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

Model Number M00564750

Device Problem Activation Failure (3270)

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

Event Date 03/19/2023

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a150101 captures the reportable event of stent failure to expand.

Event Description

It was reported to boston scientific corporation on april 04, 2023 that an ultraflex tracheobronchial covered distal stent was implanted in the left lower bronchus to treat a 10mm x 15mm malignant stenosis during a 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, the stent was deployed; however, it was noted that the stent was unable to expand as the nitinol memory metal wire of the stent remained entangled.The physician decided to wait for 48 hours but the stent was still unable to expand.The stent was removed with forceps and another ultraflex tracheobronchial stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of 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: 16795642
• MDR Text Key: 313826259
• Report Number: 3005099803-2023-02183
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: M00564750
• Device Catalogue Number: 6475
• Device Lot Number: 0028665924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 34 KG