The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a Field Safety Notice (FSN) concerning Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented), manufactured by Vascutek Ltd.
Vascutek issued a FSN to increase clinician awareness regarding bleeding, experienced by some customers when using Biplex vascular grafts and Biplex BioValsalva Conduits. Of total product sales, which includes Biplex vascular grafts and Biplex BioValsalva Conduits (stentless and stented); field events of graft bleeding are recorded as 2.6%. Of this 2.6 % total, 80% of reports are from one country, i.e. Italy. In these cases, clinicians have experienced bleeding from graft suture holes and/or anastomoses requiring additional intervention e.g. resternotomy. Bleeding and re-intervention to correct bleeding has occurred during or shortly after surgery.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 August 2012