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Model Number M00565110 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Code Available (3191)
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Event Date 12/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).According to the complainant, the suspect device has been implanted and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex colonic stent was implanted to treat a recto-sigmoidal colonic stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to release the stent.However, only the distal part of the stent was noted to have expanded.The physician decided to keep the stent implanted and the patient is scheduled for a colostomy procedure.Reportedly, the patient has been hospitalized.
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Manufacturer Narrative
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Additional information received from the complainant on january 05, 2018 and january 10, 2018.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex colonic stent was implanted to treat a recto-sigmoidal colonic stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to release the stent.However, only the distal part of the stent was noted to have expanded.The physician decided to keep the stent implanted and the patient is scheduled for a colostomy procedure.Reportedly, the patient has been hospitalized.Additional information received on january 5, 2018.It was further reported that the stent was implanted to treat a benign symmetric rigid ring circumferential stenosis in the right sigmoid region which was at 8-cm by digital palpation.The stent remains implanted and the patient was scheduled for a colostomy procedure in the same week after stent placement.Reportedly, the stent was not removed due to patient¿s tortuous anatomy.Additional information received on january 10, 2018.Medical notes were received that reported that the symmetric rigid ring circumferential recto-sigmoidal colonic stenosis was caused by probable extrinsic pelvic infiltrative injury.During the stent placement procedure, it was not possible to cross the stenosis with a colonoscope.A gastroscope was used instead, and the stenosis was examined.It was noted to be an exophytic, irregular friable lesion of infiltrative aspect.The wallflex colonic stent was advanced to the lesion and deployed.It was noted by direct vision endoscopy that the distal end of the stent expanded; however, when the stent was examined, a ¿collapse¿ was noticed in the middle third and the stent did not expand without continuity of the lumen.After evaluation in recovery, there were indications that the patient was feeding.
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Search Alerts/Recalls
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