Model Number H7493925116220 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that stent damage occurred.The over 88% stenosed target lesion was located in the right coronary artery.A 16 x 2.25 promus premier¿ 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.: stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent struts on the 2 most distal stent rows were lifted and pushed proximally.The undamaged section crimped stent maximum od (outer diameter) was measured and the result was within the maximum crimped stent profile measurement.A visual examination of the bumper tip showed 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 found no kinks along the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues with the extrusion shaft.The bicomponent bond showed no signs of damage or strain.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and 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 88% stenosed target lesion was located in the right coronary artery.A 16 x 2.25 promus premier¿ 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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