Events

Safety Alert for Amplatzer Atrial Septal Occluder

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by St Jude Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-18
  • Event Date Posted
    2013-10-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131018.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: st jude medical amplatzer atrial septal occluder the united states food and drug administration (fda) has issued a medical device safety alert concerning amplatzer atrial septal occluder (aso), manufactured by st jude medical. the fda is alerting health care providers and patients that in very rare instances, tissue surrounding the amplatzer aso can break down (erode) and result in life-threatening emergencies that require immediate surgery. according to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the amplatzer aso. as of 31 march 2013, there have been 234,103 amplatzer aso devices sold worldwide. according to the fda, tissue erosion caused by the amplatzer aso is rare, but can be life-threatening. between 2002 and 2011, the fda received more than 100 reports of erosions associated with the st. jude amplatzer aso. during the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device. the device rubbing against the wall of the heart can erode the tissue and create a hole. it can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. this scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). if too much blood builds up in this sac, the heart will not be able to work properly. immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure. the fda does not recommend device removal for patients who have the amplatzer aso unless physicians determine it is appropriate for their particular patient(s). the risks associated with device removal surgery may be equal to or greater than the risk of erosion. in addition, the fda is requiring st. jude to conduct a study of patients who have been recently implanted with the device so as to better understand how erosion impacts the performance of the amplatzer aso and assess potential risk factors related to the occurrence of erosion. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm371202.Htm http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm371145.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 october 2013.

Device

Amplatzer Atrial Septal Occluder
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: St Jude Medical Amplatzer Atrial Septal Occluder
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH