It was reported to boston scientific corporation that a wallflex esophageal stent was implanted to treat a 0.3cm anastomotic stricture in the esophagus during a stent placement procedure performed on (b)(6), 2015 as part of the e7025 wallflex esophageal fully covered benign anastomotic stricture rct clinical study.The patient had undergone a trans-thoracic esophagectomy on (b)(6), 2014.The anastomosis was combined (hand sewn and stapled).The patient had a fistula formation post esophagectomy.The post esophagectomy anastomotic stricture was originally diagnosed on (b)(6), 2014.On (b)(6), 2014, the first post esophagectomy dilation was performed and the second dilation was performed on (b)(6), 2014.The maximum diameter of the last dilation was 16mm.The patient's baseline visual analog score (vas) pain scale score was recorded as 0.On (b)(6), 2015, the patient's baseline dysphagia score was "2-ability to swallow semisolid foods".According to the complainant, during the stent placement procedure on (b)(6), 2015 the wallflex esophageal stent was successfully implanted and remained in place at the end of the procedure.The proximal edge of the stent was placed 18cm from the incisors.The proximal edge of the anastomotic stricture was located 21cm from the incisors.This procedure was completed as an outpatient procedure.On (b)(6), 2015, the patient underwent the per-protocol stent removal procedure.At this time, it was noted that the wallflex esophageal stent had a complete distal migration.The stent was successfully removed from the patient's stomach.The clinical site deemed the event a device deficiency.The migration was determined to be a result of stricture resolution.There were no adverse events associated with this event.
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