Events

Rappel de Device Recall Ovation Prime Abdominal Stent Graft System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Trivascular, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67672
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1297-2014
  • Date de mise en oeuvre de l'événement
    2014-02-27
  • Date de publication de l'événement
    2014-03-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126008
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Cause
    Communication to european physician users of the ovation prime abdominal stent graft system to notify them of changes to instructions for use.
  • Action
    Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instructed to contact their local TriVascular representative. For questions regarding this recall call 707-543-8805.

Device

Device Recall Ovation Prime Abdominal Stent Graft System
  • Modèle / numéro de série
    All codes
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
  • Description du dispositif
    Ovation Prime Abdominal Stent Graft System; || Manufacturer: || TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 || The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
  • Manufacturer
    Trivascular, Inc

Manufacturer

Trivascular, Inc
  • Adresse du fabricant
    Trivascular, Inc, 3910 Brickway Blvd, Santa Rosa CA 95403
  • Société-mère du fabricant (2017)
    Endologix Inc.
  • Source
    USFDA