IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DYNAMIC Y STENT WAS IMPLANTED IN THE TRACHEA DURING AN ENDOSCOPIC STENT DEPLOYMENT PROCEDURE PERFORMED IN (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A TRACHEOMALACIA. AT SOME TIME POST-PROCEDURE (EXACT DATE UNKNOWN), THE PATIENT STARTED EXPERIENCING COUGH AND SHORTNESS OF BREATH. ON (B)(6) 2014, THE PATIENT HAD A BRONCHOSCOPY TO CLEAR OUT SECRETIONS. THE PHYSICIAN NOTED THAT THE POSTERIOR MEMBRANE OF THE STENT HAD SEPARATED WITH A CLEAR SAW TOOTH PATTERN. IT WAS ALSO NOTED THAT THE POSTERIOR MEMBRANE HAD BROKEN. ACCORDING TO THE PHYSICIAN, THE MEMBRANE WAS COLLAPSING INTO THE PATIENT?S AIRWAY WHICH CAUSED THE PATIENT TO ACCUMULATE SECRETIONS AND DEVELOP CRUSTS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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Patient 1
THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4) STENT BROKEN. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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.
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Patient 1
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Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DYNAMIC Y STENT WAS IMPLANTED IN THE TRACHEA DURING AN ENDOSCOPIC STENT DEPLOYMENT PROCEDURE PERFORMED IN (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A TRACHEOMALACIA. AT SOME TIME POST-PROCEDURE (EXACT DATE UNKNOWN), THE PATIENT STARTED EXPERIENCING COUGH AND SHORTNESS OF BREATH. ON (B)(6), 2014, THE PATIENT HAD A BRONCHOSCOPY TO CLEAR OUT SECRETIONS. THE PHYSICIAN NOTED THAT THE POSTERIOR MEMBRANE OF THE STENT HAD SEPARATED WITH A CLEAR SAW TOOTH PATTERN. IT WAS ALSO NOTED THAT THE POSTERIOR MEMBRANE HAD BROKEN. ACCORDING TO THE PHYSICIAN, THE MEMBRANE WAS COLLAPSING INTO THE PATIENT'S AIRWAY WHICH CAUSED THE PATIENT TO ACCUMULATE SECRETIONS AND DEVELOP CRUSTS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. UPDATED INFORMATION RECEIVED ON 13MAR2014. THE PATIENT WAS READMITTED (EXACT DATE UNKNOWN) FOR WORSENING SHORTNESS OF BREATH. THE PATIENT DEVELOPED PSEUDOMONAS PNEUMONIA AND BRONCHOSCOPY WAS DONE TO CLEAR OUT THE PATIENT'S SECRETIONS. ACCORDING TO THE PHYSICIAN, THE PATIENT WILL BE SENT TO ANOTHER HEALTH CARE FACILITY FOR FURTHER TREATMENT AND POSSIBLE REPLACEMENT OF THE STENT.