2.4.20
By Mike Smith
The FDA has classified Abbott Vascular’s recent recall of nearly 14,000 NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters as a Class 1 Recall, which is the most serious classification for device recalls and are often linked to serious injury or death. According to the FDA Recall Notification, Abbot Vascular received 13 complaints related to this issue with one reported death.
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart. Balloon dilatation of the abnormal narrowing portion of a coronary artery or bypass graft, for the purpose of improving myocardial perfusion is a common treatment for narrowing coronary arteries.
By inflating a balloon, which arrives at the occlusion by way of a catheter inserted in the femoral artery and guided to the heart, a coronary arterial occlusion can be re-opened to restore coronary flow in patients who have had a type of heart attack, known as myocardial infarction – specifically patients with ST-segment elevation, which refers to the flat section of an electrocardiogram (ECG) reading and represents the interval between heartbeats.
The recalled Abbott Vascular products recalled can be used to open an arterial occlusion and also to deploy a mesh stent to help keep blood flow through that artery from being impeded again.
According to the FDA, the NC TREK RX Coronary Dilatation Catheter is indicated for use in the following cardiac (heart) procedures:
- Balloon dilatation of the abnormal narrowing portion of a coronary artery or bypass graft, for the purpose of improving myocardial perfusion.
- Balloon dilatation of a coronary artery occlusion, to restore coronary flow in patients who have had a type of heart attack, known as myocardial infarction – specifically patients with ST-segment elevation, which refers to the flat section of an electrocardiogram (ECG) reading and represents the interval between heartbeats.
- Balloon dilatation of a stent after implantation (balloon models 4.00 mm – 5.00 mm only).
Abbot Vascular recalled the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters after receiving field reports that the balloon (diameters 4.0mm, 4.5mm and 5.0mm of specific product lots) may not deflate as intended. Abbott Vascular determined that this issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing.
According to the FDA, “Use of these devices may cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blow flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to post-operative complications, including death.”