MAUDE Adverse Event Report: MICROVENTION, INC. FRED 4.0X18X12; FLOW DIVERTER

Model Number FRED4012-A

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

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 manufacturing of the device.The device has not been returned to the manufacturer for analysis.

Event Description

It was reported that the stent was unable to be repositioned at the treatment site during deployment and the stent became stuck.Attempts were made to resheath the stent, but they were unsuccessful.There was no reported patient injury or additional intervention.

Manufacturer Narrative

Additional information was provided which indicated attempts were being made to place the stent in the basilar artery.The stent was removed from the patient partially sheathed in the microcatheter, without incident.

Manufacturer Narrative

The reported complaint could not be verified as only the introducer and pusher were returned.The stent was not returned; therefore, functional testing could not be conducted to determine whether the stent could be resheathed.

• Brand Name: FRED 4.0X18X12
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10469046
• MDR Text Key: 204892428
• Report Number: 2032493-2020-00236
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00816777025531
• UDI-Public: (01)00816777025531(11)190416(17)220331(10)19041652K
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: FRED4012-A
• Device Lot Number: 19041652K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1