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

Model Number FRED4017-PMA

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

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 received by the manufacturer for investigation.

Event Description

It was reported that approximately 25% of the stent could not be recaptured by the microcatheter.The stent and microcatheter were withdrawn together into the intermediate support catheter and removed from the patient without incident.There was no reported patient injury.The patient's final condition was 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 observation, no damage was found on the stent.The stent was reloaded back into the introducer and deployed through the microcatheter without issue.The root cause of the complaint cannot be determined, as the stent was undamaged and was able to be recaptured.The root cause of this complaint may have been due to tortuous anatomy which may have made it difficult to retrieve during the procedure.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10197775
• MDR Text Key: 203830692
• Report Number: 2032493-2020-00152
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106730
• UDI-Public: (01)00842429106730(11)191007(17)220930(10)19100755TM
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: FRED4017-PMA
• Device Lot Number: 19100755TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1