MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. AERO® TRACHEOBRONCHIAL STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Catalog Number	90129-212/G
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	09/03/2024
Type of Reportable Event	Death
Event or Problem Description
The account alleges that during a tracheobronchial stent deployment procedure, the clinician was unable to deploy a stent by squeezing the deployment trigger.They switched to a new stent and had a similar issue but were successful in deploying the stent, but the stent had enfolded [invaginated].The 12x40 stent was placed via direct vision.No damage was noted to the stent or the device before or during the deployment attempt.The clinician tried to adjust the stent using a balloon inflation technique and ended up perforating the tracheobronchial wall.The physician states the patient was not in good condition before the procedure.The 58-year-old female patient who suffered from a large cancerous endobronchial tumor likely contributed to the patient's tracheobronchial perforation by weakening the tracheal wall during the balloon expansion technique resulted in perforation.A code was initiated per hospital protocols but was unsuccessful.The patient expired at 4:15 pm the same day.Cod massive hemorrhage.The patient also experienced hemoptysis 1 week before the actual stent placement and underwent photodynamic therapy (pdt) treatment 4 weeks before that actual stent placement.An autopsy is not likely due to the patient's death being attended.The device is returning for engineering evaluation.In-stent ballooning is acceptable per ifu.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was not confirmed and a root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.

• Brand Name: AERO® TRACHEOBRONCHIAL STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 20204675
• Report Number: 1721504-2024-00063
• Device Sequence Number: 17811090
• Product Code: JCT
• UDI-Device Identifier: 00884450703960
• UDI-Public: 884450703960
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 90129-212/G
• Device Lot Number: E2982189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION BALLOON
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female