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St. Jude Aortic Connector
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Man Sues Heart-Valve Maker for Wife's Death

Feb 24, 1999 |

The husband of a Northwest Side woman, who died after having a mechanical valve implanted in her heart last year, is suing the manufacturer of the device, claiming leaks in the valve led to her death. The company recently recalled the valve and other similar products.

Christine Krizin, 53, had a valve surgically inserted in her heart at Resurrection Medical Center on April 17, 1999, because she suffered from a heart condition. She died nine days later.

"She could have lived the rest of her life normally, if everything [had gone] okay with the valve," said an attorney for the Krizin family.

He said the device caused paravalvular leaks, which occur when blood seeps around the outside of the implanted valve, between it and the heart tissue.

The leakage caused Krizin's death, Baker said.

The lawsuit, filed Wednesday in Cook County Circuit Court, states that St. Jude Medical, Inc., a St. Paul, Minn.-based medical supply company, designed, produced and sold a dangerous product.

In January, the company voluntarily recalled all valves that were coated with a substance called Silzone, a type of silver.

The recall "has nothing to do with the operation of the valve mechanism," according to Peter Gove, a spokesman for St Jude Medical.

He said the recall came after the company did a clinical trial of valves with the Silzone coating and found that "leakage occurred at a higher rate with Silzone [coated valves]."

In Krizin's case, the valve's sewing cuff a polyester fabric used to stitch the valve into the heart was coated with Silzone, according to the lawsuit.

Gove said the company first introduced Silzone in 1997 to reduce infections in valve procedures.

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