MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309537

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/08/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during thrombectomy procedure that was targeting an occlusion in the distal m1 segment of the middle cerebral artery (mca), a 5 mm x 37 mm embotrap iii revascularization device (et309537 / 22b067av) and an axs catalyst® 6 catheter (stryker) were used as a combined system.The thrombus was removed via continuous aspiration prior to intracranial vascular embolectomy (captive) technique.After the embotrap iii was removed, the physician checked the embotrap iii device and suspected that the inner channel was bent.When the physician attempted to insert the embotrap iii device into the introducer sheath for a second pass, resistance was felt and insertion into the introducer sheath was ¿impossible.¿ it was reported that the physician was not able to confirm whether the inner channel was bent after the first pass.A continuous flush was maintained.The concomitant microcatheter used was a phenom¿ microcatheter (medtronic).There was no negative impact on the patient.On 23-jan-2023, the cerenovus sales representative provided additional information.The information indicated that the thrombus was removed during the first pass.A second pass was not performed and the procedure was completed; the complaint device was not used.

Manufacturer Narrative

Manufacturer¿s ref no: (b)(4).[conclusion]: the healthcare professional reported that during thrombectomy procedure that was targeting an occlusion in the distal m1 segment of the middle cerebral artery (mca), a 5 mm x 37 mm embotrap iii revascularization device (et309537 / 22b067av) and an axs catalyst® 6 catheter (stryker) were used as a combined system.The thrombus was removed via continuous aspiration prior to intracranial vascular embolectomy (captive) technique.After the embotrap iii was removed, the physician checked the embotrap iii device and suspected that the inner channel was bent.When the physician attempted to insert the embotrap iii device into the introducer sheath for a second pass, resistance was felt and insertion into the introducer sheath was ¿impossible.¿ it was reported that the physician was not able to confirm whether the inner channel was bent after the first pass.A continuous flush was maintained.The concomitant microcatheter used was a phenom¿ microcatheter (medtronic).There was no negative impact on the patient.On 23-jan-2023, the cerenovus sales representative provided additional information.The information indicated that the thrombus was removed during the first pass.A second pass was not performed and the procedure was completed; the complaint device was not used.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot: (22b067av) 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 05-feb-2023.[additional information]: on 05-feb-2023, additional information was received.The information indicated that the physician did not suspect that the inner channel of the embotrap iii device may have become bet after making the first pass.The embotrap iii device made only one (1) pass.There was no resistance during the advancement of the embotrap iii device through the concomitant phenom microcatheter.There was no difficulty encountered during the deployment of the embotrap iii device.The information indicated that the procedure was successfully completed.The requested photo of the complaint device is not available.E1: 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 5 MM X 37 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: 16250698
• MDR Text Key: 309298456
• Report Number: 3011370111-2023-00006
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 22B067AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: AXS CATALYST® 6 CATHETER (STRYKER); PHENOM¿ MICROCATHETER (MEDTRONIC)