Malfunctions Associated with Off-Label Use

The most common off-label use for biliary stents is treatment of peripheral arterial disease (PAD), which develops when leg arteries become narrowed by cholesterol plaques. In an effort to unblock the vessels, many physicians have turned to stents, flexible tubular devices which can keep the vessels propped open.

Because there is little data supporting the clinical utility and safety of biliary stents for treatment of vascular disorders, cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and colleague Jonathan Bridges, MD, decided to take a closer look.

The authors determined that biliary stent implants among PVD patients increased 21.4 percent, from 227,145 in 2003 to 275,795 in 2006; approximately 1 million biliary stents were implanted off-label in the peripheral vasculature in total. Additionally the authors reviewed all reports involving biliary stents between 2003 and 2006. During this time period, 1,036 confirmed biliary-stent malfunctions were reported, 81.2 percent of which occurred during off-label use. Malfunctions were most often due to premature stent dislodgement, premature deployment or failure of the catheter/delivery system.

In addition, notes Maisel, 87.9 percent of the 561 adverse events associated with biliary stent use during the study period occurred during off-label use, with retained product, additional catheter procedures or surgery being the most common adverse events. Thirteen patient deaths were reported during off-label use. “Like the malfunctions, we found that many more adverse events occurring during the use of biliary stents in peripheral blood vessels than when they were used in a biliary or gastrointestinal location,” he adds.; Source: Beth Israel Deaconess Medical Center