Can I Sue for Heart Attack or Stroke from Interventional Procedure?
You may have medical malpractice and product liability claims if you or a loved one had bleeding in the brain or a heart attack after a minimally invasive procedure by a interventional radiologist, cardiologist, neurologist or surgeon.
Hydrophilic and hydrophobic lubricious coating used on the following medical devices may separate during procedures, causing severe injury, including heart attack and stroke, and sometimes death:
- intravascular catheters
- balloon angioplasty catheters
- delivery sheaths
- implant delivery systems
These devises are used for minimally invasive procedures in the cerebrovascular (brain), cardiovascular (heart) and peripheral vascular systems. A procedure can seem successful, until days later the patient goes into cardiac arrest or has significant bleeding in the brain (stroke).
FDA Says 500 Reports of Injury and Wrongful Death
The FDA issued a warning to health care providers to make them aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes.
Since Jan. 1, 2014, the FDA has received approximately 500 Medical Device Reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings on medical devices such as guidewires, catheters, and introducers that had been used for cerebrovascular, cardiovascular and peripheral vascular procedures. The majority of the reports were submitted for vascular guidewires and over 75% of the reports describe device malfunctions. These reports and scientific literature (see below) involve the following adverse events:
- pulmonary embolism
- pulmonary infarction
- myocardial embolism
- myocardial infarction
- embolic stroke
- tissue necrosis
- wrongful death.
Because it may be difficult for clinicians to associate adverse events with malfunctions of the coating, the number of patients harmed may be higher than the 500 reported to the FDA.
The FDA has not concluded that any specific manufacturer or brand of these devices is associated with higher risks than others. The cause of coating separation is multifactorial, and can be associated with factors including device design, device manufacturing, and use.
Articles in scientific literature discuss 9 deaths. In these cases, occlusion of blood vessels reportedly occurred due to embolization of coating particles from devices during heart and brain catheterization procedures contributing to clinical adverse events such as heart attack and bleeding inside the brain.
One wrongful death case involved a 63-year-old woman who had a small (5-mm), unrupturred brain aneurysm.1 A Pipeline Embolization Device (PED) inserted with a coated interventional device was used to treat the aneurysm, and the procedure went well. Six days after the surgery, she had neurological decline, and a CT scan found a ipsilateral intraparenchymal hemorrhage (IPH), bleeding in the brain (hemorrhagic stroke). The autopsy found no evidence that the aneurysm had ruptured or hemorrhaged. This eliminated the possibility that the aneurysm had caused the death. What was found was small bits of polyvinylpyrrolidone (PVP), the material used for the coating of the interventional device, not the PED.
Recalls Issued Due to Possible Patient Harm from Coating Separation
Since Jan. 1, 2010, there have been 11 recalls from various manufacturers associated with these coatings peeling or flaking off of medical devices. The majority of the recalls were associated with guidewires, but there have also been recalls for other types of devices including sheaths, retrieval devices and embolization device delivery wires used in the vasculature.
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- Hu YC, Deshmukh VR, Albuquerque FC, Fiorella D, Nixon RR, Heck DH, Barnwell SL, McDougall CG, Histopathological assessment of fatal ipsilateral intraparenchymal hemorrhages after the treatment of supraclinoid aneurysms with the Pipeline Embolization Device. Journal of Neurosurgery, 2014; 120(2); 365-374.
- Mehta RI, Mehta RI, Choi JM, Mukherjee A, Castellani RJ, Hydrophilic polymer embolism and associated vasculopathy of the lung: prevalence in a retrospective autopsy study. Human Pathology, 2014; 46(2): 191-201.
- Mehta RI, Mehta RI, Chung YC, Hydrophilic polymer embolism: and underrecognized iatrogenic cause of ischemia, inflammation, and coagulopathy. Human Pathology, 2015; 46(3): 488-489.