Model Number 10667 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2020 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery.A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery (rca).A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the midly tortuous and moderately calcified rca.The patient's status was stable.
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Manufacturer Narrative
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B5 - describe event or problem updated.F10 - patient code updated.
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Manufacturer Narrative
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Device evaluated by mfr.: promus select ous mr 32 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Struts in various locations along the stent length were noted to be lifted fom the crimped profile.The undamaged stent outer diameter was measured by snap gauge and the result is within max 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 examination of the bumper tip showed no signs of damage.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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Event Description
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It was reported that stent damage occurred.The target lesion was located in the calcified right coronary artery (rca).A 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent got damaged.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 70% stenosed target lesion was located in the midly tortuous and moderately calcified rca.The patient's status is stable.
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Search Alerts/Recalls
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