CoreValve™ Evolut™ MCS-P3-29-AOA-US (UDI 00643169448544)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169448544), received between Jan 27, 2017 and Jan 27, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gradient Increase” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 11 YEARS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, CENTRAL REGURGITATION OF UNKNOWN SEVERITY WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND EXPERIENCED SYMPTOMS OF HEART FAILURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 24189249 ↗
• InjuryJan 26, 2026Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE AS TREATMENT FOR THE STENOSIS.

  Patient problems: Valvular Stenosis

  MAUDE report 24183476 ↗
• InjuryAug 1, 2025Gradient Increase; Gradient Increase

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT EIGHT DAYS FOLLOWING THE IDENTIFICATION OF THE FAILED VALVE, A REDO VALVE-IN-VALVE PROCEDURE OCCURRED AND REQUIRED HOSPITALIZATION. THE SECOND VALVE IMPLANTED WAS A NON-MEDTRONIC AORTIC VALVE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE VALVE-IN-VALVE PROCEDURE.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 22687427 ↗
• InjurySep 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338513 ↗
• MalfunctionAug 22, 2024Calcified; Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation; Calcified; Gradient Increase; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 9 YEARS AND 1 MONTH FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM DOPPLER REVEALED OVERALL MILD AORTIC REGURGITATION, MILD PARAVALVULAR LEAK, SEVERE PROSTHETIC STENOSIS, VALVE CALCIFICATION, A MEAN GRADIENT OF 65 MM HG, AND A PEAK VELOCITY OF 5.6 M/S. THE AORTIC VALVE AREA WAS 0.9 CM SQ. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased; Valvular Insufficiency/ Regurgitation

  MAUDE report 20042502 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A BIVENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IMPLANTED DUE TO A LOW EJECTION FRACTION AND DYSSYNCHRONY WITH A WIDE QRS INTERVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19991497 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 11 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 19135330 ↗
• InjuryFeb 22, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT PROCEDURE WAS PLANNED DUE TO POOR COAPTATION OF THE VALVE LEAFLETS WITH SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18763550 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND CATH. NO ADDITIONAL INTERV ENTION WAS PROVIDED TO TREAT THE THROMBUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17728507 ↗
• InjuryAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND FIVE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 17640987 ↗
• InjuryJul 27, 2023Incomplete Coaptation; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED MILD EXERTIONAL DYSPNEA AND CHEST PAIN. A DIASTOLIC MURMUR WAS NOTED BY THE PHYSICIAN. THERE WERE CONCERNS OF RECURRENCE OF PROSTHETIC VALVE AORTIC REGURGITATION, SO THE PATIENT WAS EVALUATED FOR A TANSCATHETER VALVE-IN-VALVE REPLACEMENT. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED A WELL SEATED VALVE. IT WAS NOTED THAT THERE WAS MILD EXTENSION INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), ADJACENT TO THE BASE OF THE ANTERIOR MITRAL VALVE LEAFLET, BUT IT DID NOT IMPEDE THE MITRAL VALVE LEAFLET. NO DEHISCENCE WAS OBSERVED, HOWEVER, THE LEAFLETS APPEARED TO BE MODERATELY THICKENED. NO HYPOATTENUATING LEAFLET THICKENING (HALT) WAS OBSERVED OR THROMBOSIS. SUBSEQUENTLY, A FLAIL SEGMENT OF THE LEAFLET ON THE LEFT CORONARY CUSP (LCC) POSITION WAS OBSERVED. IT WAS REPORTED THAT THE COAPTATION GAP WAS ESTIMATED TO BE 0.7 SQUARE CENTIMETERS (CM2) THAT WAS SUGGESTIVE OF CLINICALLY SIGNIFICANT MODERATE AORTIC REGURGITATION. ADDITIONALLY, TRACE MITRAL VALVE REGURGITATION WAS ALSO OBSERVED. THE PATIENT'S EJECTION FRACTION (EF) WAS REPORTED AT 65%. A 26 M

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Chest Pain; Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17409058 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN UNSPECIFIED SYMPTOMATIC ATRI O-VENTRICULAR (AV) BLOCK WAS OBSERVED. A PERMANENT PACEMAKER WAS SUBSEQUENTLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17406674 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT DUE TO MODERATE CENTRAL AORTIC INSUFFICIENCY. A VALVE REPLACEMENT PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17397117 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN UNSPECIFIED HEART BLOCK, AND WAS MONITORED AFTER. SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO AN UNSPECIFIED CONDUCTION DISTURBANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 17262771 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND NINE MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS DUE AORTIC STENOSIS. THREE DAYS LATER, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16861792 ↗
• InjuryJul 23, 2020Calcified; Gradient Increase; Perivalvular Leak; Migration; Calcified; Gradient Increase; Perivalvular Leak; Migration

