Model Number 10603 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/30/2020 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.2.50 x 20 synergy ii drug-eluting stent was selected for use to treat the lesion.However, after being prepared and loaded on the wire, it was noticed that some of the distal struts were sticking out.The device did not enter the patient's body.The procedure was completed with another of the same device.There were no patient's complications nor injuries reported.
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Event Description
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It was reported that stent damage occurred.A 2.50 x 20 synergy ii drug-eluting stent was selected for use to treat the lesion.However, after being prepared and loaded on the wire, it was noticed that some of the distal struts were sticking out.The device did not enter the patient's body.The procedure was completed with another of the same device.There were no patient's complications nor injuries reported.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ii us mr 2.50 x 20 stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Distal struts were lifted and pulled distally.The undamaged stent od outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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