Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Lotus Valve Systems [Material number (UPN): H749LTV230, H749LTV250, H749LTV270; Catalogue number: LTV23, LTV25, LTV27; Batch number: All batches].

Boston Scientific is implementing a voluntary Field Safety Notice to reinforce the training requirements associated with the use of the Lotus Valve System. A recent investigation identified a number of sites that had performed Lotus Valve cases without the mandatory support of a Boston Scientific Field Clinical Specialist (BSC FCS). All Lotus Valve cases must be supported a BSC FCS until the site is designated as "Independent" by the manufacturer.

In order for a site to be designated as Independent, the following must be complete:

• Two physicians must be certified, i.e. they must have
  • Attended face to face training;
  • Performed a minimum of six Lotus Valve cases with a Proctor and a BSC FCS and
  • Performed a minimum of four additional Lotus Valve cases with a BSC FCS
• Two catheterisation laboratory staff must be certified to prepare the Lotus Valve
• Certified physicians must be trained on Advances Techniques by BSC

Sites that are not designated as "Independent" are instructed not to perform Lotus Valve cases without the support of a BSC FCS. No product is being recalled as there is no impact to previously implanted devices.

According to the local supplier, the affected products are not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 April 2016