MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AEROMINI; PROSTHESIS, TRACHEOBRONCHIAL STENT

Model Number	00884450229859
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Went to deploy an aeromini flexible stent 14x15 and the stent would not deploy.The stent was defective.Diagnosis: bronchial fistula.Procedure performed: bronchoscopy flexible, hb stent bronchial novatech dumon via rigid bronchoscopy.Procedure in detail "decision was made to sue 14x15 mm metal wire stent to be placed via flexible bronchoscope.A guide wire was introduced through the working channel of flexible bronchoscope.With fluoroscope position of metal stent to be placed was marked.Flexible bronchoscope was removed while guide wire was left in place.A 14x16 mm metal wire stent was introduced over the guide wire and positioned in already marked area.Unfortunately stent was unable to be deployed due to faulty stent.Stent and guide wire was removed.A rigid bronchoscope was introduced into the airway.Once vocal cord was seen, ett was removed and rigid bronchoscope was advanced and positioned just above the right main stem.Patient was connected to the ventilator.A 16x40 mm dumon stent was loaded and introduced through the rigid bronchoscope.Subsequently stent was deployed in the right main stem.Stent was noted to be incompletely deployed.A 12 mm bronchial balloon was introduced through the rigid bronchoscope and inflated x2.A flexible bronchoscope was introduced through the rigid scope and advanced through the trachea and thorough the stent.I was able to pass the scope through the stent without any resistance and opening of rml and rll was noted to un obstructed by the stent.".

• Brand Name: AEROMINI
• Common Device Name: PROSTHESIS, TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10579452
• Report Number: 10579452
• Device Sequence Number: 14193599
• Product Code: JCT
• UDI-Device Identifier: 00884450229859
• UDI-Public: (01)00884450229859(17)240223(10)E1518596
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450229859
• Device Catalogue Number: AERO1415/C
• Device Lot Number: E1518596
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 08/26/2020