Model Number H7493941848300 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that premature deployment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 48mm synergy xd drug eluting stent was selected for use.However, prior to inserting the stent inside the hemostatic valve, a part of the balloon had inflated and the procedure was not completed.No patient complications were reported.
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Event Description
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It was reported that premature deployment occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 3.00 x 48mm synergy xd drug eluting stent was selected for use.However, prior to inserting the stent inside the hemostatic valve, a part of the balloon had inflated and the procedure was not completed.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy xd mr us 3.00 x 48mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was 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 no issues.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 issues were identified during analysis.
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Search Alerts/Recalls
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