MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number FRED2513-PMA

Device Problem Unintended Movement (3026)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/16/2021

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 implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that a fred stent was implanted to treat a ruptured aneurysm located at the bifurcation of the pericallosal and callosomarginal arteries.The fred moved during unsheathing but ultimately covered the aneurysm.A filling defect was noticed in the callosomarginal artery amd integrillin was administered.The filling defect was then observed to be resolved.The patient was placed on cangrelor post procedure and woke up with no neurological deficit.Mri showed no infarct the following day.

• Brand Name: FRED 21
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11676287
• MDR Text Key: 245748466
• Report Number: 2032493-2021-00135
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106587
• UDI-Public: (01)00842429106587(11)200916(17)230831(10)200916566
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FRED2513-PMA
• Device Lot Number: 200916566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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