SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

by BOSTON SCIENTIFIC - GALWAY

CardiovascularFDA 510kOn market since 2015
48
Elevated

The SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM by BOSTON SCIENTIFIC - GALWAY has a safety score of 48 out of 100, placing it in the elevated-risk category. Based on FDA MAUDE data, there have been 1,978 adverse event reports including 122 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #336 out of 386 devices in the Cardiovascular category.

Should you be concerned? A safety score of 48/100 warrants careful consideration. With 1,978 adverse event reports and 122 associated deaths, the risk profile is elevated compared to alternatives in the cardiovascular category (which averages 67/100). Ask your doctor about alternative devices with better safety records.

No recalls have been issued for this device — a positive indicator of manufacturing quality and design safety. On the market since 2015, this device has 11 years of real-world data — enough for long-term safety patterns to emerge.

Questions to Ask Your Doctor About the SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

1. “What alternatives exist to the SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM?”This device ranks #336 of 386 in the Cardiovascular category. There are 335 devices with better safety scores — ask if any are appropriate for your case.

2. “How many of these have you personally implanted or used?”Surgeon experience with a specific device significantly impacts outcomes. Higher procedure volume correlates with fewer complications.

3. “What are the specific risks for my case?”Overall adverse event rates (0 per 10,000) are averages — your individual risk depends on age, health conditions, and anatomy.

4. “Is there a newer generation of this device available?”The SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.

Adverse Events

1,978

Total reports filed with FDA MAUDE

Death Reports

122

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#336 of 386

In Cardiovascular by safety score

How This Compares

Safety Score48/100
Category Average
67
This Device
48
Best in Category
84

Important Context

Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.