BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE
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Model Number M00565580 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001)
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Event Date 01/29/2024 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a wallstent enteral uncovered stent was implanted to treat a 4cm malignant intestinal stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, after placement of the stent, it was noted that the tail end of the stent was broken and had punctured the intestinal mucosa, causing bleeding.Consequently, another wallstent enteral stent was placed to cover and compress the bleeding.The stent was removed using forceps and the procedure was completed.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1: the initial reporter's facility name is (b)(6).The initial reporter's phone number is (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a0401 captures the reportable event of stent break.
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Event Description
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It was reported to boston scientific corporation that a wallstent enteral uncovered stent was implanted to treat a 4cm malignant intestinal stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, after placement of the stent, it was noted that the tail end of the stent was broken and had punctured the intestinal mucosa, causing bleeding.Consequently, another wallstent enteral stent was placed to cover and compress the bleeding.The stent was removed using forceps and the procedure was completed.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block e1: the initial reporter's facility name is (b)(6) hospital.The initial reporter's phone number is (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a0401 captures the reportable event of stent break.Block h10: a wallstent enteral uncovered delivery system was received for analysis; the stent was not returned.Visual inspection found the outer and inner sheath kinked.No other problems were noted with the delivery system.The reported event of stent break was not confirmed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the observed events of outer and inner sheath kinked.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, hemorrhage, major and perforation are noted within the ifu as potential adverse events associated with the use of the device.There is no indication on the reported event because only the delivery system was received, and the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
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