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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot ¿ not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.

Event Description

As reported by the field, during a mechanical thrombectomy, an embotrap iii 5 mm x 37 mm (et309537, lot unknown) was used to remove thrombus at the posterior cerebral artery (pca).The embotrap was fully deployed to remove thrombus around the ba-top.However, the physician felt a little resistance when the embotrap was being retracted.There was no bleeding after the procedure or patient injury.It was unclear if continuous flush was done.

Manufacturer Narrative

Product complaint (b)(4) a review of the dhr records confirms that there were no issues with the assembly of the lot (sub and top assembly), all rejects were accounted for during the dhr review.There were no issues with sterilisation and the final number of units released reconciles with the number of units released by advant medical to cerenovus.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that the resistance was confirmed at the beginning of the procedure, therefore, probably there was no thrombus in the device.The withdrawal was performed as per the instructions for use (ifu).The withdrawal difficulty was encountered shortly after the stent was removed.The device was re-sheathed a little inside the microcatheter and resistance decreased.It was removed from the patient.It was not necessary to remove concomitant devices with the complaint device.One pass was made to attempt to retrieve the clot.The clot consistency was a ¿little firm¿.A syringe was used for aspiration.There was no severe tortuosity.Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a mechanical thrombectomy, an embotrap iii 5 mm x 37 mm (et309537, 21f103av) was used to remove thrombus at the posterior cerebral artery (pca).The embotrap was fully deployed to remove thrombus around the ba-top.However, the physician felt a little resistance when the embotrap was being retracted.There was no bleeding after the procedure or patient injury.It was unclear if a continuous flush was done.Additional information received indicated that the resistance was confirmed at the beginning of the procedure, therefore, probably there was no thrombus in the device.The withdrawal was performed as per the instructions for use (ifu).The withdrawal difficulty was encountered shortly after the stent was removed.The device was re-sheathed a little inside the microcatheter and resistance decreased.It was removed from the patient.It was not necessary to remove concomitant devices with the complaint device.One pass was made to attempt to retrieve the clot.The clot consistency was a ¿little firm¿.A syringe was used for aspiration.There was no severe tortuosity.The device was discarded, therefore, no further investigation can be performed.A review of the device history record associated with lot number 21f103av presented no issues during the manufacturing or inspection process that can be related to the reported event.Withdrawal difficulty from vessel is a potential complication associated with the use of the embotrap iii revascularization device in endovascular mechanical thrombectomy.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural factors, including vessel characteristics, tortuosity, clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the event.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• 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 ; 9497898687
• MDR Report Key: 12827624
• MDR Text Key: 282989792
• Report Number: 3011370111-2021-00146
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21F103AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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