Events

Safety Alert for PHIL Liquid Embolic System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Microvention Europe || Microvention Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1608-359
  • Event Number
    2015DM-0013279
  • Date
    2016-08-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=124
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected the possibility of dispersion of unwanted particles (metal) in the composition of the device, causing a discoloration of the embolic fluid, leading to its use may cause possible adverse events on patients.

Device

PHIL Liquid Embolic System
  • Model / Serial
    LEN10250, LEN10300 and LEN10350, lots 15062529 - 15102026 - 15102326 - 16040534 - 15052637 - 15092123 || - 16010528 - 1603142 - 15062539 - 15091029 - 16010637.
  • Product Description
    The liquid embolic system (PHIL) is based on an organic solvent, dimethyl sulfoxide (DMSO). The agent is embolicoliquido in a co-polymer soluble in DMSO and insoluble in an aqueous medium. The iodine is linked to the copolymer as the radiopacifier component. The two components of the PHILL are preloaded in a syringe each, ready to use when leaving the package without the need for a preparation pass. The purpose of the PHILL is to be used in the embolization of peripheral lesions and deneurovasculature, including arteriovenous malformations and hypervascular tumors. In the treatment of neurovascular targets, achieve occlusion of blood flow to increase the ease of surgical resection and / or embolized abnormalities without resection. MVLES can be used together with other therapeutic agents and de-embolization, such as occlusion coils and balloons. Additionally, MVLES's viable applications are as an embolization device in cases of hemorrhagic occlusion and vessel sacrifice.
  • Manufacturer
    Microvention Europe || Microvention Inc.

Manufacturer

Microvention Europe || Microvention Inc.