Recall of cardiac device has little effect in Maine

BANGOR – Last week’s recall of a tiny cardiac device used to hold open damaged blood vessels in the heart will have little impact on patients in eastern and northern Maine. Some models of the device, known as a stent, are manufactured by the Boston Scientific Corp. of Natick, Mass., and have been found to have defective elements.

On Friday of last week, the manufacturer announced a voluntary recall.

The manufacturing defect is only dangerous during placement. Once the stent is implanted, there is no danger, according to Boston Scientific.

Bangor cardiologist Peter Ver Lee of Northeast Cardiology Associates said Wednesday that about 530 of the Boston Scientific devices, which look like the spring from a ballpoint pen, have been implanted in patients from this part of Maine.

Northeast Cardiology, which places about 100 stents a month, has received a half-dozen calls from concerned patients, Ver Lee said.

“We have had no problem,” Ver Lee stated, adding that a representative from Boston Scientific came to the Northeast Cardiology offices Monday morning and removed about 250 devices from the inventory, replacing them with nondefective stock.

A stent is delivered to the site of an arterial blockage via a flexible catheter threaded along the blood vessels from the groin area to the heart. Once it’s in position, a tiny balloon is inflated briefly in the artery, allowing the stent to be erected from its folded delivery configuration to a tubular shape. The balloon is then deflated and withdrawn, leaving the stent in place.

Bare metal stents have been in use for years. About a year ago, stents were introduced that are treated to discourage the growth of body tissue into the devices. Boston Scientific’s line of treated and untreated stents was introduced in March of this year.

Between the time the products became available and July 16, when the recall was issued, Boston Scientific received 43 physician complaints on its medicated Taxus models and 52 complaints about its bare-metal Express 2 models. Doctors reported problems with deflating the balloons, making the delivery catheter difficult or impossible to remove without injuring the blood vessel. Three deaths and 43 serious injuries have occurred as a result of the deflation problem during the placement of over a million devices.

The only other manufacturer of cardiac stents is the Johnson & Johnson Corp. Ver Lee said Wednesday that area cardiologists have preferred the greater flexibility of the Boston Scientific products, but will probably be cautious using them until the improved products have been in use for a time.

People who have stents placed are given an information card with the type of device used, according to Ver Lee. Northeast Cardiology patients are welcome to call the Bangor office at 947-4940 if they have questions.

More information on the recall is available at the company Web site: www.bostonscientific.com