Evolut FX Transcatheter Aortic Valve Reports: What MAUDE Data Reveals About Safety Signals

#19,028 Reports and 2,385 Deaths: The Evolut FX Safety Signal in Numbers

Medtronic's Evolut FX transcatheter aortic valve family has generated 19,028 MAUDE reports since 2019, including 2,385 coded as fatal events and 12,152 coded as injuries. These are counts from a passive surveillance system. They are not rates, and a report filed under event type Death does not establish that the device caused the death. The data is de-identified and may be incomplete or unverified.

The volume has climbed every year. In 2019 the Evolut FX family drew 371 reports and 25 death-coded events. By 2024 that reached 4,285 reports and 528 deaths, and in 2025 it reached 5,617 reports and 604 deaths.

Year	Reports	Deaths
2019	371	25
2020	1,034	117
2021	1,266	198
2022	1,539	246
2023	2,714	431
2024	4,285	528
2025	5,617	604
2026 (Thru April)	2,202	236

Our pipeline flagged a sustained rate increase for both the Evolut FX and the Evolut PRO+, plus an increasing trend and a sequential spike for the PRO+. You can review the underlying record on the device detail page or run your own query through the public MAUDE lookup tool.

#Evolut FX: From FDA Approval to Wide Adoption

The Evolut FX is a fourth-generation, self-expanding transcatheter aortic valve replacement system from Medtronic. The FDA approved it on August 24, 2021, with a limited commercial release in fall 2021 and a full U.S. launch in early 2022.

The generation's signature change is visualization. Medtronic built gold markers into the frame to give implanters direct sightlines on depth and leaflet location, and paired them with a redesigned delivery catheter using a more flexible capsule and an optimized stability layer.

Medtronic kept iterating. The Evolut FX+ won FDA approval on March 27, 2024, adding a modified diamond-shaped coronary access frame roughly four times larger than prior iterations. In August 2025 the FDA approved an expanded Redo-TAVR indication for the PRO+, FX, and FX+ systems, allowing a new Evolut valve inside any previously failed transcatheter valve from any manufacturer in high-surgical-risk patients.

#Device and Patient Problems

The Evolut FX rows carry the largest share of reports. The top FX component lines log 3,288, 2,007, 1,653, 1,430, and 1,108 reports. The Evolut PRO+ follows with 2,670, 1,359, 1,145, and 763, and the newer Evolut FX+ logs 1,079.

Component	Reports
Evolut™ FX	3,288
Evolut™ PRO+	2,670
Evolut™ FX	2,007
Evolut™ FX	1,653
Evolut™ FX	1,430
Evolut™ PRO+	1,359
Evolut™ PRO+	1,145
Evolut™ FX	1,108
Evolut™ FX+	1,079
Evolut™ PRO+	763

On the device side, Patient Device Interaction Problem leads at 6,421 reports, followed by adverse events with no identified device or use problem at 3,967. Device dislodgement or dislocation ranks third at 3,388, with perivalvular leak at 2,233 and material invagination at 2,114.

Product problem	Reports
Patient Device Interaction Problem	6,421
Adverse Event Without Identified Device or Use Problem	3,967
Device Dislodged or Dislocated	3,388
Insufficient Information	2,580
Perivalvular Leak	2,233
Material Invagination	2,114
Activation Failure	1,435
Difficult or Delayed Positioning	731
Intravalvular regurgitation	554
Gradient Increase	463
Fluid/Blood Leak	301
Device Stenosis	295

The patient-problem table tells a mixed story. The most common entry, in 5,337 reports, is no clinical signs, symptoms, or conditions. Serious clinical events sit alongside it: heart block in 2,333 reports, stroke or CVA in 1,180, vascular dissection in 821, and cardiac arrest in 626.

Patient problem	Reports
No Clinical Signs, Symptoms or Conditions	5,337
Non specific EKG/ECG Changes	2,775
Heart Block	2,333
Valvular Insufficiency/ Regurgitation	2,194
Stroke/CVA	1,180
Insufficient Information	1,077
Low Blood Pressure/ Hypotension	1,058
Aortic Valve Insufficiency/ Regurgitation	826
Vascular Dissection	821
Cardiac Arrest	626

Reading these categories well takes care. Our guide on how to search the FDA MAUDE database walks through the traps.

#Failure Modes: Misplacement, Heart Block, and Reintervention

Grouping reports by failure mode surfaces a clear leader: Valve-in-Valve procedures for halted (HALT) implantation, at 944 reports, which points to rescue valve placement. Valve misplacement during deployment accounts for 440 reports, and transient heart block during the implant for 275.

Failure mode	Reports	Emerging
Valve-in-Valve Procedure for HALT	944	no
Valve Misplacement During Deployment	440	no
Transient Heart Block During Valve Implant	275	no
Valve Failure Due to Unspecified Regurgitation	185	no
Literature Batch: TAVR Clinical Outcomes	94	no
Structural Valve Deterioration Post-Implant	83	no
Unspecified Conduction Disturbance with Pacemaker	83	no
Registry Report: Valve Explant Without Cause	71	no
Deployment Failure Due to Cusp Interaction	68	no
Registry Report: Cardiac Arrest Post-Implant	63	no

Conduction disturbance requiring a pacemaker shows up in 83 registry reports, consistent with the known TAVR risk tied to the valve frame's proximity to the conduction system. A large real-world Evolut registry tracked that risk falling over time. Structural valve deterioration after implant (83 reports) and deployment failure from cusp interaction (68 reports) round out the longer-term and technical modes. For why clustered failure modes beat raw event counts, see our piece on why signal detection in post-market surveillance is broken.

#FDA Recalls on Evolut Product Codes

Recalls are a separate FDA system from MAUDE adverse-event reports. The public recall record carries 10 entries against Evolut product codes.

