Malfunctions and Adverse Events Associated With Off-Label Use of Biliary Stents in the Peripheral Vasculature

Abstract

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.

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“…All other comparisons were statistically significantly different (P 0.05). a Anaconda (12)/Anaconda (12) and Anaconda (12)/Anaconda (12) (P Z 0.208). b Talent (14)/Talent (14) and Zenith (12)/Zenith (12) (P Z 0.509).…”

“…This lack of information is particularly troubling in the light of concerns raised in the past few years by the US Food and Drug Administration (FDA) regarding problems that have surfaced from the routine use of drugeluting and biliary stents for off-label indications. 11,12 The increase in the use and promotion of off-label drugs and mechanical devices is an issue that the FDA is becoming more and more concerned about. Thus the need to perform appropriate studies to evaluate off-label device safety and behaviour has become even more critical.…”

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“…These devices are now widely used for stenting in renal artery stenosis. For 2003–2006, there were more than 1 million off‐label instances of these biliary devices being used for vascular applications 24 . Vascular use accounts for 88% of the reported adverse events associated with these devices 24 …”

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“…The end result was a high number of device failures, leading ultimately to tighter control of such off-label use. 36 The situation has therefore improved in recent years with an increasing number of stents being specifically designed and developed for a whole range of peripheral vessel anatomies. Even still, there are many design challenges to be addressed in these applications.…”