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

Model Number M00564870

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of a stent's suture break.Imdrf device code a0406 captures the reportable event of a stent's material deformation.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered stent was to be implanted in the middle of the tracheal section to treat a 3.8 cm long esophagotracheal fistula during a tracheal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed several times.The stent was deployed inside the patient; however, when the stent's position was adjusted, the stent's sutures at both ends were fractured, and there was a burr at the lower edge of the stent.The stent was removed from the patient with snares, and the procedure was completed with another ultraflex trachebronchial stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered stent was to be implanted in the middle of the tracheal section to treat a 3.8 cm long esophagotracheal fistula during a tracheal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed several times.The stent was deployed inside the patient; however, when the stent's position was adjusted, the stent's sutures at both ends were fractured, and there was a burr at the lower edge of the stent.The stent was removed from the patient with snares, and the procedure was completed with another ultraflex trachebronchial stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of a stent's suture break.Imdrf device code a0406 captures the reportable event of a stent's material deformation.Block h10: the ultraflex tracheobronchial stent was received for analysis.The delivery system was not received for analysis.Visual and media analyses found that the stent retention suture was broken and damaged.No other damages were noted with the stent.Product analysis confirmed the reported event of suture break; however, the reported event of stent material deformation was not confirmed because the returned stent was not deformed.The investigation concluded that suture breakage was most likely due to procedural factors such as the handling of the device or when the physician adjusted the position of the stent, which could have caused the retention suture on one side of the stent to be broken.Therefore, a review and analysis of all available information indicated that 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: 18701882
• MDR Text Key: 335302537
• Report Number: 3005099803-2024-00481
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00564870
• Device Catalogue Number: 6487
• Device Lot Number: 0029804835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 48 KG