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

Model Number M00564900

Device Problems Break (1069); Material Deformation (2976); Positioning Problem (3009); Activation Failure (3270)

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

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent suture break.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 is used to capture the use of biopsy forceps to reposition the stent.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was to be implanted to treat a tracheoesophageal fistula during a fistula closure with stent placement procedure performed on (b)(6) 2024.The patient anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was deployed; however, it was noted that the proximal end of the stent did not fully expand, and the stent blocked the left main bronchus.The physician repositioned the stent by pulling the stent retention suture using biopsy forceps.Subsequently, the stent retention suture broke, and the stent suture could not be pulled further.A rigid endoscope was used to pull the suture, and the stent was removed.The delivery system was removed with the stent deployment suture knotted at the tip of the delivery system, and the procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable.

• 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: 18979739
• MDR Text Key: 338616504
• Report Number: 3005099803-2024-01213
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00564900
• Device Catalogue Number: 6490
• Device Lot Number: 0031297157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 45 KG