MAUDE Adverse Event Report: NEURAVI LTD. UNKNOWN EMBOTRAP III; CATHETER, THROMBUS RETRIEVER

Catalog Number UNKNOWN EMBOTRAP III

Device Problem Difficult to Remove (1528)

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

Event Date 02/18/2002

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.The product catalog and lot number were not reported; udi unavailable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

As reported by the field, during a mechanical thrombectomy using a 5x37 embotrap iii thrombus retriever (unknown product/lot), the embotrap became stuck on a bend, the user was unable to retrieve it without advancing a sofia catheter over it to remove it.The patient had presented with slurred speech, gaze deviation, left neglect, left hemiparesis, rousable, nihss score of 17, aspects 7, right a2 filled by anterior communicating artery (acom) and no thrombolysis.The procedure was performed under general anesthesia via a right common femoral artery (cfa) puncture.An 8french vascular sheath was placed and a neron max guiding sheath was placed.A 6f select (bernstein) catheter and terumo combination was used to access the right internal carotid artery (ica) but this was difficult as the patient had a tonsillar loop in the ica.Right ica-t occlusion was identified on angiography.During pass, the physician attempted direct aspiration first with a sofia 6f which she was able to advance to the face of the clot in the carotid artery terminus, but nothing was removed.During pass two, the same attempt at direct aspiration with the sofia 6 french, however again no thrombus removed.At pass three, a prowler select plus 21 microcatheter (mc) and microwire were advanced into the posterior superior branch of the right middle cerebral artery (mca).During pass three, the embotrap iii (et iii) was positioned over a long clot, which was positioned more distally after the two initial passes with aspiration into the mca branch and deployed.However, upon attempt at retrieval of the embotrap iii, the physician experienced resistance despite the use of high force.The sofia was proximal in the ica at this time as it would not advance forward during initial placement of the embotrap iii.While continuing to pull the et iii with force, the sofia catheter advanced on its own to the level of the stent at which time the physician covered the proximal part of the embotrap with the sofia catheter.Once the et iii was partially recaptured in the sofia catheter, the physician felt the et iii ¿give away¿ and she was able to remove the device and system as a whole.At this point the physician replaced the et iii with a new competitor stent to complete the case.At pass four, five and sixth, a 4x35 trevo was used recanalizing thrombus achieving tici 2b.A track 21 microcatheter in posterior inferior right mca was used with a sofia 6f, no high retrieval was experienced.The embotrap did not appear damaged in any way.A continuous flush had been maintained through the catheter.

Manufacturer Narrative

Product complaint # (b)(4), updated sections on this medwatch: the correct brand name and the catalog number is unknown embotrap iii.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b3, b4, b5, g3, g6, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that there was no evidence of thromboembolism due to the withdrawal difficulty.The procedure was delayed by 26 minutes due to the event.The delay was not clinically significant.Complaint conclusion: as reported by the field, during a mechanical thrombectomy using a 5x37 embotrap iii thrombus retriever (unknown product/lot), the embotrap became stuck on a bend, the user was unable to retrieve it without advancing a sofia catheter over it to remove it.The patient had presented with slurred speech, gaze deviation, left neglect, left hemiparesis, rousable, nihss score of 17, aspects 7, right a2 filled by anterior communicating artery (acom) and no thrombolysis.The procedure was performed under general anesthesia via a right common femoral artery (cfa) puncture.An 8french vascular sheath was placed and a neron max guiding sheath was placed.A 6f select (bernstein) catheter and terumo combination was used to access the right internal carotid artery (ica) but this was difficult as the patient had a tonsillar loop in the ica.Right ica-t occlusion was identified on angiography.During pass, the physician attempted direct aspiration first with a sofia 6f which she was able to advance to the face of the clot in the carotid artery terminus, but nothing was removed.During pass two, the same attempt at direct aspiration with the sofia 6 french, however again no thrombus removed.At pass three, a prowler select plus 21 microcatheter (mc) and microwire were advanced into the posterior superior branch of the right middle cerebral artery (mca).During pass three, the embotrap iii (et iii) was positioned over a long clot, which was positioned more distally after the two initial passes with aspiration into the mca branch and deployed.However, upon attempt at retrieval of the embotrap iii, the physician experienced resistance despite the use of high force.The sofia was proximal in the ica at this time as it would not advance forward during initial placement of the embotrap iii.While continuing to pull the et iii with force, the sofia catheter advanced on its own to the level of the stent at which time the physician covered the proximal part of the embotrap with the sofia catheter.Once the et iii was partially recaptured in the sofia catheter, the physician felt the et iii ¿give away¿ and she was able to remove the device and system as a whole.At this point the physician replaced the et iii with a new competitor stent to complete the case.At pass four, five and sixth, a 4x35 trevo was used recanalizing thrombus achieving tici 2b.A track 21 microcatheter in posterior inferior right mca was used with a sofia 6f, no high retrieval was experienced.The embotrap did not appear damaged in anyway.A continuous flush had been maintained through the catheter.Additional information received on 24-may-2022 indicated that there was no evidence of thromboembolism due to the withdrawal difficulty.The procedure was delayed by 26 minutes due to the event.The delay was not clinically significant.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.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.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, 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 event.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: UNKNOWN EMBOTRAP III
• 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: 14427379
• MDR Text Key: 300319847
• Report Number: 3011370111-2022-00041
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN EMBOTRAP III
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• 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: 6F SELECT (BERNSTEIN) CATHETER; 8FRENCH VASCULAR SHEATH; NERON MAX GUIDING SHEATH; PROWLER SELECT PLUS 21 MICROCATHETER; SOFIA 6F ASPIRATION CATHETER; TERUMO CATHETER; UNSPECIFIED MICROWIRE