December 17, 2015, Trial News
FDA warns of potential injuries from coatings on intravascular medical devices
The FDA has identified a risk to patients from intravascular devices with a coating that may separate from the device and cause injury. On Nov. 23, the agency issued a safety communication to health care providers warning that the hydrophilic and hydrophobic coatings on different types of devices used for various, minimally invasive vascular procedures may “peel, flake, shed, delaminate, [or] slough off.”
The FDA has identified a risk to patients from intravascular devices with a coating that may separate from the device and cause injury. On Nov. 23, the agency issued a safety communication to health care providers warning that the hydrophilic and hydrophobic coatings on different types of devices used for minimally invasive vascular procedures may “peel, flake, shed, delaminate, [or] slough off.” According to the FDA, 11 medical devices—mostly vascular guidewires—have been recalled since 2010 due to this issue, and about 500 medical device reports have been made since 2014, including nine deaths that may be attributable to the coatings.
The coating reduces friction between the device and a patient’s blood vessels, making it easier to insert the devices—such as guidewires, sheaths, and foreign body retrieval devices—and reducing the risk of damaging blood vessels. But the coatings have been cited in adverse event reports involving pulmonary embolism, heart attack, and stroke. Coating particles may damage tissues or lead to blood clots, requiring surgery. In the nine reported deaths, the particles likely blocked blood vessels and caused serious adverse events such as heart attack and bleeding.
The agency did not identify a particular brand or manufacturer and noted it is still unclear exactly what—design, manufacturing, or improper use—causes the coating to separate from the devices. The safety communication also stated that the benefits of these devices still outweigh the risks associated with the separating coatings because they allow for minimally invasive cerebrovascular, cardiovascular, and peripheral procedures for people who otherwise may require more invasive treatment or have no other treatment option. But the FDA encourages health care providers to take certain steps to protect patients, including ensuring that the correct device is used for a specific type of procedure, carefully following storage instructions for the devices to minimize conditions that might compromise the coating, and preconditioning the devices to protect the coating. The safety communication also discourages bending or otherwise altering the device to avoid weakening the coating, even though there may be no visible cracking or flaking. The FDA will continue researching the issue and collecting information about adverse medical events from practitioners and scientific literature.
Jennifer L. Lawrence, an attorney in Covington, Ky., said that FDA safety communications are important for plaintiff attorneys to keep an eye on. “These alerts are invaluable because they provide detailed information concerning manufacturers, medical devices, the specific reported problems with medical devices, and information about the injuries patients are sustaining. They also potentially trigger the discovery date on which to base a statute of limitations against a medical device manufacturer since the communications are made within the public realm. When investigating a case on behalf of your client, determine which medical devices were used to find out if there is a potentially defective medical device that contributed to your client’s injuries. In any intravascular procedure, it is now important to determine whether the client has sustained a pulmonary embolism, myocardial infarction, stroke, tissue necrosis, or death. If the answer is yes, then your client may have been injured as a result of the coating of the intravascular medical device peeling or sloughing off at the time of the procedure.”