A patient experiencing ongoing chest pain and other symptoms went into the hospital for a cardiac catheterization in 2012. The procedure, which was performed incorrectly using the MynxGrip vascular closure system, led to an arterial thrombosis and a series of health problems in the patient.
After the procedure, the patient was in and out of the hospital for a year. She underwent several procedures and surgeries to fix the cascade of issues.
The patient was eventually awarded $2.6 million dollars after claiming that the MD in charge of the procedure was negligent.
A woman who attended the now-demolished St. Joseph Hospital in Fort Wayne, Indiana, for a cardiac catheterization in 2012 has sued for damages in the amount of $2.6 million after the procedure led to continuous hospitalizations, disability, and emotional distress.
The plaintiff and patient Zandra A. Chapman, a resident of Allen County in Indiana, came to St. Joseph Hospital when she was 51 years old to undergo a cardiac catheterization.
Chapman’s health background and context
In April 2008, four years prior to the catheterization procedure, Chapman sought care for “intermittent left-sided chest pressure and mild, intermittent nausea” at her general practitioner’s office. She felt pressure, heaviness and had severe sweats. During that office visit, she was seen by Mary Elias, FNP-C.
At this point, Elias ordered an ambulance to take Chapman to St. Joseph Hospital, where she’d see Dr. Bhaktavatasala R. Apuri, a cardiologist, for a consultation. At the hospital, Chapman reported atypical chest pain, shortness of breath, and a productive cough. She was diagnosed with bronchitis.
This visit began a series of hospitalizations for Chapman.
In January 2010, Chapman returned to see Apuri, telling him that she’d been to the hospital the week prior for “chest pain and elevated blood pressure” as well as “left-sided chest pain that was aggravated by exertion that had improved since her discharge from the hospital.” She was then diagnosed with unspecified angina pectoris and cardiomyopathy likely secondary to hypertension.
Between February 2010 and September 2012, Chapman went to the emergency department at St. Joseph Hospital in Fort Wayne on a few occasions with chest pain and other symptoms.
On the third occasion, she “reported a one month history of an irregular heartbeat that was increasing in intensity and frequency,” saying she’d “never experienced an irregular heartbeat before.” Laboratory testing revealed mostly normal findings, except for second-degree heart block, Mobitz type 1. She was released and told to follow up with Apuri.
At this point, Chapman decided to choose a new cardiologist for future treatments: Shashi Ahuja, MD, who Chapman saw for the first time on September 17, 2012, in his office in Fort Wayne.
Court documents state that Ahuja examined Chapman and found that her heart sounded normal, and that her peripheral pulses were palpable and equal. Additionally, “Ahuja performed an EKG upon Mrs. Chapman and interpreted it as showing sinus bradycardia with ‘T-wave abnormality compatible with possible anterolateral ischemia and inferior wall ischemia,’” records state.
At this point, Ahuja diagnosed Chapman with “palpitations, chest pain, hypertension, fibromyalgia by history, and pain management for chronic pain by history.” Additionally, he advised her to undergo a stress Myoview SPECT study, another echocardiogram, and a Holter monitor study.
The Holter monitor study revealed “rare, isolated ventricular and supraventricular premature beats and periods of Mobitz, Type II, AV block with the longest pause being 2.2 milliseconds” in addition to “periods of sinus tachycardia correlated to Mrs. Chapman’s feelings of fluttering and chest pain.”
The cardiac catheterization & use of a vascular closure device
At another office visit to Ahuja on September 24, 2012, Chapman complained of chest discomfort and fluttering in her chest. Ahuja found that Chapman had “edema, that her jugular venous pressure was down, that her chest was clear, and that her heart sounds were normally audible.” He then diagnosed Chapman with “ventricular and supraventricular arrhythmia and Mobitz, Type II AV block” and recommended a cardiac catheterization. On October 15, Chapman went to the hospital for the catheterization. Chapman “did not have any abnormal bleeding or coagulation issues prior to the beginning of the procedure,” the court documents say.
Things get complicated here. During the procedure, Ahuja ended up using a vascular closure system called MynxGrip (to close the entry to the artery), which he claims he told Chapman about and got permission to use.
In fact, the records state, “Dr. Ahuja claims that he often leaves the decision about whether the MynxGrip device is used in particular procedure up to the patient but admits that he sometimes makes that decision himself.” Ahuja said he thought using the MynxGrip on Chapman would be a “good idea, because she was patient with chronic pain and because it would decrease the amount of time she would have to lay on her back after the procedure.” He also says that complications aren’t common.
A little background on VCDs: VCDs were introduced in the 1990s as an alternative method of closing arterial access. The aim is to reduce patient discomfort and downtime after procedures. The court records state that meta-analyses comparing the safety and efficacy of VCDs with manual compression (MC) found no real differences “in the incidence of hematoma, blood transfusion, pseudoaneurysm, and arteriovenous fistula formation between VCDs and manual compression.”
Note that a 2022 systematic review and meta-analysis found that VCDs, compared to MC, “significantly shortens the time of hemostasis and allows earlier ambulation and discharge, meanwhile without increase in vascular complications. In addition, use of VCDs achieves higher patient satisfaction and leads cost savings for patients and institutions.”
Chapman denied that she was given the VCD option, stating, “At no time in St. Joseph Hospital on October 15, 2012, before the cath procedure was performed upon me, did Dr. Ahuja or any other person talk with me about the use of vascular closure device, including the MynxGrip device.”
