MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET307522

Device Problem Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Concomitant products: 6f sofia plus catheter, 0.021¿ via (microvention) microcatheter and unspecified guide catheter.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during the mechanical thrombectomy of a middle cerebral artery (m2 segment) occlusion, the 5mm x 22mm embotrap iii (et307522/20m078av) revascularization device was deployed but was not able to be extracted from the vessel.The device was stuck with no possibility of removal via concomitant unspecified microcatheter and 6f sofia plus (microvention) catheter.After struggling to withdraw the device, a final powerful pull was applied with high force which caused a dissection of the whole vessel without any additional possible revascularization.The reported patient consequence was large ischemia in whole territory.Additional information received indicated that the patient initially presented with an internal carotid artery (c1 segment) long dissection with mtici score of 2a.Distal rich red blood cell (rbc) clot migrated to the m1 segment of the middle cerebral artery (mca) and then to the m2 segment following thrombolysis.The intracranial vessel was ¿without atherosclerotic changes¿.Mechanical thrombectomy of the m2 segment was subsequently performed.The intraoperative dissection occurred after the first pass made with the embotrap iii device.The dissection extended to the origin of the m2 segment.The reported large ischemia did not extend beyond the baseline occlusion; however, the m2 segment remained occluded post-procedure.There was no improvement of baseline mtici score.It was reported that malignant ischemia was present in two thirds of the mca territory requiring decompressive craniectomy.The event resulted in prolongation of existing hospitalization.The current status of the patient is unknown.An 0.021¿ via (microvention) microcatheter was used in conjunction with the embotrap iii device.The 6f sofia plus catheter was located at the m1 segment, the via microcatheter was at the m2, and the guide catheter was at the c1 ostium.There was no difficulty or resistance encountered when crossing the clot.The embotrap was finally removed from the patient ¿with higher pulling force¿.The medical images/films were reviewed by independent physician on (b)(6) 2021 and the assessment reads as follows: "a case report of a difficult to remove embotrap iii is accompanied by 7 avi angio sequences.From the report it appears there was a known carotid dissection extending to c1 and following thrombolysis there was distal migration of clot to the m1 and then the m2.After deployment of the embotrap iii there was considerable difficulty in removing the embotrap.Considerable force was used with ultimate removal of the device which subsequently resulted in a dissection of the mca and ica that was not repairable.The images provided demonstrate and m2 superior division occlusion.In the images provided there appears to be a guide catheter in the proximal ica, an intermediate catheter in the petrous segment and in multiple images a microcatheter in the mca, across the m2 occlusion, and what appears to be a post thrombectomy run with a persistent m2 occlusion and a final ica run demonstrating a significant tonsillar loop of the proximal ica with stent reconstruction of the loop.No flow is seen beyond the proximal cervical ica stent.It is difficult to say why there was difficulty in removal of the embotrap iii device without knowing the position of the catheters during removal but likely while pulling the embotrap wire there was reduction of the tonsillar loop which caused a considerable amount of friction on the stentretriever wire and was essentially locked in place.This friction and resistance to removal may occur without a distal intermediate catheter or possibly even with one present as a reduction of the tonsillar loop could potentially cause collapse of the vessel or catheter locking the wire in place." the device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with lot 20m078av, presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Withdrawal difficulty from vessel and dissection or perforation are well-known potential procedural complications associated with the embotrap iii revascularization device.The embotrap iii instructions for use (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.¿ assignment of root cause for the event remains speculative and inconclusive based on the information provided.However, the event may have been secondary to a combination of multiple factors experienced in the clinical setting.There is no indication of a design or manufacturing related issue.The alleged withdrawal difficulty from the target vessel resulted in significant arterial dissection and the absence of treatment.These conditions resulted in the need for decompression craniectomy and prolongation of existing hospitalization.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

A report from the field indicated that during the mechanical thrombectomy of a middle cerebral artery (m2 segment) occlusion, the 5mm x 22mm embotrap iii (et307522/20m078av) revascularization device was deployed but was not able to be extracted from the vessel.The device was stuck with no possibility of removal via concomitant unspecified microcatheter and 6f sofia plus (microvention) catheter.After struggling to withdraw the device, a final powerful pull was applied with high force which caused a dissection of the whole vessel without any additional possible revascularization.The reported patient consequence was large ischemia in whole territory.Additional information received indicated that the patient initially presented with an internal carotid artery (c1 segment) long dissection with mtici score of 2a.Distal rich red blood cell (rbc) clot migrated to the m1 segment of the middle cerebral artery (mca) and then to the m2 segment following thrombolysis.The intracranial vessel was ¿without atherosclerotic changes¿.Mechanical thrombectomy of the m2 segment was subsequently performed.The intraoperative dissection occurred after the first pass made with the embotrap iii device.The dissection extended to the origin of the m2 segment.The reported large ischemia did not extend beyond the baseline occlusion; however, the m2 segment remained occluded post-procedure.There was no improvement of baseline mtici score.It was reported that malignant ischemia was present in two thirds of the mca territory requiring decompressive craniectomy.The event resulted in prolongation of existing hospitalization.The current status of the patient is unknown.An 0.021¿ via (microvention) microcatheter was used in conjunction with the embotrap iii device.The 6f sofia plus catheter was located at the m1 segment, the via microcatheter was at the m2, and the guide catheter was at the c1 ostium.There was no difficulty or resistance encountered when crossing the clot.The embotrap was finally removed from the patient ¿with higher pulling force¿.

• Brand Name: EMBOTRAP III 5 MM X 22 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11842739
• MDR Text Key: 265769057
• Report Number: 3011370111-2021-00043
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: 58173
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Catalogue Number: ET307522
• Device Lot Number: 20M078AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention