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Model Number 10674 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: promus elite ous mr 24 x 3.50 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage, with mid-section struts lifted and stretched distally.The undamaged crimped stent 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 signs of damage.A visual and tactile examination of the hypotube found multiple kinks.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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Event Description
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Reportable based on device analysis completed on 10jan2020.It was reported that crossing difficulties were encountered.The target lesion was located in the moderately calcified and tortuous distal right coronary artery.After pre-dilatation with a non-bsc balloon, a 24 x 3.50mm promus elite mr drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported and patient status was stable.However, returned device analysis revealed stent damage.
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Search Alerts/Recalls
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