the embotrap device, but the vessel dissection was noted after the procedure.No information regarding the location of the dissection, intervention required, or patient outcome could be obtained.There were no device malfunctions or performance issues associated with the embotrap device.Anonymized images/angiographs of the procedure are not available for review.The device was discarded; therefore, no product investigation can be performed.A review of the manufacturing documentation associated with lot number 20c089av presented no issues during the manufacturing or inspection process that can be related to the reported event.Dissection or perforation is a well-known extensively documented potential complication associated with endovascular mechanical thrombectomy and is listed in the embotrap instructions for use (ifu) as such.The root cause of the event cannot be determined; however, vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery are all factors that may contribute to dissection/perforation.There is no evidence to suggest a device malfunction or performance issue.This complaint will be reassessed if new information becomes available.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.

• 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: 11170051
• MDR Text Key: 230310725
• Report Number: 3011370111-2021-00004
• 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
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

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 Expiration Date: 01/29/2023
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 20C089AV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1