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

Model Number M00564770

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the deployment suture broken.The shaft was also bent in two sections.Functional examination was performed and the stent was able to be released by pulling the black deployment suture.No other problems were noted to the stent and delivery system.Taking all available information into consideration, the investigation concluded that the reported events and 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 physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the reported events and the observed failures.Therefore, the most probable cause is adverse event related to the procedure.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the trachea to treat a stenosis during a tracheobronchial stenting procedure performed on (b)(6) 2022.During the procedure, the stent was attempted to be deployed; however, the shaft bent, and the deployment suture broke.The stent was removed from the patient partially deployed and the procedure was completed using another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent partially deployed due to a precedent event.

• 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: 15941235
• MDR Text Key: 308012765
• Report Number: 3005099803-2022-07325
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: M00564770
• Device Catalogue Number: 6477
• Device Lot Number: 0028400326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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