Safety Alert for Business Name: HeartMate 3 - Left Ventricular Assist System. Technical Name: Other Cardiovascular Implants. ANVISA registration number: 10332340428. Class of risk: IV. Affected Model: HeartMate 3. Serial Numbers Affected: Model: 10010167 - Series Numbers: MLP-009201; MLP-009203; MLP-009205, MLP-009206; MLP-009207; MLP-009667

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by St. Jude Medical Brasil LTDA; Thoratec 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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Information for physicians to manage patients who will receive an implant or who already had an implanted HM3 device: • During the implant, by fitting the Outflow Graft to the Pump Cap, a click sound should be heard while the Screw Ring is being tightened. Continue to rotate the screw ring clockwise until it stops completely and stop making click sound for a tight hand tight connection. • If a low-flow alarm persists at any time after implantation, and other potential causes such as hypertension, low preload, right heart failure, and influx occlusion were considered as cause, computed tomography (CT) angiography should be performed to identify possibility of occlusion of the graft of the graft output. • If surgical repair of the exit graft is necessary due to a torsion occlusion, the flexion relief of the exit graft must be reconnected in its original state or repaired to avoid further folds or occlusion of the graft. Physicians who manage patients who exhibit a persistent low-flow alarm should determine home-based patient care recommendations based on a single clinical case. 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: 05/04/2018 - Date of notification notice to Anvisa: 04/06/2018 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
    This is a guiding action so doctors can manage patients who will receive an implant or who have already had an implanted hm3 device. the company received reports of flow outflow occlusions by twisting the graft in the hearttmate 3 (hm3) left ventricular assist system. as a result, patients whose devices exhibit these flow occlusions will experience a persistent low-flow alarm. graft twisting in the outflow can result in serious adverse events such as hemodynamic compromise, thrombosis and death.
  • Action
    Field Action Code HM3-04-18 triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Update, correction or complementation of the actions of use.