Amplatzer Steerable Delivery Sheath Complications

The U.S. Food and Drug Administration has issued a warning about Abbott’s Amplatzer Steerable Delivery Sheath presenting a risk of introducing air bubbles into a patient, which can lead to serious complications and even fatalities. The most serious health concerns of an air embolism include stroke or death.

An air embolism can also cause an acute or sudden reduction in blood flow to the heart, low blood pressure, an abnormally high heart rate (tachycardia) or an abnormally low heart rate (bradycardia). It can also cause low blood oxygen levels.

The ASDS is a positioning device that enters the body through the skin and provides a pathway to insert catheter-based devices into the chambers of the heart. Abbott Vascular designed the tool to improve the efficiency and ease of use when working on the left atrial appendage, a small pouch in the heart implicated in the formation of blood clots in people with an irregular heart rhythm.

An embolism is the blockage of a blood vessel caused by a foreign substance, such as a blood clot or air bubble, that travels through the bloodstream and obstructs blood flow. The body’s organs and tissues need oxygen carried in the bloodstream to function and a disruption can cause impaired organ function or even failure. With the use of the ASDS, the risk of an embolism presents a serious complication.

Abbott issued the recall after receiving 16 injury reports with a direct link to its ASDS positioning device. In addition to these injuries, the company received another 10 incident reports related to the increased risk of air bubbles.

The FDA classified the Amplatzer Steerable Delivery Sheath recall as a Class 1 event. This is the most serious type of recall the agency issues. A stroke or cardiac embolism can potentially be life-threatening.

An air embolism stemming from a cardiac catheterization that affects coronary circulation can lead to a heart attack. Cardiac catheterization is a medical procedure used to diagnose or treat some heart conditions.

Though small air embolisms have minimal clinical consequences, a large embolism can lead to myocardial infarction (heart attack), hemodynamic instability (unstable blood pressure, blood flow and oxygen delivery) and ventricular arrhythmia (a heart rhythm abnormality).

Medical intervention for a heart attack depends on the severity of the event. Medications and procedures can break up the clot, while resuscitative measures can address failed or irregular heartbeat.

The FDA also warns of the possibility of a stroke when using ASDS. A stroke occurs when there is an interruption or reduction in the supply of blood to the brain that causes cells to die. Strokes are medical emergencies, with early intervention critical for reducing brain damage and other complications.

The use of an ASDS increases the risk of a stroke because of the potential for inducing an air embolism. It’s possible for air to enter the arterial bed directly during a procedural use of ASDS.

In veins higher than the heart, higher atmospheric pressure can cause the air bubble to rise and cause a cerebral venous air embolism. This means a blood clot develops and potentially leads to hemorrhaging within the brain. This can lead to ischemia and infarction, where the blockage of a vein in the brain may result low oxygen and tissue damage.

In situations where the use of ASDS leads to an air embolism, the obstructions can impact the heart. When the heart works too hard it can lead to hypertension. Blood pressure that is too high increases the risk of a stroke.

Decreased cardiac output (the amount of blood pumped by the heart each minute) from a reaction to an embolism causes low blood pressure or hypotension. This results in reduced blood and oxygen supply to tissues, potentially leading to complications in different organs such as the heart, lungs, brain, and kidneys.

ASDS complications can include fluid build-up in the space around the heart, known as pericardial effusion. The risk is higher in procedures using a device like the ASDS to close large defects. Incomplete closure can lead to interrupted blood supply and fluid buildup. According to a report, this was the most common complication associated with insertion of this device, following air embolism.

A pericardial effusion impacts how the heart works. Left untreated, the fluid around the heart presses in on the heart and prevents it from expanding. This can prevent the heart from pumping blood effectively and result in heart failure.

If you believe you’re dealing with ASDS complications, it’s important to talk to your doctor immediately. The potential for life-threatening complications makes medical intervention a necessity. Your doctor will know your medical history and the risks you face.

Those who have experienced ASDS-related injuries are also filing Amplatzer Steerable Delivery Sheath lawsuits. Injuries named in suits include embolisms, reduced blood flow, changed heart rates or blood pressure requiring medical attention, as well as stroke, cardiac issues and death.

Suits seek compensation to cover medical expenses, lost wages and other related expenses. A consultation with an experienced product liability lawyer can best determine if you’re eligible to file.