FDA issues safety communication on lubricious coating separation from intravascular medical devices

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The US FDA (Food and Drug Administration) has issued a safety communication concerning the separation of lubricious coatings from intravascular medical devices. The message aims to make healthcare providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices and cause serious injuries to patients.

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.

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

According to the communication, there have been 11 recalls from various manufacturers since 1st January 2010 associated with these coatings 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 1st January 2014, the FDA has received approximately 500 medical device reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings on medical. The majority of the reports were submitted for vascular guidewires and over 75% of the reports describe device malfunctions. According to the FDA, MDRs are not definitive evidence of a faulty or defective medical device by themselves, and cannot be used to establish or compare rates of event occurrence. Therefore, the FDA has obtained and evaluated other relevant information, including medical literature and physician surveys.

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. Eleven MDRs described patient deaths, two of which were not attributed to the device coating. In the cases of the remaining nine death reports, occlusion of blood vessels reportedly occurred due to embolisation of coating particles from devices during heart and brain catheterisation. It may be difficult for clinicians to associate adverse events with malfunction of the coating, and the FDA claims that they may mistakenly attribute adverse events to other procedural complications or patient co-morbidities.

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, and use.

The FDA communication suggests that physicians follow these guidelines to prevent the separation of lubricious coatings from intravascular medical devices:

  • Be aware that many devices are designed, labelled and indicated for specific uses.
  • Follow manufacturer’s instructions for proper device storage.
  • When using two devices together, ensure there is sufficient room for one to pass safely within the other, taking into consideration the features of the device, and that some coatings may swell during use.
  • Follow the manufacturer’s recommended preconditioning steps (if applicable) for the device.
  • During preconditioning of the coating, use only the recommended solution.
  • Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating.
  • Avoid pre-soaking devices for longer than instructed.
  • Avoid wiping the device with dry gauze.
  • Use caution when manipulating, advancing and/or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels.
  • Be aware that attempting to alter the shape of devices by bending, twisting, or similar methods may compromise the coating integrity and that damage to the coating may not always be noticeable to the naked eye.
  • Consider replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does not perform as expected.