BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
|
Back to Search Results |
|
Model Number M00564890 |
Device Problems
Break (1069); Migration (4003)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/28/2024 |
Event Type
Injury
|
Event Description
|
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release covered stent was implanted in the trachea during a tracheal stent placement procedure performed on an unknown date.On (b)(6) 2024, during a routine follow-up, the patient coughed, and a portion of the stent was ejected from the patient.The patient outcome was reported as no patient injury.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
|
|
Manufacturer Narrative
|
Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0401 captures the reportable event of stent break.
|
|
Manufacturer Narrative
|
Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0401 captures the reportable event of stent break.Block h10: a small piece of black thread was received for analysis; the ultraflex tracheobronchial distal release covered stent and delivery system were not returned for evaluation.The reported events of stent break and stent migration cannot be confirmed as the stent and delivery system were not returned.In addition, product analysis concluded that the cause for the small piece of black thread could not be established as the source of this material is unknown.Based on the available information, there is not enough information to confirm the reported events of stent break and stent migration, therefore, most probable cause is no problem detected.
|
|
Event Description
|
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release covered stent was implanted in the trachea during a tracheal stent placement procedure performed on an unknown date.On (b)(6) 2024, during a routine follow-up, the patient coughed and a portion of the stent was ejected from the patient.The patient outcome was reported as no patient injury.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
|
|
Search Alerts/Recalls
|
|
|