Events

Avis De Sécurité sur PERCEVAL S

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par SORIN GROUP ITALIA S.R.L. / LivaNova.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2018-06-18
  • Date de publication de l'événement
    2018-02-10
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2018/10/02/vazno-obavestenje-o-medicinskom-sredstvu-perceval-s-srcana-valvula-bioloska-aortna/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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