Reported event of stent positioning problem.Investigation finding of stent unraveled.The investigation findings and reported event of stent retention suture broken.Investigation results: a fully deployed ultraflex esophageal distal release stent was received for analysis.The delivery system was not returned.Visual examination of the returned device found the retention sutures on both ends of the stent were broken and the wire loops on both ends of the stent were unraveled.There were no other issues identified during the product analysis the damages noted with the device were consistent with the application of excessive force when repositioning the stent and removing the stent with forceps.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
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It was reported to boston scientific corporation on march 17, 2017 that an ultraflex esophageal distal release stent was to be used to treat a malignant tumor in the esophagus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the stent deployment suture broke and the stent was partially deployed.The stent was removed from the patient and the procedure was not completed due to this event.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.Investigation results revealed that the stent retention sutures on both ends of the stent were broken and wire loops on both ends of the stent were unraveled; therefore, this is now an mdr reportable event.Additional information received on april 24, 2017: the complainant confirmed that the ultraflex esophageal distal release stent was fully deployed in the esophagus.After deployment, the physician used forceps to adjust the stent; then, the retention suture detached.
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