Events

Field Safety Notices about WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Boston Scientific International S.A..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    On march 29, 2016, boston scientific (bsc) initiated a voluntary medical device removal of all non- implanted watchman flx™ left atrial appendage closure (laac) devices. for previously implanted watchman flx laac devices, the notice sent to your facility recommended to continue to follow patients in accordance with the directions for use (dfu), including specified follow-up at 45 days using trans-esophageal echocardiographic (tee) imaging. subsequently, bsc has received communications from competent authorities. as a result of these communications, bsc is initiating a recommendation to expand follow-up schedule for patients implanted with a watchman flx laac device to determine whether the device remains implanted. therefore, in addition to the current dfu requirement to perform patient follow-up at 45 days using tee, it is also recommended that patient follow-up be performed at 6 and 12 months with tee. .

Device

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device

Manufacturer

Boston Scientific International S.A.
  • 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
    AMPMDRS