MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET307645

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 08/08/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The phone and email address of the initial reporter are not available / reported.(b)(4).The event came from a report from the field.During a mechanical thrombectomy procedure of a tandem right internal carotid artery (c4 segment) and middle cerebral artery (m1 segment) occlusion, a dissection was noted at the c4 segment of the ica after the first pass was made with a 6.5mm x 45mm embotrap iii revascularization device (et307645 / 20e064av).The physician reported that the dissection was likely due to underlying plaque.The baseline modified treatment in cerebral infarction (mtici) score was 0 with the approximated clot lengths 8mm (c4 segment) and 10mm (m1 segment).The approximate vessel diameter at the c4 segment was 3.5mm and at the m1 segment was 2.5mm.The physician made the first pass with the embotrap device using the sofia® 6f intermediate catheter (microvention-terumo) via a 0.021¿ progreat® microcatheter (terumo) resulted in an mtici score of 2b.The epic technique with partial device retrieval was used.The physician stated that the embotrap iii device performed very well.On 27 august 2020, a teleconference was held with the reporting physician.The information provided in this teleconference is as followed: the (b)(6)-year old male patient presented with left hemiparesis lasting lmost one hour (nihss score of 6).Emergency computed tomography (ct) scan revealed tandem ica (c4) and mca (m1) occlusion.The physician reported that he was able to reach the occlusion with the embotrap iii device and the sofia catheter without any untoward events.The physician did not have trouble navigating the sofia to the face of the occlusion.The first pass was subsequently performed with pump aspiration through sofia catheter.The save technique was utilized (partial retrieval of the embotrap iii device into sofia, then pull everything together into long guide sheath).No unusual resistance or friction was encountered during retraction of the device.The physician stated that there was not very much clot visible on the embotrap iii device.He further reported that there is no filter on the pump so there is no way to check if there was clot collected; the clot "probably" ended up there.Most of the time he cannot visualize the clot coming out through the pump unless it is a very large clot.The embotrap iii device and sofia were inspected post-use and no damage was observed.Irregularity was noted in the internal carotid artery (ica) prior to the thrombectomy most likely representing underlying pre-existing atherosclerotic plaque.Post-first pass linear defect was seen on angiogram in area of presumed plaque of ica (just below carotid siphon) along with continued irregularity of the vessel wall.Vessel reperfusion was established.Balloon expandable stent (unspecified) was placed over area of dissection with good response.Vessel patency restore at a tici score of 2b.There was no further evidence of dissection or other vascular injury.The patient underwent repeat thrombectomy on the following day due to stent occlusion but reportedly is doing fine considering the stroke.His colleague performed the second thrombectomy; therefore, the technique is unknown.The embotrap iii device is not available for evaluation.The case imaging was provided and was forwarded to independent physician for review.The returned imaging was evaluated by independent physician on 31 august 2020.And the results are as follows: ¿i reviewed the complaint and the accompanied ppt which has pre-op and intra-op imaging.Pre-procedure, there is diffuse irregularities of the ica, likely secondary to atherosclerosis.After the first pass, there is evidence of a dissection.This could have occurred during catheter or wire tracking to the clot or during the retrieval.It was treated with a balloon expandable stent.This type of adverse event is not uncommon when treating stroke and is likely due to the underlying vascular disease than the devices used in the procedure.¿ physician name and date reviewed: (b)(6) md, august 31, 2020.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (20e064av) was performed.A risk assessment was performed and confirmed that no product quality or patient safety risk were identified with the nonconformance.The event description of this complaint differs from the description of the non-conformance/capa identified and is therefore not related.Product has been risk assessed and deemed accepted as per the nc and capa processes.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Arterial dissection is a well-known extensively documented potential complication associated with endovascular mechanical thrombectomy and is listed in the embotrap instructions for use (ifu) as such.Clinical and procedural factors including vessel characteristics, tortuosity, device selection, and mechanical manipulation of devices within the artery are all factors that may contribute to dissection.Review of the available information does not allow for an exact determination of root cause; however, the physician reported that the dissection was probably related to underlying atherosclerotic plaque.There was no report of a device malfunction or performance issue such as resistance during withdrawal preceding the event.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the stretched condition observed on the returned coil was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The event came from a report from the field.During a mechanical thrombectomy procedure of a tandem right internal carotid artery (c4 segment) and middle cerebral artery (m1 segment) occlusion, a dissection was noted at the c4 segment of the ica after the first pass was made with a 6.5mm x 45mm embotrap iii revascularization device (et307645 / 20e064av).The physician reported that the dissection was likely due to underlying plaque.The baseline modified treatment in cerebral infarction (mtici) score was 0 with the approximated clot lengths 8mm (c4 segment) and 10mm (m1 segment).The approximate vessel diameter at the c4 segment was 3.5mm and at the m1 segment was 2.5mm.The physician made the first pass with the embotrap device using the sofia® 6f intermediate catheter (microvention-terumo) via a 0.021¿ progreat® microcatheter (terumo) resulted in an mtici score of 2b.The epic technique with partial device retrieval was used.The physician stated that the embotrap iii device performed very well.On 27 august 2020, a teleconference was held with the reporting physician.The information provided in this teleconference is as followed: the (b)(6)-year old male patient presented with left hemiparesis lasting almost one hour (nihss score of 6).Emergency computed tomography (ct) scan revealed tandem ica (c4) and mca (m1) occlusion.The physician reported that he was able to reach the occlusion with the embotrap iii device and the sofia catheter without any untoward events.The physician did not have trouble navigating the sofia to the face of the occlusion.The first pass was subsequently performed with pump aspiration through sofia catheter.The save technique was utilized (partial retrieval of the embotrap iii device into sofia, then pull everything together into long guide sheath).No unusual resistance or friction was encountered during retraction of the device.The physician stated that there was not very much clot visible on the embotrap iii device.He further reported that there is no filter on the pump so there is no way to check if there was clot collected; the clot "probably" ended up there.Most of the time he cannot visualize the clot coming out through the pump unless it is a very large clot.The embotrap iii device and sofia were inspected post-use and no damage was observed.Irregularity was noted in the internal carotid artery (ica) prior to the thrombectomy most likely representing underlying pre-existing atherosclerotic plaque.Post-first pass linear defect was seen on angiogram in area of presumed plaque of ica (just below carotid siphon) along with continued irregularity of the vessel wall.Vessel reperfusion was established.Balloon expandable stent (unspecified) was placed over area of dissection with good response.Vessel patency restore at a tici score of 2b.There was no further evidence of dissection or other vascular injury.The patient underwent repeat thrombectomy on the following day due to stent occlusion but reportedly is doing fine considering the stroke.His colleague performed the second thrombectomy; therefore, the technique is unknown.The embotrap iii device is not available for evaluation.The case imaging was provided and was forwarded to independent physician for review.

• Brand Name: EMBOTRAP III 6.5 MM X 45 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10472390
• MDR Text Key: 205467551
• Report Number: 3011370111-2020-00060
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Catalogue Number: ET307645
• Device Lot Number: 20E064AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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): Life Threatening; Required Intervention