Events

Alerte De Sécurité sur Cava Vein Filter ALN, Anvisa Registry # 80202910017, Lots 0107A, 0207A, 0307A and 0407A.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ALN Implants Chirurgicaux.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    928
  • Date
    2008-06-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    CAUTION: Report any circumstances of migration of this filter to Tecmedic Comércio de Produtos Médicos and to Anvisa, as well as any observed problem (or occurrence involving the product). For Anvisa, the notification must be sent through the NOTIVISA System available on the website: www.anvisa.gov.br According to the international alert, the free substitution of the product should be carried out by the company ALN Implants Chirurgicaux, in Brazil, the responsible for the product is the company Tecmedic Comércio de Produtos Médicos. MEASURES ADOPTED BY UTVIG / Anvisa: The Technovigilance Unit has maintained contact with the holder of the product registration in the country in order to follow the adoption of the measures directed by the manufacturer. In due course, the information contained in this alert will be complemented and updated here.
  • Cause
    The company aln received three complaints of incidents in which the filters of the abovementioned lots migrated. while non-filter factors (abdominal surgery and abnormal vena cava morphology) were able to explain the migration in 2 or 3 cases, analyzes made by the manufacturer revealed that the angle between the short legs and the sharp tip of the filter was slightly larger than the angle, potentially decreasing the filter attachment power, resulting in a higher frequency of filter migration. in addition, the aln states that this failure may result in the retention of the securing legs within the introducer catheter, which may result in inhibiting the implantation of the filter. aln initiated a recall by letters on february 21 and march 7, 2008. the uk's mhra - medicines and healthcare products regulatory agency is evaluating the nature of this action for further advice. the mhra has designated 2007/012/012/401/002 as the reference number for this recall.
  • Action
    Verify that the letters of February 21 and March 7, 2008 were received along with the ALN response form and / or local distributor. Identify and isolate any affected product in stock. With or without recall products, complete the form and return it to the ALN and / or local distributor by fax, as instructed. ATTENTION: PHYSICIANS SHOULD CONTACT PATIENTS IN WHICH FILTERS WERE IMPLANT AND CHECK THE ABSENCE OF FILTER MIGRATION THROUGH ABDOMINAL X-RAY.

Device

Cava Vein Filter ALN, Anvisa Registry # 80202910017, Lots 0107A, 0207A, 0307A and 0407A.

Manufacturer

ALN Implants Chirurgicaux
  • Société-mère du fabricant (2017)
    A.L.N.
  • Source
    ANVSANVISA