Model Number 9552 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 28 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, the tip of the stent strut was lifted up.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: promus premier ous mr 28 x 2.50mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts in the proximal and middle region were found to be lifted from their crimped position and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and no issues were noted.The balloon wings were wrapped and evenly folded and no signs of positive pressure were noted.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
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Event Description
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It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 28 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, the tip of the stent strut was lifted up.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.
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Search Alerts/Recalls
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