MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2022

Event Type  Injury  

Event Description

The healthcare professional reported that the patient underwent a thrombectomy procedure that was targeting an occlusion and stenosis of the internal carotid artery (ica) and an occlusion of the m1 segment of the middle cerebral artery (mca).A 5mm x 37mm embotrap revascularization device (et309537 / 22f168av) and a 132cm embovac 71 aspiration catheter (ic71132ca / 30767689) were used.Per the event description, a percutaneous transluminal angioplasty (pta) was performed initially to widen the stenotic internal carotid artery followed by implantation of a wall stent at the wide part of the ica.There was difficulty encountered during the advancement of the embovac catheter.The physician then decided to use the ¿lexus technique¿ with the embotrap iii device as an anchor.The embotrap iii device was eventually deployed at the m1 segment, however, the suction catheter was still stuck in the stent part and could not be advanced further.The physician tried to remove by pulling only the stent, but the embotrap iii became entangled in the wall of the stent, which made retraction difficult.The description documented that because the phenom¿ microcatheter (medtronic) was removed, the embotrap iii device was unable to be retracted, and the embotrap iii device ¿was left as is.¿ it was reported that continuous flush was maintained.The complaint also documented the following statement: ¿due to this health injury, some measures were taken.¿ on 05-oct-2022, additional and modified information was received from the cerenovus representative from the physician.The information indicated that a chikai neurovascular guidewire (asahi intecc) and a 9f optimo balloon catheter (tokai medical) were also used during the procedure.The information indicated the following: ¿as a result, although the complaint device got caught, the physician managed to pull out and retrieve the complaint device.Because the thrombus was at severe acute and the system itself was unable to go up very much and the lesion was unable to be approached, the m1 region was terminated without recanalization.¿ the patient¿s condition is reported to be ¿not good because the approach until m1 failed and recanalization was unable to be obtained.¿ the additional information indicated that ¿the complaint device was able to be removed.¿ the physician commented, ¿the relationship with the devices can be ruled out.The procedure is related with the issue.¿ the doctor said, ¿the procedure was very difficult and the approach was failed, therefore it cannot help.¿ the information included a ¿[cause except devices]¿ that included the following: ¿the patient's vascular condition was severe acute.The microcatheter was removed and the complaint embotrap was unable to be retrieved.The complaint devices were discarded because there are not malfunction with devices.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The healthcare professional reported that the patient underwent a thrombectomy procedure that was targeting an occlusion and stenosis of the internal carotid artery (ica) and an occlusion of the m1 segment of the middle cerebral artery (mca).A 5mm x 37mm embotrap revascularization device (et309537 / 22f168av) and a 132cm embovac 71 aspiration catheter (ic71132ca / 30767689) were used.Per the event description, a percutaneous transluminal angioplasty (pta) was performed initially to widen the stenotic internal carotid artery followed by implantation of a wall stent at the wide part of the ica.There was difficulty encountered during the advancement of the embovac catheter.The physician then decided to use the ¿lexus technique¿ with the embotrap iii device as an anchor.The embotrap iii device was eventually deployed at the m1 segment, however, the suction catheter was still stuck in the stent part and could not be advanced further.The physician tried to remove by pulling only the stent, but the embotrap iii became entangled in the wall of the stent, which made retraction difficult.The description documented that because the phenom¿ microcatheter (medtronic) was removed, the embotrap iii device was unable to be retracted, and the embotrap iii device ¿was left as is.¿ it was reported that continuous flush was maintained.The complaint also documented the following statement: ¿due to this health injury, some measures were taken.¿ on 05-oct-2022, additional and modified information was received from the cerenovus representative from the physician.The information indicated that a chikai neurovascular guidewire (asahi intecc) and a 9f optimo balloon catheter (tokai medical) were also used during the procedure.The information indicated the following: ¿as a result, although the complaint device got caught, the physician managed to pull out and retrieve the complaint device.Because the thrombus was at severe acute and the system itself was unable to go up very much and the lesion was unable to be approached, the m1 region was terminated without recanalization.¿ the patient¿s condition is reported to be ¿not good because the approach until m1 failed and recanalization was unable to be obtained.¿ the additional information indicated that ¿the complaint device was able to be removed.¿ the physician commented, ¿the relationship with the devices can be ruled out.The procedure is related with the issue.¿ the doctor said, ¿the procedure was very difficult and the approach was failed, therefore it cannot help.¿ the information included a ¿[cause except devices]¿ that included the following: ¿the patient's vascular condition was severe acute.The microcatheter was removed and the complaint embotrap was unable to be retrieved.The complaint devices were discarded because there are not malfunction with devices.¿ based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (22f168av)) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.