FDA warns of 9 deaths due to coatings on minimally invasive intravascular medical devices

The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability. These lubricious coatings are included on a wide variety of minimally invasive medical devices including intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths and implant delivery systems in cerebrovascular, cardiovascular and peripheral vascular systems.

However, data from the agency indicate that guidewires, in particular, are the source of most of the recalls and patient reports relating to flaking or peeling of a device coating.

These coatings--that include both hydrophilic and hydrophobic materials such as silicone, polytetrafluoroethylene and polyvinylpyrrolidone--may peel or flake off, thereby causing serious injury to patients, the regulatory agency warns. This can be caused by a number of elements including proper usage that involves a difficult procedure. But the FDA notes that use of the wrong device for a given procedure, improper preparation or storage of the device as well as design and manufacturing issues can all be implicated in this potentially dangerous peeling of coatings.

"The FDA wants to make healthcare providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients," said the agency's statement.

"Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient's anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes," it added.

The agency notes that since the start of 2010, there have been 11 recalls from various manufacturers associated with the peeling or flaking of these coatings from medical devices. Most of these were for guidewires, but here have also been recalls for devices such as sheaths, retrieval devices and embolization device delivery wires used in the vasculature.

The FDA also has gotten about 500 medical device reports since the beginning of 2014 that these coatings are separating. Again, most of these were for vascular guidewires with about three-quarters of them describes as device malfunctions. Of these, 9 described patient deaths due to problems with the device coating that occurred during heart and brain catheterizations.

It advises that to help prevent the displacement of coatings, healthcare providers must make sure they are using devices for the properly indicated use, as well as follow proper device storage procedures and to ensure that two devices used together, such as a catheter and introducer sheath, be used properly together.

Also recommended are using proper preconditioning steps, avoiding the use of alcohol, antiseptic solutions or other solvents to pretreat the device, avoiding wiping the device with dry gauze, as well as caution in their insertion and manipulation.

But these kinds of coatings have been used on devices successfully across millions of patients for more than 20 years, the FDA acknowledges. Its intent is to warn patients and providers of this specific risk but not to discourage use of these kinds of devices.

Summed up the agency, "Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use."

- here is the FDA statement