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

Model Number 6487

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A fully deployed ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Per media analysis, it was observed that the stent was partially deployed on the delivery system.Visual examination of the returned device found the loops of the stent were bent.The outer diameter 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 partially deployed was confirmed; the stent was observed to be partially deployed during media analysis.The investigation concluded that the reported event was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, the techniques used by the user, and the tight anatomy of the patient, limited the performance of the device and contributed to the partial deployment of the stent during the procedure.Additionally, there is not enough sufficient information of what could be the cause of the stent loops bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.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, there is no information that this device was used in a manner inconsistent with 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 an esophageal carcinoma compressing the trachea and tracheobronchial stenosis during a stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the black deployment suture could not be pulled and the stent was not deployed.The physician removed the stent from the patient and noted that the front end of the stent was partially deployed.Reportedly, the stent could not be re-advanced 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.A photo of the complaint device was provided by the complainant after the procedure, and it shows that the stent was partially deployed.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the loops of the stent 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: 10586226
• MDR Text Key: 208552560
• Report Number: 3005099803-2020-04220
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: 6487
• Device Catalogue Number: 6487
• Device Lot Number: 0022880300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2018
• 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: 70 YR
• Patient Weight: 55