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A POST-OPERATIVE ECHOCARDIOGRAM REVEALED TRIVIAL PARAVALVULAR LEAK (PVL), MODERATE-SEVERE MITRAL VALVE REGURGITATION (MR), AN EJECTION FRACTION OF 60% AND A SYSTOLIC MEAN DOPPLER GRADIENT OF 12 MMHG. THE VALVE IMPLANT DEPTHS WERE NOT REPORTED. IN CONTRAST TO THE ECHOCARDIOGRAM PERFORMED ON DAY OF IMPLANT, THE VALVE APPEARED TO BE FURTHER INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), AND MORE CLOSELY SITUATED TOWARDS THE ANTERIOR MITRAL LEAFLET. THESE FINDING SUGGESTED POSSIBLE MIGRATION TOWARDS THE LEFT VENTRICLE. PER THE PHYSICIAN, THIS FINDING MAY HAVE PLAYED A MECHANISTIC ROLE IN THE INCREASED DEGREE OF SEVERE MITRAL REGURGITATION. APPROXIMATELY FIVE YEARS LATER, THE PATIENT PRESENTED AND WAS HOSPITALIZED FOR SYMPTOMATIC PROSTHETIC STENOSIS AND HEART FAILURE SYMPTOMS. SYMPTOMS REPORTED WERE DYSPNEA STARTING AFTER WALKING ONE BLOCK, PRESYNCOPE WITH EXERTION, ANGINA WITH PAIN RADIATING TO JAW AND LOWER EXTREMITY (LE) EDEMA. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH SHOWED DEGENERATION OF THE VALVE WITH IMMOBILITY OF THE LEFT CORONARY CUSP

  Patient problems: Angina; Aortic Valve Stenosis; Congestive Heart Failure; Dyspnea; Edema; Insufficiency, Valvular; Low Cardiac Output; Mitral Regurgitation; Pain; Syncope

  MAUDE report 10318117 ↗
• InjuryJun 11, 2020Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS, 11 MONTHS AND 26 DAYS FOLLOWING THE IMPLANT OF THIS 29 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH INCREASED GRADIENT AND POSSIBLE AORTIC INSUFFICIENCY. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED ALONG WITH AN ECHOCARDIOGRAM WHICH REVEALED LEAFLET THROMBOSIS ON ALL THREE BIOPROSTHETIC VALVE LEAFLETS. IT WAS REPORTED THAT THE THROMBOSIS WAS ALSO CAUSING THE SEVERE AORTIC INSUFFICIENCY. A 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE IN VALVE. FOLLOWING THE VALVE IN VALVE IMPLANT, THE AORTIC INSUFFICIENCY HAD RESOLVED AND THERE WAS NO GRADIENT ON THE FINAL HEMODYNAMIC MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Regurgitation, Valvular; Thrombosis

  MAUDE report 10145399 ↗
• InjurySep 16, 2019Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS, TWO MONTHS AND ELEVEN DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS REPLACED VALVE-IN-VALVE DUE TO A MEAN GRADIENT OF 40 MM HG AND CALCIFICATION OF THE LEAFLETS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9072440 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST-IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 8453255 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FIVE DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8349902 ↗
• InjuryApr 23, 2018Calcified; Gradient Increase; Material Deformation; Calcified; Gradient Increase; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE GRADIENT WAS GREATER THAN 40 MMHG. TWO YEARS AND NINE MONTHS FOLLOWING THE VALVE IMPLANT, THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; No Known Impact Or Consequence To Patient

  MAUDE report 7450154 ↗
• InjuryAug 31, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE YEAR AND ELEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, MODERATE-SEVERE PARAVALVULAR LEAK (PVL) WAS REPORTED. TWO YEARS AND THIRTY DAYS POST VALVE IMPLANT, A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6834176 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT NINE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (B)(4), A SECOND VALVE (B)(4) WAS IMPLANTED VALVE IN VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304791 ↗
• InjuryJan 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE YEAR AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED DUE TO CALCIFICATION AND STENOSIS AND A NON-MEDTRONIC MECHANICAL VALVE WAS IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Stenosis

  MAUDE report 6282953 ↗

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-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-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-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