Pathologist Raises Questions About Polymer Coatings on Medical Devices

A University of Rochester Medical center pathologist warns that hydrophilic polymer coatings on catheters, guide wires, and other vascular medical devices can peel or flake off during clinical use and cause serious complications in some patients, including death. Her work has been cited by the U.S. Food and Drug Administration and was recently published in Human Pathology.

Rupal I. Mehta, M.D., assistant professor of Pathology and Laboratory Medicine and the Center for Neural Development and Disease (CNDD), first described hydrophilic polymer embolism in 2009 and has been investigating the health complications associated with the medical device coating materials for more than eight years. Her work has helped to increase awareness among patients undergoing catheterization and minimally invasive cardiac and vascular procedures.

Polymer coating gels are applied to the surfaces of medical devices for lubrication and to improve maneuverability within blood vessels. These coated devices are used in millions of patients worldwide each year for various cerebrovascular, cardiovascular, and peripheral vascular conditions such as coronary angioplasty procedures for coronary artery disease.

Mehta’s team has shown that polymeric coating particles may flake off of devices and unexpectedly deposit in vessels throughout the body. In a recent article, Mehta reviewed the cases of 32 patients with documented complications associated with polymeric coatings and showed that associated tissue changes within the brain were diverse, including structural abnormalities of small vessels (in 63% of patients), inflammation (38%), stroke (28%) and/or aseptic meningitis (22%).

Mehta was invited to present her work on this subject at the FDA Center for Devices and Radiological Health special grand rounds last fall. A recent FDA public safety communication highlights the issue and cites her work. The FDA has acknowledged important gaps in current national and international device standards, Mehta said, and the agency is working with stakeholders to better characterize and evaluate coating performance to mitigate risks of these complications in patients.

The study was co-authored by Rashi Mehta, M.D., assistant professor Radiology at SUNY Upstate Medical University in Syracuse. The National Institute of Neurological Disorders and Stroke and the New York State/United University Professions supported the study.

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