Catalog Number 1804300-28 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
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Patient Problems
Angina (1710); Foreign Body In Patient (2687)
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Event Date 12/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch report #0300890000-2023-8010.
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Event Description
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This event was reported thru the receipt of a medwatch which stated: describe the event or problem: per cardiac catheterization note - i attempted to cross the blockage with xience skypoint¿ stent however it would not cross.While it was being retrieved, stent came off the balloon in the proximal circumflex.There was still thrombolysis in myocardial infarction (timi) 3 flow however at this point.I focused to cross the stent struts against the vessel wall.Multiple wires, balloon and support catheters were used including pilot, fielder, run-through, whisper along with turnpike versus small support balloons but i could not cross beyond this segment.Patient was having active pain for which i decided to stabilize left main into left anterior descending artery (lad).3.5 x 30 onyx stent was then deployed from mid left main into proximal lad.Same stent balloon was used for post dilation of this stented segment.Further postdilation was done using 4.0 noncompliant balloon in left main and proximal lad.I attempted to rewire the circumflex with the stent struts, and i was able to get through the proximal stent where i had a 2.0 balloon to open up stent struts.I could still not go beyond mid circumflex where stent had dislodged.I decided to accept this result as further attempts were likely going to be unsuccessful.Impella was weaned off.Brilinta had been loaded and will be continued.Impella was removed.Preclose's were deployed and patent hemostasis was achieved.The patient tolerated the procedure well and left the cardiac catheterization laboratory pain-free and stable condition where he was taken back to an electrocardiographic a monitored site.No additional information was provided.
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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 reported patient effect of angina is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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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