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

Model Number M00564900

Device Problem Break (1069)

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

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of stent break.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted to treat a stenosis in the main airway due to tumor pressure during a stent placement procedure performed on (b)(6) 2023.The patient anatomy was tight and was dilated prior to stent placement.During the procedure, the stent was able to be deployed in the airway.However, the proximal end of the stent was noted to be fractured.The stent was removed from the patient with biopsy forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable and has been discharged from the hospital.

Manufacturer Narrative

Block b5 has been updated with the additional information received on may 9, 2023.Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h10: the ultraflex tracheobronchial covered distal stent was returned for analysis; however, the delivery system was not returned.Visual inspection revealed no damage to the stent.Product analysis did not confirm the reported device malfunction of stent break because inspection of the returned stent revealed no damages and the device met all the manufacturing requirements, and it passed the visual inspection during the product analysis.Therefore, review and analysis of all available information indicated that 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 february 22, 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted to treat a stenosis in the main airway due to tumor pressure during a stent placement procedure performed on (b)(6) 2023.The patient anatomy was tight and was dilated prior to stent placement.During the procedure, the stent was able to be deployed in the airway.However, the proximal end of the stent was noted to be fractured.The stent was removed from the patient with biopsy forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable and has been discharged from the hospital.Additional information received on may 9, 2023: it was reported that the ultraflex tracheobronchial stent was implanted to treat a malignant stenosis.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h10: the ultraflex tracheobronchial covered distal stent was returned for analysis; however, the delivery system was not returned.Visual inspection revealed no damage to the stent.Product analysis did not confirm the reported device malfunction of stent break because inspection of the returned stent revealed no damages and the device met all the manufacturing requirements, and it passed the visual inspection during the product analysis.Therefore, review and analysis of all available information indicated that 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 february 22, 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted to treat a stenosis in the main airway due to tumor pressure during a stent placement procedure performed on (b)(6) 2023.The patient anatomy was tight and was dilated prior to stent placement.During the procedure, the stent was able to be deployed in the airway.However, the proximal end of the stent was noted to be fractured.The stent was removed from the patient with biopsy forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be stable and has been discharged from the hospital.

• 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: 16549810
• MDR Text Key: 311371709
• Report Number: 3005099803-2023-01302
• 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,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: M00564900
• Device Catalogue Number: 6490
• Device Lot Number: 0028226486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 74 KG