MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309522

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 03/10/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 22mm embotrap iii (et309522/21j113av) and a 5mm x 37mm embotrap iii (et309537/21l196av) and experienced a subarachnoid hemorrhage (sah) immediately post-procedure.It was reported that the patient is hospitalized.The treating physician commented that there is a high possibility that perforations were made with wires.Details of the procedure: a phenom 21 microcatheter (medtronic) was delivered to the target position.The 5mm x 22mm embotrap iii was then deployed at the distal m1 segment of the mca.Three passes were performed with the device.Then, a 5mm x 37mm embotrap iii was then utilized.Recanalization was achieved, and the procedure was completed.After that, a sah was found.The devices were allegedly used according to the instructions for use (ifu).Additional information received indicated that the treating physician commented that ¿there is a possibility that perforations were made with wires but, it is higher possible that perforations were made with the complaint et iii than that.¿.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2022-00032.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: it was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a middle cerebral artery (mca) (distal m1 segment) occlusion with a 5mm x 22mm embotrap iii (et309522/21j113av) and a 5mm x 37mm embotrap iii (et309537/21l196av) and experienced a subarachnoid hemorrhage (sah) immediately post-procedure.It was reported that the patient is hospitalized.The treating physician commented that there is a high possibility that perforations were made with wires.Details of the procedure: a phenom 21 microcatheter (medtronic) was delivered to the target position.The 5mm x 22mm embotrap iii was then deployed at the distal m1 segment of the mca.Three passes were performed with the device.Then, a 5mm x 37mm embotrap iii was then utilized.Recanalization was achieved, and the procedure was completed.After that, a sah was found.The devices were allegedly used according to the instructions for use (ifu).Additional information received indicated that the treating physician commented that ¿there is a possibility that perforations were made with wires but, it is higher possible that perforations were made with the complaint et iii than that.¿ the device was discarded therefore no further investigation can be performed.A review of the device history record (dhr) associated with lot number 21l196av presented no issues during the manufacturing or inspection process that can be related to the reported event.Hemorrhage and vessel perforation are well-known extensively documented potential complication associated with endovascular mechanical thrombectomy and is listed in the embotrap instructions for use (ifu) as such.With the limited information provided, it is not possible to determine the root cause of the sah; however, patient, procedural, and pharmacological factors may have contributed with no evidence of a device malfunction or quality issue.The sah secondary to vessel perforation is considered a serious injury and the relationship of the embotrap iii to the reported event cannot be excluded.The file will be re-reviewed if additional information is received at a later date.

• Brand Name: EMBOTRAP III 5 MM X 22 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 ; 9497898687
• MDR Report Key: 13938311
• MDR Text Key: 288135944
• Report Number: 3011370111-2022-00031
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082866
• UDI-Public: 10886704082866
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ET309522
• Device Catalogue Number: ET309522
• Device Lot Number: 21J113AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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
• Treatment: EMBOTRAP III 5 MM X 37 MM; PHENOM 21 MICROCATHETER (MEDTRONIC)