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

Model Number XFRED2508-MVE

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

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 05/24/2022

Event Type  Injury  

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 and hemorrhage as potential complications associated with the use of the device.

Event Description

It was reported that ten minutes post-implantation of a flow diverter a thrombus was observed.The patient later required additional device implantation and medication and post-treatment, a sab in the treatment area was observed and the patient was under observation.Treatment was performed on a small aneurysm on the right media artery.Implantation of the flow diverter was performed without any issues.Ten minutes post-implantation a thrombus was observed in the proximal part of the device.A bolus of integrilin was given and a further perfusion of integrilin was administered for 24 hours.Four days post index procedure an mri showed an infarction of the central region without clinical symptoms; the patient was discharged from hospital four days post index procedure.Twenty-one days post index procedure, the patient returned with left hemiparesis and testing showed an infarction of the basal ganglia; in-stent stenosis was observed.The multiplate test before the angiography prove the efficiency of the medication.The patient was responding to the antiplatelet therapy.Heparin was given additional to ass + plavix.The patient was referred to the critical care unit for observation.Thirty days post index procedure, a control angiography was performed and a progredient stenosis of the initially implanted flow diverter was observed.Treatment via implantation of a competitor coronary flow diverter was planned.After crossing the initially implanted flow diverter with a guidewire, a predilatation of the stenosis was performed with 1.5 mm balloon.A second dilatation with a balloon was not possible.A competitor device 2.5/14 was implanted.Post-implantation, a thrombus formation was observed inside the stents/stenosis in both devices.Integrilin was given and the thrombus dissolved.The examination was finished with good result.The patient was transferred to the critical care unit for observation.Later the same day, after re-treatment/implantation of the competitor device, the patient showed a sab in the stented area.Thirty-five days post index procedure, the patient was stated to be under observation.Follow-up imaging was planned.The device remains implanted in the patient.

Manufacturer Narrative

Corrections: h6: health effect - impact code: add 4624 component code: remove 4755; add 515 b5: additional information was received stated that an angiography result from (b)(6) 2022 revealed a progredient blister aneurysm at the media artery.The aneurysm was treated with a coil and a competitor flow diverter and the aneurysm was occluded post treatment.Ventilation of the patient ceased on (b)(6) 2022.The patient experienced pneumonia post implantation of the fred x.The patient was released from the hospital on (b)(6) 2022 and transferred to a rehabilitation center with a report that rehabilitation was ongoing.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

Image review: no product was returned for evaluation, but nine dsa images were provided.The images initially show the stent well positioned, less filling of the aneurysm, and with no thrombus.A mild amount of thrombus is later observed in the mid portion of the stent, proximal to the aneurysm (seen as attenuation of contrast material).Mild attenuation in the mid portion of the stent was observed, where the prior clot, or early stenosis, had been seen; furthermore, there may have been a small dissection in the mid portion of the stent.After the second (coronary) stent was implanted, it was observed that the dissection was resolved and there was very minimal smooth narrowing in the mid portion of the stents, but the aneurysm was still occluded.These images confirm the complaint and show the presence of a thrombus; however, the images do not explain the cause of the thrombus formation on the treatment day, or of the stenosis on the follow-up.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: 15048436
• MDR Text Key: 296135959
• Report Number: 2032493-2022-00281
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107355
• UDI-Public: (01)00842429107355(11)210112(17)231231(10)21011212P
• 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: XFRED2508-MVE
• Device Lot Number: 21011212P
• 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: 01/12/2021
• 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: 62 YR
• Patient Sex: Female