MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number FRED4007-PMA

Device Problems Activation Failure (3270); Migration (4003)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2021-00192.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for evaluation.Intraprocedural images were provided.The provided images show the first fred stent foreshortening, thrombus formation with blockage of flow, use of pta and placement of a second fred stent and use of aggrastat to treat thrombus and reestablish flow.Without the returned and physical evaluation of the device, the investigation is unable to determine if a condition existed that caused or contributed to the reported event.The instructions for use identifies thrombosis and migration or misplacement as potential complications associated with use of the device.

Event Description

It was reported that a fred stent was implanted to treat a supraclinoid wide neck aneurysm.Immediate post implantation imaging showed good wall apposition, aneurysm status, and good perfusion.Three minutes later, a second angio run was performed and there was complete occlusion of fred with no distal perfusion and the device appeared to have thrombus affixed to it.After taking additional spot fluoro images, the device did not appear fully open, it had foreshortened, and it had also migrated proximally.Aggrastat ia was administered and percutaneous transluminal angioplasty (pta) was performed twice.A second fred stent was implanted since the first stent was no longer covering the aneurysm.Angio showed good wall apposition and reperfusion, but thrombus continued to form.Further medication was administered and pta was performed, but clot continued to form.The physician repeated pta multiple times and after waiting 15 minutes, patient had adequate flow.The physician decided to stop the case and see how the patient woke up.Post anesthesia, the patient woke up moving all extremities and was able to speak.This event refers to the first stent implanted.

Manufacturer Narrative

A follow-up email received on 05/28/2021 indicated that the patient had a stroke 5 days post-procedure and was entering hospice.It was also indicated that the proximal end of the stent was not opening or filling properly.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11904851
• MDR Text Key: 256279127
• Report Number: 2032493-2021-00191
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)190507(17)220430(10)190507547M
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED4007-PMA
• Device Lot Number: 190507547M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 85