MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309645

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (22j089av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.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.Vessel dissection and stenosis are possible complications associated with the use of the embotrap iii revascularization device and are listed as such in the instructions for use (ifu).According to the information provided, the device performed as intended.Clinical and procedural factors, including vessel characteristics, device selection, device interaction, and operator technique, may have contributed to the event rather than the design or manufacture of the device.However, given that the adverse events occurred during the procedural use of the embotrap iii device and that the patient underwent an additional surgical intervention by placing a stent, this event is usfda reportable under 21 cfr 803 with a classification of ¿serious injury.¿ 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 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 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 on (b)(6) 2023, during a thrombectomy procedure to treat an acute ischemic stroke (ais) with the occlusion between the internal carotid artery (ica) to the m1 segment of the middle cerebral artery (mca), aspiration was performed with a red 68 reperfusion catheter (penumbra) after a chikai neurovascular guidewire (asahi intecc) crossed the lesion by gaining access from the right femoral artery.Thrombus retrieval was performed with the red 68 reperfusion catheter and a 6.5mm x 45mm embotrap iii revascularization device (et309645 / 22j089av) used in a combined technique.Recanalization was confirmed by angiography after the first pass, but it was reported that before the procedure was deemed completed, a new angiography showed there was ¿stenosis or dissection¿ in the ica area.The physician checked the contrast image ¿of the first shot, but since the ica was blocked,¿ the physician was unable to confirm how the ica originally appeared.As a precaution, an 8mm x 40mm protégé¿ stent (medtronic) was placed in the area where stenosis or dissection was suspected.After the placement of the protégé stent, the procedure was completed.It was reported that a branchor 9fr bgc (asahi-intecc) and a phenom¿ microcatheter (medtronic) were also used during the procedure.Continuous flush was maintained during the procedure.It was also documented in the complaint event description that there were no negative symptoms observed in the patient post-procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-may-2023.[additional information]: on 19-may-2023, the following additional information was received.The location of the clot was at c3 and m1 proximate.The clots were found in two (2) sites.The embotrap iii device made a total of one (1) pass.The physician commented that it was difficult to determine if the original stenosis or the vessel dissection, because ¿the first shot image was not available.¿ the information indicated that the phenom microcatheter used was a phenom¿ 27 microcatheter (medtronic).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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 07-may-2023.[additional information]: on 07-may-2023, additional information was received.The information confirmed that recanalization was achieved after the first pass.The information indicated that it was not known if the patient suffered from a stenosis or a dissection, but it was noted after the first pass.No bleeding was confirmed.The patient was not symptomatic.The placement of the 8mm x 40mm protégé stent is the intervention for the stenosis.There was no device performance issue related to the embotrap iii device.There was no difficulty deploying the embotrap iii device.The patient is reported to be in stable condition.There was no clinically significant delay in the procedure as a result of the reported event.Section e.1: 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 III 6.5 MM X 45 MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16704702
• MDR Text Key: 312933768
• Report Number: 3011370111-2023-00045
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ET309645
• Device Catalogue Number: ET309645
• Device Lot Number: 22J089AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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: 8MM X 40MM PROTÉGÉ¿ STENT (MEDTRONIC); BRANCHOR 9FR BGC (ASAHI-INTECC); CHIKAI NEUROVASCULAR GUIDEWIRE (ASAHI INTECC); PHENOM¿ 27 MICROCATHETER (MEDTRONIC); PHENOM¿ MICROCATHETER (MEDTRONIC); RED 68 REPERFUSION CATHETER
• Patient Outcome(s): Required Intervention