デバイスの故障および患者関連の有害事象と内視鏡的静脈瘤結紮デバイス：MAUDEデータベース分析

Endoscopic variceal ligation (EVL) is indicated in the treatment of esophageal variceal hemorrhage. Despite the widespread use of EVL, there is a shortage of studies comparing the 2 most widely used banding devices available in the United States. We aimed to investigate outcomes associated with these devices following U.S. Food and Drug Administration approval.

We analyzed postmarketing surveillance data for the Boston Scientific Speedband Superview Super 7 and the Cook Endoscopy 6 Shooter banding devices from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to September 2021.

During the study period, 3531 reports describing 4720 device failures and 258 patient-related adverse events were identified. Of the 2782 reports in the Boston Scientific device group, the most common device failures reported were failure to fire (n = 1878 [49.1%]) and premature activation (n = 486 [12.7%]); the most common patient-related adverse event was bleeding/hemorrhage (n = 62 [63.3%]). Of the 749 reports in the Cook Endoscopy device group, the most common device failures reported were premature activation (n = 218 [24.4%]) and failure to fire (n = 181 [20.2%]); the most common patient-related adverse event was presence of a foreign body (n = 111 [69.4%]).

Both commercially available EVL devices had significant reports of failure to fire and premature activation. Inadvertent bleeding/hemorrhage may be an underrecognized adverse event of EVL. These findings can inform operators of these devices about potential failures and their relative risk of resultant patient injury.