EVOLUT PRO PLUS VALVE
by MEDTRONIC HEART VALVES DIVISION
The EVOLUT PRO PLUS VALVE by MEDTRONIC HEART VALVES DIVISION has a safety score of 36 out of 100, placing it in the high-risk category. Based on FDA MAUDE data, there have been 5,677 adverse event reports including 742 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #375 out of 386 devices in the Cardiovascular category.
Should you be concerned? A safety score of 36/100 is a serious red flag. 5,677 adverse events including 742 deaths have been reported. The incident rate of 0 per 10,000 units is significantly higher than comparable devices. We strongly recommend discussing alternatives with your healthcare provider before proceeding.
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 EVOLUT PRO PLUS VALVE
1. “What alternatives exist to the EVOLUT PRO PLUS VALVE?”This device ranks #375 of 386 in the Cardiovascular category. There are 374 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 EVOLUT PRO PLUS VALVE has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.
Adverse Events
Total reports filed with FDA MAUDE
Death Reports
Death reports associated with device
Incident Rate
Per 10,000 units in use
Recalls
No recalls on record
Estimated Units in Use
Based on market data estimates
Category Ranking
In Cardiovascular by safety score
How This Compares
Other Cardiovascular Devices
CORDIS CROWN STENT POWERGRIP DELIVERY SYSTEM
Unknown
CADENCE TIERED THERAPY DEFIBRILLATOR
Unknown
VENTAK PRX2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Unknown
HANCOCK II AORTIC HEART VALVE
Unknown
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.