MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Difficult to Remove (1528)

Patient Problems Vasoconstriction (2126); Thrombosis/Thrombus (4440)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported via a complaint submission tool that a physician believes that he felt more friction/force when pulling back on the 5 mm x 37 mm embotrap iii device (et309537) in comparison to the solitaire revascularization device (medtronic).He believes this may be caused by the design of the embotrap device on the vessel wall, which may be causing the vasospasm.In addition, he felt ¿there were back-to-back mt cases¿ where vasospasm occurred due to embotrap.The procedure was completed successfully and there were no patient consequences, but the physician communicated that he now has concerns about using the embotrap device on anything more distal than the m1 segment of the middle cerebral artery.

Manufacturer Narrative

Product complaint # (b)(4).The lot number is not available.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).Section b5: additional information received on 20-dec-2022 indicated that the event/procedure date is unknown.The lot number is not known.They purchased all of their embotrap inventory upfront, so the lot numbers that were present at the time are not known.Multiple passes of the device were made, and a thrombus was found on the third attempt.The device was removed as a unit with their aspiration catheter.Three (3) passes were made in an attempt to retrieve the clot.The event did not result in thromboembolism.The withdrawal was performed as per the ifu.Aspiration was applied by using a syringe at the time of clot retrieval.The vasospasm occurred during the attempt to remove the thrombus.The vasospasm was treated.Section 6.Health effect - clinical code: thrombosis.Section 6.Health effect - impact code - medication required.Complaint conclusion: it was reported via a complaint submission tool that a physician believes that he felt more friction/force when pulling back on the 5 mm x 37 mm embotrap iii device (et309537) in comparison to the solitaire revascularization device (medtronic).He believes this may be caused by the design of the embotrap device on the vessel wall, which may be causing the vasospasm.In addition, he felt ¿there were back-to-back mt cases¿ where vasospasm occurred due to embotrap.The procedure was completed successfully and there were no patient consequences, but the physician communicated that he now has concerns about using the embotrap device on anything more distal than the m1 segment of the middle cerebral artery.Additional information received indicated that the the event/procedure date is unknown.The lot number for the device involved is not known.Multiple passes of the device were made, and a thrombus was found on the third attempt.The device was removed as a unit with their aspiration catheter.Three (3) passes were made in an attempt to retrieve the clot.The event did not result in thromboembolism.The withdrawal was performed as per the ifu.Aspiration was applied by using a syringe at the time of clot retrieval.The vasospasm occurred during the attempt to remove the thrombus.The vasospasm was treated.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Vasospasm and thrombosis are potential complications associated with the embotrap device and are listed in the instructions for use (ifu) as such.In addition, withdrawal difficulty from the vessel could result in vessel trauma, vessel spasm, and damage to the basket with the potential for the release of emboli and subsequent ischemia or infarction and/or the need for additional intervention.Therefore, this event does meet 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 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: EMBOTRAP III REVASCULARIZATION DEVICE
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 16015791
• MDR Text Key: 305819314
• Report Number: 3011370111-2022-00122
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/09/2023
• 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
• Treatment: SOLITAIRE REVASCULARIZATION DEVICE (MEDTRONIC)
• Patient Outcome(s): Life Threatening