MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problem Difficult to Remove (1528)

Patient Problems Vasoconstriction (2126); Thromboembolism (2654); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A device history review associated with lot 21e091av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a mechanical thrombectomy, an embotrap ii 5x33 revascularization device (et009533, 21e091av) was deployed at the m2 obstruction.The physician tried to remove the thrombus with a jetd by captive technique.However, it was unable to retract at all when the embotrap ii reached at m1 horizon.A marksman microcatheter (mc) was re-sheathed partially but the situation was not resolved.Therefore, it was re-sheathed overall and the embotrap ii was removed.After that, the embotrap ii was not used.The jetd only was used, and a direct aspiration first pass technique (adapt) was performed, and the procedure was completed.It was unclear if a continuous flush was done.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Section b5: procedural films were provided and reviewed by a neurointerventionalist, the assessment reads as follows: "the description in the text is in keeping with the provided video with a left mca occlusion.The embotrap is deployed and upon retrieval there is movement of the head of the patient.A control contrast injection is performed, and the mca is occluded from the origin at the carotid t with vasospasm in the distal carotid and only filling of the aca.Subsequently the embotrap was retrieved using a resheathing technique.The proximal mca was open at this point but clearly spastic.Distal aspiration (adapt) was performed with runs showing adequate recanalization.The reason for the movement of the patients¿ head and the subsequent inability to remove the embotrap can lie in the engagement with a fibrin rich clot.Once the device engages the friction between the clot and the vessel wall increases too, with movement of the vessels as a result.Once spasm occurs due to the vessel movement it will be more difficult to remove the device from the spastic segment.The physician dealt with the situation in the best possible way by retrieving the device while recapturing.Another option would have been to give local spasmolytics to enable retrieval after the spasm would have subsided." based on the medical image review performed on (b)(6) 2021, health effect - clinical code "vasoconstriction" and health effect - impact code "recognized device of procedural complications" were added to this medwatch report.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).Based on additional information received, the event of thromboembolism has been added to this supplemental medwatch report under section h6.Health effect - clinical code.Section b5: additional information received indicated that there was no thrombus noted within the device at the time of the reported withdrawal difficulty.However, the event did result in thromboembolism.There was no report of vessel damage or injury due to the event.The target clot/thrombus was described as soft.The device withdrawal was allegedly performed as per the instructions for use (ifu).The concomitant devices functioned as expected.Two passes were made to attempt to retrieve the clot.Reportedly, excessive force had not been applied to the device.The length of time the procedure was delayed due to the event was not reported.However, the physician felt that the prolongation of procedure was not clinically significant.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that during a mechanical thrombectomy of a middle cerebral artery (mca) (m2 segment) occlusion, the physician tried to remove the thrombus with a jet d reperfusion catheter (penumbra) and 5mm x 33mm embotrap ii revascularization device (et009533/21e091av) using continuous aspiration prior to intracranial vascular embolectomy (captive) technique but was unable to retract the embotrap when it reached the m1 horizon.The physician attempted to partially resheath the device with the marksman microcatheter (medtronic), but the situation did not resolve.Therefore, the embotrap ii device was fully resheathed and removed.Direct aspiration (adapt technique) with the jet d catheter was used to complete the procedure.There was no report of patient injury.The device is not available for evaluation.Additional information was received indicating that there was no thrombus noted within the device at the time of the reported withdrawal difficulty.However, the event did result in thromboembolism.There was no report of vessel damage or injury due to the event.The target clot/thrombus was described as soft.The device withdrawal was allegedly performed as per the instructions for use (ifu).The concomitant devices functioned as expected.Two passes were made to attempt to retrieve the clot.Reportedly, excessive force had not been applied to the device.The length of time the procedure was delayed due to the event was not reported.However, the physician felt that the prolongation of procedure was not clinically significant.Procedural films were provided and reviewed by a neurointerventionalist, the assessment reads as follows: "the description in the text is in keeping with the provided video with a left mca occlusion.The embotrap is deployed and upon retrieval there is movement of the head of the patient.A control contrast injection is performed, and the mca is occluded from the origin at the carotid t with vasospasm in the distal carotid and only filling of the aca.Subsequently the embotrap was retrieved using a resheathing technique.The proximal mca was open at this point but clearly spastic.Distal aspiration (adapt) was performed with runs showing adequate recanalization.The reason for the movement of the patients¿ head and the subsequent inability to remove the embotrap can lie in the engagement with a fibrin rich clot.Once the device engages the friction between the clot and the vessel wall increases too, with movement of the vessels as a result.Once spasm occurs due to the vessel movement it will be more difficult to remove the device from the spastic segment.The physician dealt with the situation in the best possible way by retrieving the device while recapturing.Another option would have been to give local spasmolytics to enable retrieval after the spasm would have subsided." the reason for the movement of the patients¿ head and the subsequent inability to remove the embotrap can lie in the engagement with a fibrin rich clot.Once the device engages the friction between the clot and the vessel wall increases too, with movement of the vessels as a result.Once spasm occurs due to the vessel movement it will be more difficult to remove the device from the spastic segment.The physician dealt with the situation in the best possible way by retrieving the device while recapturing.Another option would have been to give local spasmolytics to enable retrieval after the spasm would have subsided." the device was discarded; therefore, no further investigation can be performed.A device history review associated with lot 21e091av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Withdrawal difficulty from vessel is a known potential procedural complication associated with the embotrap ii device.The embotrap iii ifu states the following: ¿withdraw the device and microcatheter slowly and carefully as a unit to the guide catheter tip while aspirating through the guide catheter with a syringe.As the device reaches the guide catheter apply vigorous aspiration, withdraw the device and microcatheter into the guide catheter and continue to aspirate until the device reaches the proximal rhv.If withdrawal into the guide catheter is difficult (as may be the case with a large clot burden) then deflate the balloon (if applicable) and withdraw the guide, microcatheter and device together through the introducer sheath.The ifu also cautions 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.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known potential complication with any invasive procedure during which devices are introduced into vessels.Embolization of thrombus is a known potential complication during mechanical restoration of flow and thrombus removal procedures in which the embotrap ii is used.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.With the information provided and without the return of the device for evaluation, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including vessel characteristics, clot burden/characteristics, device interaction, operator technique, and mechanical manipulation of devices within the artery that may have contributed rather than the design or manufacture of the device.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 to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12786913
• MDR Text Key: 284132980
• Report Number: 3011370111-2021-00140
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

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 Expiration Date: 04/19/2024
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 21E091AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/26/2021; 01/11/2022
• Supplement Dates FDA Received: 12/06/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: MARKSMAN MICROCATHETER.; PENUMBRA JET¿ D REPERFUSION CATHETER.