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

Model Number ET309645

Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an acute ischemic stroke (ais) procedure with an internal carotid artery occlusion (ico), the thrombus at the internal carotid artery (ica) was removed after the complaint device, a 6.5mm x 45mm embotrap iii revascularization device (et309645 / 22m044av) used with an axs vecta 74 intermediate catheter (stryker) crossed the lesion and the stent was deployed.The embotrap iii device was removed from the balloon guide catheter (bgc) (unspecified brand) while ¿biting¿ the thrombus at the tip of the vecta.It was reported that to remove the complaint device, the delivery wire was pushed in the direction of the catheter tip, but there was an intense resistance felt, and when the embotrap iii device was pushed again, it came out ¿in the shape of the hiragana character ¿ku¿.¿ it was reported that presumably because the lumen of the aspiration catheter (ac) was wide and the wire was pushed hard while the thrombus was engaged at the catheter tip, the proximal end of the embotrap iii device was bent into the lumen and the part was entangled with the outer cage.It was reported that continuous flush was maintained.The procedure was completed without any negative patient impact.On 21-mar-2023, additional information was received.The limited information indicated that there was no difficulty deploying the embotrap iii revascularization device.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (22m044av ) 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.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.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 23-mar-2023.[additional information]: on 23-mar-2023, additional information was received.The complaint device was used for thrombus removal.The lesion was an internal carotid (ic) occlusion and thrombus removal was performed by aligning the proximal end of the 6.5mm x 45mm embotrap iii revascularization device around the ic-top.The information indicated that there was no calcification and the vessel tortuosity was moderate.The vessel diameter was reported to be about 3mm to 6mm.The information reported the following: ¿as a factor, the physician felt resistance at the tip of the catheter when the stent was retrieved into the ac (aspiration catheter) with a hard thrombus in the flow of thrombus retrieval, so it was removed in one lump.After that, when the delivery wire was pushed outside the body at the timing when the stent was removed from the ac, the physician thinks that the wire bent into a doglegged shape inside the ac and the distal end of the wire got entangled with the stent.¿ the information also indicated that the 9f optimo¿ balloon guide catheter (tokai medical), axs vecta 74 intermediate catheter (stryker), and the phenom¿ 21 microcatheter (medtronic) were used together.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 ; 3035526892
• MDR Report Key: 16595140
• MDR Text Key: 312295679
• Report Number: 3011370111-2023-00037
• 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
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309645
• Device Catalogue Number: ET309645
• Device Lot Number: 22M044AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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: 9F OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); AXS VECTA 74 INTERMEDIATE CATHETER (STRYKER); BALLOON GUIDE CATHETER (UNSPECIFIED BRAND); PHENOM¿ 21 MICROCATHETER (MEDTRONIC); PHENOM¿ MICROCATHETER (MEDTRONIC)