Affected products
Paclitaxel-coated balloons and paclitaxel-eluting stents
Manufacturers
All manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents
Background
On 16 April 2019 and 08 July 2019, Swissmedic published information for the treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: Publication 16 April 2019, Publication 8 July 2019
Some manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents are modifying the instructions for use of their devices in Europe to provide information regarding the potential risk of increased long-term mortality. The product-specific clinical data is also being made available in the instructions for use.
The manufacturers will inform the affected customers of these changes directly by means of a Field Safety Notice (FSN), which Swissmedic is publishing on its website in the “List of Field Safety Corrective Actions (FSCA) and recalls”: https://fsca.swissmedic.ch
Further investigations are ongoing to identify the link between mortality and paclitaxel-coated and paclitaxel-eluting devices.
Swissmedic's recommendations
All the information available to Swissmedic calling the device's safety into question will be analysed. Swissmedic is continuing to gather data on this subject.
Since the devices available on the market possess valid CE certificates they can remain on the Swiss market. The result of the various ongoing analyses will determine whether further recommendations or other regulatory actions will be needed.
Note for patients
If you have health concerns connected with your treatment or your implants, please consult a healthcare professional.
Note for professional users
Doctors must discuss all risks (e.g. increased long-term mortality) associated with paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of femoropopliteal lesions with their patients before surgery so that they can then make an informed decision that is appropriate for their individual situation. Furthermore, the findings and recommendations of the FDA (US Food & Drug Administration) and EAG (Expert Advisory Group) should also be taken into consideration: FDA recommendations, EAG recommendations
All serious incidents connected with paclitaxel-coated balloons and paclitaxel-eluting stents must be reported to Swissmedic: Link