Model Number 9305 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the left coronary artery.A 2.25x16mm promus element stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device is a combination product.Promus element, mr, ous 2.25 x 16 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage to distal stent rows with stent struts lifted and pulled distally.The undamaged crimped stent od (outer diameter) was measured within maximum crimped stent profile measurement.The tip was visually and microscopically examined and no damage was noted.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 tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the left coronary artery.A 2.25x16mm promus element stent was advanced to treat the lesion.However, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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