SentreHEART Lariat Suture Device Linked to Deaths, Injuries: FDA Warns
Federal regulators indicate that the SentreHEART Lariat anti-stroke device has been linked to at least six deaths and dozens of injuries, leading to a warning that indicates doctors should try other, safer procedures before using the device.
A safety communication was issued by the FDA on July 13, warning about the risk of complications with the LARIAT suture delivery device for left atrial appendage (LAA) closure.
The agency indicates that numerous reports have been received involving the SentreHEART device lacerating or perforating the heart, as well as LAA detachment, bleeding, low blood pressure, and the collection of fluid around the heart.
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The FDA found 45 adverse events reported to the Manufacturer and User Facility Device Experience (MAUDE) database, including six patient deaths. About 75% of the cases required emergency heart surgery.
The LARIAT is used to close the left atrial appendage in patients with atrial fibrillation to prevent strokes. It is often a procedure used in patients who cannot tolerate blood thinners due to the risk of bleeding or other side effects.
The FDA indicates that the agency has not established the safety and effectiveness of the LARIAT for closing the LAA and preventing strokes in patients with atrial fibrillation. The agency suggests that healthcare professionals should try more proven procedures and treatments first, and if they do conduct a LARIAT procedure, to make sure the patient is informed of the benefits and risks of all treatment options.
Patients are advised to be aware of the risks associated with the LARIAT Suture Delivery Device, and to be aware that there are other, proven, treatments for preventing strokes from atrial fibrillation. Patients should review all treatment options with their health care provider, the FDA advised.
The FDA is not taking any action at this time to issue a SentreHEART Lariat recall, but indicates that it will continue to monitor reports and inform the public if significant new information becomes available in the future. Adverse events associated with the LARIAT Suture Delivery Device can be reported to the FDA’s adverse event reporting program, MedWatch.
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