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

Model Number FRED5514-PMA

Device Problems Material Twisted/Bent (2981); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  Injury  

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 was not returned to the manufacturer for analysis.The root cause cannot be determined,.

Event Description

It was reported that after the fred had been deployed in the supraclinoid internal carotid artery (ica), part of the stent did not appear to be opened.A wire, microcatheter, and a guide catheter were used to open the stent.Integrilin was administered to the patient during the procedure.Upon closer inspection post-procedure, the implanted stent appeared to be twisted in the proximal segment.There was no reported patient injury and the patient is reported to be in good condition.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9918024
• MDR Text Key: 191384879
• Report Number: 2032493-2020-00076
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106853
• UDI-Public: (01)00842429106853(11)190507(17)220430(10)19050754NM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED5514-PMA
• Device Lot Number: 19050754NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention