Events

Avis De Sécurité sur HeartMate 3™ Left Ventricular Assist System

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Abbott.

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
    2017-05-18
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Abbott has observed cases in which the outflow graft bend relief (ogbr) on the heartmate 3 (hm3) left ventricular assist system (lvas) was not fully and evenly secured to the outflow graft. as a result, we conducted an internal review of x-rays from both the u.S. momentum 3 ide and continuous access protocol (cap) studies, and identified additional cases where the ogbr was not properly secured. at this time, we are providing you this letter to notify you of updated patient management recommendations and a new training to reinforce the ogbr connection technique described in the hm3 lvas instructions for use (ifu). .

Device

HeartMate 3™ Left Ventricular Assist System
  • Modèle / numéro de série
    # 106524INT 105581INT – Packaged assembly Outflow, HM3(INT)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS