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Model Number M00565030 |
Device Problems
Break (1069); Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral stent was to be implanted to treat a malignant gastric outlet obstruction in the duodenum during a duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the wallflex enteral stent could not be deployed as the steel rod became twisted.The stent was removed fully covered by the outer sheath and the procedure was not completed due to device availability.There were no patient complications due to 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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(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral stent was to be implanted to treat a malignant gastric outlet obstruction in the duodenum during a duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the wallflex enteral stent could not be deployed as the steel rod became twisted.The stent was removed fully covered by the outer sheath and the procedure was not completed due to device availability.There were no patient complications due to 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 e1: initial reporter address:(b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a wallflex enteral duodenal stent and delivery system were returned for analysis.The stent was returned fully covered by the outer sheath and undeployed.Visual examination of the returned device found the outer blue sheath kinked in different sections.The stainless steel (handle) was kinked and separated.No other problems were noted to the stent and delivery system.The reported event of handle break was confirmed; the stainless steel handle was separated.The reported event of stent failure to deploy was confirmed; due to the condition of the returned device (handle kinked and separated), the stent could not be deployed during device analysis.The reported events and observed failures were likely due to factors encountered during the procedure.It may be that the characteristics of the lesion, how the device was handled, and/or the technique used by the user, limited the performance of the device.Therefore, contributing to the kinks noted on the outer sheath and the stainless steel handle and separation/ detachment of the stainless steel handle and resulted to inability to deploy the stent.Based on the available information, the investigation concluded that the reported events and observed failures were likely due to factors encountered during the procedure.Therefore ,the most probable cause is based on the available information is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Search Alerts/Recalls
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