BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number 26650 |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2022 |
Event Type
Injury
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Event Description
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It was reported that the stent partially deployment occurred.Vascular access was obtained via femoral artery.The 60% stenosed, 40x18mm target lesion was located in the non-tortuous and mildly calcified inferior vena cava.After a 0.035 x 260cm amplatz super stiff guidewire crossed the lesion, pre-dilatation was performed with a 18mmx20mm balloon catheter.A 20 x 55mm x 75cm wallstent-uni endoprosthesis stent was advanced, however, the stent did not fully deploy.Even after post-dilatation with a 20mm x 20mm balloon catheter, the proximal end of the stent was still not fully open and the physician had to use a second stent to keep it open and completed the procedure.No patient complications were reported and the patient status was stable.
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Manufacturer Narrative
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(b5) describe event or problem- corrections to information previously reported.(h6) device codes corrected from activation, positioning or separation problem to activation failure including expansion failures.
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Event Description
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It was reported that stent expansion failure occurred requiring additional intervention.Vascular access was obtained via femoral artery.The 60% stenosed, 40x18mm target lesion was located in the non-tortuous and mildly calcified inferior vena cava.After a 0.035 x 260cm amplatz super stiff guidewire crossed the lesion, pre-dilatation was performed with a 18mmx20mm balloon catheter.A 20 x 55mm x 75cm wallstent-uni endoprosthesis stent was advanced, however, the stent did not fully deploy.Even after post-dilatation with a 20mm x 20mm balloon catheter, the proximal end of the stent was still not fully open and the physician had to use a second stent to keep it open and completed the procedure.No patient complications were reported and the patient status was stable.
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