Model Number 10621 |
Device Problem
Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/24/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that stent damage occurred.The 85% stenosed, 28mm x 2.5, target lesion was located in the moderately tortuous and moderately calcified left circumflex artery (lcx).A 2.25 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent was kinked when crossing the distal end of the lcx and the stent struts were lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
|
|
Event Description
|
It was reported that stent damage occurred.The 85% stenosed, 28mm x 2.5, target lesion was located in the moderately tortuous and moderately calcified left circumflex artery (lcx).A 2.25 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent was kinked when crossing the distal end of the lcx and the stent struts were lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: synergy ous mr 2.25 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the mid-section lifted and pulled.The undamaged crimped stent outer diameter was measured using snap gauge and the result is 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 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.
|
|
Search Alerts/Recalls
|