MEDTRONIC TRANSCATHETER VALVE Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)

Total Reports

1,070

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Literature Batch: TAVR Clinical Outcomes

devices, evolut, patients, study, included

reports

Valve Failure Due to Stenosis After 7 Years

approximately years, years months, following implant, implant transcatheter, years

reports

Paravalvular Leak Identified Post-Deployment

deployment, dcs, non medtronic, implant transcatheter, balloon

reports

Structural Valve Deterioration After 2.5 Years

tav, bioprosthetic, implant transcatheter, bioprosthetic valve, years

reports

AV Block Post-Implant with Pacemaker

stenosis, discharged, underwent, implant procedure, block

reports

Valve Dislodgement During Retrieval

gradient, leak, non medtronic, bioprosthetic, evolut

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Class II

Jun 11, 2021 · Open, Classified

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Evidence

Related research

Balloon-Expandable Valve for Treatment of Evolut Valve Failure

Mariama Akodad, et al. · JACC: Cardiovascular Interventions · 2022

Clinical Impact of Standardized TAVR Technique and Care Pathway

Kendra J. Grubb, et al. · JACC: Cardiovascular Interventions · 2023

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus

Howard C. Herrmann, et al. · New England Journal of Medicine · 2024

Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial

Hölger Thiele, et al. · European Heart Journal · 2020

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

John K. Forrest, et al. · Journal of the American College of Cardiology · 2023

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.