Events

Alerta De Seguridad para CORE VALVE REVALVING SYSTEM - Registered in Anvisa under number 80065320080 - Affected lots - 14AUG2009J - 22AUG2009K - 07DEC2009E - 08FEB2010I - 23APR2010E - See also the distribution list .. (http://portal.anvisa.gov.br/wps/wcm /connect/4684eb8043dbffd5bdd4bf4eca73f154/alerta+1028+2010+distribution+list+.pdf?MOD=AJPERES)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CMS PRODUTOS HOSPITALARES LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1028
  • Fecha
    2010-09-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    It is not a question of withdrawal or discontinuation of use of the product. Anvisa is following the field action.
  • Causa
    Based on customer reports, the following problems were identified in the implant, which will be treated with additional training and changes in implant practices: 1. reports of locking or gripping of the micro button were received during retraction of the protective sheath (where it is contained valve) of the delivery system by positioning the valve (pav) according to the instructions for use. to counteract this locking or adhesion, the maneuver was used to press the macro button up and continue to turn the micro button, successfully. 2. an account was reported describing an attempt to reposition the pav with a traction movement of the delivery system, which resulted in the exposure of the proximal pav loops, releasing it. it is not clear if the macro button has been locked to prevent movement of the pav out of the protective sheath. if the macro button is not locked and the clinician trains the delivery system, the capsule can be opened and the pav released. 3. reports of difficulty were released to release the proximal vas loops from the delivery system sheath, in the final stages of vap implantation. it should be noted that this is a safety alert, not involving recall or discontinuation of the use of the implant system.
  • Acción
    Measures to be taken by the user: The risks when using the CoreValve® system remain low and acceptable; however, training and additional recommendations may lessen the implant problems described above. All users of the CoreValve® system will receive training so that they are aware of the new recommendations and instructions of the new Delivery System. This training will be given by a Medtronic representative (Chief / Implant Therapy Specialist or promoter) between August 11, 2010 and December 17, 2010. Before completing the training, the CoreValve® system can be used in accordance with current practices . In addition, customarily, no implant is performed without the accompaniment of a company professional.

Device

CORE VALVE REVALVING SYSTEM - Registered in Anvisa under number 80065320080 - Affected lots - 14A...

Manufacturer

CMS PRODUTOS HOSPITALARES LTDA