Recall	Class	Date	Status	Reason
Z-0494-2025	Class II	2024-10-17	Open, Classified	Manufacturing error: leaflet deflection outside specifications
Z-0495-2025	Class II	2024-10-17	Open, Classified	Manufacturing error: leaflet deflection outside specifications
Z-0493-2025	Class II	2024-10-17	Open, Classified	Manufacturing error: leaflet deflection outside specifications
Z-0492-2025	Class II	2024-10-17	Open, Classified	Manufacturing error: leaflet deflection outside specifications
Z-0491-2025	Class II	2024-10-17	Open, Classified	Manufacturing error: leaflet deflection outside specifications
Z-2041-2021	Class II	2021-06-11	Open, Classified	Reports of actuator separation in delivery catheter systems
Z-2043-2021	Class II	2021-06-11	Open, Classified	Reports of actuator separation in delivery catheter systems
Z-2042-2021	Class II	2021-06-11	Open, Classified	Reports of actuator separation in delivery catheter systems
Z-0730-2021	Class I	2020-11-17	Terminated	Visual inspection error before locking the valve during deployment
Z-0728-2021	Class I	2020-11-17	Terminated	Visual inspection error before locking the valve during deployment

Five Class II recalls dated October 17, 2024 (Z-0491-2025 through Z-0495-2025) cover a manufacturing error that let valves with out-of-specification leaflet deflection values pass acceptance. Three more Class II recalls dated June 11, 2021 address actuator separation in delivery catheters built before July 11, 2020. The two Class I recalls dated November 17, 2020 cover a failure to perform the visual inspection correctly before locking the valve, which could block release of the delivery system. All five 2024 recalls remain open and classified.

#Head-to-Head: Evolut FX vs. Edwards SAPIEN in the SMART Trial

The SMART trial randomized 716 patients, 87% of them women, across more than 80 sites, comparing the Evolut PRO/PRO+/FX platform against the Edwards SAPIEN 3 and 3 Ultra in patients with small aortic annuli at or below 430 mm².

One-year results, published in the New England Journal of Medicine on April 7, 2024, showed Evolut met non-inferiority for clinical outcomes and reached superiority for valve function: 9.4% bioprosthetic valve dysfunction with Evolut versus 41.6% with SAPIEN (p<0.001).

The gap widened over time. Three-year data presented at EuroPCR 2025 reported bioprosthetic valve dysfunction of 16.3% with Evolut against 54.4% with SAPIEN (p<0.001), plus five times less prosthetic valve thrombosis in the Evolut arm. A JAMA Cardiology sub-analysis in December 2024 examined women with small annuli, the majority of the cohort. An active randomized trial, COMPARE-TAVI 2, now compares Evolut FX directly against the SAPIEN 3 Ultra Resilia.

#What MAUDE Data Can and Cannot Tell Us

MAUDE is a passive reporting system. Manufacturers, providers, and patients submit reports, reporting is voluntary, and the incentives behind who files what can skew the record. The system documents events. It does not establish causation. A death coded in MAUDE can reflect patient comorbidity, operator technique, or true device failure, and the data alone cannot separate those.

The 19,028 reports span four Evolut iterations across years of changing design and technique. Aggregating across product lines and time can mask a signal specific to one generation or one period. That is why controlled evidence from SMART, COMPARE-TAVI 2, and the Optimize PRO FX work matters: trials produce comparative outcomes, while MAUDE produces population-level signals that warrant investigation, not proof of harm.

For the broader picture, see our explainer on post-market surveillance in the United States, the case for why signal detection is broken, and the practical walkthrough of what MAUDE won't tell you.

#For Patients and Clinicians

Patients with symptomatic severe aortic stenosis heading to TAVR should talk through valve platform choice with their implanting team, including each device's complication profile and the trial evidence behind it.

The Evolut platform carries supporting data on two fronts. A large real-world registry of 54,014 procedures showed 30-day permanent pacemaker implantation falling from 16.6% in Q3 2018 to 10.8% in Q2 2021, a 34.9% decrease across quarters (p<0.001). The SMART trial showed superior valve function against the balloon-expandable competitor.

Design refinements continue. The Optimize PRO FX Addendum Study, published in JACC: Cardiovascular Interventions in 2025, evaluated the cusp overlap technique with the redesigned FX delivery system and its three gold markers positioned 3 mm from the inflow, reporting conduction outcomes comparable to prior PRO/PRO+ studies.

Clinicians should report adverse events to MAUDE and track FDA recall and safety communications. Patients should weigh both the trial benefits and the rare but serious complications, heart block, stroke, and valve dislodgement among them, with their care team before implantation.

#Methodology: How These Numbers Were Derived

All figures come from the FDA MAUDE database, aggregated by Claripulse for the Evolut FX product family. Reports are coded by event type (Death, Injury, Malfunction) and mapped to component, product problem, and patient problem categories as submitted by reporters.

The 19,028 total includes all reports linked to Evolut product codes since 2019. The 2,385 death-coded reports are a subset flagged as fatal events, not a verified count of attributable deaths. MAUDE counts are subject to underreporting, duplicate submissions, and delayed entry, so we use FDA recalls and clinical trial data to validate and contextualize the signals. The year-over-year increase may reflect expanded adoption, better reporting compliance, sharper clinical awareness of complications, or some mix of all three. Causation cannot be inferred from MAUDE trends alone. The full search approach is documented in our guide on how to search the FDA MAUDE database.

This analysis is based on publicly available FDA MAUDE data and published literature. It does not constitute medical advice. MAUDE reports are submitted under FDA regulation, are de-identified, and may be incomplete or unverified. No attempt should be made to re-identify any patient.