Events

Safety Alert for Clip Delivery System - Mitraclip System, model CDS02ST, registration 80146501877, Risk class IV. The following lots are in stock at Abbott Vascular: 50930U101, 50930U102. 50930U103, 50930U104, 50930U105, 50930U106, 50930U107, 50930U108, 50930U110, 50930U111, 50930U112, 50930U113, 50930U115, 50930U116, 50930U117, 50930U118, 50930U119, 50930U126, 50930U132, 50930U129, 50930U128, 50930U131, 50930U130, 50930U127, 50930U133, 50930U134, 51118U106, 51118U113, 51118U119, 51118U128.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Evalve Inc..

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
    1815
  • Date
    2016-02-04
  • 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
    Cases reported as serious adverse events resulted in surgical interventions and, in one case, the patient died after the operation due to severe comorbidities. After investigating the case, Abbott Vascular has determined that a chuck fracture may occur if stress is exerted on the Single-Directional Knob to implant the Clip. Tension occurs if the Arm Positioner is not in Neutral position during clip release.
  • Reason
    Nine case reports related to the single-directional pushbutton clip delivery system device (batch number 50714u1 and above) according to which the user attempted to deploy a mitraclip but could not remove the clip from the delivery system due to a fracture in the mandrel. the chuck is an internal component of the clip delivery system, integral to the operation and deployment of the clip. after investigating the case, abbott vascular has determined that a chuck fracture may occur if stress is exerted on the single-directional drive knob to implant the clip.
  • Action
    Safety notice. Change of Instructions for Use. Action Code: February 4, 2016. As long as the user follows the procedure described in the revised instructions for use contained in the notice of this field action, there are no consequences for the use of products at risk. It should be noted that in addition to this statement, Abbott Vascular has a trained professional to follow all the procedures that involve the use of the product in Brazil, ensuring the correct use by the physician, according to the new instructions.

Device

Clip Delivery System - Mitraclip System, model CDS02ST, registration 80146501877, Risk class IV. ...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Evalve Inc.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA