MAUDE Adverse Event Report: MICROVENTION, INC. FRED X21; FLOW DIVERTER

Model Number XFRED3009-MVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that treatment was planned for a blister aneurysm on the right media artery.The indication for treatment was to prevent a subarachnoid haemorrhage (sab).The implantation of the flow diverter was successful without any issues or observations.Ten minutes post implantation a thrombus was observed inside the distal portion of the flow diverter causing the device to be occluded.A bolus of integrilin was given and the thrombus resolved after approximately twenty minutes.Twenty-four hours perfusion of integrilin was provided.The patient has a history of numerous previously treated aneurysms.The patient is doing well.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is implanted in the patient and is therefore, not available for return to the manufacturer for analysis.Additionally, the procedural images were not made available for review.On this basis, the event as described could not be confirmed.Should any procedural images be made available at a later date, an investigation will be performed and a supplemental report will be submitted.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with the use of the device.

Manufacturer Narrative

Corrections: h6: health effect - clinical code: add 2422.Component code: remove 4755; add 515.Type of investigation: add: 4112 and 41114.Investigation findings: remove 3221; add 213.B5: additional information was received stated that the patient was previously treated in 2019 with a competitor flow diverter (fd).New information was received that infarction was observed after the patient was discharged from the hospital and post implantation of the fred x.The patient was discharged from the hospital on (b)(6) 2022.On (b)(6) 2022, the patient was re-admitted to the hospital.The angiography performed indicated a new infarction in the media artery which was previously treated with the fred x flow (b)(6) 2022 the patient was discharged from the hospital and transferred to a rehabilitation center.Image review: one image was initially provided for review.The image is a magnified, coned-down native ap radiograph centered at the right skull base, just above the right orbit, in the presumed location of the right mca.It shows a fred in what appears to be the m1 portion of the right mca.On this image, the proximal and distal radiopaque markers appear open, as well as the opaque helix.Without an actual angiogram, the clot/occlusion, or incomplete opening of the inner braid, as described in the complaint report cannot be verified.Additional images were later received for evaluation; however, the investigation of the additional images has not yet begun.Upon completion of the additional evaluation, a supplemental report will be submitted.

Manufacturer Narrative

Additional images review: no product was returned for evaluation, but ten images were provided.The images show there to be mild to moderate clot in the proximal and distal portions of the stent; however, the amount of clot appeared to have decreased moderately over time.Minimal to mild residual clot was observed, mostly in the proximal part of stent.These images confirm the complaint and show the formation of the clot/thrombus; however, the cause for the problem reported was not seen on the images.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: FRED X21
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15048285
• MDR Text Key: 296131191
• Report Number: 2032493-2022-00280
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107393
• UDI-Public: (01)00842429107393(11)210126(17)231231(10)21012611F
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: XFRED3009-MVE
• Device Lot Number: 21012611F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male