DYNAMIC Y STENT

Additional Manufacturer Narrative

(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DYNAMIC Y STENT WAS USED IN THE TRACHEA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A MALIGNANT STRICTURE CAUSED BY METASTATIC LUNG CANCER. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN TRIMMED THE DYNAMIC Y STENT TO THE DESIRED LENGTH. THE PHYSICIAN GRASPED THE STENT WITH FREITAG FORCEPS AND ATTEMPTED TO PASS THE STENT THROUGH THE VOCAL CORDS. HOWEVER, UNDER DIRECT VISUALIZATION WITH THE GLIDE SCOPE, THE PHYSICIAN NOTED THAT THE BACK SIDE OF THE STENT HAD TORN. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DYNAMIC Y 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.