MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. AERO TRACHEOBRONCHIAL STENT

Catalog Number 90129-204/C

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

Patient Problem Death (1802)

Event Date 10/01/2017

Event Type  Death  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account reports that a patient with benign tracheal stenosis has expired.A tracheobronchial stent was placed on (b)(6) 2017 without incident.The stent had great apposition and was correctly sized.The procedure went well according to the physician.The patient was discharged to home the same day.The patients pcp contacted the physician a week prior to the event to report the patient was doing great.The physician stated that the patient's son told him, that the patient went to bed about 9:00pm and at 1:00am on sunday, (b)(6) 2017 the patient walked into her daughter's room and was grasping her neck, the patient then collapsed on the daughter's bed and expired.The physician does not believe that there was an association between the death and use of the aero stent.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer (Section G): MERIT MEDICAL SYSTEM, INC.; merit medical systems, inc.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: ron boswell, bs-hsa, rcis ; 1600 merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 6948726
• MDR Text Key: 89284044
• Report Number: 3010665433-2017-00065
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 90129-204/C
• Device Lot Number: E1189364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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): Death