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Model Number M00565060 |
Device Problems
Mechanical Problem (1384); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2023 that a wallflex colonic stent was to be implanted to treat a 5cm malignant stenosis in the colon during a colon stent deployment procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous.During the procedure, the stent was partially deployed; however, due to intestinal peristalsis and the positioning of the stent, it was attempted to be recaptured.During the attempted recapture, the delivery system got stuck, and the stent was unable to be fully recaptured.The physician then decided to remove the stent; however, the tip of the device was stuck in the intestinal wall.A foreign body forcep was used to remove the stent, and another wallflex colonic stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific corporation on june 14, 2023 that a wallflex colonic stent was to be implanted to treat a 5cm malignant stenosis in the colon during a colon stent deployment procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous.During the procedure, the stent was partially deployed; however, due to intestinal peristalsis and the positioning of the stent, it was attempted to be recaptured.During the attempted recapture, the delivery system got stuck, and the stent was unable to be fully recaptured.The physician then decided to remove the stent; however, the tip of the device was stuck in the intestinal wall.A foreign body forcep was used to remove the stent, and another wallflex colonic stent was used to complete the procedure.There were no patient complications reported as a result of this event.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 h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Block h10: a wallflex enteral colonic stent and delivery system were returned for analysis.Visual examination of the returned device found the stent fully deployed and damaged (wire broken, unraveled, and loose).The outer sheath and inner sheath were also kinked.No other issues were noted with the stent and delivery system.The observed failure of the outer sheath and inner sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device, and the technique used by the physician when trying to reconstrain the stent, limited the performance of the device and contributed to the outer sheath and inner sheath kinks.Additionally, the damages noted on the stent could have occurred during the removal of the stent.The reported event of delivery system difficult to remove and stent difficult to reconstrain cannot be confirmed as this occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that the reported events and observed failure were likely due to factors encountered during the procedure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
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Search Alerts/Recalls
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