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

Model Number M00564760

Device Problems Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the bronchial tube for the treatment of esophageal cancer during a bronchial stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex tracheobronchial stent was deployed; however, upon checking under fluoroscopy immediately after deployment, it was noted that the ultraflex tracheobronchial stent did not expand.The delivery system was attempted to be removed; however, it got caught on the ultraflex tracheobronchial stent.The ultraflex tracheobronchial stent was removed together with the delivery system.Another ultraflex tracheobronchial stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex tracheobronchial covered distal release stent was to be implanted in the bronchial tube for the treatment of esophageal cancer during a bronchial stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex tracheobronchial stent was deployed; however, upon checking under fluoroscopy immediately after deployment, it was noted that the ultraflex tracheobronchial stent did not expand.The delivery system was attempted to be removed; however, it got caught on the ultraflex tracheobronchial stent.The ultraflex tracheobronchial stent was removed together with the delivery system.Another ultraflex tracheobronchial stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a150101 captures the reportable event of stent failure to expand.Block h10: an ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully expanded.The shaft was bent.A media inspection was performed of a photo provided by the complainant, and it was observed that one section of the stent was not fully expanded.No other issues to the stent and delivery system were noted.The reported event of stent failure to expand was confirmed.The reported event of delivery system difficult to remove could not be confirmed; the failure occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Based on all available information, the investigation concluded that the reported events and the observed failures were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, the technique used by the user and/ or normal procedural difficulties encountered, limited the performance of the device and may have contributed to stent unable to expand and shaft bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.

• 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: 15414654
• MDR Text Key: 306239768
• Report Number: 3005099803-2022-05201
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0027103521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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