Model Number 9553 |
Device Problems
Failure to Advance (2524); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
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 left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.
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Event Description
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It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, severely calcified, and not tortuous.
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Manufacturer Narrative
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A promus premier ous mr 32 x 2.25mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified that stent struts at the proximal edge of the stent were lifted.The stent was securely crimped between both markerbands.The stent od (outer diameter) was measured 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 and microscopic examination of the bumper tip identified no tip damage.A visual and tactile examination of the hypotube shaft found no damage.Visual, microscopic and tactile examinations of the distal extrusion identified no damage.No other issues were identified during 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 left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, severely calcified, and not tortuous.
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Search Alerts/Recalls
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