Rappel de Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biotronik 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-2015-RN-00440-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-25
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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
    Biotronik has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. stents that have already been implanted are not affected as the issue occurs during deployment of the stent.
  • Action
    Users are advised to discontinue any further use of the affected stock and remove them from their inventory. A sales representative will contact customers to collect the affected stock. This action has been closed-out on 02/12/2016.

Device

  • Modèle / numéro de série
    Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) Pulsar-35Product Codes: 379921, 379941, 379926, 379946, 379931, 379951Specific LotsARTG number: 169368 Pulsar-18 Product Codes: 366812, 366832, 366817, 366837, 366822, 366842, 366827, 366847Specific LotsARTG number: 142025
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DHTGA