MAUDE Adverse Event Report: MICROVENTION, INC. FRED 3.5X17X11; FLOW DIVERTER

Model Number FRED3511

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 not returned to the manufacturer for investigation.The root cause of the complaint cannot be determined.

Event Description

It was reported that after the stent had been deployed approximately 40%, the stent could not be resheathed into the microcatheter.The intermediate catheter was advanced over the stent to remove the device together with the microcatheter from the patient.There was no reported patient injury or additional intervention.The current patient's condition is reported to be good.

Manufacturer Narrative

The stent was returned for evaluation.A new pusher, introducer and microcatheter were used for the investigation.Upon initial investigation, there did not appeared to be damage to the stent.The stent was reloaded onto a pusher and was able to be advanced and resheathed in the catheter.The stent was able to be fully deployed without any issues.The stent did not have issues resheathing.The root cause of this complaint cannot be determined, but may have been due to tortuous anatomy preventing the stent from being able to resheath during the procedure.

• Brand Name: FRED 3.5X17X11
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10115090
• MDR Text Key: 194151682
• Report Number: 2032493-2020-00128
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425020968
• UDI-Public: (01)00811425020968(11)200117(17)221231(10)20011755C
• 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
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: FRED3511
• Device Lot Number: 20011755C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1