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

Model Number ET309537

Device Problem Material Separation (1562)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The healthcare professional that on (b)(6) 2023, the 5mm x 37mm embotrap iii revascularization device (et309537 / 20k094av) was used during a product training session using a flow model.The placement of the device was as expected.The embotrap iii device was pulled back with normal force, it engaged with the thrombus and it was pulled back into the cerebase long guide sheath (lgs).At the lgs, it was reported that there was aspiration through a vac lok.The team wanted to have a look at the clot outside of the flow model and the delivery wire of the embotrap device ¿was without the embotrap.¿ the embotrap stent component was found in the syringe that was used for aspiration at the lgs.There was no patient involvement as the device was used for a training session.On 05-jun-2023, additional information was received.Related to whether the entire embotrap stent component became separated from the shaft and ended up in the syringe used for aspiration, the cerenovus rep stated, ¿i did not see how the process happened.We retrieved the embotrap, grabbed some clot and when we wanted to see the clot in the embotrap component outside the model, it was in the syringe, completely.¿ the syringe used was a typical vacloc.No damage was recognized on the embotrap stent component.There was no anomaly noted on the device shaft of delivery wire for the rest of the embotrap device.The information indicated that this was a training device, it was used several times, ¿probably more than 10.¿ when the reported issue occurred, with the embotrap stent completely in the syringe, it was on the first pass used in the fluid model, ¿cannot say anything about the total [number] of pass[es] since we used the embotrap for the model in total.¿ the embotrap iii device was able to remove all of the thrombus.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Patient-related information is not applicable ¿ the device was used during a product training.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of the manufacturing documentation associated with this lot (20k094av) 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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab 30-jun-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the embotrap device was returned in two components: the nitinol shaft and the distal assembly (inner channel and outer cage).A visual examination of the returned embotrap device confirmed that while the stent and shaft components were free from damage or deformation, the adhesive proximal bond and proximal joint were not intact.Detachment of the distal stent portion of the device from the proximal shaft portion of the returned embotrap device was evident.The returned embotrap device had been previously used multiple times for demo purposes.Multiple uses of the device in a flow model and under non-clinical settings, potentially affected the adhesive proximal coil bond and shaft to cage joint, causing damage to the coil and detachment of the stent portion of the device.Event recreation was not performed as part of this complaint investigation.Investigation conclusion: the returned embotrap device shows detachment of the distal assembly (inner channel and outer cage) from the proximal section (nitinol shaft) of the device.The proximal coil was dislocated and damaged.The complaint event was confirmed.The features of the inner channel and outer cage components which form part of the proximal and distal bonds showed no evidence of damage or deformation.The distal step of the shaft which forms part of the proximal bond showed no evidence of damage or deformation.The complaint event occurred during a demonstration of the product, therefore the controls and conditions in place when storing, preparing, and testing the product cannot be confirmed.Moreover, the returned embotrap device was used multiple times in a flow model for demo purposes.Although the cause of the complaint event could not be confirmed, the overuse of the device potentially caused damage to the proximal bond and joint, therefore leading to the detachment of the distal assembly from the proximal section of the embotrap device.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.A review of the manufacturing documentation associated with this lot (20k094av) 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.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.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: 17132117
• MDR Text Key: 317691332
• Report Number: 3011370111-2023-00063
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 20K094AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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: GS 90, 90 CM, STRAIGHT, DISTAL.