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 Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 07/19/2022

Event Type  Injury  

Event Description

The healthcare professional reported that the patient underwent a mechanical thrombectomy procedure targeting an occlusion in the m2 segment of the middle cerebral artery (mca).The procedure was initiated with a tron 6mm stent retriever (biomedical solutions, inc.) and a sofia¿ 6f intermediate catheter (microvention) used in a combined technique.However, the thrombus was not removed.A 5mm x 37mm embotrap iii revascularization device (et309537 / 22e105av) was used as per the instructions for use (ifu); the embotrap iii device was deployed via the trak microcatheter (stryker), and while it was being retracted, there was resistance and the device was unable to be re-sheathed.The physician kept retracting the embotrap iii device and at the bifurcation between the m1 and m2 segments, the vessel got damaged and a subarachnoid hemorrhage (sah) occurred.Coil embolization was subsequently performed and hemostasis was achieved.The procedure was completed.It was reported that ¿the condition of the patient has not been changed since transportation.¿ the physician commented that, ¿the embotrap iii is related to this bleeding because the complaint embotrap iii damaged blood vessel.¿ the event was considered serious because the patient had severe bleeding.It was reported that ¿there was no problem with the prognosis.No further details were provided.The complaint device was reported as not available to be returned for evaluation.On 21-aug-2022, limited additional information was received.The information indicated that it was a vessel dissection that resulted in the reported subarachnoid hemorrhage (sah).It was unknown if a continuous flush was maintained.

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 available / reported.[conclusion]: the healthcare professional reported that the patient underwent a mechanical thrombectomy procedure targeting an occlusion in the m2 segment of the middle cerebral artery (mca).The procedure was initiated with a tron 6mm stent retriever (biomedical solutions, inc.) and a sofia¿ 6f intermediate catheter (microvention) used in a combined technique.However, the thrombus was not removed.A 5mm x 37mm embotrap iii revascularization device (et309537 / 22e105av) was used as per the instructions for use (ifu); the embotrap iii device was deployed via the trak microcatheter (stryker), and while it was being retracted, there was resistance and the device was unable to be re-sheathed.The physician kept retracting the embotrap iii device and at the bifurcation between the m1 and m2 segments, the vessel got damaged and a subarachnoid hemorrhage (sah) occurred.Coil embolization was subsequently performed and hemostasis was achieved.The procedure was completed.It was reported that ¿the condition of the patient has not been changed since transportation.¿ the physician commented that, ¿the embotrap iii is related to this bleeding because the complaint embotrap iii damaged blood vessel.¿ the event was considered serious because the patient had severe bleeding.It was reported that ¿there was no problem with the prognosis.No further details were provided.The complaint device was reported as not available to be returned for evaluation.On 21-aug-2022, limited additional information was received.The information indicated that it was a vessel dissection that resulted in the reported subarachnoid hemorrhage (sah).It was unknown if a continuous flush was maintained.Based on complaint information, the device is not available to be returned for analysis.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 22e105av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Subarachnoid hemorrhage is a known complication associated with the use of the embotrap iii device and is mentioned in the instructions for use (ifu) as such.Withdrawal difficulty from the vessel could 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.In addition, coils were used to complete the procedure and the treating physician commented, "the complaint embotrap iii related to this bleeding because the complaint et iii damaged blood vessel¿.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ withdrawal difficulty from vessel is a well-known potential procedural complication associated with the embotrap revascularization device.The ifu also warns the user to not withdraw the device against significant resistance.The cause of the resistance should be assessed using fluoroscopy and the microcatheter should be advanced over the device to resheath or partially resheath to aid in withdrawal.The root cause of the event cannot be conclusively determined based on the information available for review and without the complaint device available for evaluation.However, there are clinical and procedural factors, including clot burden, vessel characteristics, device selection, and operator technique, that may have contributed rather than the design or manufacture of the device.Based on the manufacturing documentation review, 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.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.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 26-aug-2022.[additional information]: on 26-aug-2022, additional event information was received, the information indicated that anonymized images / angiographs of the procedure are difficult to obtain, but if they are available, they will be provided.The clot characteristics are not known.Details related to the current status of the patient is not known; but the patient has left the hospital.It was not known if the adverse event reported resulted in prolongation of the patient¿s hospitalization.The pre- and post-procedure tici score is 0.The information indicated that it was vessel dissection that resulted in the reported subarachnoid hemorrhage (sah).It was not known if a continuous flush was maintained during the procedure.It is not clear what the physician considered to be the source of the resistance encountered with the embotrap iii device.Only one pass was made with the embotrap iii; the resistance encountered was on the first and one pass made.The thrombus was not retrieved.There is no further future treatment planned.The reported event did result in a procedure delay due to the reported bleed that was embolized with coil.No patient information was available.Subarachnoid hemorrhage and vessel dissection are known complications associated with the use of the embotrap iii device and are mentioned in the instructions for use (ifu) as such.Withdrawal difficulty from the vessel could result in vessel trauma, vessel spasm, and damage to the basket with the potential for the release of emboli and subsequent ischemia or infarct, and/or the need for additional intervention.In addition, coils were used to complete the procedure and the treating physician commented "the complaint embotrap iii related to this bleeding because the complaint et iii damaged blood vessel¿.The additional information received on 26-aug-2022 mentioned that the patient experienced a vessel dissection.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15271750
• MDR Text Key: 298384524
• Report Number: 3011370111-2022-00078
• 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
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 22E105AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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: SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION); TRAK MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention