Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was repositioned by dr.(b)(6).Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f23 is being used to capture the additional intervention of repositioning the migrated stent.Imdrf device code a010402 captures the reportable event of stent migration.
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It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement procedure.On (b)(6) 2023, the patient presented with worsening dysphagia, which had started two weeks prior to the procedure.Upon checking, it was noted that the stent had distal partial migration due to stricture resolution.Subsequently, the stent was repositioned, and the procedure was completed.On (b)(6) 2023, the patient passed away.The clinical cause of the patient's death was a malignant esophageal neoplasm.
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