Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has issued a medical device safety alert concerning 24 PVS27/XL, Perceval Sutureless Heart Valves, 4 PS25 Pericarbon More Heart Valves and 1 PS33 Pericarbon More Heart Valve, manufactured by Sorin Group.
The manufacturer has identified the presence of Corynebacterium spp in the pre-sterile bio-burden monitoring of Tissue Heart Valve test samples in July 2014. According to the manufacturer, Corynebacterium spp has never been identified during the pre-sterile bio-burden testing or in-process devices or in other controlled environments of the manufacturing facilities. The bacteria identification showed that the contamination is from Corynebacterium (C. jeikeium, C. urealyticum, C. pseudodiphtercum) that are common microbial flora found on human skin and mucosal membranes. All the valves released have been sterilized with a validated sterilization process conforming to the specifications and passed a final sterility test. However, Corynebacteria were not included in the validation study and the final sterility test is only indirect indicator of sterility. The manufacturer has decided to recall the captioned devices.
If a contaminated valve is implanted, there is the potential for development of infectious endocarditis with all attendant complications including death, while treatment may require intravenous antibiotic therapy and reoperation for valve explantation or other measures as determined necessary by medical personnel.
The manufacturer advises users to discontinue use and return any remaining inventory of the affected devices. If the affected product has been utilized, the cardiac surgeons or cardiologists primarily responsible for care of the affected patient should be notified immediately to ensure informed decision making regarding the need for further diagnostic evaluation and treatment.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON445980
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 August 2014