Alerte De Sécurité sur Trade name: Thoracic Gastro TAG Endoprosthesis. Technical name: Endoprosthesis (vascular). ANVISA registration number: 80067930032. Risk class: IV. Model Affected: AW1346-PT3. Serial Numbers Affected: N / A

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 W. L. Gore & Associates do Brasil Ltda.; W. L. Gore & Associates, Inc..

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
    2399
  • Date
    2017-10-17
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    Gore is updating the Device Instructions for Use to include the following warnings and precautions: (1) If you feel the abnormal or inconsistent resistance of the discharge line during the initiation of the delivery, STOP the delivery action immediately. If the device remains restricted, remove the device through the introducer sheath. If you feel resistance during the removal of the restricted endoprosthesis, stop and remove the device and the introducer sheath together; (2) If the device is restricted or attached to the catheter and remains in a partial delivery state, the physician should seriously consider immediate conversion to open surgical repair to avoid additional procedure time and potential impairment of additional endovascular maneuvers. Gore also recommends adhering to approved device prompts and reviewing current device warnings on the UI. The full Use Instructions should be reviewed for all indications, contraindications, instructions, warnings, precautions, etc. There are no actions required for patients who received the device. Patients who wish to report technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 07/31/2017 - Date of notification notice for Anvisa: 10/17/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    Since december 2016, gore has received 4 similar reports of incomplete and / or partial deliveries of the ctag device. at each event, the physician noted that a portion of the ctag device opened and the other portion remained restricted in the delivery catheter. engineering evaluations for two returned devices indicated that one of the partial openings was the result of an incorrect seam in the delivery line and another was the result of a damaged delivery line (the origin of the damage is unknown). the other two devices were not returned. the potential failure modes of all events have not yet been determined and the investigation continues. even though deliveries or incomplete openings are known and identified adverse events in the instruction of use (ui), gore has seen a higher frequency (in total 0.03%) of similar events in ctag devices that were manufactured between may 4, 2016 and may 3, 2017. this deadline represents the date on which the delivery sleeve of the first event was manufactured (may 4, 2016) and the date on which a new training for operators was completed (may 3, 2017) with an emphasis on adherence to manufacturing procedures. the term also includes the date of manufacture of all sleeves and final products for the devices involved in the four events mentioned above.
  • Action
    Field Action Code 001/2017 triggered under the responsibility of the company WL Gore & Associates do Brasil Ltda. It will update, correct or supplement the instructions for use.

Manufacturer