FDA Issues Safety Communication on Lubricious Coating Separation in Intravascular Medical Devices

November 23, 2015—The US Food and Drug Administration (FDA) issued a safety communication regarding lubricious coating separation on medical devices, including intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems. The FDA is making health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (eg, peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. The FDA safety communication is available online and includes information and actions for health care providers to reduce the potential of serious adverse events.

The FDA stated that it 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, and use. Current FDA analysis suggests that use-related issues may be mitigated through proper device selection, preparation, and other considerations noted in the full communication.

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 before use.

The FDA advised that health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Forms and contact information is also included in the safety alert and communication.

According to the FDA, 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. 

The FDA advised that since January 1, 2010, there have been 11 recalls from various manufacturers associated with coatings either peeling or flaking off of medical devices. The majority of the recalls were associated with guidewires, but there have also been recalls for other types of devices, including sheaths, retrieval devices, and embolization device delivery wires used in the vasculature.

In addition, since January 1, 2014, the FDA has received approximately 500 medical device reports (MDRs) describing the separation of hydrophilic and/or hydrophobic coatings on medical devices, such as guidewires, catheters, and introducers, that had been used for cerebrovascular, cardiovascular, and peripheral vascular procedures. The majority of the reports were submitted for vascular guidewires, and more than 75% of the reports describe device malfunctions.

Serious adverse events reported in these MDRs and in the scientific 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 requiring surgical intervention to mitigate the consequences, adverse tissue reactions, and thrombosis, advised the FDA.