MAUDE Adverse Event Report: MERIT MEDICAL PEARLAND AERO TRACHEOBRONCHIAL STENT

Catalog Number 90129-215

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The physician reported that a stent had fractured within the patient's left main stem bronchus during a follow up appointment in (b)(6) 2018.The stent was placed in (b)(6) 2017 for extrinsic compression from an enlarged heart.The patient has experienced bouts of severe coughing.The fractured stent was removed and a new stent was placed under fluoro.No further injury to the patient was reported.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database and device history record could not be performed since the lot number was not provided.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL PEARLAND; 14646 kirby dr.; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL PEARLAND; 14646 kirby dr.; houston TX 77047
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 7201127
• MDR Text Key: 97576496
• Report Number: 3010665433-2018-00001
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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
• Device Operator: Physician
• Device Catalogue Number: 90129-215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention