Medical Malpractice

• Micro-bubble contrast agents may cause death or serious cardiapulmonary reactions

  Jamie Sheller | November 16, 2007 10:14 AM | 0 CommentsPhiladelphia, PA

  Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...

• Medtronic Recalls Sprint Fidelis Cardiac Leads

  Jamie Sheller | October 16, 2007 11:00 AM | 0 CommentsPhiladelphia, PA

  Medtronic has removed its Sprint Fidelis defibrillation leads from the market after several adverse events in patients. Defibrillators are used to monitor the heart rate in patients. If the defibrillator detects an irregular heart rhythm, it sends an electrical shock to the heart to restore normal rhythm. Medtronic has found that the leads are prone to fracture. These fractures may cause the...

• More Recalls of Guidant Heart Devices

  Jamie Sheller | April 12, 2007 12:36 PM | 0 CommentsPhiladelphia, PA

  Due to a defect causing shortened battery life, Guidant has recalled several models of its implantable cardiac defibrillators (ICD's) and cardiac resynchronization therapy defibrillators (CRT-D's). The recall involves about 73,000 devices, which have faulty capacitors possibly leading to rapid battery depletion. The Guidant ICD's and CRT-D's included in this recall are the Contak Renewal 3 HE...

• Kidney Disease Associated With Gadolinium-Based Contrast Agent

  Jamie Sheller | December 26, 2006 10:27 AM | 0 CommentsPhiladelphia, PA

  Recently, the FDA updated an earlier public health advisory concerning gadolinium-based contrast agents used with MRI and MR angiography procedures. There have been a number of reports of a new disease called nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NSD) occuring in patients with moderate to end-stage kidney disease. Some patients developed NSF/NSD after only one...

• Recall of Some Boston Scientific Guide Catheters

  Jamie Sheller | December 22, 2006 4:30 PM | 0 CommentsPhiladelphia, PA

  The FDA has recalled 12 lots of Boston Scientific's Mach 1 Guide Catheters. These devices are tubes that are thread through the body and used to help treat coronary artery disease. Excess strands of resin may be inside of some of the catheters. In the event that excess resin is present and detaches while the catheter is being used in treatment, embolization may occur. Embolization in a blood...

• Off Label Use of Drug Eluting Stents Carries Increased Risks

  Jamie Sheller | December 12, 2006 1:57 PM | 0 CommentsPhiladelphia, PA

  According to the FDA, off-label use of drug-eluting stents carries an increased risk of thrombosis, myocardial infarction and death. An FDA advisory panel recommended changing the labels of such stents. The two approved devices are Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting). Approximately 60% of the three million drug-eluting stents implanted in Americans, are off-label. In...

• Recall of Blood Clotting Test Strips

  Jamie Sheller | October 25, 2006 12:38 PM | 0 CommentsPhiladelphia, PA

  Recently, Roche Diagnostics issued a recall of CoaguCheck PT test strips. Patients using anticoagulants or blood thinners have their blood tested to determine clotting time. The strips are used for that purpose, both by patients at home and by medical professionals. Depending on the blood clotting time, corrective measures may need to be taken. A defect in the CoaguCheck PT strips may cause...

• Guidant Settles Lawsuit Over Defibrillator

  Jamie Sheller | September 15, 2006 11:51 AM | 0 CommentsPhiladelphia, PA

  Recently, the Guidant Corporation settled a lawsuit over one of its cardiac defibrillators. The fraud suit was filed in Texas, and trial was scheduled to start on September 18, 2006. In the lawsuit, plaintiffs Beatrice Hinojosa and Louis Motal claimed that Guidant failed to warn them about the risk of failure for their implanted heart devices. In 2005, Guidant recalled thousands of its...

• Mechanical Heart Approved for Strictly Limited Use

  Jamie Sheller | September 10, 2006 4:18 PM | 0 CommentsPhiladelphia, PA

  AbioCor, a fully implantable mechanical heart manufactured by Abiomed, Inc., gained FDA approval for very limited use. "Only patients who have advanced heart failure that has affected the left and right ventricles and who are not candidates for a heart transplant will be eligible to receive the device under the agency's Humanitarian Use Device provisions." The mechanical heart is powered by a...

• Safety Concerns Reported for Coronary Stents

  Jamie Sheller | September 08, 2006 9:16 AM | 0 CommentsPhiladelphia, PA

  At a recent European medical meeting, there were several reports about stent safety. Among the safety concerns was information showing increased risk of blood clots with the use of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent. Boston Scientific and Johnson & Johnson are the two biggest stent makers. Stents are used to keep arteries open after blockages are cleared in...