Model Number 1804225-33 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event - estimated, treatment / therapy start date - estimated.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported the 2.25x33mm xience skypoint stent delivery system was used in a procedure and separated.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initial medwatch report, it was noted that the following occurred sometime during this reported procedure: it was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with heavy calcification.Pre-dilatation was performed with a non-abbott balloon.Then a 2.25 x 33mm xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however the stent failed to cross due to anatomical challenges.Therefore, the sds was removed and resistance was noted during removal due to anatomical challenges.A flared stent strut was observed.There was no adverse patient effect and no clinically significant delay in the procedure.A second dilatation was performed with a non-abbott balloon followed by deployment of another xience skypoint stent to complete the procedure.This was filed under patient identifier cn-(b)(6).No additional information was provided.
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Manufacturer Narrative
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A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.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 was unable to determine a conclusive cause for the reported material separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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