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

Model Number	FRED3014-PMA
Medical Device Problem Codes	Activation Failure (3270); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11573146
• Report Number: 2032493-2021-00092
• Device Sequence Number: 11668042
• Product Code: OUT
• UDI-Device Identifier: 00842429106624
• UDI-Public: (01)00842429106624(11)200610(17)230531(10)20061054V
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: FRED3014-PMA
• Device Lot Number: 20061054V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention