The recall comes on the heels of complaints that the medical device’s filter sometimes breaks during the plaque-removing arterial procedures. The company designed the filter to support plaque-removing arterial procedures with anti-clotting effects.
The Company—Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc. (CSI) provides innovative solutions for the treatment of peripheral and coronary artery disease. Their peripheral artery disease (PAD) and coronary products are catheter-based platforms designed to restore blood flow. The products also reduce calcium in the treatment of arterial calcium buildup.
After beginning WIRION sales in March 2021, the company reported a 66.8% quarter-over-quarter revenue increase for their fourth quarter.
During atherectomy procedures, the WIRION Embolic Protection Device is intended to capture and remove debris or blood clots in the bloodstream before they find their way to vital organs. An atherectomy is similar to an angioplasty procedure. However, the catheter in an atherectomy procedure has a rotating shaver on its tip. This cuts away plaque from the artery.
The WIRION filter is part of a catheter that physicians insert into a patient’s leg during the plaque-removing procedures. The device acts like a basket, catching the nefarious blood clotting material that can occur during these procedures. After FDA approval, CSI distributed approximately 700 WIRION devices in the U.S from March to November 2021.
Initial Warm Welcome
Initially, coronary physicians welcomed the WIRION device. Coronary physicians said it made debris capture very efficient in atherectomy procedures. Additionally, it allowed them to give individualized patient intervention. CSI’s chairman, president, and chief executive officer proclaimed that the “product will be an important part of our comprehensive portfolio of differentiated products designed to save limbs and improve outcomes for patients undergoing complex peripheral interventions.” Studies had shown that WIRION had a lower major adverse event rate than other lower extremity embolic protection filers. In fact, WIRION had a rate of 1.9%.
Reported Product Defects
Complaints about WIRION filter breakage during retrieval of the device started to surface. Cardiovascular Systems Inc. received reports of nine device malfunctions and no reports of deaths at the time of the recall. Reports indicated that sometimes the filter basket was too full. This made retrieval of the filter assembly difficult to withdraw from a patient. The FDA states that “in this situation, withdrawal may cause the WIRION system filter component to tear or separate, which may result in series adverse events such as embolization, need for additional medical procedures, or possibly death.”
The FDA labeled the WIRION Embolic Protection Device a Class I recall, the most serious type of recall. The regulator added that “[U]se of these devices may cause serious injuries or death.”
The FDA specifically warns of the possible need for embolization if a WIRION filter tears or separates upon withdrawal. The regulator’s statement links to this definition: “Embolization (em-buh-luh-ZAY-shun) is a procedure done by interventional radiology specialists. In it, they use a long, thin tube called a catheter to put plugging material or a plugging object into a blood vessel to block it.” It’s the intentional plugging of a vessel.
In simpler terms, an “ [e]mbolization is a minimally-invasive procedure that stops blood flow in target areas.” The procedure is done to keep tissues healthy while dealing with problematic bleeding.
Among other things, physicians use embolization to stop ongoing bleeding from a traumatic injury and bleeding in the brain. Physicians also use embolization to keep a swollen blood vessel from leaking or bursting.
One can only imagine the serious medical effects from excessive, abnormal bleeding. In addition, it seems possible that if the WIRION device tears some of the debris or clots it captured, it could get into the bloodstream and reach major organs. This could cause blockages that result in heart attacks, strokes, or pulmonary problems.
Cardiovascular Systems, Inc. Recall
On November 24, 2021, CSI announced the WIRION Embolic Protection System voluntary recall. The company initiated the recall of all unused devices “due to complaints of filter breakage during withdrawal.”
The company recalled all customer inventory of the WIRION Embolic Protection Device (Model WRN-D6).
The recall notice also stipulates that consumers can report adverse reactions or quality problems experienced with the WIRION System to the FDA MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Given the serious nature of the medical risks from the WIRION filter breakage and tearing during withdrawal, medical product liability cases are likely looming on the horizon. CSI may face individual or even class-action lawsuits asserting that WIRION manufacturing, design, and marketing defects caused serious injuries.
In medical product liability cases, the legal standard is a strict liability rather than negligence. Under this standard, plaintiffs need to only show that the device was defective and that it caused their injuries. There is no requirement to prove that the defendant was negligent, which can be more difficult to prove.
Expert Bound to Be in Demand
As these medical device cases emerge, attorneys will need experts with specialized knowledge and credentials. Experts in medical device design and manufacturing can help lawyers understand where things went wrong as CSI brought WIRION to market. Attorneys will need medical experts in atherectomy procedures to advise and testify on the use and efficacy of embolic protection devices in general, and WIROIN in particular.
Depending on the injuries suffered, attorneys will also likely call upon specialized medical experts in excessive bleeding, clotting, and related serious injuries or death.