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

Model Number M00564870

Device Problem Material Deformation (2976)

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

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal stent was to be implanted in the main airway to treat a malignant main airway stenosis secondary to a thyroid tumor oppression during a stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the deployed stent was noted to be severely deformed.The stent was removed from the patient with forceps, fully deployed from the delivery system.The procedure was completed with another ultraflex tracheobronchial 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 a0406 captures the reportable event of stent material deformation.Block h10: the ultraflex tracheobronchial covered stent was received for analysis.The delivery system was not received for analysis.Visual inspection found that the stent was fully expanded and deployed, and it was deformed.No other damages were noted to the stent.Product analysis confirmed the reported event of stent material deformation.The investigation concluded that the reported event was most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damage encountered in the device.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.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal stent was to be implanted in the main airway to treat a malignant main airway stenosis secondary to a thyroid tumor oppression during a stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the deployed stent was noted to be severely deformed.The stent was removed from the patient with forceps, fully deployed from the delivery system.The procedure was completed with another ultraflex tracheobronchial 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.

• 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: 18338196
• MDR Text Key: 330677367
• Report Number: 3005099803-2023-06722
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 0029804836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG