Pieces of Broken AngioDynamics SmartPort Entered Woman’s Right Ventricle, Lawsuit Alleges

Port catheter broke less than one month after it was implanted, leading to the need for surgical removal, woman’s son claims.

When Anna McDonald received an AngioDynamics SmartPort catheter implant, no one warned her or her family that the device could fracture and release dangerous shards into her body, according to a lawsuit filed by her son.

The complaint (PDF) was brought by Robert McDonald, heir and representative of the estate of Anna McDonald, who died from factors not linked to the lawsuit, which names AngioDynamics, Inc. and Navilyst Medical, Inc. as defendants.

The SmartPort is one of several port catheter brands manufactured and sold by AngioDynamics, which also include Vortex Ports and Xcela Ports. The implants are venous access devices used to deliver medications, nutrients and other fluids directly into a patient’s bloodstream. They are used to give doctors a consistent port to easily inject treatments into the body.

Although they are sold as a safe and effective medical device, there are now more than 160 AngioDynamics port catheter lawsuits being pursued in the federal court system, each alleging that the implants are defectively designed and prone to causing infections, fracturing, migrating out of position or simply failing. This can lead to complications that often require the implant to be surgically removed, often disrupting or delaying the routine treatments the ports are designed to help deliver.

In addition to the growing number of AngioDynamics port catheter lawsuits being filed, another manufacturer, C.R. Bard, also faces a series of similar Bard PowerPort lawsuits, each indicating that the port catheters are defectively manufactured with barium sulfate that makes the devices prone to fracturing, infections and failures.

McDonald, of Florida, was implanted with a SmartPort on June 10, 2021. However, according to the complaint, she began experiencing complications within just a few weeks. 

In July, she underwent an evaluation of the port following its implantation, only to find out that the device had already fractured, with pieces migrating to the right ventricle of McDonald’s heart. The problems were discovered on July 6, 2021, and she had the broken port catheter fragments removed from her body on July 7, 2021, with the remainder of the implant was surgically removed the next day, according to the lawsuit.

The lawsuit claims AngioDynamics used barium sulfate as a material in the construction of the catheter components, which McDonald says is prone to deterioration, resulting in fractures, device migration and serious infections.

McDonald’s lawsuit claims AngioDynamics knew, or should have known, about the problems long before the implant was placed inside his mother but failed to adequately warn the medical community or patients undergoing the procedure.

“Defendants advertised, promoted, marketed, sold, and distributed the SmartPort as a safe medical device when Defendants knew or should have known the SmartPort was not safe for its intended purposes and that the product could cause serious medical problems,” the lawsuit states. “Defendants had sole access to material facts concerning the defective nature of the products and their propensity to cause serious and dangerous side effects.”

McDonald presents claims of negligence, failure to warn, design defect, breach of warranty, fraudulent concealment, and violations of Florida’s deceptive trade act.

AngioDynamics Port Catheter Lawsuits

McDonald’s lawsuit will be consolidated in the Southern District of California under U.S. District Judge Jinsook Ohta, where similar federal lawsuits have been centralized as part of an AngioDynamics port catheter multidistrict litigation (MDL) for coordinated pretrial proceedings.

As part of the coordinated management of the growing litigation, Judge Ohta is expected to establish a bellwether trial process, during which a handful of representative cases will be selected for early trial dates. These trials will allow the parties and court to evaluate how juries may respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the results of those bellwether trials would not be binding, they could help the parties reach an AngioDynamics port infection lawsuit settlement agreement. If the parties do not reach an agreement, and no other resolution is found to the litigation, Judge Ohta may then remand each case back to the U.S. District Court where it originated for a future trial date.