MAUDE Adverse Event Report: VISIONAIR SOLUTIONS VISIONAIR 3D STENT (PATIENT-SPECIFIC AIRWAY STENT); PROSTHESIS, TRACHEAL, PREFORMED/MOLDED

Catalog Number 0010-0126

Device Problem Migration (4003)

Patient Problem Pulmonary Dysfunction (2019)

Event Date 03/27/2021

Event Type  Injury  

Manufacturer Narrative

The instructions for use provided with the finished device defines stent modification as a contraindication.

Event Description

A patient-specific airway stent was ordered on (b)(6) 2021, for a patient with right upper lobectomy ((b)(6) 2019) and demonstrating a kinked right mainstem bronchus with >95% airway obstruction.Multiple stents had been previously placed and failed to alleviate the patient's bronchial stenosis/malacia, including straight silicone stents (due to granulation/secretion obstruction) and self-expanding metal stents (proximal migration).The patient-specific airway stent (s/n: (b)(4)) was shipped to (b)(6) on 15-feb-2021.The patient-specific airway stent was a bifurcated (y-stent) beginning within the trachea and extending into the left and right mainstem bronchi.The date of procedure, the stent was brought to the or where the physician opened the sealed box with the stent inside, in a sealed plastic bag.The physician modified the stent by removing the left mainstem limb prior to implantation due the patient's stenosis involving the right side of the airway, which resulted in a stent with a tracheal component and right limb.The device was then implanted on the date of (b)(6) 2021.On (b)(6) 2021, at 2:00am, the patient had coughed and felt the stent move.Ems was called and the patient was taken to the emergency department where he was intubated for respiratory distress.The patient was then transferred to the institution where the stent was implanted, where a ct scan was completed and showed that the stent had migrated proximally in the patient's airway.The stent was explanted and the patient was extubated in the same day.The patient was discharged at his baseline respiratory status the next morning, (b)(6) 2021.

• Brand Name: VISIONAIR 3D STENT (PATIENT-SPECIFIC AIRWAY STENT)
• Type of Device: PROSTHESIS, TRACHEAL, PREFORMED/MOLDED
• Manufacturer (Section D): VISIONAIR SOLUTIONS; 7100 euclid ave.; suite 180; cleveland OH 44103
• Manufacturer Contact: adrianna baiera ; 7100 euclid ave; suite 180; cleveland, OH 44103 ; 3307153878
• MDR Report Key: 11657266
• MDR Text Key: 245500350
• Report Number: 3010197296-2021-03291
• Device Sequence Number: 1
• Product Code: NWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2021
• Device Catalogue Number: 0010-0126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 74