MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problems Difficult to Remove (1528); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported by the field, during a mechanical thrombectomy, it was sometimes difficult to match the recommended expansion position of an embotrap ii 5x33 revascularization device (et009533, lot unknown) with the proximal end of the thrombus and the proximal gold marker.In addition, sometimes strong resistance may be felt when the device is retracted to m2 distal and m3 where the device was deployed.Inner-channels may be involved, which may be caused by tight adhesion of the inner channels to the blood vessel wall in small blood vessels.It is necessary to adjust the position of deployment, partial deployment, and re-sheath.A continuous flush was done.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.The lot number was 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.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that the device lot number is not available.No additional intervention was required due to the alleged product malfunction.There was no report of any damage to the concomitant devices.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, it was sometimes difficult to match the recommended expansion position of an embotrap ii 5x33 revascularization device (et009533, lot unknown) with the proximal end of the thrombus and the proximal gold marker.In addition, sometimes strong resistance may be felt when the device is retracted to m2 distal and m3 where the device was deployed.Inner-channels may be involved, which may be caused by tight adhesion of the inner channels to the blood vessel wall in small blood vessels.It is necessary to adjust the position of deployment, partial deployment, and re-sheath.A continuous flush was done.Additional information received indicated that the device lot number is not available.No additional intervention was required due to the alleged product malfunction.There was no report of any damage to the concomitant devices.The device has not been returned for analysis and therefore no further investigation can be performed at this time.The lot number is not known; therefore, a device history record review cannot be completed.Withdrawal difficulty from vessel and deployment difficulties are potential complications associated with the use of the embotrap ii 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 events.However, there are clinical, procedural factors, including vessel characteristics, severe tortuosity, clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the events.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 12655920
• MDR Text Key: 284009895
• Report Number: 3011370111-2021-00126
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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