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

Model Number M00564760

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered distal release stent and delivery system were received for analysis.The stent was received completely deployed and was not fully expanded.Visual inspection was performed and it was found that the loops of the stent were bent.Functional examination was performed by submerging the stent in warm water for 15 minutes and the stent expanded.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was not confirmed; the stent was returned completely deployed and was not fully expanded.However, the stent was submerged in warm water for 15 minutes and the stent was able to expand passing the functional examination.Additionally, the stent loops were bent; however, there is insufficient information about what could be the cause for this failure.There was no confirmation on what the customer indicated because the stent was returned completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a 2cm malignant tumor in the left distal main bronchus during a stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was a bit tight but not tortuous and was not dilated prior to stent placement.According to the complainant, the stent was attempted to be deployed under fluoroscopy guidance.During the procedure, it was noted that the stent did not fully deploy.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another ultraflex tracheobronchial stent of a different size.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.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: 11067188
• MDR Text Key: 226300381
• Report Number: 3005099803-2020-06404
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0024975801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2020
• 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: 74 YR
• Patient Weight: 53