Complications and failure modes of covered coronary stents: Insights from the MAUDE database

Michael Megaly, Magdi Zordok, Amgad Mentias, Yashasvi Chugh, Rupinder S. Buttar, Mir B. Basir, M. Nicholas Burke, Dimitrios Karmpaliotis, Lorenzo Azzalini, Khaldoon Alaswad, Emmanouil S. Brilakis

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Data on the mechanisms of failure of covered coronary stents [Graftmaster, 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 FDA 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 Graftmaster compared with PK Papyrus (59.1% vs. 6.8%, p < 0.001). Stent dislodgement was more often reported with PK Papyrus compared with Graftmaster (75.7% vs. 4.9%, p < 0.001) and was managed by device retrieval or by crushing the stent. Conclusions: 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 Graftmaster, while stent dislodgement was more common with PK Papyrus. Further improvements in covered stent design are needed to optimize deliverability and minimize the risk of complications.

Original languageEnglish (US)
JournalCardiovascular Revascularization Medicine
DOIs
StateAccepted/In press - 2021

Keywords

  • Covered stents
  • Graftmaster
  • PK papyrus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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