Erosions with ASD devices quantified by FDA

 The US FDA has provided  with figures from its MAUDE database on erosions with Amplatzer septal-occluder devices (St Jude Medical) until July 21, 2011. This follows a report last week in which some doctors expressed concerns about the safety of these devices, particularly with regard to erosions.

Karen Riley (Office of Public Affairs, FDA, Silver Spring, MD) told  that the FDA has received and entered into its database 742 medical device reports for these septal occluders. "Of these, 72 can be considered as either confirmed or possible erosion events. Seven of these were reported as death, and the remaining ones as serious injuries," she says.

The devices have been approved in the US for percutaneous closure of atrial septal defects (ASD) for more than 10 years. Interventionalists are divided as to whether erosions are an issue, with one saying last week that this was the one adverse effect that made him pause before using the devices, because of the potentially serious consequences and the fact that there are no indicators that erosion is about to happen or any way of predicting who will suffer this fate. But another physician said that as long as the devices are used for their intended indication and not off-label, he was confident about using them. And the manufacturer maintains that the septal-occluder devices are safe and reliable.

The FDA was unable to supply with the actual number of Amplatzer devices implanted over the period during which the 72 erosions were reported, so it's difficult to calculate the "rate" of erosion, which St Jude Medical has put at 0.1%. Spokesperson Amy Jo Meyer (St Jude Medical, St Paul, MN) said the company does not disclose sales data by individual product line, so she was unable to provide the number of implantations in the US.

Two years ago, reviewers combed the FDA's MAUDE database and documented 51 known cardiac perforations, erosions, or ruptures with Amplatzer septal-occluder devices between January 2002 and June 2007. At the time, the authors were also unable to obtain the number of implantations from the manufacturer, but they estimated the figure at 18 000 for that five-and-a-half year period.