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Model Number M00565050 |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, 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) 2021 that a wallflex colonic stent was implanted to treat a 3 cm length recto-sigmoid malignant lesion in the rectum during a colonic stent placement procedure performed on (b)(6) 2021.Reportedly, the patient had a tortuous anatomy prior to stent placement.On (b)(6) 2021, post stent placement procedure, fluoroscopic imaging was performed and the stent was noted to be migrated into the patient's bowel.The physician was comfortable keeping the original stent implanted and another wallflex colonic 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.
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Search Alerts/Recalls
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