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 Problems Intracranial Hemorrhage (1891); Paralysis (1997)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number is not available.(b)(6).The device was discarded; therefore, no further investigation can be performed at this time.The lot number is not known; therefore, a device history record review cannot be completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that a (b)(6) year old female patient with a medical history of arrhythmia underwent a mechanical thrombectomy procedure using a 5 x 33mm embotrap ii (et009533/unknown lot#) revascularization device to treat an acute ischemic stroke (ais) at the target lesion site of the m2 segment of the middle cerebral artery (m2).It was reported that the embotrap ii was used as per the instructions for use (ifu).Two passes were made with the embotrap ii in attempt to remove the thrombus however the clot was not able to be retrieved as intended.Furthermore, a subarachnoid hemorrhage (sah) was confirmed by findings.Therefore, the procedure was completed as it was.The patient was discharged to a rehabilitation hospital with a mrs score of 4 with slightly strengthened paralysis.The symptoms the patient exhibited were considered slightly mild.There was no additional procedure after the thrombectomy.Per the doctor¿s comment, the patient¿s symptoms were not considered serious as the patient¿s mrs score was 4.It was considered moderate as a sequela after thrombus removal.However, the doctor indicates that this is not due to the sah but to the underlying disease of ais.Although the physician¿s findings cannot exclude the relationship of the device to the reported event of sah, there was severe acute angulation and tortuosity in the blood vessel.He believes the characteristics of the blood vessel might have caused this issue.The complaint devices are not available for evaluation.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).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 91-year-old female patient with a medical history of arrhythmia underwent a mechanical thrombectomy procedure using a 5 x 33mm embotrap ii (et009533/unknown lot#) revascularization device to treat an acute ischemic stroke (ais) at the target lesion site of the m2 segment of the middle cerebral artery (m2).It was reported that the embotrap ii was used as per the instructions for use (ifu).Two passes were made with the embotrap ii in attempt to remove the thrombus however the clot was not able to be retrieved as intended.Furthermore, a subarachnoid hemorrhage (sah) was confirmed by findings.Therefore, the procedure was completed as it was.The patient was discharged to a rehabilitation hospital with a mrs score of 4 with slightly strengthened paralysis.The symptoms the patient exhibited were considered slightly mild.There was no additional procedure after the thrombectomy.Per the doctor¿s comment, the patient¿s symptoms were not considered serious as the patient¿s mrs score was 4.It was considered moderate as a sequela after thrombus removal.However, the doctor indicates that this is not due to the sah but to the underlying disease of ais.Although the physician¿s findings cannot exclude the relationship of the device to the reported event of sah, there was severe acute angulation and tortuosity in the blood vessel.He believes the characteristics of the blood vessel might have caused this issue.The complaint devices are not available for evaluation.No further information is available.The device was discarded; therefore, no further investigation can be performed at this time.The lot number is not known; therefore, a device history record review cannot be completed.Subarachnoid hemorrhage and neurological impairment (paralysis) are well-known potential procedural complications associated with the embotrap device and are listed in the ifu as such.Review of the available information suggests that the event of paralysis is an expected evolution of the underlying disease process of ais.It was not considered serious.The event of paralysis was not considered serious, did not require intervention, and is an expected evolution of the underlying disease.The root cause of the sah event could not be determined based on the available information and without procedural films to review; however, clinical and procedural factors including clot burden/characteristics, vessel characteristics, tortuosity, device selection, and operator technique are all factors that may have contributed.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: 11108187
• MDR Text Key: 231953326
• Report Number: 3011370111-2021-00001
• 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: 12/21/2020

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 Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR