MAUDE Adverse Event Report: VISIONAIR SOLUTIONS / NEW COS INC. VISIONAIR 3D CUSTOM SILICONE AIRWAY Y-STENT; PROSTHESIS, TRACHEAL, PREFORMED/MOLDED

Model Number 0010-0126

Device Problems Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423); Migration (4003)

Patient Problems Airway Obstruction (1699); Pneumonia (2011); Stenosis (2263); Fungal Infection (2419); Respiratory Failure (2484)

Event Date 03/27/2021

Event Type  Injury  

Event Description

Product name: visionair 3d custom silicone airway stent.Event: proximal migration three days after placement resulting in respiratory failure requiring endotracheal intubation and icu admission, with prompt subsequent removal of the migrated stent, extubation, and discharge home at his baseline respiratory status without any long-term sequala from this event.This patient underwent right upper lobectomy in (b)(6) 2019 related to post-infectious (histoplasma) stenosis of rul airways resulting in recurrent/chronic pneumonia.Presented to interventional pulmonary practice in late 2019 with failure to recover back to his pre-surgery respiratory status.Ct and subsequent bronchoscopy demonstrated a kinked right mainstem bronchus with >95% airway obstruction, with a dramatically >90 degree curved distal right main bronchus + bronchus intermedius and bronchomalacia present throughout most of the rms/bi, an unusual complication of right upper lobectomy.Multiple stents failed to alleviate his bronchial stenosis/malacia, including straight silicone stents (obstructed with granulation/secretions within days of placement) and self-expanding fully covered metal stents (failed two months after placement due to proximal migration).Therefore, a custom silicone stent by visionair was created to match his highly unusual airway anatomy.This stent is created as a y-shaped stent with right, left, and tracheal limbs.As his stenosis only involved his right-sided airways, it was further customized prior to implantation by removing the left mainstem limb of the stent, leaving only the right-sided component and a short tracheal component."customizing" silicone tracheobronchial stents at the time of stent placement is commonplace among interventional pulmonologists, often after initial placement reveals a problem with the size, shape, or fit of the stent, or to strike a balance between risk of migration vs.Risk of mucus plugging.Regarding the latter, a known issue with any silicone stent is a trade-off between the risk of mucus plugging and the risk of stent migration.Longer stents tend to be more susceptible to mucus plugging, while shorter stents tend to migrate more frequently (less surface area in contact with / anchoring to airway mucosa).In this case, there was concern about the overall length of the stent between right sided, left-sided, and tracheal limbs and the risk for accumulation of in-stent secretions causing stenosis or plugging, particularly given his history of mucus plugging of a prior stent.He also had a history of proximal stent migration, thought at the time to be related to his highly curved right-sided airways.Once the custom right-sided limb negotiated his highly curved/kinked right-sided airways, however, it was believed that the right mainstem kink would provided an adequate hold on the stent to prevent migration (the point of maximal narrowing was at the midpoint of the stent in the airway, which is typically ideal).This calculation proved incorrect, with proximal stent migration observed several days later.I attribute this to (my) user miscalculation re: choice in balance between tendency to mucus plug and tendency to migrate, which led to the further customization of the stent with removal of the left mainstem limb.Fda safety report id # (b)(4).

• Brand Name: VISIONAIR 3D CUSTOM SILICONE AIRWAY Y-STENT
• Type of Device: PROSTHESIS, TRACHEAL, PREFORMED/MOLDED
• Manufacturer (Section D): VISIONAIR SOLUTIONS / NEW COS INC. ; cleveland OH 44103
• MDR Report Key: 11602513
• MDR Text Key: 243559532
• Report Number: MW5100477
• Device Sequence Number: 1
• Product Code: NWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0010-0126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Weight: 74