Catalog Number RSINT30018X |
Device Problems
Failure to Advance (2524); Patient-Device Incompatibility (2682); Material Deformation (2976); Material Integrity Problem (2978); 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 04/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st and 18th stent wraps with struts raised.No deformation was evident to the distal tip.The guidewire 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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Event Description
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During the procedure, an attempt was made to use one resolute integrity drug eluting stent to treat a severely calcified lesion, located in the distal left anterior descending artery, exhibiting 75% stenosis.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.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 used during delivery.It was reported that the stent could not pass through the lesion.Procedure was completed using another medtronic stent.It was informed that the event was due to use of the device in difficult lesion morphology.Patient status post-procedure is alive with no injury.When the device was retuned to the manufacturing facility, it was noted that the stent was damaged.
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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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