Events

Safety Alert for LOTUS VALVE SYSTEM Technical Name: Heart Valve Prosthesis ANVISA Registration Number: 10341350785 Hazard Class: IV Model Affected: H749LTV230; H749LTV270; H749LTV250

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 Limited.

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
    2223
  • Date
    2017-02-23
  • 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
    If you identify any product from the affected batches within your inventory, please quarantine the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. If you are a distributor, please note that the depth of this action is up to the hospital level, and this notification should be forwarded to all of your customers. 1. Discontinue use immediately and segregate affected product. • Immediately remove all affected products from your inventory • Segregate this product in a safe place for return to Boston Scientific. 2. Complete and return the Response Verification Tracking Form (FRVR). • Complete the attached Response Verification Tracking Form (even if you do not have any product to return) by following the instructions on this page and the Response Verification Tracking Form. • Return the Account Response Verification Tracking Form: Email: calidad@bsci.com or Fax to: 5545-9001 Please email or fax your Verification Tracking Form (s) to Answer immediately. You will be contacted by Boston Scientific and will receive a Returned Goods Authorization (RGA) number after your FRVR is received. When returning the product, return the original form with the returned products. 3. Pack / Ship the Affected Product. • Pack any product being returned in an appropriate shipping box. • Attach a shipping label to the outside of the shipping carton. • Write the RGA number in large letters on the outside of the box on or near the shipping label. • Feel free to use our Federal Express Number 0554-0315-5 to return this package through second day delivery. • Seal the carton and return it to: • Boston Scientific do Brasil Ltda Av. Das Nações Unidas, 21746 - P8 / P9 / P10 Vl. Almeida - São Paulo - SP CEP: 04795-000 - A / C: Quality Department
  • Reason
    Boston scientific (bsc) is implementing a voluntary field security corrective action for the lotus ™ valve system to remove all units from the field. the specific list of upns and shipments is included in attachment 1. the bsc has recently received a larger than expected number of reports of early pin release prior to valve locking in the final position. should this occur, the valve is unable to be fully latched, which requires the valve to be re-sheathed and removed from the patient, prolonged procedure. removal of the valve was successful in all but one case; in this case, the valve was embolism and fixed in the descending aorta. all affected patients were successfully treated with another valve except for one reported case where the affected valve was removed but an aortic dissection occurred during the second valve implant and the patient died. there are no safety concerns for patients who have previously received a lotus valve, and the problem does not impact the performance of the implanted valve. it is a potential problem only during the deployment procedure itself.
  • Action
    Field Action Code 92066792 triggered under the responsibility of Boston Scientific do Brasil Ltda. Company will inform customers.

Device

LOTUS VALVE SYSTEM Technical Name: Heart Valve Prosthesis ANVISA Registration Number: 10341350785...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific Limited
  • 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