Events

Avis De Sécurité sur Pipeline Embolization Device

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 Covidien.

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
    2012-05-12
  • Date de publication de l'événement
    2013-01-17
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/01/17/vazno-obavestenje-o-medicinskom-sredstvu-pipeline-embolization-device-sredstvo-za-embolizaciju-cerebralnih-aneurizmi/
  • 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
    Since commercialization of the pipeline embolization device (ped), covidien has conducted postmarket surveillance of the clinical use of our ped system. our current postmarket data continues to demonstrate morbidity and mortality rates in alignment with those noted in the pufs (pipeline for failed aneurysm) trial that was clinical basis for us commerical approval of the device. rates of major neurologic complications or death in the pufs clinical trial were 5.6% (2.8% for morbidity and 2.8% for mortality). with over 15,000 ped devices implanted to date, the rate of overall morbidity and mortality are 2.6% and 1.6% respectively.

Device

Pipeline Embolization Device
  • Modèle / numéro de série
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ALIMSA