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

Model Number M00564900

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of ultraflex tracheobronchial stent partially deployed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted in the main airway to treat a 2 cm malignant subglottic stenosis due to thyroid tumor compresses the airway during an airway stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, when the delivery system reached the lesion, a small part of the stent was released from the tip of the delivery system.Subsequently, the physician had difficulty crossing the delivery system across the stenosis.The ultraflex tracheobronchial stent was removed from the patient partially deployed on the delivery system.Another ultraflex tracheobronchial stent used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on april 7, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted in the main airway to treat a 2 cm malignant subglottic stenosis due to thyroid tumor compresses the airway during an airway stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, when the delivery system reached the lesion, a small part of the stent was released from the tip of the delivery system.Subsequently, the physician had difficulty crossing the delivery system across the stenosis.The ultraflex tracheobronchial stent was removed from the patient partially deployed on the delivery system.Another ultraflex tracheobronchial stent used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of ultraflex tracheobronchial stent partially deployed.Block h10: the ultraflex tracheobronchial stent and delivery system were received for analysis.Visual examination found that the stent was partially deployed, and the shaft was slightly bent.Microscopic inspection found no damages or knots in the deployment suture.Functional inspection revealed the stent was able to be released gradually from the delivery system by retracting the finger ring.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported device malfunction of stent partially deployed.The reported event of stent difficult to cross lesion was not confirmed as it happened during the procedure, and it was not possible to replicate in the laboratory.The investigation concluded that the reported events and the observed failure were most likely due to procedural factors encountered during the procedure.It may be lesion characteristics, handling of the device, the technique used by the user and the amount of force applied trying to cross the stenosis could have resulted to bending of the shaft which could have prevented the stent to deploy during the procedure causing partial deployment.Therefore, review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: 16820356
• MDR Text Key: 314085174
• Report Number: 3005099803-2023-02246
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2024
• Device Model Number: M00564900
• Device Catalogue Number: 6490
• Device Lot Number: 0029244233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 45 KG