Catalog Number 1550350-18 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problem
Vessel Or Plaque, Device Embedded In (1204)
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Event Date 10/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery.The xience sierra stent delivery system was advance in the patient, but failed to cross due to the heavily calcified anatomy.During removal, there was resistance with the anatomy, and the stent dislodged from the balloon.A non-abbott stent was deployed and crushed the stent to the vessel wall to complete the procedure.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
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Search Alerts/Recalls
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