Events

Alerte De Sécurité sur Greenfield Stainless steel vane vial filter. Reg. 10341350319. Lot: 9371382

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 Boston Scientific do Brasil LTDA.;Boston Scientific Corporation.

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
    903
  • Date
    2008-03-10
  • 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
    Manufacturer's Description: Company holding the registration in Brazil: The product registration in Brazil is valid until 11-10-2009. Source: Anvisa / Datavisa / Consultation held on 10-10-2007.
  • Cause
    Boston scientific do brasil ltda. has informed the national sanitary surveillance agency (anvisa) that a death occurred on 09/26/2007, associated with the use of the product for health greenfield stainless steel vial filter - reg. 10341350319, dated september 26, 2007. death was not reported to the technovigilance unit by the hospital. the company imported five units of lot 9371382, all of them commercialized, of which four were implanted, including the case of the patient who died. the unit not implanted was collected by the company.
  • Action
    Immediately after receiving the notification at the UTVIG / Anvisa Technological Surveillance Unit, the epidemiological and health investigation was initiated, together with the three entities of the National Health Surveillance System: Anvisa, through its UTVIG (UTIVIG / Anvisa); São Paulo Health Secretariat (CVS / SES-SP) and Sanitary Surveillance Coordination of the Health Department of the Municipality of São Paulo (Covisa / SSM São Paulo). Among the activities already carried out, the following stand out: analysis of the medical record, meetings with the hospital staff where the death occurred, meetings with medical examiners of the Medical Legal Institute of the municipality where the death occurred, meetings between the three SNVS entities, meetings with the company that holds the record in Brazil. In addition to these activities, CVS / SES-SP published on December 21, 2007 the CVS Communiqué - 245/2007 - Tecnovigilância / DITEP prohibiting the commercialization and use of Lot 9371382 of the product, as well as the collection of non-implanted units. The case is still under investigation by the SNVS. UPDATE: Of the five units imported, four were implemented: i. in the patient who generated this Alert; ii. an 81-year-old patient diagnosed with deep venous thrombosis who developed pulmonary thromboembolism. The patient died due to the severity of his health and not the use of the product; iii. patient with grade III endometrial adenocarcinoma brain metastasis presented deep venous thrombosis, which evolved to death with sepsis as a function of the evolution of pathological state; iv. patient in the 4th episode of pulmonary embolism and had the product implanted, which evolved well, did not present sequelae of post-thrombotic syndrome or another episode of pulmonary embolism. One of the units was not implanted and was collected by the company according to CVS / SES-SP determination.

Device

Greenfield Stainless steel vane vial filter. Reg. 10341350319. Lot: 9371382

Manufacturer

Boston Scientific do Brasil LTDA.;Boston Scientific Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA