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

Model Number M00564850

Device Problems Material Integrity Problem (2978); Activation Failure (3270)

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

Event Date 03/30/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial covered distal stent was to be implanted in the trachea to treat a malignant tracheoesophageal fistula during a tracheal fistula closure procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed but did not fully expand.The stent was removed from the patient with forceps and the procedure was completed with another ultraflex tracheobronchial stent.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Impact code f2301 is being used to capture the additional device required to remove the stent.

Manufacturer Narrative

H6: imdrf device code a150101 captures the reportable event of stent failure to expand.Impact code f2301 is being used to capture the additional device required to remove the stent.Imdrf device code a04 captures the reportable product investigation result of stent cover damaged.H10: the ultraflex tracheobronchial covered stent was received for analysis; the delivery system not returned.Media inspection revealed that the stent was not fully expanded.Visual inspection found that the stent was not fully expanded, and the stent cover had holes.Functional inspection was performed by submerging the stent in warm water for 15 minutes, and it was found that the stent expanded without problems.No other issues were noted with the stent.Product analysis did not confirm the reported event of stent failure to expand, as the stent expanded when submerged in warm water for 15 minutes.The damage noted to the stent cover was most likely due to the technique used by the physician when removing the stent or any interaction with other surfaces during the procedure.Taking all available information into account, there is no confirmation of what the customer reported as the stent expanded without problems, and the device met all the manufacturing requirements and passed all the controls and inspections during device analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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 on (b)(6) march 30, 2023, that an ultraflex tracheobronchial covered distal stent was to be implanted in the trachea to treat a malignant tracheoesophageal fistula during a tracheal fistula closure procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed but did not fully expand.The stent was removed from the patient with forceps and the procedure was completed with another ultraflex tracheobronchial stent.There were no reported patient complications as a result of this event.The patient's condition following 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: 16775141
• MDR Text Key: 313632816
• Report Number: 3005099803-2023-02082
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: M00564850
• Device Catalogue Number: 6485
• Device Lot Number: 0028392664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 145 KG