Events

Safety Alert for IMPLANT FOR ANEURISMA MATRIX - Model MATRIX2 Standard 2D SR 8mm x 30cm. Anvisa Registry: 10341350546.

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

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
    1035
  • Date
    2010-11-18
  • 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
    According to the product registration holder in Brazil, during the product implantation procedure there is a risk of foreign body embolization due to the release of the PGLA coating, which could lead to a stroke in the patient (in a more critical scenario) . PGLA is a bioactive polymer that covers the product's platinum spring and, according to Boston Scientific's risk assessment, the increased risk of its detachment (and consequent embolization) is limited to the surgical procedure. 05/2011): Boston Scientific do Brasil Ltda closed the field action on the Matrix product in January 2011, according to a letter sent to UTVIG (file: 083134 / 11-4). According to the company, 13 units of the product were collected in the Brazilian market, out of a total of 1429 units (0.9%).
  • Reason
    Premature degradation of the pgla (polyglycolic-polylactic acid) suture, before expiration of the shelf-life of the product.
  • Action
    Recommended actions to professionals / users / patients of the product: (1) cease use of the product immediately; (2) Segregate the affected units, identifying them so that they are not used inadvertently; (3) Return the product to the record holder (Boston Scientific do Brasil Ltda); and (4) in the case of distributors, notify the customers who own the affected products. The company Boston Ltda has already started collecting the product.

Device

IMPLANT FOR ANEURISMA MATRIX - Model MATRIX2 Standard 2D SR 8mm x 30cm. Anvisa Registry: 10341350...

Manufacturer

Boston Scientific Corp
  • 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