4 deaths prompt updated instructions for embolic agent used in IR procedures

Following a recall from the U.S. Food and Drug Administration, Boston Scientific has updated the instructions for one of its embolic agents used during interventional procedures. 

The Obsidio Conformable Embolic is routinely used for vascular embolization procedures. Boston Scientific issued an Urgent Medical Device Product Advisory to customers in February of 2024 due to receiving reports of adverse events related to the agent’s use. At that time, the FDA issued a Class 1 recall, which is the most serious type due to the associated risk of serious harm or death. 

A subsequent investigation revealed that a certain procedural technique—the aliquot technique—using the agent put patients at greater risk of gastrointestinal bleeding.  

“The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy. Use of this product with the aliquot technique may prevent blood and oxygen flow to organs including the small bowel (ischemia) or nontarget embolization, all of which may lead to prolonged hospitalization, the need for additional surgery or death,” the FDA’s initial warning stated. 

The recall did not require customers to stop using the product, but rather an update on how to use it. The new instructions were shared on October 11.  

The labeling updates are as follows: 

• Do not use the aliquot technique or push Obsidio Embolic with saline when performing embolization for any gastrointestinal bleeding with the Obsidio Conformable Embolic device. 

• Do not make forceful injections in or near the Obsidio Embolic. These could change its properties and raise the risk of off-target embolization. 

• Do follow the revised instructions included in the Recommended Procedure section of the labeling. 

Reports of 15 adverse events and four deaths were behind the push to adjust the product’s clinical use guidelines. 

Providers and consumers who have experienced adverse events with the product are encouraged to report them to MedWatch. 

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