Events

Rappel de CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native 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 Medtronic Australasia 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-2013-RN-01253-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-26
  • 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-2013-RN-01253-1
  • 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
    Medtronic has received thirty-eight (38) reported nose cone separation events (.08 percent of implant procedures); five (5) of these reported events (.01 percent of implant procedures) led to the need for surgical intervention. a thorough review and investigation of the reported events has identified that a majority of these reported events occurred in situations cautioned against in current labelling. in addition, medtronic has determined that the following situations can lead to nose cone separations:-using the corevalve accutrak dcs to retrieve (remove) a partially deployed valve.- removing the corevalve accutrak dcs from the patient, after valve deployment, without fully closing the corevalve accutrak dcs capsule. -continuing to pull on the corevalve accutrak dcs if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during corevalve accutrak dcs retrieval.
  • Action
    To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials for CoreValve AccuTrak DCS models DCS-C4-18Fr and DCS-C4-18Fr-23. Medtronic is advising that physicians implement the updated IFU recommendations to reduce occurrences of nose cone separation events during the CoreValve implant procedure.

Device

CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Ao...
  • Modèle / numéro de série
    CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)Models DCS-C4-18Fr and DCS-C4-18Fr-23Supplied in Australia under the Clinical Trial Notification (CTN) and Authorised Prescriber Schemes
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA