It was reported to boston scientific corporation on (b)(6), 2023, that a wallflex esophageal fully covered stent was implanted in the esophagus to treat an esophagotracheal fistula during an esophageal stent implantation procedure performed on an unknown date.The stent had been implanted for one month.On (b)(6) 2023, during the patient's review, it was noted that the implanted wallflex esophageal stent had laminating holes on the stent cover.The stent was removed from the patient with pincers.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note; a photo of the complaint device was provided by the complainant and showed the stent was outside the patient with holes on the stent cover.
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