Events

Safety Alert for BEGRAFT BENTLEY Coronary Stent System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Bentley Innomed Gmbh.

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
    R1706-247
  • Event Number
    2014DM-0011011 ; 2014DM-0012309
  • Date
    2017-06-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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 has identified that the use of the referenced devices has presented problems related to the compatibility of use with the 7 f sheath, since the passage through the sheath can be critical, it could cause prolonged bleeding times or perforations of the vessel, leading to their potential presentation. adverse events on patients.

Device

BEGRAFT BENTLEY Coronary Stent System
  • Model / Serial
  • Product Description
    Indicated for transluminal implantation in the coronary arteries or grafts derived from the aorta-coronary for the treatment of: acute perforation or rupture of the coronary arteries, aneurysms of the coronary arteries or vein bypass graft. Patients who are being considered for endoprosthesis implantation must be acceptable candidates for coronary artery bypass graft surgery. Indicated for chronic intraluminal implant in renal oilic arteries for restoration and improvement of distensibility and treatment of aneurysms and perforations, ruptures and fistulas sharp
  • Manufacturer
    Bentley Innomed Gmbh

Manufacturer

Bentley Innomed Gmbh