Medical Device Alerts issued in May 2019

Alerts were issued about paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease, and Aisys and Aisys CS2 anaesthesia devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 19 June 2019

• Therapeutic area: Anaesthesia and intensive care, Cardiovascular disease and lipidology, Haematology, Respiratory disease and allergy

In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

• Recommendations for ongoing use of paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD) (MDA/2019/023). Issued 4 June 2019. Recommendations are in place following concerns over an increase in patient mortality from 2 years after treatment. Paclitaxel drug coated balloons (DCBs) or drug-eluting stents (DESs) are not to be used in the routine treatment of patients with intermittent claudication until further notice.

• Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 – risk of patient awareness due to inadequate anaesthesia (MDA/2019/022). Issued 30 May 2019. Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode.

Article citation: Drug Safety Update volume 12, issue 11: June 2019: 6.

Published 19 June 2019