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

Model Number M00564800

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered stent was received for analysis.The delivery system was not returned.Visual examination of the returned device found the stent was received completely deployed.The loops of the stent were found bent.The outer diameter (od) of the stent was measured, and was found to be within specification.No other issues were noted to the stent.The reported event of stent failed to deploy, and shaft kinked were not confirmed.The stent was received completely deployed, and the delivery system was not returned.Taking all available information into consideration, the investigation concluded that the reported events, and the observed failures may be due to factors encountered during the procedure.It may be that how the unit was handled or manipulated, and/or the patient anatomy contributed to the reported events of stent failure to deploy, and shaft kinked.However, there was no confirmation on what the customer indicated because the stent was returned completely deployed, as well as the delivery system was not returned.Additionally, the loops of the stent were bent.However, there is not sufficient information about what could be the cause for this failure.Therefore, a review and analysis of all available information indicated the most probable cause is "no problem detected." a review of the device history record (dhr) was performed, and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/ product label.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a bronchial stenosis in the bronchus during a transfiberscope stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the delivery shaft was kinked, and the stent deployment suture could not be pulled.The stent failed to deploy inside the patient, and the procedure was completed with another ultraflex tracheobronchial stent.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: this event has been deemed an mdr reportable event based on investigation result which revealed the stent loops were bent.

• 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: 10507437
• MDR Text Key: 206524676
• Report Number: 3005099803-2020-03752
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 0024113351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• 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 Age: 65 YR
• Patient Weight: 55