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Model Number M00565050 |
Device Problems
Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the stent remains implanted and the delivery system was contaminated and disposed; 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 enteral colonic stent was implanted to treat an intestinal obstruction in the colon during a stent implantation performed on (b)(6) 2021.During the procedure, there was resistance when the stent was deployed and the two ends of the stent failed to expand once fully deployed.The stent was indwelled and could not be removed; the patient underwent a surgery.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b5, d6a, h6 (device code) and block h10 have been updated with additional information received on november 12, 2021 and november 16, 2021.Block h6: impact code f19 is being used to capture the reportable surgical intervention.Medical device problem code a150101 captures the reportable event of stent failure to expand.Medical device poblem code a150207 captures the reportable event of stent difficult to remove.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the delivery system was contaminated and was disposed; 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 enteral colonic stent was implanted to treat an intestinal obstruction in the colon during a stent implantation performed on (b)(6) 2021.During the procedure, there was resistance when the stent was deployed and the two ends of the stent failed to expand once fully deployed.The stent was indwelled and could not be removed; the patient underwent a surgery.There were no patient complications reported as a result of this event.Additional information was received on november 12, 2021 and november 16, 2021 it was reported that the wallflex enteral colonic stent was implanted to treat a 5cm lesion obstructing the intestinal colon.After the stent was deployed inside the patient, imaging was performed and confirmed the stent did not expand.Reportedly, several attempts were made to remove the stent but it was unsuccessful.The patient was sent for surgery to cut the tumor and the stent was successfully removed using snares and forceps.The patient's condition following the procedure was reported to be fine.
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Search Alerts/Recalls
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