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

Model Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the part/lot number combinations of the actual devices could not be performed, as the part and lot numbers were not provided.The devices were implanted in the patient and not returned to the manufacturer for analysis.Procedural or post-procedural images were not provided; therefore the reported event could not be confirmed.The instructions for use identifies rupture or perforation of the aneurysm, stent thrombosis, and device migration as potential complications associated with use of this device.

Event Description

As reported through the article titled, "safety and efficacy results of the flow redirection endoluminal device (fred) stent system in the treatment of intracranial aneurysms: us pivotal trial," after undergoing aneurysm treatment with a fred stent, re-treatment occurred in eight subjects four were carried out to deal with complications of aneurysm rupture or thrombosis, and four because of continued aneurysm filling.Three of these treatment failures were due, at least in part, to device migration (or foreshortening).All eight subjects were re-treated by placement of additional flow diverters.".

• Brand Name: FRED
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12364216
• MDR Text Key: 268019468
• Report Number: 2032493-2021-00345
• Device Sequence Number: 1
• Product Code: OUT
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention