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Model Number 10667 |
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 12/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 44mm x 3.00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following pre-dilation, a 3.00 x 48mm synergy drug-eluting stent (des) and a 32 x 3.00mm promus premier select des were advanced for treatment.However, both devices failed to cross the lesion and the stent struts got damaged.Both devices were removed and the procedure was successfully completed with a 2.50x24mm and 3.00x24mm promus premier select des.No patient complications were reported and the patient status was stable.
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 44mm x 3.00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following pre-dilation, a 3.00 x 48mm synergy drug-eluting stent (des) and a 32 x 3.00mm promus premier select des were advanced for treatment.However, both devices failed to cross the lesion and the stent struts got damaged.Both devices were removed and the procedure was successfully completed with a 2.50x24mm and 3.00x24mm promus premier select des.No patient complications were reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: promus premier select ous mr 32 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the proximal struts misaligned.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured using snap gauge 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 showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple hypotube kinks.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.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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