Note: this report pertains to one of the four devices used on the same patient.Refer to manufacturer report # 3005099803-2023-03775, 3005099803-2023-03835, and 3005099803-2023-03836 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that four (4) epic biliary stents were to be implanted in the common bile duct at the hepatic bifurcation to treat a 2 cm malignant klatskin's tumor during an endoscopic retrograde cholangiopancreatography (ercp) with self-expandable metallic stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, two epic biliary stents were attempted to be placed bilaterally at the same time.The first epic biliary stent (the subject of mfr.Report # 3005099803-2023-03775) was lodged in the working channel of the scope, the delivery system could not be advanced, and the stent was removed from the patient partially deployed on the delivery system.The second epic biliary stent (the subject of this report) was also difficult to advance through the scope, and the outersheath became buckled and kinked.During withdrawal, the second epic biliary stent became partially deployed on the delivery system.Another two epic biliary stents were opened and attempted to be placed bilaterally at the same time, and the same situation occurred.The third epic biliary stent (the subject of mfr.Report # 3005099803-2023-03835) was difficult to advance through the scope; the outer sheath was kinked, and the stent became partially deployed on the delivery system.The fourth epic biliary stent (the subject of mfr.Report # 3005099803-2023-03836) was also difficult to advance through the scope; the outer sheath was kinked, and the stent was partially deployed on the delivery system.A different device was used to complete the procedure.There were no reported patient complications as a result of this event.Note: it was reported that the epic biliary devices were inserted in pairs during a bilateral stent placement procedure.Per the instructions for use (ifu), when treating multiple lesions, the most distal lesions should be stented first followed by the stenting of proximal lesions.Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents that have already been placed.The user did not follow the steps of the ifu.
|