AngioDynamics Port: Side Effects, Risks and FDA Safety Information
Doctors use implantable AngioDynamics port catheters to deliver medications and fluids. Device side effects include infections and blood clots. Patients have reported device fractures, which can cause organ perforations, symptoms similar to a heart attack and even death.
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What Is the AngioDynamics Port, and How Does It Work?
The AngioDynamics port is an implantable port that doctors place in the arm or chest for long-term access to a patient’s vein for treatments. The port can deliver medications or other fluids, draw blood, or deliver contrast fluid for CT scans.
AngioDynamics markets ports such as the SmartPort, SmartPort+ and SmartPort CT Port Access System.
When doctors insert the port, they sedate the patient with general anesthesia and make a small incision in the chest. They create a space for the port and insert it, then connect a catheter between the port and the vein. Patient recovery from a port insertion is typically about one to two weeks.
Medical providers insert a needle into the port to deliver medications or draw blood samples without having to stick a needle into the patient’s arm to access a vein.
AngioDynamics Port Side Effects
The most common AngioDynamics port side effects and complications include pain around the port site, a burning sensation during medication infusion, catheter blockages and infections.
- Accumulation of blood or fluid between the lung and chest wall (hemothorax, hydrothorax)
- Air entering the space between the lung and chest wall
- Air, catheter or catheter fragments blocking a blood vessel (embolism)
- Allergic reaction
- Arterial puncture
- Bacteria entering the bloodstream (bacteremia)
- Bleeding
- Blood clot
- Cardiac puncture
- Catheter blockage, malposition, dislodgment, fragmentation, migration, disconnection or rupture
- Catheter or port erosion through skin/blood vessel
- Death
- Hematoma
- Implant rejection, rotation or extrusion
- Infection
- Inflammation
- Irregular heartbeat
- Nerve damage
- Pain at or around port pocket site
- Risks normally associated with local and general anesthesia, surgery, and post-operative recovery
- Scarring of skin over implant area (necrosis)
- Stuck or difficult-to-remove catheters
According to a 2022 study in the Cureus Journal of Medical Science, there was a 10.5% complication rate from 807 implanted port catheters, including AngioDynamics SmartPorts. These included blood clots, infections and mechanical failures. About 70% of complications occurred more than a month after implantation.
If you experience these symptoms or any other unusual symptoms, make sure to tell your doctor right away.
Serious Side Effects and Safety Warnings
AngioDynamics faces several lawsuits for serious injuries associated with SmartPort side effects, including death. Some of these injuries required additional surgery to remove the defective device.
According to AngioDynamics SmartPort lawsuits, the catheters were manufactured with too much barium sulfate, making them more likely to fracture and degrade, causing injuries.
- Blood clots
- Death
- Hemorrhage
- Infection
- Irregular heartbeat and other symptoms resembling a heart attack
- Perforation of tissue, blood vessels and organs
- Pressure caused by blood buildup around the heart (cardiac tamponade)
- Severe pain
In a MAUDE Adverse Event Report received by the FDA, a cancer patient was implanted with a SmartPort to receive chemotherapy. The device fractured, and she had to have surgery to remove the device. She suffered hemorrhage, irregular heartbeat and other serious symptoms as well as blood and fluid buildup around her heart, which is a medical emergency.
If you suffer from any of these side effects, you may need surgery to treat complications or remove the catheter.
Has the FDA Recalled the AngioDynamics SmartPort?
Despite safety concerns raised by lawsuits, the FDA has not asked AngioDynamics to recall the SmartPort for early device fracture.
However, in August 2011, AngioDynamics issued a voluntary recall for 1,095 SmartPort CTs because they may contain the wrong size catheter and introducer.
Then, in February 2021, AngioDynamics issued a voluntary recall for 267 SmartPort CT catheter kits because the packaging of some devices could be compromised, making them less sterile.
Who Should Not Use the AngioDynamics SmartPort?
If you have certain medical conditions or can’t tolerate a port catheter, you should talk to your doctor about whether the AngioDynamics port catheter is right for you.
- Allergies to any materials in the AngioDynamics port catheter
- An infection
- Anatomy that can’t accommodate the size of the port or catheter
- Blood that clots easily
- Past radiation treatment in the potential port site
- Previous intolerance for implanted devices
- Surgeries and blood clots in the potential port site
- Tissue problems that could prevent the port from being stable
As always, discuss any concerns with your doctor. They may suggest an alternative to an AngioDynamics port catheter for your treatment plan.
What To Do If You’re Having Side Effects
If you’re experiencing side effects from an AngioDynamics SmartPort catheter, seek immediate medical attention and notify your health care provider. You can consider notifying the FDA through its MedWatch Safety Information and Adverse Event Reporting Program. You can also explore legal options if a SmartPort harms you.
- Seek medical care
- Report any signs of infection (fever, redness, swelling), blood clots, pain or device problems to your health care provider immediately. Complications may require emergency intervention, surgery or device removal.
- Monitor for warning signs
- Watch for symptoms such as inability to flush or withdraw blood from the port, unexplained pain, swelling or discomfort.
- Do not attempt to remove or adjust the device
- Only a qualified clinician can safely check if the port is failing.
- Report adverse events
- Patients and healthcare providers should report side effects and complications to the FDA's MedWatch program so regulators can track safety signals and intervene if needed.
- Document everything
- Keep records of symptoms, treatments, healthcare visits and communications with medical staff regarding port complications.
- Explore legal help
- Patients who experienced serious injury — such as infection, blood clot, device fracture or organ perforation — due to a SmartPort catheter may be eligible for compensation through ongoing lawsuits or wrongful death claims. Drugwatch can help you find a lawyer, and there’s no pressure to file a lawsuit.
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