Defective Medical Device

Representing the injured, the wronged and their families

What is the CYPHER™ Coronary Stent?
The Cypher™ Coronary Stent is a tiny metal scaffold used to open clogged arteries in patients undergoing angioplasty procedures. The stent is mounted on a balloon and is opened once inside the coronary artery. The device props open a cleaned out artery and, unlike bare metal stents, emits the drug sirolimus to reduce the chances the artery will clog again, a condition called restinosis.

In April 2003 the Cypher stent became the first licensed drug-coated stent available in the United States. The Cordis Corporation, a subsidiary of Johnson & Johnson, makes the Cypher Stent.

What are the risks?
The Cypher stent has been used to treat more than 500,000 patients worldwide. As of November 21, 2003, mere months after the Cypher stent was first marketed, the FDA had received 360 adverse event reports of blood clots, including 70 deaths.

In addition, the FDA has received more than 50 reports, including some deaths, attributed to hypersensitivity or allergic-type reactions related to the Cypher stent. The symptoms of a hypersensitivity reaction include:

• Rash
• Pain
• Hives
• Itching
• Fever
• Respiratory alterations
• Blood pressure changes
  

What is being done to protect patients?
In July 2003, three months after the Cypher stent was marketed, the FDA issued a warning stating it had received reports of blood clots in 34 patients who received the Cypher stent, including five deaths.

In October, the FDA issued a second public health notification advising doctors of the significant jump in adverse event reports linked with the Cypher Coronary Stent including more than 290 reports of thrombosis (blood clots) that formed within 30 days after patients received the new device. In more than 60 of the 290 reports, the Cypher stent was associated with patient death, and the remaining patients sustained serious injury requiring surgical or medical treatment.

In April 2004 federal regulators from the FDA issued a warning letter to Cordis Corporation following inspections of several sites involved in the production of Cypher stents. The letter stated that Cordis failed to meet specifications for design, manufacturing, packing and storage of the Cypher stent.

The cause of the adverse events associated with the Cypher stent is not yet known. The FDA continues to closely monitor medical complications connected with the Cypher stent. The FDA is also working with the regulatory bodies of other countries to gather more information about their experience with the Cypher stent.

What if a Cypher stent was used during my procedure?
If you or someone you love has experienced a serious adverse event related to a Cypher stent after an angioplasty procedure, we would like to help. Call us or fill out a Free Online Consultation Form for an immediate evaluation of your case.

This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice please consult with your physician.

CYPHER™ is a trademark of Cordis Corporation. The reference to the trademarks of Cordis Corporation is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Cordis Corporation, Johnson & Johnson, or the FDA.

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