Model Number 10607 |
Device Problem
Premature Activation (1484)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2020 |
Event Type
malfunction
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Event Description
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It was reported that stent premature deployment occurred.The target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent partially deployed from the balloon catheter before it was placed in the correct spot in the patient.The stent was able to be pulled back to the distal end of the catheter and was removed from the patient's body with the wire before it was fully deployed.The procedure was completed with another of same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ii us mr 2.50 x 38 stent delivery system was returned for analysis.Device was returned inside a eb 375.071 guidecatheter with a 0.0140" guidewire inserted through and a haemostatic valve.It was noted that the stent was bunched at the distal end of the guidecatheter and the device could not be removed.The device was soaked to allow for sds removal from guidecatheter.The device was removed from the bath and could still not be removed.The device was cut by analyst 27 cm distal to the distal end of the strain relief to allow for the distally removal of the device from within the guidecatheter.A visual examination of the stent found stent damage.Struts from the proximal to mid stent region lifted, pulled and bunched distally, struts in distal region lifted and pulled distally.The undamaged stent outer diameter was measured and the result 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found kinks.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 premature deployment occurred.The target lesion was located in the non-tortuous and non-calcified left anterior dscending artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, during procedure, the stent partially deployed from the balloon catheter before it was placed in the correct spot in the patient.The stent was able to be pulled back to the distal end of the catheter and was removed from the patient's body with the wire before it was fully deployed.The procedure was completed with another of same device.No patient complications were reported.
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Search Alerts/Recalls
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