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 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.(b)(4).[the healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion at the m3 segment of the middle cerebral artery for an acute ischemic stroke (ais) using the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown), the device was deployed but ¿got stuck.¿ the device was removed from the patient; however, bleeding complication occurred.As a result, the embotrap ii device was replaced with a competitor product and revascularization was achieved.Details regarding the severity of the bleeding, intervention / treatment, hospitalization, and patient outcome was not reported.The current status of the patient is not known.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty from vessel, vascular injury, and hemorrhage are known potential complications associated with the use of the embotrap ii revascularization device in endovascular mechanical thrombectomy.With the limited information provided and without the product being available to be returned for analysis, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including vessel characteristics, tortuosity, clot burden, device selection, and mechanical manipulation of devices within the artery that may have contributed to the reported event, rather than the design or manufacture of the device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion at the m3 segment of the middle cerebral artery for an acute ischemic stroke (ais) using the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown), the device was deployed but ¿got stuck.¿ the device was removed from the patient; however, bleeding complication occurred.As a result, the embotrap ii device was replaced with a competitor product and revascularization was achieved.Details regarding the severity of the bleeding, intervention / treatment, hospitalization, and patient outcome was not reported.The current status of the patient is not known.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12/21/2020.[additional event information]: the healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion at the m3 segment of the middle cerebral artery for an acute ischemic stroke (ais) using the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown), the device was deployed but ¿got stuck.¿ the device was removed from the patient; however, bleeding complication occurred.As a result, the embotrap ii device was replaced with a competitor product and revascularization was achieved.Details regarding the severity of the bleeding, intervention / treatment, hospitalization, and patient outcome was not reported.The current status of the patient is not known.Additional information was received indicating that continuous flush was maintained through the catheter.The ancillary devices used during the procedure were the phenom¿ 17 microcatheter (medtronic) and the optimo¿ balloon guide catheter (tokai medical products).E.1: the initial reporter phone: (b)(6).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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: 10931537
• MDR Text Key: 219198388
• Report Number: 3011370111-2020-00088
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTIMO¿ BALLOON CATHETER (TOKAI MEDICAL PRODUCTS); PHENOM¿ 17 MICROCATHETER (MEDTRONIC)
• Patient Outcome(s): Life Threatening