(b)(4).The complainant indicated that the device was disposed 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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It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex colonic stent was to be implanted to treat colon cancer during a colonoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.According to the complainant, during the procedure, the stent prematurely deployed into the stricture.The stent was attempted to be repositioned with rat-tooth forceps; however, the stent fully unraveled losing its shape.Reportedly, the stent was then removed from the patient where there was slight resistance pulling the stent through the stricture.The procedure was completed with another wallflex colonic stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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