Events

Field Safety Notices about PERCEVAL S

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by SORIN GROUP ITALIA S.R.L. / LivaNova.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2018-06-18
  • Event Date Posted
    2018-02-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2018/10/02/vazno-obavestenje-o-medicinskom-sredstvu-perceval-s-srcana-valvula-bioloska-aortna/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    In the past ten years, 49 complaints have been filed pertaining to the folding of perceval, with an increase in the number of cases in 2017, with complaints more frequently reported in sizes s and m. stent bending is defined as the deformation of the stent inwards at the level of the annulus. a key cause of bending a stent is the large size of the valvular, associated with other factors. in addition, patients who have perceval valvula implanted may experience bending of the valvular stent when emergency cardiovascular procedures are followed after implantation, such as cardiopulmonary resuscitation ("cpr"). bending the valvular stent can lead to paravalvular or central leakage, in some cases associated with high pressure, which may be significant enough to require reoperation.

Device

PERCEVAL S

Manufacturer

SORIN GROUP ITALIA S.R.L. / LivaNova