08.05.2007

Recall of Cypher Stent and Ancure Endograft Stent

Stents are small mesh tubes which are inserted into diseased arteries. Stents are often implanted at the same time other procedures are carried out including balloon angioplasties. It is either an expandable wire form or perforated tube that is inserted into a natural conduit of the body to prevent or counteract a disease-induced localised flow constriction.

The stent is used in patients who have a narrowing in their coronary arteries caused by the collection of fatty substances such as cholesterol along the lining of the coronary arteries.

In previous years there have been a number of cases where stents have been recalled from production following adverse effects suffered by patients.

Cypher Stent

The Cypher Stent, manufactured by Cordis Corporation, which is a subsidiary of Johnson and Johnson, is coated in a drug called sirolimus. The drug is released slowly into the body and reduces the build-up of plaque in the arteries.

In October 2003 the FDA issued a public health alert advising that more than 60 people had died from blood clots forming around the device and causing heart attacks. In other cases the device has caused injuries requiring medical or surgical treatment. Further reports have been received from patients suffering from pain, rashes, respiratory difficulties, hives and blood pressure changes.

Ancure Endograft Stent

The Andure Endograft Stent, produced by a subsidiary of Guidant Corporation, has been linked to 12 deaths and 57 emergency operations. On 12 June 2003 Guidant pleaded guilty to 10 charges for covering up malfunctions with the device and was fined $92.4 million dollars. The defective device became stuck whilst it was being implanted.

The Guidant Ancure Endograft Stent, which has now been withdrawn from the market, worked differently to the Cypher Stent. The device was used to repair the aorta, without open heart surgery. However, when complications during implanting occurred, and the device could not be dislodged for it to be removed from the patient's body, open heart surgery had to be performed.

If you or someone you know has been affected, you may be able to claim compensation for your injury and loss. Irwin Mitchell has experience in handling claims involving defective medical devices and products, and would be happy to answer any questions you may have. You may not be alone, in which case, we will refer you to the best contact in our group action team.