MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING AERO DV.STENT, TRACHEOBRONCHIAL.; TRACHEOBRONCHIAL STENT

Catalog Number 90129-302EU/C

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

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 account alleges that during a post procedure stent placement review on (b)(6) 2021, it was discovered that the tracheobronchial stent had fractured within the patient.The stent was implanted on (b)(6) 2020.No patient injury to report.Additional procedure necessary.Stent was implanted for tracheobronchial tumor.

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is attributed to patient anatomy and/or condition.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 DV.STENT, TRACHEOBRONCHIAL.
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 11373582
• MDR Text Key: 233330344
• Report Number: 3010665433-2021-00013
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450034736
• UDI-Public: 884450034736
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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: Health Professional
• Device Expiration Date: 01/06/2023
• Device Catalogue Number: 90129-302EU/C
• Device Lot Number: E1734697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention