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

Catalog Number ET307537

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 02/19/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that the 5mm x 37mm embotrap iii revascularization device (et309537/21l112av) remained blocked in the carotid siphon; there was no resistance in the first 5 centimeters (cm) to the siphon and then blocked.The team managed to recapture it millimeter (mm) by mm with a 5f catalyst distal access catheter (stryker).The result was a focal dissection of the carotid siphon with no impact on blood flow and the clot could not be removed.It was reported that the procedure was not successfully completed.At the end of the procedure, the patient's artery was permeable.The practitioner noted no visible defects on the device; no device fragments were generated.The surgery was not delayed due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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.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).Updated sections on this medwatch: b4, b5, g3, g6, h2, h3, h6, h10 and concomitant products.Section b5: additional information received indicated that the target occlusion was located at the distal m1 segment of the middle cerebral artery (mca).The embotrap iii was used in conjunction with a headway 21 microcatheter (stryker).During the first pass, the embotrap iii was positioned at the site of the clot.During retrieval, both the embotrap iii and headway 21 microcatheter did not move.There was no damage noted to the concomitant headway 21 microcatheter.The operator used the catalyst dac to cross over the embotrap iii.With the aspiration, the operator succeeded in removal of the embotrap and headway 21.The operator then used the catalyst for "3 aspiration" but with no effect.Thus, the operator decided to use a solitaire stent retriever (medtronic) for an additional pass, and then the embotrap iii one last time.The final/end of procedure mtici score was 0.The treating physician suspects that the embotrap ii caused or contributed to the dissection.No medical or surgical intervention was performed for dissection.The dissection did not result in prolonged hospitalization.Returned medical imaging was reviewed by the neurointerventionalist and the assessment is as follows: "the description mentions that the occlusion was in the left m1 with video images supporting this.The embotrap in the still images is an et iii with multiple markers visible and a clear straightening of the device across the curves of the carotid siphon.This suggests that the device is distally held by an external force.What the reason for this is cannot be deducted from the images with certainty.There is no clear spasm, nor plaque like lesion visible.Theoretically, it can be engagement on a clot or plaque that is not visible.The ¿resheating¿ with the distal access catheter made recapture and removal possible.There are clear disturbances in the contrast filling visible which is consistent with either clot build-up or focal dissection of the arterial wall.The event can not be explained from the images only, analysis of the device may shed a light on the causative factor." based on the additional information provided on 15-apr-2022, the medical device problem code ¿failure to advance¿ (a150204) has been removed from the report.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complain conclusion: it was reported by a healthcare professional that the 5mm x 37mm embotrap iii revascularization device (et309537/21l112av) remained blocked in the carotid siphon; there was no resistance in the first 5 centimeters (cm) to the siphon and then blocked.The team managed to recapture it millimeter (mm) by mm with a 5f catalyst distal access catheter (stryker).The result was a focal dissection of the carotid siphon with no impact on blood flow and the clot could not be removed.It was reported that the procedure was not successfully completed.At the end of the procedure, the patient's artery was permeable.The practitioner noted no visible defects on the device; no device fragments were generated.The surgery was not delayed due to the event.Additional information received on 15-apr-2022 indicated that the target occlusion was located at the distal m1 segment of the middle cerebral artery (mca).The embotrap iii was used in conjunction with a headway 21 microcatheter (stryker).During the first pass, the embotrap iii was positioned at the site of the clot.During retrieval, both the embotrap iii and headway 21 microcatheter did not move.There was no damage noted to the concomitant headway 21 microcatheter.The operator used the catalyst dac to cross over the embotrap iii.With the aspiration, the operator succeeded in removal of the embotrap and headway 21.The operator then used the catalyst for "3 aspiration" but with no effect.Thus, the operator decided to use a solitaire stent retriever (medtronic) for an additional pass, and then the embotrap iii one last time.The final/end of procedure mtici score was 0.The treating physician suspects that the embotrap iii caused or contributed to the dissection.No medical or surgical intervention was performed for dissection.The dissection did not result in prolonged hospitalization.Returned medical imaging was reviewed by the neurointerventionalist and the assessment is as follows: "the description mentions that the occlusion was in the left m1 with video images supporting this.The embotrap in the still images is an et iii with multiple markers visible and a clear straightening of the device across the curves of the carotid siphon.This suggests that the device is distally held by an external force.What the reason for this is cannot be deducted from the images with certainty.There is no clear spasm, nor plaque like lesion visible.Theoretically, it can be engagement on a clot or plaque that is not visible.The ¿resheating¿ with the distal access catheter made recapture and removal possible.There are clear disturbances in the contrast filling visible which is consistent with either clot build-up or focal dissection of the arterial wall.The event can not be explained from the images only, analysis of the device may shed a light on the causative factor." the initial examination of the returned embotrap device showed the presence of significant residual thrombus material on the returned embotrap device.This thrombus material had dried in place, and in some areas of the device the