MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING AERO TRACHEOBRONCHIAL STENT

Catalog Number	90129-211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/22/2024
Type of Reportable Event	Death
Event or Problem Description
The account alleges that during a routine aero tracheobronchial polyurethane stent follow-up appointment for a female cancer patient currently receiving palliative care due to cancer.The aero stent was placed for a cancer-related stricture approximately two weeks ago without issue.The patient received one treatment of radiation therapy post-stent implant on an unknown date.During the follow-up appointment, the physician noted some narrowing and with minor granulated tissue [connective tissue] present at the aero stent site.The interventional pulmonologist recommended removing the existing aero stent and upsizing it to a larger stent for the patient.During the stent removal procedure, a merit pulmonary balloon dilatation catheter was used to dilate the inner diameter of the stent under fluoroscopic guidance and an attempt to remove the stent with a pair of raptor forceps was initiated successfully.The actual stent removal process was unremarkable.Soon after the stent was removed bleeding was noted at the stent site.Suction was attempted but unsuccessful in controlling the hemorrhaging.The patient became hemodynamically unstable and a code blue was initiated.Life-saving protocols were attempted for this patient with no success.The patient expired early afternoon [approx 2 pm 8-22-2024] in the procedure room.The physician states the merit balloon and aero stent system did not malfunction during this procedure, both medical devices operated as intended.No device returning at this time.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A review of the device history record and complaint database could not be performed as a lot number was not provided.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Common Device Name: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston, tx 77047 ; EI 77047
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20085157
• Report Number: 3010665433-2024-00030
• Device Sequence Number: 15394761
• Product Code: JCT
• UDI-Device Identifier: 00884450703977
• UDI-Public: 00884450703977
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 90129-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: MERIT PULMONARY BALLOON.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female