SYNERGY MEGATRON Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Jan 2021 · 28 device variants grouped
Total Reports
165
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Late stent thrombosis in the context of both extraluminal migration and fracture
Luís Fernández González, et al. · European Heart Journal - Case Reports · 2023
Platinum chromium everolimus-eluting stents for the treatment of (complex) coronary artery disease; from SYNERGY™ to the MEGATRON™
Pascal Frederiks, et al. · Expert Review of Medical Devices · 2024
The everolimus eluting Synergy MegatronTMdrug‐eluting stent platform: Early outcomes from the European Synergy MegatronTMImplanters' Registry
Kalpa De Silva, et al. · Catheterization and Cardiovascular Interventions · 2023
Initial Experiences of Percutaneous Coronary Intervention Using a New-Generation Everolimus-Eluting Stent Platform
Jonathan A. Mailey, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2021
Left main stem stenosis angioplasty with intravascular ultrasound optimisation criteria guidance using a new generation everolimus drug-eluting stent.
Lok Bin Yap, et al. · PubMed · 2023
Citations indexed from PubMed.
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