D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DYNAMIC Y STENT WAS ATTEMPTED TO BE PLACED WITHIN THE RIGHT MAIN STEM OF THE BRONCHUS OF A CANCER PATIENT ON (B) (6) 2010 ((B) (6) FEMALE; WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A MALIGNANT TUMOR THAT WAS OCCLUDING THE PATIENT?S AIRWAY. THE PATIENT WAS REPORTED TO BE OK AT TIME OF PROCEDURE, BUT HAD BEEN UNSTABLE THROUGHOUT THE PRIOR DAY. THE LESION WAS PREDILATED; HOWEVER THE RIGHT MAIN STEM BRONCHUS WAS STILL PARTIALLY OCCLUDED BY THE TUMOR. PER THE DIRECTIONS FOR USE, THE STENT LENGTH WAS MODIFIED PRIOR TO THE PROCEDURE. APPROXIMATELY 2 CM OF THE TRACHEAL LENGTH AND 2 CM OF THE LEFT MAIN STEM LENGTH WERE CUT OFF. THESE MODIFICATIONS WERE PERFORMED USING MEASUREMENTS TAKEN UNDER FLUOROSCOPY AND DIRECT VISUAL ASSESSMENT WITH RIGID SCOPE. FOLLOWING THESE MODIFICATIONS, THE STENT WAS IMPLANTED UNDER THE AID OF FLUOROSCOPY VIA LARYNGOSCOPE AND FREITAG FORCEPS. THE STENT APPEARED TO BE SUCCESSFULLY PLACED. UPON REMOVAL OF THE FORCEPS; HOWEVER, THE STENT MIGRATED APPROXIMATELY 2 CM TOWARDS THE TRACHEA, THEREBY OBSTRUCTING THE PATIENT?S AIRWAY. NO SIGNIFICANT RESISTANCE HAD BEEN NOTED DURING THE REMOVAL OF THE FORCEPS; HOWEVER, THE FORCEPS DID CONTACT THE STENT AND COULD HAVE PULLED IT SLIGHTLY OUT OF POSITION. THE PHYSICIAN WAS UNABLE TO CONFIRM IF IT WAS THE FORCEPS OR THE PATIENT?S ANATOMY THAT CAUSED THE STENT TO MIGRATE. SEVERAL ATTEMPTS WERE MADE ATTEMPTING TO PUT THE STENT BACK IN POSITION. WHEN IT WAS DETERMINED THAT REPOSITIONING THE STENT WAS NOT POSSIBLE, SEVERAL ATTEMPTS WERE THEN MADE WITH VARIOUS GRASPING FORCEPS TO TRY AND REMOVE THE STENT. DURING THESE ATTEMPTS, THE PATIENT?S AIRWAY BECAME INCREASINGLY OCCLUDED WITH BLOOD AND TISSUE. THE PHYSICIAN WAS UNABLE TO EXPLAIN WHY THE BLEEDING OCCURRED AT THE LEVEL THAT IT DID, BUT THE PHYSICIAN DID STATE THAT THE MORE RETRIEVAL ATTEMPTS HE ATTEMPTED THE MORE THE BLEEDING OCCURRED. SUCTION AND IRRIGATION WERE USED TO TREAT THE BLEEDING; HOWEVER, THE BLEEDING CONTINUED AND MADE IT VERY DIFFICULT TO VISUALIZE THE STENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE STENT AND THE PATIENT EXPIRED. NO AUTOPSY WAS PERFORMED, BUT THE PHYSICIAN?S ASSESSMENT OF THE CAUSE OF DEATH WAS THAT THE STENT BLOCKED THE AIRWAY CAUSING THE PATIENT TO SUFFOCATE.