Model Number RSINT30015X |
Device Problems
Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the procedure, an attempt was made to use one resolute integrity drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the proximal right coronary artery, exhibiting 85% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.Resistance was encountered when advancing the device.It was reported that the stent deformation occurred in-vivo during positioning due to use of the device in difficult lesion morphology.The procedure was completed using another resolute integrity stent.Patient status post-procedure is alive with no injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device analysis: kinks were evident on the hypotube from 40.5cm to 132.5cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands but not meeting specifications due to deformation of distal stent wrap.Deformation was evident to the 1st distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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