Model Number H7493911324270 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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It was reported that stent damage occurred.The over 90% stenosed target lesion was located in the left circumflex artery.A 2.75x24mm promus element¿ drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, it was noted that the stent strut was lifted up.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 evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the stent found that the first distal stent row was damaged with a stent strut lifted.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip found no signs of damage.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 device found no issues along the hypotube.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that stent damage occurred.The over 90% stenosed target lesion was located in the left circumflex artery.A 2.75x24mm promus element¿ drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, it was noted that the stent strut was lifted up.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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