Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Summary Safety Review - Esophageal Stents - Assessing the potential risk of damage to the esophagus and nearby major blood vessels

March 29, 2017

Product

Esophageal Stents

Potential Safety Issue

Damage to the esophagus and nearby major blood vessels

Key Messages

  • Esophageal stents are medical devices authorized for sale in Canada that help allow for the proper passage of food and drink through the esophagus (from the mouth to the stomach). They are metal or plastic hollow tubes that are placed inside the esophagus to widen areas that have become narrow due to cancer or scarring, or to seal off leaks in the esophagus.
  • Health Canada reviewed the potential risk of damage to the esophagus and nearby major blood vessels after receiving a Canadian report in which an esophageal stent placed in a patient had worn through the esophagus and damaged the aorta (a large blood vessel connected to the heart), causing death.
  • Health Canada’s review of the available information has confirmed the potential risk of esophageal stents to damage the esophagus and nearby major blood vessels. Health Canada will work with device manufacturers to update the safety information for all esophageal stents to include details about this potential risk and potential factors that may increase this risk.
  • In addition, Health Canada will issue an article in the Health Product InfoWatch to raise awareness of this safety issue and will continue to monitor the safety of esophageal stents.

Overview

Health Canada reviewed the potential risk of damage to the esophagus and nearby major blood vessels after receiving a Canadian report in which an esophageal stent placed in a patient had worn through the esophagus and damaged the aorta (a large blood vessel connected to the heart), causing death.

Use in Canada

  • Esophageal stents are medical devices authorized for sale in Canada to allow for proper passage of food and drink from the mouth to the stomach. They are hollow tubes placed inside the esophagus to widen areas that have become narrow because of cancer or scarring, or to seal off leaks in the esophagus.
  • Esophageal stents have been marketed in Canada since 1999. There are multiple esophageal stent systems currently sold in Canada by 5 different companies. They are made of metal or plastic.

Safety Review Findings

  • At the time of the review, Health Canada had received a total of 14 unique Canadian reports related to esophageal stents. Only 1 of these cases was related to damage (erosion) of the esophagus and damage (perforation) of a nearby blood vessel. In this report, a patient had a stent placed in their esophagus to seal off a leak. Just over two weeks later, the patient began coughing up large amounts of blood and later died. The autopsy showed that the stent had worn through the esophagus and perforated the aorta.  
  • A review of the scientific and medical literature found 18 other cases of these stents damaging the esophagus and nearby major blood vessels. Out of these 18 reports, 11 were fatal. Most of the events occurred from 1 to 2 months after stent placement, but some events happened after the stent had been in place for about 12 to 18 months.
  • Factors that may increase the risk of damaging the esophagus and nearby major blood vessels include a history of radiation treatment or chemotherapy, recent chest or heart infection, patients with uncommon blood vessel location, and specific characteristics of the stent used.

Conclusions and Actions

  • Health Canada’s review of the available information has confirmed the potential risk of esophageal stents to damage the esophagus and nearby major blood vessels.
  • The current safety information for esophageal stents does not specifically describe this risk. Therefore, Health Canada will work with device manufacturers to update the safety information for all esophageal stents to include details about this potential risk and potential factors that may increase this risk. In addition, Health Canada will issue an article in the Health Product InfoWatch to raise awareness of this safety issue.
  • Health Canada will continue to monitor safety information involving esophageal stents, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of this device both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.