In a November 23, 2015, Safety Communication, the U.S. Food and Drug Administration (FDA) reported that intravascular medical devices may pose the risk of harming patients due to the possibility of lubricious coating separation. This means that the slippery coating on the device that is necessary to reduce friction between the device and blood vessels during an endovascular procedure may peel or flake off of the device, leaving coating fragments in the patient.
According to the FDA, lubricious coating separation from intravascular medical devices can be the result of several factors, such as the practitioner technique, using the wrong device for the procedure, improper preconditioning of the device, improper storage conditions, and/or issues with device design or manufacturing processes.
Cases of lubricious coating separation has been found mostly in guidewires, but there have also been cases associated with sheaths, retrieval devices and embolization device delivery wires used in the vasculature.
500 Reported Cases of Lubricious Coating Separation, 9 Reported Deaths
Since January 1, 2014, there have been about 500 reported cases, according to the FDA, of lubricious coating separation from intravascular medical devices, including nine cases that resulted in death.
These nine lethal reports of lubricious coating separation from intravascular medical devices were specifically due to “embolization of coating particles from devices during heart and brain catheterization procedures contributing to clinical adverse events such as heart attack and bleeding inside the brain.”
Other serious possible injuries caused by lubricious coating separation from intravascular medical devices include:
• pulmonary embolism,
• pulmonary infarction,
• myocardial embolism,
• myocardial infarction,
• embolic stroke,
• tissue necrosis.
If the lubricious coating separation from intravascular medical devices leads to remaining coating fragments in patient, this could require surgical intervention to mitigate the consequences, adverse tissue reactions, and thrombosis.
The FDA has yet to pinpoint a specific manufacturer or brand of these devices as more susceptible to lubricious coating separation than any other. The FDA has, however, stated that the cause of coating separation is “multifactorial, and can be associated with factors including device design, device manufacturing, and use.”
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The Weinberg Law Firm is currently assisting individuals injured by medical devices. If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please contact our law firm toll free at 1-877-934-6274 for a free legal case evaluation.
