Catalog Number RSINT30015X |
Device Problems
Calcified (1077); Failure to Advance (2524); Material Deformation (2976)
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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 07/11/2018 |
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 mid 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 the stent failed to cross the lesion and stent deformation occurred during positioning.Patient status post-procedure is alive with no injury.
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Manufacturer Narrative
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The lesion was not adequately pre-treated.If information is provided in the future, a supplemental report will be issued.
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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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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