Catalog Number 1070350-48 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2021 |
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 other incidents from this lot.It is possible that interactions with the anatomy and/or other devices resulted in shortening of the stent and/or user perception/inaccurate measuring under fluoroscopy may have resulted in difficulties visualizing the stent; however this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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Event Description
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It was reported that the procedure was performed to treat a lesion in the mid right coronary artery.A 3.5x48mm xience xpedition stent was implanted, and the stent was noted to be shorter than labeled length.The stent was explanted with a snare, and a non-abbott stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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