MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564810

Device Problem Material Deformation (2976)

Patient Problem Dyspnea (1816)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered distal release stent and delivery system were received for analysis.Visual examination of the returned device found the stent was partially deployed.The loops of the stent were bent.Functional evaluation was performed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.By retracting the finger ring, the stent was gradually released from the delivery system.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The investigation concluded that the observed failure of stent partially deployed was likely due to factors encountered during the procedure and/or the size of the stent used.It is possible that when the physician noticed the stent was too long for the patient's anatomy during deployment, the stent was removed partially deployed on the delivery system.The loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Additionally the patient had difficulty breathing; this is most likely caused because the stent was too long and it blocked the carina.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the bronchus to treat an external pressure stenosis of bronchial tumor during a tracheal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during stent deployment, the physician noticed that the stent was too long for the patient's anatomy.Reportedly, as a result, the stent blocked the carina and the patient had difficulty breathing.The stent was pulled out from the patient and the patient was able to breathe normally.There were no additional interventions taken.The procedure was completed with a 16 x 40 uncovered stent.Reportedly, the patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed a reportable event based on the investigation finding of stent loops were bent.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10838740
• MDR Text Key: 216385553
• Report Number: 3005099803-2020-05118
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: M00564810
• Device Catalogue Number: 6481
• Device Lot Number: 0022783613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• 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 Age: 65 YR
• Patient Weight: 63