Health Product InfoWatch - March 2017 - Page 2

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New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Case report

Recent Canadian or international cases are selected based on their seriousness, frequency of occurrence or the fact that the reactions are unexpected. Case Reports are considered suspicions and are presented to stimulate reporting of similar suspected adverse events.

Esophageal stents and the risk of vascular erosion

Esophageal stents are hollow tubes of varying composition implanted into the esophagus to restore structure and function, and allow for proper swallowing and passage of food and drink from the oropharynx to the stomach.^{Footnote 1Footnote 2} Initially used to treat malignant esophageal strictures and fistulas caused by esophageal or other nearby cancers, these devices have also been more recently used to treat benign conditions, including tracheo-esophageal fistula, esophageal perforations and leaks, and benign esophageal strictures. Currently, the most commonly used esophageal stents are self-expandable metal stents (SEMS) and self-expandable plastic stents (SEPS).^{Footnote 3} Some models of SEMS are partially or fully covered with a coating such as a plastic membrane or silicone.^{Footnote 4} In Canada, esophageal stents are typically classified as class III medical devices (IV being the highest risk class).

In October 2015, Health Canada received a report of an adverse incident associated with a fully-covered SEMS. The patient had initially been admitted to hospital with a spontaneously perforated esophagus after severe vomiting. Surgery was undertaken to drain the area and repair the esophagus. Just under 2 weeks later, the patient was diagnosed with a persistent esophageal leak. A fully covered SEMS was implanted, with correct positioning of the stent confirmed via post-operative X-ray imaging. On the 17^th day after stent implantation, some blood was noted to be found draining from the left side of the patient's chest. On the 19^th day after implantation, the patient experienced sudden hematemesis, became acutely unstable due to hypovolemic shock and, despite resuscitation efforts, passed away due to massive hemorrhage.

An autopsy subsequently revealed that the stent had eroded through the esophagus and into the patient's aorta. The eroded area was near the proximal end of the stent in a location distinct from the area of original esophageal perforation. The cause of death was stated as aorto-esophageal fistula (AEF).

Some case reports of AEF associated with esophageal stenting have been published in the literature.^{Footnote 5Footnote 6} Smaller herald bleeds may precede the massive hemorrhage seen in cases of AEF associated with esophageal stents.^{Footnote 5} Mediastinal contamination due to delayed stent placement or persistent esophageal leakage may lead to a local inflammatory environment that increases the risk of AEF after stenting.^{Footnote 5} It is recommended that healthcare professionals maintain a high index of suspicion for the possibility of this life-threatening complication when there is bleeding around the stent placement site.^{Footnote 6}

Health Canada encourages the reporting of vascular erosion, AEF and other adverse incidents suspected of being associated with the use of esophageal stents to the Regulatory Operations and Regions Branch through the toll free hotline (1-800-267-9675). The adverse incident reporting form and guidelines can be found on the Health Canada Web site.

References

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