Catalog Number 1120400-12 |
Device Problems
Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 07/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement causing the reported difficulty to advance and subsequent stent dislodgement with device embedded.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous brachial artery.The 4.0x12mm xience alpine stent delivery system had mild resistance with the guiding catheter then the stent dislodged.The dislodged stent was crushed into the brachial artery.No other stent was used to treat the lesion.There was no adverse patient sequela reported.No additional information was provided.
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Search Alerts/Recalls
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