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 Paralysis (1997); Vasoconstriction (2126)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # :(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number 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.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 (b)(6) female patient underwent mechanical thrombectomy of a middle cerebral artery (mca (m2 segment) occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) on (b)(6) 2021 and exhibited symptoms of paralysis two days following the procedure.Imaging demonstrated arterial spasm of the treated blood vessel with considerable narrowing.Percutaneous transluminal angioplasty (pta) was performed as treatment, and most of the stenosis had reversed.The patient was discharged from the hospital ten days after event onset.During the index procedure, the embotrap ii was deployed, and recanalization was achieved with two device passes.The device is not available for evaluation.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information received on 12-sep-2021 indicated that the patient fully recovered from the event; the paralysis symptoms had resolved.She was discharged from the hospital 10 days later.It is not known if the narrowing of the blood vessel was secondary to vasospasm or true stenosis of the blood vessel.It is also unknown if the event resulted in a stroke.No further information could be obtained from the customer.Section e1: initial reporter phone: (b)(6).The device was discarded; therefore, no further investigation can be performed.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.

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 47-year-old female patient underwent mechanical thrombectomy of a middle cerebral artery (mca (m2 segment) occlusion with a 5mm x 33mm embotrap ii revascularization device (et009533/unknown lot number) on 08-aug-2021 and exhibited symptoms of paralysis two days following the procedure.Imaging demonstrated arterial spasm of the treated blood vessel with considerable narrowing.Percutaneous transluminal angioplasty (pta) was performed as treatment, and most of the stenosis had reversed.The patient was discharged from the hospital ten days after event onset.During the index procedure, the embotrap ii was deployed, and recanalization was achieved with two device passes.Additional information received on 12-sep-2021 indicated that the patient fully recovered from the event; the paralysis symptoms had resolved.She was discharged from the hospital 10 days later.It is not known if the narrowing of the blood vessel was secondary to vasospasm or true stenosis of the blood vessel.It is also unknown if the event resulted in a stroke.The device was discarded, therefore, no furthers investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm.Neurological deficit, including paralysis, and vasospasm are known potential complications associated with the use of the embotrap ii in mechanical thrombectomy procedures.Review of the available information suggests that vessel characteristics, patient, and procedural factors may have contributed to the reported event rather than a manufacturing issue or defect of the device.Since the event required surgical intervention (i.E., pta) and prolongation of existing hospitalization to preclude permanent impairment and the event cannot be disassociated from the embotrap device.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 pa; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 12406543
• MDR Text Key: 276573683
• Report Number: 3011370111-2021-00108
• 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,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR