April 14, 2014 Medical Device Alert: Amplatzer Septal Occluder may cause risk of erosion.
St. Jude Medical Inc., in collaboration with Health Canada, has issued a communication regarding a rare but serious risk of erosion associated with the AMPLATZER Septal Occluder (ASO). The ASO is a medical device implant that is used in adults and children to close an opening (hole) in the wall (also known as septum) of the heart.
St. Jude Medical has updated the label for the ASO with respect to the adverse event of erosion. Erosion is a rare but potential life threatening event which may be caused by the ASO rubbing against the wall of the heart or surrounding structures. Symptoms of possible erosion may include shortness of breath, chest pain, fainting, and/or rapid or irregular heart beat. Any patient with an ASO who experiences any of the symptoms of erosion should immediately call his or her heart specialist, or go to the nearest emergency room. Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Any case of erosion or other serious or unexpected adverse incidents with an ASO should be reported.