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Model Number UNK758 |
Device Problems
Migration or Expulsion of Device (1395); Difficult to Remove (1528); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Jin, uram, et.Al., 'longitudinal stent-strut injury at the distal end of a newer-generation drug-eluting stent', korean circ j 2018 feb;8(2):176-178.Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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It was reported via literature that stent damage, prolapse and difficult removing occurred.Coronary angiography revealed total occlusion of the left anterior descending coronary artery (lad) ostium and intermediate stenosis of the proximal left circumflex artery (lcx).After stenting with a 3.5×38-mm non-bsc stent from the left main (lm) to the lad, t-stenting was attempted with a 2.75×18-mm promus premier¿ stent in the compromised lcx ostium.Despite repeated pre-dilation and kissing balloon inflation at the lm bifurcation, the stent failed to cross the lcx ostium and its distal tip became stuck.After removing the whole stent system, prolapse and deformation of the distal struts were noted.A 2.5×14-mm non-bsc stent was chosen instead and successfully deployed.
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Search Alerts/Recalls
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