It was reported to boston scientific corporation on (b)(6) 2022, that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat a 3 cm extrinsic malignant duodenal stricture due to pancreatic cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the delivery handle snapped in two places, and the control hub was noted to be broken.The wallflex duodenal stent was unable to fully deploy and was removed from the patient partially covered by the outer sheath.The procedure was cancelled, and the patient was scheduled for another stent placement at another healthcare facility.There were no patient complications reported as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed the stainless-steel handle was slightly bent, the blue outer sheath was separated from the exterior tube handle, and the wallflex duodenal stent was partially deployed outside the patient.
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