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FDA Issues Warning About Intravascular Device Coatings
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The FDA issued a safety communication warning health care providers of the possibility that hydrophilic and/or hydrophobic coatings may separate from intravascular devices and potentially cause serious injuries to patients.
This warning includes coated devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths and implant delivery systems that are commonly used during minimally invasive procedures in the CV, cerebrovascular and peripheral vascular systems, according to the safety communication.
Since Jan. 1, 2010, there have been 11 recalls from various manufacturers associated with these devices peeling or flaking off medical devices; most recalls were associated with guidewires.
Since Jan. 1, 2014, the FDA has received approximately 500 Medical Device Reports describing separation of hydrophilic and/or hydrophobic coatings on medical devices that had been used for CV, cerebrovascular and peripheral vascular procedures. The majority of reports were submitted for vascular guidewires. Serious adverse events reported include death, embolic stroke, myocardial embolism, MI, pulmonary embolism, pulmonary infarction and tissue necrosis. Serious injuries included the persistence of coating fragments in patients, requiring surgical intervention to mitigate the consequences; adverse tissue reactions and thrombosis. Eleven reports described patient deaths; two deaths were not attributed to the device coating.
The FDA noted that coated intravascular devices have been used for more than 20 years on millions of patients to decrease friction between the device and blood vessels. The agency has not concluded that any specific manufacturer or brand of devices is associated with higher risk. Coating separation can be caused by a number of factors including device design, manufacturing and use.
Based on current understanding of the benefits and risks of devices with these coatings, the FDA stated that the overall benefits continue to outweigh the risks. The agency recommended several actions to reduce the potential of serious adverse events, including:
- follow manufacturer’s instructions for proper device storage and preconditioning steps, if applicable;
- when using two devices together (e.g. catheter and introducer sheath), ensure there is sufficient room for one to pass safely within the other;
- 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 to avoid destruction or separation of the outer coating;
- consider replacing a device if it does not move freely, is visibly kinked or damaged, or does not perform as expected.