Model Number M00513730 |
Device Problems
Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the lower part of the esophagus to treat a malignant 6 cm stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was then removed from the patient partially deployed on the delivery system.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.
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Event Description
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It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the lower part of the esophagus to treat a malignant 6 cm stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was then removed from the patient partially deployed on the delivery system.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.Block h10: the ultraflex esophageal ng delivery system was received for analysis.Visual inspection found that the shaft was kinked in different sections; however, the stent was not returned for analysis.No other damages were noted with the delivery system.Product analysis did not confirm the reported event of the stent being partially deployed because the stent was not returned for analysis.Additionally, the investigation determined that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) could have resulted in the additional investigation finding of shaft bending.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
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Search Alerts/Recalls
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