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Model Number 26920 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 02/22/2024 |
Event Type
Injury
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Event Description
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It was reported that stent damage occurred, and additional intervention done to remove the stent and open the vessel.The patient was being treated for peripheral arterial disease in the moderately tortuous superficial femoral artery.The lesion was predilated at 4 atmospheres and post dilated at 5 atmospheres using a mustang balloon catheter.A 5x200x130 innova was selected for treatment.However, during deployment, the stent was not able to open up and there was foreshortening in the stent length from 200mm to 140mm.It was also noted that the stent was crumpled at the distal end, and there was no flow in the artery.The patient was referred for surgery to open the vessel.
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Event Description
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It was reported that stent damage occurred, and additional intervention done to remove the stent and open the vessel.The patient was being treated for peripheral arterial disease in the moderately tortuous superficial femoral artery.The lesion was predilated at 4 atmospheres and post dilated at 5 atmospheres using a mustang balloon catheter.A 5x200x130 innova was selected for treatment.However, during deployment, the stent was not able to open up and there was foreshortening in the stent length from 200mm to 140mm.It was also noted that the stent was crumpled at the distal end, and there was no flow in the artery.The patient was referred for surgery to open the vessel.It was further reported that the physician used surgical approach for the treatment and did femoropopliteal bypass graft placement.
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Search Alerts/Recalls
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