Biliary stents are approved by the U.S. Food and Drug Administration only to treat biliary strictures resulting from cancer. However, these devices are often used “off-label” to treat peripheral vascular disease. This study was designed to determine the number and type of malfunctions and adverse events associated with off-label use of biliary stents in the peripheral vasculature. Confirmed biliary stent malfunctions and adverse events were identified by reviewing biliary stent-related adverse events reported to the U.S. Food and Drug Administration between January 2003 and December 2006. The annual number and type of biliary stent malfunctions and adverse events and the annual number of off-label biliary stent implants were determined. More than one million biliary stents were implanted off-label in the peripheral vasculature during the study period. Most biliary stent malfunctions (81.2% of 1036 malfunctions) and adverse events (87.9% of 561 adverse events) occurred during off-label stent use in the peripheral vasculature. From 2003 to 2006, the annual number of malfunctions increased 80% and adverse events more than doubled, although malfunction and adverse event rates did not significantly increase. Stent malfunctions were most often the result of premature dislodgement or deployment. Retained product, additional percutaneous interventions, or surgery were the most frequently observed adverse events associated with off-label stent use. Thirteen deaths were reported during off-label use. Off-label use of biliary stents in the peripheral vasculature occurs frequently and is increasing in rate. Most adverse events and device malfunctions associated with biliary stent use occur during off-label use. Endovascular treatment of peripheral arterial disease is an important therapy that has benefited many patients. Efforts should be directed at improving the evaluation of peripheral vascular device performance to better identify the patient subsets that will most benefit from this promising therapy.
Medical Device Safety Institute and Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Dr. Maisel is an FDA consultant, immediate past Chairman of the FDA Circulatory System Medical Device Advisory Committee, and a member of the Medicare Coverage Advisory Committee (MedCaC). The opinions expressed in this manuscript are those of the authors and do not necessarily represent the practices, policies, positions, or opinions of the FDA or CMS.
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