Events

Retiro De Equipo (Recall) de ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por COOK (CANADA) INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    120539
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-06-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    William cook europe aps has learned of an issue affecting the zenith alpha thoracic endovascular grafts. as described in the recent field safety notice 2017fa0001 of march 2017 regarding the zenith alpha thoracic endovascular graft there were complaints involving thrombosis/occlusion of the product when used to treat blunt thoracic aortic injury (btai). since that time cook medical has received additional complaints for the same problem. although the complaints were from patients treated prior to issuance of the above noted field safety notice cook medical is initiating a voluntary correction of the instructions for use (ifu) and is also voluntarily removing specific sizes of the zenith alpha thoracic endovascular graft from the market. the manufacturer is voluntarily removing the indication for blunt thoracic aortic injury. the specific sizes of 18-22 mm used for the btai indication is being recalled from the market and will no longer be available. the instructions for use (ifu) will be corrected for the remaining sizes on the market used for endovascular treatment of patients with isolated lesions of the descending thoracic aorta.

Device

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT
  • Modelo / Serial
    Model Catalog: ZTA-DE-26-104 (Lot serial: ALL); Model Catalog: ZTA-D-46-211 (Lot serial: ALL); Model Catalog: ZTA-D-44-211 (Lot serial: ALL); Model Catalog: ZTA-D-42-204 (Lot serial: ALL); Model Catalog: ZTA-D-40-197 (Lot serial: ALL); Model Catalog: ZTA-D-40-147 (Lot serial: ALL); Model Catalog: ZTA-D-38-197 (Lot serial: ALL); Model Catalog: ZTA-D-36-190 (Lot serial: ALL); Model Catalog: ZTA-D-34-190 (Lot serial: ALL); Model Catalog: ZTA-D-32-160 (Lot serial: ALL); Model Catalog: ZTA-D-30-160 (Lot serial: ALL); Model Catalog: ZTA-P-46-233 (Lot serial: ALL); Model Catalog: ZTA-P-46-179 (Lot serial: ALL); Model Catalog: ZTA-P-46-152 (Lot serial: ALL); Model Catalog: ZTA-P-46-125 (Lot serial: ALL); Model Catalog: ZTA-P-44-233 (Lot serial: ALL); Model Catalog: ZTA-P-44-179 (Lot serial: ALL); Model Catalog: ZTA-P-44-125 (Lot serial: ALL); Model Catalog: ZTA-P-42-225 (Lot serial: ALL); Model Catalog: ZTA-P-42-173 (Lot serial: ALL); Model Catalog: ZTA-P-42-121 (Lot serial: ALL); Model Catalog: ZTA-P-40-217 (Lot se
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.