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

Model Number M00564780

Device Problems Use of Device Problem (1670); Activation Failure (3270)

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

Event Date 02/17/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on february 20, 2023 that an ultraflex tracheobronchial covered distal stent was to be implanted to treat a left main bronchial stenosis during a tracheobronchial stenting procedure performed on (b)(6)2023.During the procedure, the stent was deployed; however, microscopic examination was performed after stent deployment and it was noted that the stent was loose and had not fully opened in the airway.The stent was removed with biopsy forceps.The procedure was not completed due to device availability.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.Note: it was reported that the ultraflex tracheobronchial covered distal stent was to be implanted to treat a benign bronchial stenosis.Per the instructions for use (ifu), "the ultraflex tracheobronchial stent system is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms." the stent is not indicated for the treatment of benign stenosis.

Manufacturer Narrative

The initial reporter's healthcare facility name is (b)(6).Imdrf device code a150101 captures the reportable event of stent failure to expand.

• 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: 16503284
• MDR Text Key: 310886079
• Report Number: 3005099803-2023-01185
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: M00564780
• Device Catalogue Number: 6478
• Device Lot Number: 0029335564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG