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Model Number M00517440 |
Device Problems
Device Markings/Labelling Problem (2911); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the lot number of the suspect device; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure 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 an agile esophageal fully covered stent was to be implanted in the esophagus to treat a 4cm esophageal cancer during an esophagogastroduodenoscpopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was successfully deployed inside the patient; however, the physician noticed that the proximal and distal end of the stent were not covered with silicone coating.The physician believed that the stent implanted was a partially covered stent rather than a fully covered stent as indicated on the label.Additionally, the stent cover was damaged with 3 to 5 holes in it.The stent was removed from the patient with grasping forceps and a different device was implanted to complete the procedure.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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