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

Model Number MV-F401227

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

Patient Problems Hemorrhage, Cerebral (1889); Rupture (2208); Cerebral Edema (4403)

Event Date 07/13/2020

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 was not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.

Event Description

It was reported that treatment was performed for an aneurysm in the middle cerebral artery (mca).As the distal flare of the fred stent was deployed in the m2, the microcatheter was pulled too much and the stent was pulled down to c1.As the microcatheter was pushed to redeliver the stent to the m2, the stent slid into the aneurysm.After withdrawal of the microcatheter and the fred, subsequent angiography demonstrated a rupture of the aneurysm.A balloon catheter was delivered across the aneurysm neck to stop blood flow to the aneurysm.Approximately fifteen (15) coils were placed in the aneurysm and hemostasis was achieved.Another fred was then placed at the aneurysm as originally planned.Heparin was not reversed.There appears to be no damage to the brain stem.The patient was reported to be in serious condition, but is recovering.

Manufacturer Narrative

Follow-up information was provided that indicated the day after the procedure, extensive cerebral infarction and brain swelling were observed in the ipsilateral cerebral hemisphere.Decompressive craniotomy was performed and medications were administered; however, there was no improvement and the patient died on (b)(6) 2020.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10396973
• MDR Text Key: 202578407
• Report Number: 2032493-2020-00198
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121845
• UDI-Public: (01)04987892121845(11)200211(17)230131(10)20021151C
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: MV-F401227
• Device Lot Number: 20021151C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention