Events

Rappel de IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of small peripheral arteries)Supplied in Australia under the Special Access Scheme (SAS)

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-01153-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-08
  • 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-01153-1
  • 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
    Based on data from clinical study, the in.Pact amphirion drug-eluting balloon (deb) did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty (pta) control. the study also identified a potential safety signal given a trend towards an increased rate of major amputations in the deb study arm. causality between major amputation and use of the in.Pact amphirion deb could not be established or excluded.
  • Action
    Medtronic is advising hospitals to quarantine all units of the IN.PACT Amphirion DEB that remain in their inventory.

Device

IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of s...
  • Modèle / numéro de série
    IN.PACT Amphirion Drug-Eluting Balloon (DEB) (used for percutaneous transluminal angioplasty of small peripheral arteries)Supplied in Australia under the Special Access Scheme (SAS)
  • 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