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 Thromboembolism (2654); No Code Available (3191)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, 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 initial reporter phone: (b)(6).The initial reporter email address was not provided.The device manufacture date is not known as the product lot number of the device is not available / not reported.(b)(4).Conclusion: the healthcare professional reported that during a mechanical thrombectomy procedure to treat an acute ischemic stroke using the 5 x 33mm embotrap ii revascularization device (et009533 / lot# unknown), a distal thromboembolism occurred.The baseline occlusion was located at the internal carotid (ic)-m1 segment of the middle cerebral artery (mca).It was reported that resistance was felt as usual, but the resistance was less / lighter at the carotid syphon.Deployment of the embotrap device was performed in accordance to the instructions for use (ifu), but no thrombus was attached to the embotrap stent retriever.Imaging revealed that the thrombus had embolized to the a3 of the anterior cerebral artery (aca) and the distal m1 (m1d) segment.The distal embolism at the m1d was removed with a suction catheter, but the thrombus at the a3 was not able to be removed using the 4max¿ distal delivery catheter (ddc) (penumbra).The procedure was completed as is.The patient is in rehabilitation and the symptoms are mild.It was reported that the physician may have deployed the device by pushing the wire ¿unconsciously¿ and he/she will deploy the device by unsheathing as usual next time.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Embolization of thrombus is a known potential complication during mechanical restoration of flow and thrombus removal procedures in which the embotrap is used.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.The root cause of the event cannot be determined based on the information available for review; however, clinical and procedural factors including clot burden, vessel characteristics, and device manipulation, may have contributed with no indication of a device malfunction.The event narrative states that the physician may have deployed the device by pushing the wire ¿unconsciously¿; therefore, this technique may have been a contributing factor of the reported distal thromboembolism.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 to treat an acute ischemic stroke using the 5 x 33mm embotrap ii revascularization device (et009533 / lot# unknown), a distal thromboembolism occurred.The baseline occlusion was located at the internal carotid (ic)-m1 segment of the middle cerebral artery (mca).It was reported that resistance was felt as usual, but the resistance was less / lighter at the carotid syphon.Deployment of the embotrap device was performed in accordance to the instructions for use (ifu), but no thrombus was attached to the embotrap stent retriever.Imaging revealed that the thrombus had embolized to the a3 of the anterior cerebral artery (aca) and the distal m1 (m1d) segment.The distal embolism at the m1d was removed with a suction catheter, but the thrombus at the a3 was not able to be removed using the 4max¿ distal delivery catheter (ddc) (penumbra).The procedure was completed as is.The patient is in rehabilitation and the symptoms are mild.It was reported that the physician may have deployed the device by pushing the wire ¿unconsciously¿ and he/she will deploy the device by unsheathing as usual next 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
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9701121
• MDR Text Key: 192378810
• Report Number: 3011370111-2020-00009
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention