Model Number 9394 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the right femoral artery.The chronic total occlusion target lesion with reference vessel diameter of 2.5-3.00mm was located in the severely calcified and non tortuous right coronary artery.A 2.75x38mm promus element plus drug-eluting stent was advanced for treatment.However, the device was fractured when deploying it in the vessel.The device was completely removed without any medical interventions.No patient serious injury or adverse event were reported and the patient status was stable.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: a visual and microscopic examination of the crimped stent identified distal stent damage.Damage was noted to distal end of stent with struts stretched in distal direction.There was no break or fracture in the stent struts.The stent showed no signs of any expansion.The od (outer diameter) of the undamaged crimped stent was measured within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube identified multiple kinks along the hypotube.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination found that there was no damage to the tip.No other issues were identified during the product analysis.
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Event Description
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It was reported that stent damage occurred.Vascular access was obtained via the right femoral artery.The chronic total occlusion target lesion with reference vessel diameter of 2.5-3.00mm was located in the severely calcified and non tortuous right coronary artery.A 2.75x38mm promus element plus drug-eluting stent was advanced for treatment.However, the device was fractured when deploying it in the vessel.The device was completely removed without any medical interventions.No patient serious injury or adverse event were reported and the patient status was stable.
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Search Alerts/Recalls
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