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.This complaint was discussed with the medical safety officer (mso) on 19-oct-2022.Pulling the embotrap out across the implanted wall stent from the pta procedure done prior to the thrombectomy is a contraindication unless the embotrap is fully resheathed before going across the stenosis.However, it cannot be resheathed since the microcatheter was not in place which can become a problem especially if a clot is in there.The appropriate action in this case is to put the microcatheter back and resheath the embotrap.Hence, it appears that the embotrap iii was not used per the instructions for use (ifu) since it is being withdrawn against another stent.Upon analysis of the overall events, it seems that the physician was able to move the embotrap at the level of the stent.However, it got caught on the stent ledge and there was difficulty in retrieving it which is not unreasonable and can happen.The reference in the event description of the device getting stuck in the stent only meant that the device could not advance further.The failure to recanalize the m1 segment is not considered a treatment or device failure since the embotrap iii did not go through 3 passes which is how it is defined in the ifu.Withdrawal difficulty from the vessel is a known potential complication associated with the use of the embotrap iii in mechanical thrombectomy procedures, especially if it is being done against another stent.Per the device ifu, embotrap iii should not be withdrawn through a previously stented vessel.Based on the information provided, there had been a recent deployment of an endovascular stent to treat the ica stenosis hence the difficulty in its removal at the level of the stent.The difficulty in withdrawing the device through the vessel may require the use of increased force and puts the patient at risk for a vascular injury.This could then result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli, and subsequent ischemia or infarct and/or the need for additional intervention.Therefore, this event is considered serious and mdr reportable.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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.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 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on (b)(6) 2022.[additional information]: on (b)(6) 2022, additional information was received.The information indicated that anonymized images / angiographs of the procedure are not available.The clot characteristic is not known.The current status/patient condition is not known.It was not known if the patient was symptomatic.The pre- and post- procedure tici scores was 0.There was no damage noted on the embotrap iii device when it was removed from the patient.The information indicated that recanalization of the m1 occlusion was not obtained from this procedure, ¿it is impossible to confirm correctly because the device was unable to reach the thrombus.¿ the microcatheter used to attempt to retrieve the embotrap iii device was a phenom microcatheter with inner diameter 0.027 inch.The duration of the patient¿s hospitalization is not known.The embotrap iii device made only one pass, it became stuck on the first pass.Updated sections: b.4, g.3, g.6, h.2, and h.10.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25-oct-2022.[additional information]: on 25-oct-2022, additional information was received.The information indicated that the patient¿s condition was documented as ¿not good¿ is related to the patient¿s primary disease / condition that could not be resolved by the procedure.The stent that was placed was not affected by the reported issue.Related to the statement, ¿due to this health injury, some measures were taken¿ indicated that the physician managed to withdraw the device from the patient, no surgical treatment was required.Recanalization of the m1 occlusion was not obtained / achieved with the procedure.This was the patient¿s ¿health injury¿ documented.The patient¿s vasculature is tortuous with acute bends.The information indicated that there was no vessel trauma / injury reported.There was no evidence of distal embolization.No further treatment is planned.Per the information, the ¿lexus technique¿ was mistakenly documented.It was the rexas (rapid exchange aspiration after stenting).There were no performance issues nor device malfunction associated with the embotrap iii nor with the concomitant 132cm embovac 71 aspiration catheter.The additional information confirmed that devices were removed from the patient.A continuous flush was maintained during the procedure.Withdrawal difficulty from the vessel is a known potential complication associated with the use of the embotrap iii in mechanical thrombectomy procedures, especially if it is being done against another stent.Per the device ifu, embotrap iii should not be withdrawn through a previously stented vessel.Based on the information provided, there had been a recent deployment of an endovascular stent to treat the ica stenosis hence the difficulty in its removal at the level of the stent.The difficulty in withdrawing the device through the vessel may require the use of increased force and puts the patient at risk for a vascular injury.This could then result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli, and subsequent ischemia or infarct and/or the need for additional intervention.Therefore, this event is considered serious and mdr reportable.The complaint will be reassessed if additional information becomes available.E.1: initial reporter phone: (b)(6).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.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15658070
• MDR Text Key: 302263574
• Report Number: 3011370111-2022-00102
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 22F168AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: 9F OPTIMO BALLOON CATHETER (TOKAI MEDICAL); CHIKAI NEUROVASCULAR GUIDEWIRE (ASAHI INTECC); IC 71, 132 CM, CE, ASP. IND.; PHENOM¿ MICROCATHETER (MEDTRONIC)
• Patient Outcome(s): Hospitalization; Life Threatening