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Model Number M00565020 |
Device Problem
Material Deformation (2976)
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Patient Problems
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
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Event Description
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It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat stenosis secondary to metastasis of the left colon tumor during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent was noted to be bent and kinked after placement.Subsequent remediation was carried out.The stent was removed from the patient, and the procedure was completed with another wallflex enteral duodenal stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat stenosis secondary to metastasis of the left colon tumor during an endoscopic intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent was noted to be bent and kinked after placement.Subsequent remediation was carried out.The stent was removed from the patient, and the procedure was completed with another wallflex enteral duodenal stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.***additional information received on february 28, 2024 and march 20, 2024*** it was reported that the stent was successfully deployed and implanted inside the patient when the stent was found to be deformed, bent, kinked, and not fully deployed.The stent was not removed from the patient and a second stent was inserted to help keep it deployed.It was reported that surgery will be performed later.In addition, it was reported that the patient has ileus and that it is not an underlying condition.However, there is no was information regarding the exact relationship between the patient's condition of ileus and the wallflex enteral duodenal stent and if an intervention was required.
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Manufacturer Narrative
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Blocks b5 and h6 have been updated with the additional information received on february 28, 2024.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
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Search Alerts/Recalls
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