FDA Warns of Potentially Serious Problems With Intravascular Device Coatings


The US FDA is warning healthcare providers about potential problems with the coatings on intravascular devices following 11 recalls since January 2010 and approximately 500 reports to their adverse event reporting program since the beginning of 2014. Separation of these coatings from their devices may possibly cause serious injury to patients and even result in death, according to an FDA safety communication released on November 23, 2015.

No specific device or brand is named in the alert.

Peeling, flaking, shedding, delaminating, disintegration, and sloughing off are among the issues affecting the coatings of intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems used in cardiovascular, cerebrovascular, and peripheral vascular procedures. The lubricious hydrophilic and/or hydrophobic coatings on these devices are intended to reduce friction between the surface of the device and the vascular lining offering physicians “greater maneuverability, and may result in less trauma to blood vessels and reduced thrombogenicity for patients,” the document says.

Serious events listed in the MedWatch Medical Device Reports (MDR) database potentially related to peeling or fragmentation of device coating include tissue reactions, thrombosis, pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. In some instances, surgical intervention has been required to “mitigate the consequences.” Approximately 20 deaths reported in the MDR or in the published literature appear to be related to embolization of device coating fragments, the FDA says, warning, “It may be difficult for clinicians to associate these adverse events with malfunction of the coating; instead, they may mistakenly attribute the adverse events to other procedural complications or patient comorbidities.”

Many of the products affected by the alert, however, have been used for more than 20 years in millions of diagnostic and therapeutic procedures, the agency notes. As such, the benefits of having friction-reducing coatings likely outweigh any risks

The causes of coating problems are likely multifactorial, related to device design, manufacturing, and—importantly—how the devices are used. In order to reduce the potential risks, the FDA is providing operators with a list of recommendations:

  • Be aware that devices designed for a particular indication may be more susceptible to problems if used in a different vascular bed.
  • Follow label instructions for proper device storage.
  • When using devices together, ensure there is sufficient space for one to safely pass another, keeping in mind that some coatings may expand during use. Manipulation of devices past sharp edges and metallic equipment as well as bending or twisting of devices may damage coatings. Damage may not be visible to the naked eye.
  • Devices that do not move freely, are visibly kinked or damaged, or are not performing as expected may need to be replaced. 

Operators who suspect they have a device in which hydrophilic and or hydrophobic coatings may be damaged, delaminating, or disintegrating should report the case to MedWatch.


Source: 
Food and Drug Administration. Lubricious coating separation from intravascular medical devices: FDA safety communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm473794.htm. Published on: November 23, 2015. Accessed on: November 23, 2015.  

 

 

Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

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