thrombus material was present on both the inner channel and outer cage of the device.This residual thrombus material has constrained the inner channel and outer cage in such a way that the inner channel and outer cage are misaligned in places and results in a deformed appearance to the device.This deformation is the result of the thrombus material drying in place between the inner channel and outer cage, as no kinks or localized deformation was observed on the outer cage and inner channel of the device.It was also reported in the complaint event description that no damage or deformation was observed on the embotrap following the procedure, therefore it can be concluded that the deformation observed was not present during or directly following the procedure and is a result of the residual thrombus material drying in place during return of the embotrap device for investigation.No further damage or deformation of the device was noted.All radiopaque markers and coils were confirmed as present and undamaged.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints fully intact and undamaged.The returned embotrap device could not be retracted through a 0.0195¿ flared ptfe inspection tube.This test is carried out to confirm that a device conforms to the profile required for delivery through a 0.021¿ microcatheter.The failure of the returned embotrap device to retract into the flared ptfe tube is a result of the presence of dried residual thrombus material.The returned device retracted initially with no issue or high force, but as the area of the first body section, where residual thrombus material was present, entered the ptfe tube, the device failed to retract.The returned device therefore cannot be retracted through a 0.0195¿ ptfe tube in its current condition, but this is a result of the dried residual thrombus material, and not a true representation of the returned device¿s compatibility with 0.021¿ microcatheter under usual conditions i.E.Without the presence of residual dried thrombus material.The complaint event description reported resistance when using the embotrap device during clot retrieval.Clot retrieval assessments cannot be carried out with the returned embotrap in its current condition; it cannot be loaded into a sample insertion tool or delivered through a sample 0.021¿ microcatheter in its current condition as demonstrated through the functional check with the 0.0195¿ flared ptfe tube.It is therefore not possible to recreate the complaint event conditions with the returned device, and the complaint event cannot be confirmed using the returned device.The embotrap iii clot retrieval performance has been evaluated through animal studies as well as through ease of use bench top testing.During these tests withdrawal of the device during clot retrieval is one of the criteria evaluated, with the embotrap iii device design being shown to meet the user needs and intended uses of a sterndrive being used in a mechanical thrombectomy procedure.As there was no damage observed on the returned device (other than the deformation caused by the residual thrombus material present on the device) there is nothing to suggest the complaint event was a result of a defect with the embotrap device.A review of the manufacturing documentation associated with lot 21l112av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The returned embotrap device shows a significant amount of residual thrombus material is present on the returned device.This residual thrombus material has dried in place and resulted in the inner channel and outer cage of the device becoming misaligned.No other visible damage or deformation was observed on the returned device, with all radiopaque markers and coils, and adhesive bonds present and undamaged.The ancillary devices used during the complaint event were not available for visual inspection.The returned embotrap device could not be retracted through a 0.0195¿ flared ptfe inspection tube in its returned condition, as the residual dried thrombus created additional material on the device which prevented it from collapsing fully.As a result, clot retrieval assessments could not be carried out with the returned device.The complaint event description reports the embotrap device retrieving through the first 5cm up to the siphon with no resistance, and at this point the embotrap device failed to retrieve any further.The embotrap iii device design has been shown to meet the user needs and intended uses required for a stent retriever being used in a mechanical thrombectomy procedure through testing in animal studies and ease of use bench top testing, where withdrawal of the device during clot retrieval is considered.As there were no signs of damage or deformation (other than that caused by the residual thrombus material) present on the returned embotrap device, there is no indication that the complaint event was caused by the embotrap device.The complaint event description also reports that subsequent attempts with aspiration and other stent retrievers were unsuccessful in retrieving the clot.It is possible that the complaint event is a result of a patient/procedure specific contributing factor such as tough patient anatomy (tortuous anatomy) or clot composition.The root cause of this complaint event cannot be determined.There is no indication that this complaint was a result of a defect with the embotrap device.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.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 events.Carotid artery dissection is a known possible adverse event that may complicate an endovascular procedure and is listed in the instructions for use as such.Based on the information available, the treating physician suspects that the embotrap iii caused or contributed to dissection.Furthermore, the events occurred during procedural use of the embotrap iii device and cannot be disassociated.This file will be reassessed if additional information becomes available.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.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 13949849
• MDR Text Key: 288191850
• Report Number: 3011370111-2022-00033
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET307537
• Device Lot Number: 21L112AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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: 5F CATALYST DISTAL ACCESS CATHETER (STRYKER).; HEADWAY 21 MICROCATHETER, STRYKER.; SOLITAIRE STENT RETRIEVER (MEDTRONIC).