BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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Model Number M00553570 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter facility name, address, and phone number: (b)(6).Imdrf patient code e0506 captures the reportable patient complication of bleeding.Impact code f08 captures additional hospitalization to monitor patient's condition due to bleeding.
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Event Description
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It was reported to boston scientific corporation on march 13,2023 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to pancreas to treat a walled-off-necrosis (won) during an endosonography procedure performed on (b)(6) 2023.During the procedure.Bleeding was noted in the stomach after stent placement.The axios stent was removed from the patient with forceps, and the procedure was completed.The walled-off-necrosis was drained through the puncture site and the size has been reduced.The patient was monitored in the (imc) intermediate care unit for one night due to bleeding.On (b)(6) 2023, the patient was discharged.
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