Events

Rappel de Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LivaNova Australia Pty Ltd.

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
    RC-2016-RN-01197-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-10-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01197-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Following some cases (55 out of 16048 devices sold) of intra/peri-operative central leak, livanova is providing clarifications about the implant techniques for the perceval sutureless aortic heart valve and bringing to the attention of users some steps that may influence procedural success and potential complications. this information is being provided in the document im-00763 perceval implant key points and will subsequently be integrated into upcoming revisions of the instructions for use (ifu) and the inservice guide training material.
  • Action
    LivaNova is providing users with information that clarifies implantation steps, in the form of the document IM-00763 Perceval Implant Key Points. Upcoming revisions of the IFU and InService Guide will incorporate this information. This action has been closed-out on 16/02/2017.

Device

Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
  • Modèle / numéro de série
    Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd