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

Catalog Number ET307537

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

As reported by the field, during a mechanical thrombectomy, a physician could not take out an embotrap iii 5 mm x 37 mm (et307537, lot unknown) from the patient¿s cerebral vessels.Finally, the device was removed using more force.No consequences to the patient and for the operation.No additional information is available at this time.

Manufacturer Narrative

Product complaint # (b)(4).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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a mechanical thrombectomy, a physician could not take out an embotrap iii 5 mm x 37 mm (et307537, lot unknown) from the patient¿s cerebral vessels.Finally, the device was removed using more force.No consequences to the patient and for the operation.No additional information is available.The device was discarded; therefore, no further investigation can be performed.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Withdrawal difficulty from vessel is a potential complication associated with the use of the embotrap iii revascularization device in endovascular mechanical thrombectomy.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural factors, including vessel characteristics, severe tortuosity, clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the event.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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 ; 3035526892
• MDR Report Key: 15770762
• MDR Text Key: 307772317
• Report Number: 3011370111-2022-00109
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 12/14/2022

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 Catalogue Number: ET307537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/14/2022
• 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