FDA MedWatch: *Update* Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents - Letter to Health Care Providers

A MedWatch Safety Alert was just added to the FDA Medical Device Safety webpage. 

TOPIC: *Update* Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents: Letter to Health Care Providers - Potentially Associated with Increased Mortality

AUDIENCE: Cardiology, Risk Manager, Health Professional

ISSUE: Earlier this year, FDA notified health care professionals about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. We are issuing this update to provide the latest information on our analysis of long-term follow-up data from pre-market trials and to provide summary information from our June 2019 advisory panel meeting. In addition, we are including recommendations to health care professionals for assessing and treating patients with PAD using paclitaxel-coated devices.

Based on the conclusions of our analysis and recommendations of the advisory panel, the FDA is taking additional steps to address this signal, including working with manufacturers on updates to device labeling and clinical trial informed consent documents to incorporate information about the late mortality signal. The FDA is also continuing to actively work with the manufacturers and investigators on additional clinical evidence development for assessment of the long-term safety of paclitaxel-coated devices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.