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

Safety alert

903

2008-03-10

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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.

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.