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

Catalog Number 90129-216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/28/2014

Event Type  Death  

Event Description

The user reported that two bronchial stents were placed at the trachea and right main bronchus.The pt was sent to recover in the icu.The pt expired approximately five hrs later.The pt's cause of death was pneumonia, which led to respiratory arrest.

Manufacturer Narrative

Device eval: no device is expected to be returned for eval.Since the lot number was not provided, the device history record and complaint database could not be reviewed.The user's clinical opinion is that merit's device did not contribute to this event.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4135190
• MDR Text Key: 4797124
• Report Number: 1721504-2014-00234
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 90129-216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death