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

Catalog Number 90129-318

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

Patient Problems Death (1802); Internal Organ Perforation (1987)

Event Date 03/19/2018

Event Type  Death  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that during an aero stent placement procedure under fluoroscopic visualization, the patient's upward left main bronchus which had an abnormal anatomical takeoff was perforated during stent placement.The patient had a pneumonectomy of the left lung in the past for unknown reasons.Post-stent placement procedure, the patient underwent surgery to repair the left main bronchus perforation, the tip of aero delivery system was found to have also pierced the patient's pericardium.The physician noted that the patient's anatomy was extremely rare, and that the patient's injuries are unrelated to the aero stent delivery system.Patient has since expired on unknown date for unknown reasons.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: ron boswell b.s.hca,rcis ; 1600 west merit parkway; south jordan, UT 92154
• MDR Report Key: 7401207
• MDR Text Key: 104520394
• Report Number: 3010665433-2018-00026
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2018

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?: No
• Device Operator: Physician
• Device Catalogue Number: 90129-318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/05/2018
• 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): Death; Life Threatening; Required Intervention