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

Model Number MV-F552627

Device Problems Retraction Problem (1536); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 was returned to the manufacturer for investigation.The investigation is underway.

Event Description

It was reported that during deployment of the fred stent, the stent did not deploy "properly" approximately 10 to 15mm from the distal end of the stent.An attempt was made to resheath the stent, but the resistance was too high and the stent could not be retrieved into the microcatheter.The stent was withdrawn using the intermediate catheter and successfully removed from the patient.There was no reported patient injury.The current condition of the patient was reported to be "no health damage.".

Manufacturer Narrative

The stent was returned for evaluation.Upon initial inspection, the stent was found damaged.The stent was too damaged to be loaded onto a new pusher, and therefore further investigation into the stent's ability to deploy could not be conducted.The root cause of the complaint may have been due to the friction and resistance felt when attempting to resheath, and pulling the stent back may have damaged the stent during the procedure.The microcatheter used in the procedure was not available to be evaluated, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10193002
• MDR Text Key: 196999593
• Report Number: 2032493-2020-00145
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121982
• UDI-Public: (01)04987892121982(11)200215(17)230131(10)200215515
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: MV-F552627
• Device Lot Number: 200215515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1