Malpractice Case Studies

Improper Stent Placement Claimed in Tracheal Stenosis Necessitating Later Subglottic Resection

Written by ProAssurance Risk Management | December 2020

Allegation:

Pulmonologist violated the standard of care by placing an uncovered metallic stent instead of recommending resection for a tracheal stenosis. He also intentionally misrepresented that the stent could be easily removed and placed a second stent with lack of informed consent.

The Case:                                                                                                                                     

A 44 YOF (5’1”, 167 lbs.) presented to her ENT physician for a laryngoscopy with bronchoscopy. A CT scan revealed narrowing of the subglottic region of the trachea suggesting tracheal stenosis. The laryngoscopy revealed subglottic tracheal stenosis 2 cm below the cords for a distance of 1.5 cm, and overall narrowing of 7 mm. The ENT physician consulted the defendant pulmonologist. 

The next day, the defendant pulmonologist examined the patient and discussed possible treatment options, including trach stenting, which he recommended. The next week, the patient presented for an elective tracheal dilation and stent placement by the defendant pulmonologist. He documented in the chart that he discussed the risks, benefits, and alternatives of the procedure with the patient. 

During the procedure, the defendant pulmonologist noted an area of stenosis that was 2 cm distal to the vocal cords which was biopsied. He placed a 16 mm x 40 mm uncovered metallic tracheobronchial Wallstent™, noting the proximal portion of the stent was just below the vocal cords. He then dilated the stent and trachea which was 5-6 mm in size to 12 mm. Pathology revealed nonspecific acute and chronic inflammation, with no evidence of malignancy. 

The patient developed a cough three months later, and had an elective bronchoscopy by the defendant pulmonologist. He noted the upper quarter Wallstent was epithelialized as well as areas of granulation tissue on the anterior and posterior walls of the trachea. Another bronchoscopy was done six months later when the patient developed stridor. The defendant pulmonologist removed a web of tissue that was dividing the tracheal orifice in half and markedly narrowing the area above the stent. He debrided knobs of granulation tissue from the distal portion of the stent. 

Three months later, which was one year post surgery, the defendant pulmonologist again debrided granular and inflammatory tissue from the distal portion of the stent. He noted an area of cartilaginous tissue coming from the left wall of the anterior trachea extending from 12:00 o’clock to 8:00 o’clock, which he was unable to remove. The biopsy revealed chronic ulcer. 

The patient underwent another bronchoscopy one month later. The consent form indicated the patient was aware that conditions may require an extension of the procedure. There was exuberant granulation tissue, which reduced the airway to 2-3 mm. The defendant pulmonologist attempted to dilate the distal portion of the stent twice; however due to exuberant granulation tissue, which reduced the airway to 2-3 mm, he was unsuccessful. He then placed a 14 mm x 40 mm uncovered metallic Wallstent at the distal portion of the previous stent. 

In two weeks, the patient returned due to a productive cough and shortness of breath. During a bronchoscopy, the defendant pulmonologist found inflammation, edema, and erythema of the subglottic area without narrowing; he also found the stents were in satisfactory position. His impression was acute tracheobronchitis. 

The next month, the patient told the defendant pulmonologist she was feeling better than she had in decades. She was instructed to follow-up in 3-4 months. Nine months later, she presented for bronchoscopy due to some recent dyspnea. At the level of the proximal stent, the defendant pulmonologist noted narrowing and a 5 mm tracheal lumen. He scheduled a tracheal dilation. He was only able to dilate the area to 7 mm, and he diagnosed tracheal stenosis, idiopathic/post-traumatic. The patient was referred to a thoracic surgeon to consider surgery. 

The thoracic surgeon heard an audible stridor on forced inspiration during his exam. On x-ray, he saw the stents were occupying almost half the length of her trachea. He recommended stent removal and temporary placement of a tracheostomy tube. The patient underwent tracheal resection and placement of a tracheostomy tube. The patient was discharged the next day with good airway and voice function. 

The trach was removed a year later. The bronchoscopy revealed no narrowing in the subglottic region and the airway was stable. The patient had excellent voice quality. 

Two years later, the patient saw the thoracic surgeon with a complaint of stridor. A bronchoscopy was performed, and a normal airway was found with a subglottic stricture which did not allow the passage of a #6 rigid scope without dilation. The patient was advised she would likely need a subglottic resection in the future. Seven months later, she had a successful resection and did well. Six months later, which marked six years after she sought treatment, the surgeon told her she had achieved a permanent cure. 

The lawsuit was filed four years into her course of treatment. The patient’s subsequent treating surgeon served as the patient’s expert witness. 

Defense experts testified it was appropriate for the defendant pulmonologist to place stents during the initial procedures. In the following years, it became known that the subglottic area was more prone to granuloma formation and that surgery was the favored treatment for stenosis in that area. 

Verdict: 

After deliberation, the case resulted in a defense verdict.  

---  

If you have questions on this topic, please email RiskAdvisor@ProAssurance.com or call 844-223-9648.