Catalog Number RSINT30038X |
Device Problems
Material Deformation (2976); Positioning Problem (3009); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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 non-tortuous and severely calcified lesion located in the left anterior descending artery, exhibiting 90% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent deformation occurred during positioning due to use of the device in difficult lesion morphology.The device was removed from the patient and the procedure was completed using two medtronic devices.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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Evaluation summary: there was a kink on the transition tubing 47cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.Misalignment was evident to the 28th distal stent wrap 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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