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Model Number M00565020 |
Device Problems
Positioning Failure (1158); Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on april 19, 2022 that a wallflex duodenal stent was to be implanted to treat 7cm malignant stenosis during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous prior to stent placement.During the procedure, the stent failed to deploy.The stent was removed from the patient fully covered by the delivery system and another wallflex duodenal stent was implanted to complete the procedure.After the wallflex was removed, the stent accidentally deployed outside the patient/scope.There were no patient complications 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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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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