TCT-504 Complications and Failure Modes of Covered Coronary Stents: Insights From the MAUDE Database

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Conference Proceeding

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Publication Title

J Am Coll Cardiol


Background: Data on the mechanisms of failure of covered coronary stents (Graftmaster and PK Papyrus) are limited.

Methods: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between August 2018 (when the PK Papyrus stent was US Food and Drug Administration approved) and December 2020 for reports on covered coronary stents.

Results: We identified 299 reports in the MAUDE database (after excluding duplicates, peripheral vascular reports, and incomplete records) (Graftmaster, n = 225; PK Papyrus, n = 74). The most common mechanism of failure of covered stents was failure to deliver the stent (46.2%), followed by stent dislodgement (22.4%) and failure to seal the perforation (19.7%). Failure to deliver the stent was more often reported with the Graftmaster compared with the PK Papyrus (59.1% vs 6.8%; P < 0.001). Stent dislodgement was more often reported with the PK Papyrus compared with the Graftmaster (75.7% vs 4.9%; P < 0.001) and was managed by device retrieval or by crushing the stent.

Conclusion: The most common failure mechanisms of covered stents are failure of delivery, stent dislodgement, and failure to seal the perforation. Failure of delivery was more common with the Graftmaster, while stent dislodgement was more common with the PK Papyrus. Further improvements in covered stent design are needed to optimize deliverability and minimize the risk for complications.





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