Catalog Number 1800350-12 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.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 that before use of a 3.5x12mm xience skypoint drug eluting stent (des), while advancing the stent delivery system on the guide wire, the stent was noted to be missing and was found in the protective sheath.There was no patient involvement and no clinically significant delay in the procedure.A new des was used to successfully complete the procedure.No additional information was provided.
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Event Description
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Subsequent to the initial mdr report, the following information was noted:
the stent delivery system was not on the guide wire, but was getting ready to be inserted onto the guide wire.
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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 was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5: description of event.
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Search Alerts/Recalls
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