Model Number 9394 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2020 |
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 and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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Patient code corrected.
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Event Description
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It was reported that stent damage occurred and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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The promus element plus, mr, ous 3.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the struts on proximal end bunched distally.The undamaged crimped stent outer diameter was measured within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.This device was loaded onto 0.014 guidewire without issue.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 and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
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Search Alerts/Recalls
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