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

Model Number UNKNOWN

Device Problem Activation Problem (4042)

Patient Problem Aneurysm (1708)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and was not available for return to the manufacturer for analysis.Medical imaging was not available.Therefore, the reported event could not be confirmed.

Event Description

It was reported that a fred stent was implanted approximately one year ago to treat an unruptured aneurysm of the right ica.The patient eventually started to experience symptoms again and the device was not diverting flow as effectively.The proximal portion of the stent had shortened and another stent had to be implanted.The second procedure was completed successfully.There was no reported patient injury.

• Brand Name: FRED
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15859240
• MDR Text Key: 304276597
• Report Number: 2032493-2022-00430
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• 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