Botched Thrombus Aspiration: $1.5M Medical Malpractice Settlement  

Off-label use of Vortex catheter during thrombus Aspiration Results in Perforated Artery and Death of 69-Year-Old

2023 Medical Malpractice Settlement Report
By Adam R. Satin, Attorney for plaintiff

Case summary

This is a wrongful death claim in which the 69-year old decedent was found to have a large intraluminal thrombus of the distal aortic arch and descending aorta. She was transferred to a nearby hospital and scheduled for a thrombus aspiration and thoracic endovascular stent graft placement in May 2014.

For the decedent’s procedure, the defendants utilized a Vortex catheter that required a size 26 French sheath. Prior to the procedure, the defendants did not obtain a computed tomography angiography (CTA) to measure the size of the decedent’s arteries. Notably, the defendants’ use of the Vortex catheter for this procedure was considered an “off label” use in that the FDA had only approved the use of this catheter for the venous system, and not the arterial system. After placement of the guidewire in the decedent’s arterial system, the defendants attempted to advance the 26 French sheath over the wire but encountered resistance, presumably due to the large size of the sheath and the small diameter of the decedent’s vessels. Although the defendants were able to advance the Vortex catheter to aspirate the large thrombus, they created an arterial tear and lost the wire position when they withdrew the sheath. Without the wire, the defendants were unable to promptly deliver a stent to control bleeding and the decedent became hypotensive. Despite attempts to repair the artery, the decedent ultimately suffered cardiopulmonary arrest and died.

Plaintiff’s counsel was prepared to present expert testimony that the defendants negligently failed to obtain a CTA of the decedent’s vessels, which would have demonstrated that her arteries were inadequate for the passage of the sheath. Defense claimed that it was not a deviation from the standard of care for the defendants to utilize the sheath without knowing the arterial diameter because arteries often stretch to accommodate such sheaths. Defense further claimed that while the Vortex catheter was approved to be used in veins and not arteries, the off-label usage of medical devices is common practice and was an appropriate exercise of medical and surgical judgment by the defendants under these circumstances. To counter this defense, the plaintiff was prepared to show that the attending physicians disregarded the increased risk of arterial injury posed by the size mismatch during the procedure and failed to properly supervise their resident to ensure that the wire position was maintained in the event arterial injury occurred.

The case settled for $1,500,000.

Lubin & Meyer medical malpractice attorneys Andrew C. Meyer, Jr. and Adam R. Satin represented the plaintiff in this case.

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