FDA Warning: 9 Deaths Due to Coatings on Medical Devices

November 23, 2015 — The FDA has issued a Safety Communication warning that certain coatings on intravascular medical devices can separate and cause life-threatening side effects.

Hydrophilic and/or hydrophobic coatings include silicone, polyvinylpyrrolidone (PVP), and polytetrafluoroethylene (PTFE). They decrease friction between intravascular devices and blood vessels.

Unfortunately, the coating can separate (e.g, peeling, flaking, shedding, delamination, disintegration, and sloughing off) and cause serious adverse events, including heart attack, stroke, and death.

Since the beginning of last year, the FDA has received about 500 adverse events describing separation of coatings on medical devices, including nine deaths during heart and brain catheterizations.

Manufacturers have issued 11 recalls since the beginning of 2010, mostly for guide-wires but also sheaths, retrieval devices, and embolization device delivery wires.

Many factors could cause the coatings to separate, including difficulty of the procedure, patient anatomy, user technique, using the wrong device, improper pre-conditioning, improper storage, or issued with defective design and manufacturing.

According to the FDA:

“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 prior to use.”

Adverse events linked to the problem:

• Pulmonary embolism
• Pulmonary infarction
• Myocardial embolism
• Myocardial infarction (heart attack)
• Embolic stroke
• Tissue necrosis
• Adverse tissue reactions
• Thrombosis (blood clots)
• Surgery to retrieve coating fragments
• Death

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