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

Model Number MV-F403827

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

Patient Problems Infarction, Cerebral (1771); Paralysis (1997)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was not available.Therefore, a search for non-conformances associated with the device's part/lot number combination could not be performed.The device was not returned to the manufacturer for evaluation.The cause of the event cannot be confirmed.No information suggesting there was a device malfunction was received by the manufacturer.The instructions for use (ifu) identifies neurologic deficits including stroke as a potential complication associated with the procedures in which the device is used.

Event Description

It was reported that the fred was implanted without incident as treatment for a fusiform basilar aneurysm.The day after the procedure, the patient developed paralyses on the right face and lower extremities, sensory disturbance in the right upper and lower extremities, and left eye abduction.An mri demonstrated a cerebral infarction at the left pontomedullary junction.Edaravone was administered to the patient.No thrombus was observed in the fred; however, a perforating branch infarction was identified at the site of the fred deployment.The patient's current condition is unknown.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10497287
• MDR Text Key: 205891533
• Report Number: 2032493-2020-00243
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MV-F403827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 74 YR