Coating on Intravascular Devices May Peel Off, Causing Injury and Death, FDA Warns

Government health officials have issued a warning about the potential dangers associated with use of intravascular devices with hydrophilic or hydrophobic lubricious coatings, after data suggest there may be over 500 incidents of coating separations resulting in injuries and at least nine deaths since 2014. 

The FDA issued a safety communication on intravascular medical devices on November 23, warning healthcare professionals using coated intravascular medical devices on patients to be aware of the potential for the coating to separate from the device.

Incidents of coating separation have been linked to serious adverse health consequences, including blockage of blood vessels, heart attacks, strokes, and death.

The intravascular devices, include intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths and implant delivery systems, are typically used during minimally invasive surgeries on cerebrovascular, cardiovascular, and peripheral vascular systems. Many of these devices are covered in a hydrophilic or hydrophobic lubricious coating to reduce the friction between the devices and the blood vessels.

The coatings allow for greater maneuverability by the physician and have been determined to cause fewer traumas to the blood vessels. However, a recent analysis of FDA adverse event reports found hundreds of incidents involving injuries and death that were caused by the separation of device coating during procedures.

The FDA warns that the coating could separate from the device by means of peeling, flaking, shedding, delaminating, or sloughing off, leaving remains inside the blood vessels of the patient. The coating separations could occur for a number of reasons; including patient’s anatomy, physician’s technique, improper storage, use of the wrong device or a device defect from the manufacturer.

FDA investigators found more than 500 incidents of coating separation on intravascular medical devices since January 1, 2014. According to the FDA, the majority of incident reports involved coated guidewires and resulted in a range of serious and life threatening injuries. Of the 500 reported incidents, researchers found a wide variety of injuries including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, and tissue necrosis.

A total of eleven deaths were reported, although investigators decided that two of the deaths were not linked to coating separation. However, the remaining nine deaths involved situations that included embolization of separated device coatings that caused severe blood vessel occlusion during brain and heart catheterizations. Although the reports have not determined the deaths to be directly cause by the embolization of particles, the separated pieces ultimately contributed to the fatal heart attacks and brain bleeds.

Over the last five years there have been at least 11 recalls of medical devices equipped with coatings that reportedly peeled or flaked of the of the devices during use.

Despite the injuries and recalls, the FDA warning indicates that the agency still believes the benefit of the coated devices outweighs the risks, and that without these devices, some patients may be forced to undergo more extensive and invasive surgeries which tend to have longer recoveries and put patients at more risk of infections.

The FDA’s warning does not indicate any specific manufacturer’s product is better or safer to use than another’s, but does suggest that healthcare professionals take into consideration the purpose of the device used, storage and labeling information of devices, execution of multiple devices together, and pre- and post-surgery monitoring of patients before taking action.