June 20, 2018

Labeling Considerations for Devices With Lubricious Coatings Addressed in FDA Draft Guidance

June 20, 2018—The US Food and Drug Administration (FDA) has issued a draft guidance document on labeling considerations for devices containing lubricious coatings used in the vasculature.

The guidance addresses hydrophilic- and/or hydrophobic-coated devices used in minimally invasive diagnostic and therapeutic cerebrovascular, cardiovascular, and peripheral vascular procedures to decrease friction between the device and blood vessels. The devices include intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems used during diagnostic and therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems.

The purpose of this guidance document is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications or premarket notification submissions for 510(k) clearance for class 3 and class 2 devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. Recommended labeling considerations proposed in the guidance document include the following: information on device descriptions; indications for use statements; warnings, precautions, and preparation steps; and adverse events.

According to the document, recent evidence indicates that the coating may separate from intravascular devices in some circumstances. The FDA has received and analyzed information concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating from intravascular medical devices. This information has included voluntary recalls of guidewires, sheaths, retrieval devices, and embolization device delivery wires, as well as Medical Device Reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings from medical devices such as guidewires, catheters, and introducers that have been used for cerebrovascular, cardiovascular, and peripheral vascular procedures.

The FDA has also evaluated other relevant information, including peer-reviewed medical literature and physician surveys. Serious adverse events reported in these MDRs and in the medical literature include pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. Serious injuries associated with the peeling of coatings reported in MDRs included the persistence of coating fragments in patients, some of which required surgical intervention to mitigate the consequences, adverse tissue reactions, and thromboses.

The document notes that the FDA has not concluded that any specific manufacturer or brand of these devices is associated with higher risks than others. The cause of coating separation is multifactorial and can be associated with factors including device design, device manufacturing (including formulation and raw material sourcing), and clinical use. Current FDA analysis suggests that clinical use–related issues may be mitigated through proper device selection, preparation, adequate premarket testing, and other labeling considerations that are addressed within this guidance document.

This draft guidance document provides labeling recommendations for both class 3 and class 2 devices such as intravascular catheters, wires, and delivery systems with lubricious coatings used in the vasculature. Due to higher risks that are associated with the use of these devices in the neuro, coronary, and peripheral vasculature, the FDA has focused the scope of this guidance on devices used in those vascular regions, although some of these considerations could be applied to devices with similar coatings used in other types of interventional procedures. The scope of this guidance document includes a wide variety of devices and product codes.


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