SYNERGY XD Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared May 2020 · 65 device variants grouped

Total Reports

1,197

Reports (30d)

11

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

Balloon Retrieval Difficulty and Shaft Break

synergy, delivery, selected, shaft, synergy drug

24

reports

2

Residual Stenosis Post-Stent Treatment

residual stenosis, timi flow, synergy, aspirin, residual

11

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access
Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.