Events

Safety Alert for Trade name: Innova Over the Wire - Self-expanding Stent. Technical Name: Stent for Peripheral Arteries. ANVISA registration number: 10341350762. Class of risk: III. Model affected: Innova 180mm; Innova 20mm. Serial numbers affected: 17360209; 17363938; 17369922; 17468906; 17393388; 17379139; 17339472; 17389600; 17349970; 17515256; 17631664; 17717276; 17567309; 17363935; 17400326; 17733644; 17759557; 17779595; 17751229; 17692709; 17563580; 17515257; 17751231; 17879723; 17933183; 17645316; 17837622; 17884340; 17918022; 17977931; 18002828; 17993487; 17351561; 18004286; 18008900; 18010628; 17916568; 17968687; 18065189; 18025896; 18045282; 18006854; 18010629; 17951215; 18151350; 17959306; 18085879; 18065191; 18010625; 18085873; 18320374; 18028548; 18065193; 18194261; 18261826; 18270159; 17842281; 17933192; 18193713; 17507374; 18305612; 18350856; 18360974; 18242556; 17672511; 17974380; 18251442; 18205490; 18320373; 18028547; 18261827; 18311336; 18412269; 18290109; 18268062; 18356937; 18320365; 18393665; 18305640; 18412264; 18242554; 18431548; 18305613; 18412278; 18447004; 18530138; 17565344; 18463399; 18045281; 18587999; 18505164; 17349971; 18412270; 18463751; 18363018; 18074216; 17900991; 18320379; 18363017; 18572704; 18523620; 18431551; 18592948; 18488417; 18775746; 18920644; 18708475; 18771905; 18523626; 18505175; 18813754; 18065192; 18708601; 18530131; 18838475; 18838474; 18598903; 18010634; 18999958; 18713953; 18813758; 18478732; 18972076; 18972078; 18,754,507; 19105369; 18682281; 17360218; 19021789; 19129190; 18591335; 18881999; 19134315; 19039522; 19178740; 19048097; 19155962; 19129192; 19139328; 18628195; 19129188; 18785731; 19178742; 19129191; 19406217; 19367657; 19454503; 19079547; 18934945; 19426951; 18751467; 19458596; 19237436; 19574803; 18802852; 19684641; 19178744; 19105371; 19178747; 19469659; 19602765; 19597809; 19654093; 19728400; 18892416; 19699232; 20013954; 19858438; 20013951; 20084781; 19664962; 19597807; 19786768; 19129193; 20013953; 20089472; 20149243; 20133564; 20205065; 20313037; 20233662; 19212926; 19238403; 20234802; 20013943; 20223203; 20176442; 20210386; 19775531; 19039533; 19294321; 20244724; 20410523; 20347584; 20042126; 19984995; 20316577; 19946630; 20303720; 20109694; 20234804; 20427173; 20127894; 20313036; 19946636; 20303721; 20642269; 20589399; 20042120; 20478645; 19907848; 20247006; 20171185; 20791401; 20557178

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda.; Boston Scientific Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2405
  • Date
    2017-11-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    1. Discontinue use immediately and segregate the product to be collected. • Immediately remove all products affected by this withdrawal from your stock. • Please dispose of this product in a safe place for return to Boston Scientific. 2. Complete and return the Response Verification Tracking Form. • Report all stock to be returned and report it in unit quantity (s), not in boxes. • Return the Response Verification Tracking Form. 3. Pack / Deliver the Product Taken. If you wish to notify 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: 02/11/2017 - Date of notification notice to Anvisa: 10/11/2017 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. (...) "
  • Reason
    Boston scientific is initiating a voluntary withdrawal of the innova ™ 180 mm and 200 mm self-expanding stent system due to the high complaint rates related to partial stent implantation. the partial implant occurs when the stent is unable to be fully released from the delivery system. part of the stent may be anchored to the vessel, while the rest of the stent remains within the delivery system. no other size of the innova ™ stent system is included in this voluntary withdrawal. additionally, this action does not include previously deployed devices.
  • Action
    Field Action Code 92169170-FA / ref 2017-008 triggered under the responsibility of Boston Scientific do Brasil Ltda. Will do Recolhimento.

Device

Trade name: Innova Over the Wire - Self-expanding Stent. Technical Name: Stent for Peripheral Art...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific Corporation
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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