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Model Number M00569810 |
Device Problems
Entrapment of Device (1212); Mechanical Problem (1384); Premature Activation (1484); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was received fully deployed.Visual examination was performed and it was observed that the stainless steel (handle) was kinked/bent.The outer clear sheath was kinked and buckled.One side of the stent was damaged.No other issues were noted to the stent and delivery system.The reported event of stent difficult to reconstrain was confirmed although functional examination was not performed, as findings from visual evaluation indicates that there were issues to reconstrain the stent.The reported event of stent premature deployment and device stuck in scope could not be confirmed; these failure occured during the procedure and it is not possible to replicate in the laboratory of analysis.The investigation concluded that the reported events and the observed failures were most likely due to procedural factors encountered during the procedure.Kinks observed in the outer clear sheath and handle might be a result of device manipulation and handling.Once the system is kinked, it can caused friction between the components in the kinked areas and cause difficulties to remove the device from the scope.Attempts to reconstrain the stent under this device condition can result in buckling of the outer sheath, and could lead to difficulty in reconstraining the stent.Additionally, when removing an unconstrained stent can cause damage to the stent and delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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It was reported to boston scientific corporation that a wallstent biliary rx uncovered stent was to be implanted in the common bile duct to treat bile duct cancer during a biliary metal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was partially deployed within the reconstrainability limit.The physician attempted to readjust the stent but it was unable to reconstrain.The device was removed and another wallstent biliary stent was implanted 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.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed the stent was damaged.Additional information received on july 1, 2021 and july 12, 2021: while removing the stent, it got stuck within the working channel of the scope and hence got kinked, damaged and deployed during the retrieval process.The stent was removed together with the scope.
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Search Alerts/Recalls
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