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

Catalog Number ET307537

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

Patient Problem Vascular Dissection (3160)

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported a patient underwent a thrombectomy procedure; a 5mm x 37mm embotrap iii revascularization device (et307537 / lot# unknown).It was reported that the embotrap iii device caused a dissection at the internal carotid artery (ica) during a thrombectomy procedure.The complaint documented that ¿a total of two times at the same location (m2).¿ there was very limited information available at the complaint initiation.It is not known if there were any medical and/or surgical intervention provided.The status of the patient is also not known.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.Dissection is a possible complication associated with the use of the embotrap iii revascularization device and is listed as such in the instructions for use (ifu).The device performed as intended and no new patient consequences have occurred related to the use of the device.However, the relationship between the event and the embotrap iii device cannot be excluded given that it occurred during the procedural use of the device.Therefore, this event meets mdr reporting criteria as a ¿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 a patient underwent a thrombectomy procedure; a 5mm x 37mm embotrap iii revascularization device (et307537 / lot# unknown).It was reported that the embotrap iii device caused a dissection at the internal carotid artery (ica) during a thrombectomy procedure.The complaint documented that ¿a total of two times at the same location (m2).¿ there was very limited information available at the complaint initiation.It is not known if there were any medical and/or surgical intervention provided.The status of the patient is also not known.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 27-feb-2023.[additional information]: additional information was received on 27-feb-2023 and added to the complaint file on 03-mar-2023.The information indicated the following: ¿in fact, in korea, you can only know which product has a defect and where it occurred.We cannot collect patient information or follow-up information from the procedure.Please note that it is difficult to provide detailed information.¿ limited information was received: the lot number of the embotrap iii device is not known; it is also not known what lot numbers of the subject device were present at the account at the time of the event.The location of the occlusion was the m2 segment.Vessel tortuosity is not known.The information confirmed that only two (2) passes were made with the embotrap iii device.Related to anonymized procedure images, they can be made possible, ¿if i ask the doctor.¿ no images were included with the information received.There was no device performance issue related to the embotrap iii device during the procedure.The embotrap iii device did not appear damage in any way.Photo of the device is not available.It was indicated by the additional information received that it is not known if the embotrap iii device is available for return.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: 16267705
• MDR Text Key: 308442525
• Report Number: 3011370111-2023-00007
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET307537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• 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
• Patient Outcome(s): Life Threatening