It was reported to boston scientific corporation that an ultraflex esophageal covered stent was implanted during a stent placement procedure performed on (b)(6) 2013.According to the complainant, the stent was implanted to treat an esophageal fistula and provide pulmonary gastropleural access.The physician planned to remove the stent once the fistula closed and the patient was placed on a liquid diet.The physician reported that two weeks following stent placement the fistula had closed.On (b)(6) 2013, endoscopy was performed and tissue ingrowth was noted within the stent.On (b)(6) 2013, the stent was removed with great difficulty; causing the patient¿s tissue to tear and bleed.Adrenaline was injected to treat the torn tissue and bleeding, which resolved successfully.Following sent removal, the physician noted that the stent cover was missing from the 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.
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