D
Patient 1
ON APRIL 25, 2007, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "PERFORMANCE OF A SELF-EXPANDING SILICONE STENT IN PALLIATION OF BENIGN AIRWAY CONDITIONS", PUBLISHED IN CHEST (AMERICAN COLLEGE OF CHEST PHYSICIANS/CHEST 2006; 130;1419-1423). THE STUDY CONDUCTED WAS A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS OF ALL PATIENTS IN WHOM A POLYFLEX STENT WAS USED TO TREAT A SYMPTOMATIC BENIGN AIRWAY CONDITION. THE FOLLOWING INFORMATION WAS DERIVED FROM THAT ARTICLE. CASE #1 A MALE PATIENT EXPECTORATED A LARGE FRAGMENT OF THE DISTAL INNER LINING OF A POLYFLEX STENT 7 MONTHS AFTER STENT PLACEMENT IN THE TRACHEA. A FOLLOW-UP BRONCHOSCOPY REVEALED A TOTAL LOSS OF STENT INTEGRITY. THE POLYFLEX STENT WAS SUCCESSFULLY REMOVED AND REPLACED WITH A T-TUBE. "ALL PATIENTS WITH STENT-RELATED COMPLICATIONS HAD INCREASED SHORTNESS OF BREATH AND COUGH". SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PATIENT'S CURRENT STATUS TO NO AVAIL. "A CT SCAN OF THE CHEST AIDED THE SELECTION OF A STENT WITH AN APPROPRIATE DIAMETER. STENTS WERE OVERSIZED BY 1 TO 2 MM COMPARED TO THE DESIRED LUMEN; THE LATTER WAS BASED ON THE PROXIMAL EXTENT OF THE ABNORMALITY. THE LENGTH OF THE STENT WAS BASED ON A DIRECT MEASUREMENT OF THE OBSTRUCTED SEGMENT USING A FLEXIBLE BRONCHOSCOPE. DEPENDING ON THE DEGREE AND TYPE OF THE STENOSIS, DILATION OF THE INVOLVED AIRWAY WAS PERFORMED EITHER USING A RIGID BRONCHOSCOPE (RB) OR A BALLOON PRIOR TO THE STENT PLACEMENT. ENDOBRONCHIAL ELECTROSURGERY WAS USED TO CUT CONCENTRIC-TYPE, WEB-LIKE STENOSIS, IF INDICATED. ALL STENTS WERE PLACED VIA AN RB OR A SUSPENSION LARYNGOSCOPE UNDER GENERAL ANESTHESIA AND FLUOROSCOPIC GUIDANCE USING A TEAM APPROACH."