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

Model Number ET309537

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 01/11/2022

Event Type  Injury  

Event Description

The healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21h062av) and experienced subarachnoid hemorrhage (sah) during the procedure.The physician made three passes with the embotrap iii device, but the target thrombus was not able to be removed and sah occurred.It was stated that since the patient's vascular condition was very poor, it is hard to think that there is a causal relationship with the embotrap device.This was the physician¿s first time using the embotrap iii device.The physician¿s impression was that the radial force was higher than that of the embotrap ii, and it was hypothesized that the ¿blood vessels might have reduced protection.¿ it was reported that a continuous flush was not done.Concomitant devices used are unknown and the complaint device is not available for evaluation.On 13-feb-2022, additional information was received.The information confirmed that the procedure date is (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.There was no device performance issue as related to the embotrap iii device during the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not reported / available.[conclusion]: the healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21h062av) and experienced subarachnoid hemorrhage (sah) during the procedure.The physician made three passes with the embotrap iii device, but the target thrombus was not able to be removed and sah occurred.It was stated that since the patient's vascular condition was very poor, it is hard to think that there is a causal relationship with the embotrap device.This was the physician¿s first time using the embotrap iii device.The physician¿s impression was that the radial force was higher than that of the embotrap ii, and it was hypothesized that the ¿blood vessels might have reduced protection.¿ it was reported that a continuous flush was not done.Concomitant devices used are unknown and the complaint device is not available for evaluation.On 13-feb-2022, additional information was received.The information confirmed that the procedure date is (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.There was no device performance issue as related to the embotrap iii device during the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (21h062av) 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.All product rejected during manufacturing was identified as scrap and properly accounted for.The device is not available to be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Hemorrhage secondary to vascular injury and treatment failure are well-known potential complications associated with the use of the embotrap iii revascularization device in mechanical thrombectomy procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors including vessel characteristics, clot burden, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event rather than the design or manufacture of the device.Since sah secondary to vascular injury is considered a serious injury and the relationship of the embotrap iii to the reported event cannot be excluded, the event meets mdr reporting criteria.Note: the embotrap iii instructions for use (ifu) recommends that a continuous flush is maintained through the devices.Based on the manufacturing documentation reviews, there is no indication that the event is related to the device manufacturing process.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.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).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not reported / available.[conclusion]: the healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21h062av) and experienced subarachnoid hemorrhage (sah) during the procedure.The physician made three passes with the embotrap iii device, but the target thrombus was not able to be removed and sah occurred.It was stated that since the patient's vascular condition was very poor, it is hard to think that there is a causal relationship with the embotrap device.This was the physician¿s first time using the embotrap iii device.The physician¿s impression was that the radial force was higher than that of the embotrap ii, and it was hypothesized that the ¿blood vessels might have reduced protection.¿ it was reported that a continuous flush was not done.Concomitant devices used are unknown and the complaint device is not available for evaluation.On 13-feb-2022, additional information was received.The information confirmed that the procedure date is (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.There was no device performance issue as related to the embotrap iii device during the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (21h062av) 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.All product rejected during manufacturing was identified as scrap and properly accounted for.The device is not available to be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Hemorrhage secondary to vascular injury and treatment failure are well-known potential complications associated with the use of the embotrap iii revascularization device in mechanical thrombectomy procedures.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors including vessel characteristics, clot burden, device selection, and mechanical manipulation of devices within the artery that may have contributed to the event rather than the design or manufacture of the device.Since sah secondary to vascular injury is considered a serious injury and the relationship of the embotrap iii to the reported event cannot be excluded, the event meets mdr reporting criteria.Note: the embotrap iii instructions for use (ifu) recommends that a continuous flush is maintained through the devices.Based on the manufacturing documentation reviews, there is no indication that the event is related to the device manufacturing process.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.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.

Event Description

The healthcare professional reported that the patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 37mm embotrap iii revascularization device (et309537 / 21h062av) and experienced subarachnoid hemorrhage (sah) during the procedure.The physician made three passes with the embotrap iii device, but the target thrombus was not able to be removed and sah occurred.It was stated that since the patient's vascular condition was very poor, it is hard to think that there is a causal relationship with the embotrap device.This was the physician¿s first time using the embotrap iii device.The physician¿s impression was that the radial force was higher than that of the embotrap ii, and it was hypothesized that the ¿blood vessels might have reduced protection.¿ it was reported that a continuous flush was not done.Concomitant devices used are unknown and the complaint device is not available for evaluation.On 13-feb-2022, additional information was received.The information confirmed that the procedure date is (b)(6) 2022.Anonymized images / angiographs of the procedure are not available.There was no device performance issue as related to the embotrap iii device during the procedure.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13561108
• MDR Text Key: 286022333
• Report Number: 3011370111-2022-00018
• 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
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21H062AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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
• Patient Outcome(s): Life Threatening