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Model Number 10675 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2020 |
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 fracture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 24mm x 3.5mm, concentric, de novo target lesion was located in the moderately calcified and mildly tortuous left anterior descending artery (lad).After successful pre-dilatation of the lesion with a 2.5mm balloon, a 28 x 3.00 promus elite was advanced to the target lesion and deployed.A stent fracture was noted during deployment due to the moderate calcium.The stent was not fully deployed and was not well apposed and was removed.The procedure was not completed due to this event.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
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Event Description
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It was reported that stent fracture occurred.Vascular access was obtained via the radial artery.The 90% stenosed, 24mm x 3.5mm, concentric, de novo target lesion was located in the moderately calcified and mildly tortuous left anterior descending artery (lad).After successful pre-dilatation of the lesion with a 2.5mm balloon, a 28 x 3.00 promus elite was advanced to the target lesion and deployed.A stent fracture was noted during deployment due to the moderate calcium.The stent was not fully deployed and was not well apposed and was removed.The procedure was not completed due to this event.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
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Manufacturer Narrative
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Device is a combination product.A promus elite ous mr 28 x 3.00mm stent delivery system (sds) was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from the proximal end were noted to be lifted from their crimped position.The undamaged crimped stent od (outer diameter) was measured using a snap gauge and the result was within max crimped stent profile measurement.An examination of the distal 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 of the hypotube found no issues.A visual 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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Search Alerts/Recalls
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