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

Model Number MV-F501927

Device Problem Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 09/17/2020

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 the manufacturing of the device.The device was not returned to the manufacturer for evaluation; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that during deployment of the fred to treat an internal carotid artery (ica) aneurysm, the stent did not completely open after several repositioning attempts.Angiography was then performed, which demonstrated a new carotid cavernous fistula.The stent was withdrawn from the patient and the procedure was completed successfully with another flow diverter.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10693167
• MDR Text Key: 211759148
• Report Number: 2032493-2020-00291
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121951
• UDI-Public: (01)04987892121951(11)200218(17)230131(10)20021858K
• 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: 10/16/2020

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: 01/31/2023
• Device Model Number: MV-F501927
• Device Lot Number: 20021858K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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: 69 YR