Model Number M00576620 |
Device Problems
Positioning Problem (3009); Activation Failure (3270)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/19/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.
|
|
Event Description
|
It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
|
|
Manufacturer Narrative
|
Blocks d4 (lot number and expiration date) and h4 (device manufacture date) have been updated with the additional information received on march 17, 2023.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.
|
|
Event Description
|
It was reported to boston scientific corporation on january 19, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
|
|
Event Description
|
It was reported to boston scientific corporation on january 19, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.Block h10: the ultraflex tracheobronchial covered distal stent and delivery system were received for analysis.Visual inspection revealed that the stent was fully expanded and deployed and that the shaft was kinked.No other issues were noted with the delivery system.Product analysis revealed the shaft was kinked which was most likely due to procedural factors such as lesion characteristics, handling of the device, or the techniques used by the user.However, product analysis did not confirm the reported device malfunction of stent failed to expand as the stent was returned fully deployed and expanded.The reported failure of stent positioning issue cannot also be confirmed because this happened during the procedure and is not possible to replicate in the laboratory for analysis.There is no indication of what the customer reported because the stent was returned completely expanded.Therefore, review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
|
|
Search Alerts/Recalls
|