CoreValve™ Evolut™ MCS-P4-23-AOARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169430310), received between Jun 24, 2020 and Oct 29, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Device Stenosis” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P130021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  IT WAS REPORTED APPROXIMATELY TEN AND A HALF YEARS FOLLOWING IMPLANT OF A MEDTRONIC TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), VALVE FAILURE WAS NOTED. THE PRIMARY MODE OF VALVE FAILURE WAS STRUCTURAL VALVE DETERIORATION; PREDOMINANT AORTIC STENOSIS WITH SEVERE HEMODYNAMIC VALVE DETERIORATION. THIS WAS CHARACTERIZED BY AN INCREASE IN MEAN GRADIENT >=20MM HG FROM BASELINE AND MEAN GRADIENT >=30MM HG. THE PATIENT WAS ENROLLED IN A CLINICAL STUDY WITH EXISTING, BASELINE VALVE FAILURE TO DETERMINE WHETHER A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, TAV-IN-TAV, WAS APPROPRIATE. APPROXIMATELY TWO MONTHS, THREE WEEKS AFTER THE VALVE FAILURE WAS NOTED, THE PATIENT WAS TREATED WITH RE-INTERVENTION FOR THE FAILED TAV. A NON-MEDTRONIC (EDWARDS) VALVE WAS IMPLANTED WITHIN THE MEDTRONIC TAV. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions; Peripheral Edema

  MAUDE report 23417842 ↗
• DeathJun 24, 2020Gradient Increase; Material Integrity Problem; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Material Integrity Problem; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS, ELEVEN MONTHS, TWENTY-FIVE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PROBABLE VALVE THROMBUS WAS NOTED ON THE PROSTHETIC VALVE. AN ECHOCARDIOGRAM SHOWED A GRADIENT OF 37 MM HG, AN INCREASE FROM 26 MM HG FOLLOWING VALVE IMPLANT. FOUR YEARS, ONE MONTH, FOURTEEN DAYS FOLLOWING VALVE IMPLANT, THE GRADIENTS HAD RETURNED TO NORMAL LIMITS. FOUR YEARS, NINE MONTHS, TWENTY-EIGHT DAYS FOLLOWING VALVE IMPLANT, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THE AORTIC VALVE PEAK GRADIENT WAS 86 MM HG AND THE MEAN GRADIENT WAS 51 MM HG. FOUR YEARS, TEN MONTHS, NINETEEN DAYS FOLLOWING VALVE IMPLANT, AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND ELEVATED TRANSVALVULAR GRADIENTS WERE INCIDENTALLY NOTED. FOUR YEARS, ELEVEN MONTHS, SEVENTEEN DAYS FOLLOWING VALVE IMPLANT, A TTE SHOWED AORTIC STENOSIS OF THE BIOPROSTHETIC VALVE AS A RESULT OF PANNUS OR SUPERIMPOSED THROMBUS. IT WAS REPORTED THE AORTIC VALVE AREA INDEX WAS SEVERELY REDUCED 0.65 AND THE AORTIC VALVE MEAN GRADIENT WAS 55 MM HG. MEDICATION WAS CONTINUED FOR PRESUMED AORTIC VALVE THROMBUS. FIVE YEARS, ONE MONTH, FIVE DAYS FOLLOWING THE IMPLANT OF THE VALVE, THE PATI

  Patient problems: Aortic Valve Stenosis; Cardiac Enzyme Elevation; Cardiomyopathy; Cough; Death; Dyspnea; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Ischemia; Melena; Pleural Effusion; Thrombosis/Thrombus; Thrombus

  MAUDE report 10193100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130021. One submission often covers many models, so check the product and lot details in each record.

• Z-0560-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 B
• Z-0561-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as
• Z-0559-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE
• Z-2264-2015 · Jul 15, 2015 · Terminated
  EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evol