Catalog Number RSINT35009X |
Device Problems
Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Material Deformation (2976)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 08/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The patient had 3 resolute integrity rx drug eluting stents implanted in the lad in (b)(6) 2016.One of the stents was a 3.5 x 9mm resolute integrity rx drug eluting stent implanted in the bifurcation of the lad and the cx.Approximately 8 weeks later the physician was attempting to treat a lesion in the cx exhibiting 80% stenosis using a 3.0 x 22mm resolute integrity rx drug eluting stent.No damage was noted to the device packaging and no issues noted removing the device from the hoop/tray.The device was inspected with no issues noted.The lesion was pre-dilated.It was reported that during the procedure, the physician used two wires to place the resolute integrity stent in the cx.The first wire was a (bmw) middle weight wire.No resistance was encountered when advancing the 3.0 x 22 mm device and no excessive force used.The stent was deployed successfully and the delivery system was removed successfully.The first wire stuck in the vessel between the bifurcation and the target lesion.It is reported that the stent migrated when the first wire was removed.No patient injury reported.Three unknown brand stents were implanted in the left main, prox.Lad and prox.Cx as intervention.
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Manufacturer Narrative
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Evaluation summary: analysis of returned stent confirmed that the stent that migrated was the previously implanted 9mm resolute integrity rx stent.The stent and two guide wires returned for analysis without the delivery system.The stent was bunched, stretched and deformed.The returned stent was confirmed to a resolute integrity 9mm stent.Image review: review of the procedural images confirm the presence of previously deployed stents at the bifurcation between the lad and the lcx.For treatment of the lcx the procedural wires appear to be delivered through a distal the cell of the previously deployed stent.The lcx lesion was treated successfully with stent deployment.Image show that the stent structure appears to have been disrupted at the bifurcation between the lcx and the lad and the procedural wire appears to be caught inside the stent in the left main.This stent was subsequently pulled from it's original place of deployment by the procedural wire.This confirms the reported migration.The vessel was then rewired and after multiple balloon inflations and stent deployments the patency of the vessels were restored.
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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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