Catalog Number RSINT30038X |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2018 |
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 proximal right coronary artery, exhibiting 95% 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.Thedevice 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, due to lesion calcification.It was reported that the stent failed to cross the lesion and stent deformation and a catheter fracture occurred during positioning.It was reported that the event was due to use of the device in difficult lesion morphology.Procedure was completed using a medtronic device.Patient status post-procedure is alive with no injury.
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Manufacturer Narrative
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Evaluation summary: a kink was evident on the transitional tubing 37.5cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 11th and 12th 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.The device returned with a detachment on the hypotube 82.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.No kinks were evident on the hypotube near the detachment site.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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