Abbott initiated a recall of its Amplatzer Steerable Delivery Sheath used in surgical procedures that help prevent blood clots. The FDA has identified this as a Class 1 recall, the most serious kind, resulting from a flaw in the device design. Continued use poses a risk of serious injury or death.
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What Is the Amplatzer Steerable Delivery Sheath?
The Amplatzer Steerable Delivery Sheath is a tool used by surgeons to accurately place a device that blocks off the left atrial appendage, a small pouch in the heart. The Amplatzer Steerable Delivery Sheath has a flexible design capable of bidirectional movement up to 120 degrees once inserted.
Among patients with a heart condition called atrial fibrillation (AF), the left atrial appendage (LAA) is the most common source of blood clots. Closing the LAA is an alternative to taking blood thinners to prevent strokes. This procedure prevents blood clots from leaving the left atrial appendage in the heart and entering into the blood stream.
How the device works:
Surgeons use the steerable sheath during surgery, guiding it into the heart to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.
Doctors fully remove the ASDS when completing the surgery so no part of the sheath remains in the patient.
Left atrial appendage closure is an alternative stroke prevention measure for patients who cannot tolerate anticoagulants (blood thinners).
The ASDS allows improved efficiency and accuracy when placing the device that blocks off the LAA, Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder. Using this delivery system may help shorten surgery time and reduce complications in complex cases.
Amplatzer Steerable Delivery Sheath Warnings and Precautions
Abbott issued several warnings and precautionary statements associated with its delivery sheath. Specifically, it says that surgeons should use caution when removing the dilator and sheath from a patient to prevent air embolisms.
“An air embolism occurs when a bubble of air enters the bloodstream and blocks blood flow, which can cause serious problems in organs like the heart, lungs or brain. This often happens as a complication from medical procedures.”
Additionally, the alternative small-bore connector used on the ASDS is different from others in the ISO 80369 series, which may cause complications and potentially hazardous situations for patients. Users should take measures to reduce these foreseeable risks.
According to Abbott, contraindications for the Amplatzer Steerable Delivery Sheath include individuals presenting with blood clots in the heart as well as active infections. It’s also not suitable for use with a power injection system.
Potential Complications Linked to the Amplatzer Steerable Delivery Sheath
Abbott lists several serious and potentially fatal adverse effects related to the use of its Amplatzer Steerable Delivery Sheath.
These include air embolism, arrhythmia, bleeding, heart failure, hypertension, hypotension, stroke, thrombosis, transient ischemic attack and vessel failure. Additionally, Abbott cautions about proper device use and the risk of introducing air during Amulet delivery.
Air embolism can lead to serious injuries, including:
Acute reduction in blood flow to the heart
Bradycardia (lower-than-normal heart rate)
Desaturation (low blood oxygen levels)
Hypotension (low blood pressure)
Tachycardia (higher-than-normal heart rate)
Stroke
Death
In addition to standard potential adverse effects associated with the ASDS, a higher-than-expected number of air embolisms occurred with use. This led to Amplatzer Steerable Delivery Sheath complications in 26 instances, resulting in 16 injuries. These incidents were the impetus for the Abbott recall.
Is Abbott’s Catheter Dangerous?
Testing showed the Amplatzer Steerable Delivery Sheath to be a safe medical device that can greatly reduce complications in certain complex left atrial appendage occlusion procedures. Its use leads to shorter surgeries and more precise implant delivery compared to using rigid sheaths.
However, Abbott’s design uses a different connector than similar devices, which may increase the risk of misuse. Device literature offers suggestions for safety precautions to minimize risk. Additionally, scheduled clinical trials aim to measure the effectiveness and safety of steerable devices compared to rigid models.
Despite its advances, a higher-than-expected number of complications resulted from using the Amplatzer Steerable Delivery Sheath. This led to a June 2023 recall of 675 units of the device.
Talk to your surgeon about whether they used the Abbott steerable sheath in your catheterization. If you or a loved one have suffered complications from an Amplatzer Steerable Delivery Sheath, you may be eligible for compensation.
Amplatzer Steerable Delivery Sheath Recall
Abbott issued a voluntary Amplatzer Steerable Delivery Sheath recall on June 12, 2023, because of a design flaw. This resulted in an overall reported incidence rate of 0.77% related to observed or potential air embolism during use.
Of the 26 incidences reported, most resolved on their own without treatment, while a small number required medical intervention. There are 16 injuries and no fatalities associated with the steerable sheath.
Air embolism is a rare but potentially fatal medical event where an air bubble enters a vein or artery. Patients may experience mild symptoms or none at all. However, there is potential for more serious complications, including cardiovascular collapse, stroke and death.
The U.S. Food and Drug Administration designated this a Class 1 recall, the most serious type, indicating that continued use of the device presents a reasonable risk of serious health injury or death. Recommended actions include returning unused devices, switching to the alternative fixed curve TorqVue 45 degree by 45 degree delivery system for future Amulet implants, and returning a letter of acknowledgment.
Lawsuit Information
People who suffered serious complications after using an Amplatzer Steerable Delivery Sheath cardiac catheter are filing lawsuits.
Amplatzer Steerable Delivery Sheath Lawsuits Filed Over Air Embolism Risk
People who experienced an embolism after surgery have filed Amplatzer Steerable Delivery Sheath lawsuits to recover damages resulting from the device. Families who lose a loved one due to embolism after surgery can file wrongful death suits.
If you sustained injuries resulting from a recalled Abbott steerable sheath, you should consult an experienced lawyer for guidance. Product liability attorneys will assess your case, guide you through the litigation process and negotiate a settlement on your behalf.
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“An air embolism occurs when a bubble of air enters the bloodstream and blocks blood flow, which can cause serious problems in organs like the heart, lungs or brain. This often happens as a complication from medical procedures.”
