BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE
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Model Number M00565580 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bowel Perforation (2668)
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Event Date 04/19/2023 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation on april 20, 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: patient code e1006 captures the reportable event of intestinal bleeding.
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Manufacturer Narrative
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Block h6: patient code e1006 captures the reportable event of intestinal bleeding.Block h10: a wallstent enteral delivery system was received for analysis.The stent was not returned.During visual inspection, the delivery system was inspected and no problems were noted.The reported event of perforation, bowel could not be confirmed as this occurred during the procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, perforation is noted within the ifu as a potential complication associated with the use of the device.Based on the available information, there is not enough evidence to establish the cause of the reported event as the stent was not returned for analysis.The investigation concluded that, without proper evaluation of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable cause of the event.
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Event Description
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It was reported to boston scientific corporation on(b)(6) 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.Additional information received on may 10, 2023.The stent remained implanted and is scheduled to be surgically removed on a later date.
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Manufacturer Narrative
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Blocks b5, d6b (rfb explant date), and h6 (impact codes) have been updated with additional information received on may 10, 2023.Block h6: patient code e1006 captures the reportable event of intestinal bleeding.
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Event Description
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It was reported to boston scientific corporation on april 20, 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.The stent remained implanted and is scheduled to be surgically removed on a later date.
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