Model Number 10666 |
Device Problems
Break (1069); Failure to Advance (2524); Material Deformation (2976)
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Patient Problems
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 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications 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.A 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications reported.It was further reported that the lesion was 70% stenosed, mildly tortuous and moderately calcified.The shaft was bent while advancing the stent shaft.After removal, the physician attempted to straighten the device but the shaft broke.
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Manufacturer Narrative
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Device evaluated by mfr.: promus premier select ous mr 28 x 2.75 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with proximal to mid-section struts bunched proximally.The undamaged crimped stent outer diameter 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 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.A 28 x 2.75 promus premier select drug eluting stent was advanced for treatment.However, the device could not be tracked and the stent was damaged.The device was removed and the procedure was completed with a different device and there were no patient complications reported.It was further reported that the lesion was 70% stenosed, mildly tortuous and moderately calcified.The shaft was bent while advancing the stent shaft.After removal, the physician attempted to straighten the device but the shaft broke.
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Search Alerts/Recalls
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