TY - JOUR
T1 - Complications and Failure Modes of Covered Coronary Stents
T2 - Insights From the MAUDE Database
AU - Megaly, Michael
AU - Zordok, Magdi
AU - Mentias, Amgad
AU - Chugh, Yashasvi
AU - Buttar, Rupinder S.
AU - Basir, Mir B.
AU - Burke, M. Nicholas
AU - Karmpaliotis, Dimitrios
AU - Azzalini, Lorenzo
AU - Alaswad, Khaldoon
AU - Brilakis, Emmanouil S.
N1 - Funding Information:
Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens; owner, Hippocrates LLC; shareholder: MHI Ventures.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2022/2
Y1 - 2022/2
N2 - 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.
AB - 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.
KW - Covered stents
KW - Graftmaster
KW - PK papyrus
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U2 - 10.1016/j.carrev.2021.04.002
DO - 10.1016/j.carrev.2021.04.002
M3 - Article
C2 - 34052127
AN - SCOPUS:85106901809
VL - 35
SP - 157
EP - 160
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
SN - 1553-8389
ER -