MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number FRED3014-PMA

Device Problems Activation Failure (3270); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination could not be conducted, as the part and lot number are not available.The stent was returned fully deployed and appeared damaged.The pusher was returned damaged at the proximal end and at the distal coil.The stent could not be loaded onto a pusher for investigation due to the damage to the proximal long loop.The damage to the proximal long loop and pusher is consistent with excessive force used in attempting to advance the stent and retrieving the stent with a snare during the procedure.

Event Description

It was reported that the proximal portion of a fred stent did not open properly.The delivery pusher then got caught in one of the flared ends of the stent.The fred device was snared and removed.Another fred device was then used to treat the patient.There was no reported patient injury or further intervention.

• Brand Name: FRED 21
• 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: 11573146
• MDR Text Key: 242383048
• Report Number: 2032493-2021-00092
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106624
• UDI-Public: (01)00842429106624(11)200610(17)230531(10)20061054V
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: FRED3014-PMA
• Device Lot Number: 20061054V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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