MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Difficult to Remove (1528)

Patient Problem Thromboembolism (2654)

Event Date 10/25/2021

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.The device was discarded; therefore, no further investigation will be performed.A device history review associated with lot 21g074av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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

It was reported by a healthcare professional that a (b)(6) female patient underwent mechanical thrombectomy of a middle cerebral artery (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537/21g074av) and embovac aspiration catheter (unknown product code & lot number) and experienced intraoperative thromboembolism with infarct of the peripheral vessels.The distal portion of the superior m2 segment was obstructed.It was stated that the physician approached them, but the size of the parent vessel was thin.The physician aborted the procedure at this point.The patient is being monitored in the intensive care unit (icu).Additional treatment is undetermined.The physician also stated that this was a case that ¿overlapped with a bifurcation, so if [stent retriever] was passed through either of them, it was probably the case in which either of them could not be obtained¿.The physician does not think this was an embolism to new territory (ent) ¿spilled from the sr¿.¿m2 superior was obstructed to begin with, and there was a possibility that it was pushed by blood flow, etc.And obstructed distally during treatment.¿ the event was not considered serious because the main infarction was recanalized and some of the peripheral infarcts were treated.A balloon guiding catheter (size/brand not specified) was advanced to the right internal carotid artery (ica).When imaging was performed, infarction of the mid m1 segment was confirmed.The physician approached the embovac from the balloon guide catheter, and a rebar 18 microcatheter (medtronic) crossed the lesion.The embotrap ii was inserted and allegedly deployed as per the instructions for use (ifu) at the inferior trunk of the m2 to make the first pass.Three small, hard clots were removed via the embotrap and suction syringe.When imaging was performed later on, it was confirmed that the distal portion of the superior m2 was obstructed.Additional information received on 28-oct-2021 indicated that the company sales representative did not comment on any device malfunction or adverse event associated with the embovac catheter.Furthermore, there were no device malfunctions or performance issues associated with the embotrap.The target occlusion was at the mid m1 segment of the mca.The embotrap was deployed at m2 inferior trunk to m1 distal.The patient¿s baseline and post-procedure tici, nihss, aspects, and/or mrs scores are unknown.The current health status of the patient is also unknown.Additional information received on 04-nov-2021 indicated that the patient was recovering, so she was transferred to a rehabilitation facility on (b)(6) 2021.Additional information received on 09-nov-2021 indicated that when the physician was retracting the complaint embotrap iii device, the resistance encountered was more than that of the embotrap ii.

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: it was reported by a healthcare professional that a 78-year-old female patient underwent mechanical thrombectomy of a middle cerebral artery (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537/21g074av) and embovac aspiration catheter (unknown product code & lot number) and experienced intraoperative thromboembolism with infarct of the peripheral vessels.The distal portion of the superior m2 segment was obstructed.It was stated that the physician approached them, but the size of the parent vessel was thin.The physician aborted the procedure at this point.The patient is being monitored in the intensive care unit (icu).Additional treatment is undetermined.The physician also stated that this was a case that ¿overlapped with a bifurcation, so if [stent retriever] was passed through either of them, it was probably the case in which either of them could not be obtained¿.The physician does not think this was an embolism to new territory (ent) ¿spilled from the sr¿.¿m2 superior was obstructed to begin with, and there was a possibility that it was pushed by blood flow, etc.And obstructed distally during treatment.¿ the event was not considered serious because the main infarction was recanalized and some of the peripheral infarcts were treated.A balloon guiding catheter (size/brand not specified) was advanced to the right internal carotid artery (ica).When imaging was performed, infarction of the mid m1 segment was confirmed.The physician approached the embovac from the balloon guide catheter, and a rebar 18 microcatheter (medtronic) crossed the lesion.The embotrap ii was inserted and allegedly deployed as per the instructions for use (ifu) at the inferior trunk of the m2 to make the first pass.Three small, hard clots were removed via the embotrap and suction syringe.When imaging was performed later on, it was confirmed that the distal portion of the superior m2 was obstructed.Additional information received on 28-oct-2021 indicated that the company sales representative did not comment on any device malfunction or adverse event associated with the embovac catheter.Furthermore, there were no device malfunctions or performance issues associated with the embotrap.The target occlusion was at the mid m1 segment of the mca.The embotrap was deployed at m2 inferior trunk to m1 distal.The patient¿s baseline and post-procedure tici, nihss, aspects, and/or mrs scores are unknown.The current health status of the patient is also unknown.Additional information received on 04-nov-2021 indicated that the patient was recovering, so she was transferred to a rehabilitation facility on (b)(6) 2021.No additional treatment will be provided.Additional information received on 09-nov-2021 indicated that when the physician was retracting the complaint embotrap iii device, the resistance encountered was more than that of the embotrap ii.No further information was provided.The device was discarded; therefore, no further investigation will be performed.A device history review associated with lot 21g074av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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.Review of the available information suggests that vessel characteristics, patient, and procedural factors may have contributed to the reported clot dislodgement.During the course of the procedure, it appears that m2 clot dislodged to a more peripheral location which despite having ischemic effects on portion of brain tissue, the risks of additional intervention with current technology was considered to outweigh the benefit of clot removal from this area.Withdrawal difficulty is a known potential procedural complication associated with the embotrap iii device.The root cause of the resistance encountered during withdrawal could not be determined.However, there are vessel characteristics, clot burden/characteristics, and operator technique that may have contributed rather than the design or manufacture of the 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12786722
• MDR Text Key: 284376593
• Report Number: 3011370111-2021-00139
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21G074AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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
• Treatment: BALLOONGUIDING CATHETER (SIZE/BRAND NOT SPECIFIED).; REBAR 18 MICROCATHETER (MEDTRONIC).; UNKNOWN_EMBOVAC.
• Patient Age: 78 YR
• Patient Sex: Female