Court documents reveal Chapman’s affidavit testimony on how the conversation around her catheterization procedure played out. She stated:
“Dr. Ahuja spoke with me briefly on this date about undergoing cardiac cath. He briefly told me how the procedure would be performed. He told me that a small catheter would be inserted into an artery in my right groin so that pictures could be taken of various structures in my heart. He told me that at the end of the procedure, a nurse would apply pressure with hand on the catheter insertion site in my groin for fifteen minutes to help the hole in my artery clot over and seal.
He also told me that I would have to lay in bed and rest for several hours to make certain that the artery in my leg remained sealed. Dr. Ahuja did not talk with me at this time, or at any later time prior to the cardiac cath, about inserting any type of plug in or on the hole in the artery in my leg at the end of the cath procedure.
I have since learned that such plugs are called vascular closure devices. Dr. Ahuja never discussed any form of vascular closure device with me before or at the conclusion of the cath procedure. I had no objection to undergoing cardiac cath or to having to lay still for several hours after that procedure.”
The catheterization began at 9:36 a.m. Ahuja reported that the left and right coronary artery were free of significant narrowing but that the left ventriculogram showed mild, diffuse hypokinesia of the apical region. The treatment plan at that point? Medical management.
The court documents state that the procedure took 12 minutes and that Ahuja “removed the sheath to the femoral artery to visualize it before applying MynxGrip vascular closure system at 9:48:21.”
A nurse’s report states Ahuja did a “very fast deployment of the MynxGrip sealant”—in just 11 seconds. Ahuja says this isn’t true and that it took longer. Additionally, Ahuja says that he only performed “part of the MynxGrip procedure” (the insertion and deployment of the sealant) and that a technician, Kristie Leffers, came in for other parts (the removal).
More so, Ahuja’s notes on how long manual compression occurred differ from notes taken by a monitor, Jordan Nordvik, who says, “manual compression was applied to Mrs. Chapman’s arteriotomy site for no more than two minutes and thirty seconds,” while Ahuja claims it was held for five minutes. In fact, Nordvik says Ahuja scrubbed out at 9:50, while manual compression began at just 9:49.
After the procedure, records state that Chapman’s arteriotomy site was “oozing,” when she was in a post-procedure holding room. Ahuja (who came back to Chapman’s bedside) thought the oozing was “superficial, like it was coming from subcutaneous tissue or the skin.”
He then told Leffers to “apply manual compression about one inch above the skin puncture site,” which, records note, “would not be the correct location to apply manual compression if Ahuja believed that the bleeding was coming from subcutaneous tissue at the skin puncture site….”
The implication? “Having tech Leffers apply manual compression at that location suggests that Ahuja was concerned that bleeding was coming from the femoral artery puncture site,” the documents state.
Regarding Ahuja’s experience with VCDs, the records note that he provided “confusing testimony regarding training that he received regarding the use of the Mynx VCD.”
Chapman was discharged later that day. But over the next two days, she “had consistent pain in her right calf,” documents state. Records state that she called the hospital several times and asked Ahuja’s staff members if she could massage the pain site or apply heat. She says his staff members told her that she could.
However, Ahuja has no record of these calls. Chapman brought herself back to the hospital on October 18. She was seen by Ahuja and other doctors to rule out the cause of the issue.
After the catheterization, a slew of issues
Among many details included in the court records, it was stated that Ahuja had not ordered an arteriogram for Chapman “after learning that an arterial Doppler study had revealed significant decrease in arterial blood flow velocity at the level of the popliteal artery.” Records show that other doctors were “appalled” by this decision.
Court documents say that at this point, Chapman’s health deteriorated. She would face renal issues, wound healing problems, and bleeding, requiring numerous transfusions. In November, it was found that her lateral right lower extremity had extensive myonecrosis and that “underlying the superficial, debrided tissue was muscle that had very little, if any, blood flow.”
At some point, above-the-knee amputation of her right lower extremity was suggested, which Chapman did not accept. By November 25, Chapman’s leg began to hemorrhage, and she went into shock. Further treatment was given.
By December 12, Chapman was discharged from St. Joseph Hospital by Ahuja and transferred to Select Specialty Hospital in Fort Wayne, where she gradually improved. By January 14, 2013, she was stable and went home, where she mostly remained sedentary.
After she went home, Chapman began seeing Dr. Thomas Lazoff, a psychiatrist. Lazoff reported that Chapman was “depressed and angry secondary to her overall situation and that she cried intermittently during the appointment.”
Charges & the verdict
Eventually, Chapman brought charges against Ahuja, citing claims that he:
Had failed to inform Mrs. Chapman that he would use the MynxGrip vascular closure device.
Had used the device without Chapman’s knowledge and permission.
Failed to comply with reasonable standards of medical care in his use of the MynxGrip vascular device.
Failed to urgently examine Chapman after learning on October 16 and 17, 2012, that she was in “substantial pain in her right calf after undergoing cardiac catheterization.”
Failed to comply “with reasonable standards of medical care in his treatment of Mrs. Chapman on and after October 15, 2012,” which “contributed to cause personal injury and damage to Mrs. Chapman.”
Additionally, Chapman brought forth charges against Cardinal Health AccessClosure for heralding “the development of the MynxGrip vascular closure device.”
Chapman now has a severe and permanent ischemic injury to soft tissues in her right lower extremity, causing substantial impairments and emotional distress—in addition to limitations on her ability to enjoy life. She also has to pay for significant medical bills and future care.
In the end, Chapman was only able to sue Ahuja—a case eight years in the making. In May 2023, a 10-jury trial at Allen Superior Court decided in favor of Chapman, who was awarded $2,670,000 in damages.