Complications and Failure Modes of Covered Coronary Stents: Insights from the MAUDE Database

Department

Medicine

Document Type

Article

Publication Title

Cardiovascular Revascularization Medicine

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.

First Page

157

Last Page

160

DOI

10.1016/j.carrev.2021.04.002

Volume

35

Publication Date

2-1-2022

PubMed ID

34052127

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