MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING AERO TRACHEOBRONCHIAL STENT

Model Number 00884450030813

Device Problems Material Fragmentation (1261); Material Separation (1562); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  Injury  

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 alleges that during a tracheobronchial stent removal procedure the stent fragmented within a male patient.The original stent implant date was (b)(6) 2019.The stent placed for tracheal stenosis due to cancer.No difficulty occurred during implantation.The stent was successfully placed under x-ray visualization.No abnormality was identified on the stent post placement.The stent was placed within the upper portion of the airway however, it migrated down to the vicinity of tracheal bifurcation within a few days after the placement.The stent was placed for extrinsic compression.The physician states the stent had previously fractured within the patient and the retrieval knot at the end of the stent was pulled, but only a piece of the stent was successfully removed without resistance.The physician grasped as many of the stents supporting points as possible with grasping forceps.During the removal procedure the stents polyurethane cover had split as well and had occluded the patient's trachea, causing a serious decrease in spo2 levels.A flexible scope was forcefully inserted into the patient and airway was cleared.An intratracheal intubation tube was placed, and the procedure was completed.

Manufacturer Narrative

The suspect device has not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: AERO TRACHEOBRONCHIAL STENT
• Type of Device: TRACHEOBRONCHIAL STENT
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston, tx
• MDR Report Key: 10457975
• MDR Text Key: 204523235
• Report Number: 3010665433-2020-00031
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00884450030813
• UDI-Public: 00884450030813
• Combination Product (y/n): N
• PMA/PMN Number: K082284
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 00884450030813
• Device Catalogue Number: 90129-201/JPC
• Device Lot Number: E1403811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention