CoreValve™ Evolut™ PRO EVOLUTPRO-23-US (UDI 00763000017811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00763000017811), received between Aug 23, 2018 and Sep 22, 2026 — classified as 4 deaths, 38 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Perivalvular Leak; Insufficient Device Problem Information

  It was reported that approximately 6 years and 8 months following the implant of a transcatheter aortic valve, the valve failed due to unspecified degenerative changes. Trace paravalvular leak (PVL) and dyspnea on exertion were also observed. Per the physician, the initial depth of implant contributed to this event. No patient complications were reported as a result of this event.

  Patient problems: Dyspnea; Valvular Insufficiency/ Regurgitation

  MAUDE report 50858734 ↗
• InjuryAug 7, 2026Perivalvular Leak

  It was reported that following the implant of a transcatheter aortic valve, moderate paravalvular leak (PVL) was identified. Subsequently, a second valve was implanted valve-in-valve.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 50174911 ↗
• InjuryJul 30, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  It was reported that following the implant of a transcatheter aortic valve, a second valve was implanted valve-in-valve for an unspecified reason. Following the implant of the second valve, it was inactivated for an unspecified reason.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Foreign Body In Patient; Insufficient Information

  MAUDE report 50086494 ↗
• InjuryJun 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE VALVE WAS DEPLOYED TO 80%. AT 80% DEPLOYMENT, ST ELE VATION WAS OBSERVED. SUBSEQUENTLY, THE ATTENDING PHYSICIAN SUSPECTED THAT A PARTIAL CORONARY OBSTRUCTION HAD OCCURRED. IN RESPONSE, THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT'S BODY VIA THE DELIVERY CATHETER SYSTEM (DCS). THE PATIENT'S ST ELEVATION THEN SUBSIDED. A NON-MEDTRONIC TRANSCATHETER VALVE WAS THEN UTILIZED TO COMPLETE THE PROCEDURE.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 25448561 ↗
• MalfunctionMay 20, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO AN UNSPECIFIED CAUSE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body Reaction; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 25233806 ↗
• InjuryMay 15, 2026Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 6 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT SUFFERED HEMODYNAMIC INSTABILITY AND WAS HOSPITALIZED AS A RESULT. SUBSEQUENTLY, THE VALVE WAS EXPLANTED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Stenosis; Hemodynamic instability

  MAUDE report 25191786 ↗
• DeathMay 7, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 5 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE FAILED DUE TO SEVERE RESTENOSIS AND A MEAN GRADIENT OF 86 MILLIMETERS OF MERCURY (MMHG). THE PATIENT EXPERIENCE SHORTNESS OF BREATH AND WAS HOSPITALIZED AS A RESULT.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Transvalvular Pressure Gradient Increased

  MAUDE report 25111741 ↗
• MalfunctionApr 28, 2026Activation Failure

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. UPON FIRST DEPLOYMENT TO THE WORKING POSITION, IT WAS NOTED THAT THE VALVE FRAME WAS SEVERELY COMPRESSED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT TO ALLOW FOR THE GUIDEWIRE DIRECTION TO BE ADJUSTED. THE DCS WAS REINSERTED INTO THE PATIENT AND THEN ADVANCED THROUGH THE PATIENT'S ANATOMY. HOWEVER, THE DCS WAS UNABLE TO ADVANCE PAST THE AORTIC VALVE BECAUSE THE "MARKER" DIRECTION WAS INCORRECT. SUBSEQUENTLY, THE DCS WAS AGAIN WITHDRAWN FROM THE PATIENT AND A NEW DCS WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021572 ↗
• MalfunctionMar 10, 2026Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE VALVE DISLODGED. SUBSEQUENTLY, A SECOND VALVE WAS IM PLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE IMPLANT PROCEDURE AND A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE DEPLOYMENT STARTING POINT WAS AT THE MID-PIGTAIL. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS FOUND TO BE AT A RELATIVELY HIGH POSITION AND A RECAPTURE WAS ATTEMPTED; HOWEVER, THE VALVE WAS UNABLE TO BE RECAPTURED. THEREFORE, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE PULLED TO THE DESCENDING AORTA AND DEPLOYED. IT WAS CLARIFIED THAT THE VALVE DID NOT DISLODGE AFTER RELEASE FROM THE DCS. A POST-IMPLANT BAV WAS NOT PERFORMED AFTER THE IMPLANT OF THE FIRST VALVE. A SECOND TRANSCATHETER VALVE WAS IMPLANTED IN THE NATIVE AORTIC VALVE; HOWEVER, RESTRICTED VALVE MORPHOLOGY AND A MEAN PRESSURE GRADIENT OF 40 MILLIMETERS OF MERCURY (MM HG) WERE OBSERVED. THEREFORE, A POST-IMPLANT BAV WAS PERFORMED FOR THE SECOND VALVE WHILE THE PATIENT WAS RAPIDLY PACED. AFTER THE POST-IMPLANT BAV, THE VALVE'S MORPHOLOGY IMPROVED. PER THE PHYSICIAN, THE PATIENT'S SEVERE CALCIFI CA

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 24560270 ↗
• InjuryMar 4, 2026Difficult or Delayed Positioning; Difficult to Open or Close; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE VALVE DISLODGED. SUBSEQUENTLY, A SECOND VALVE WAS IM PLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24507706 ↗
• MalfunctionJan 8, 2026Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MODE OF FAILURE WAS SEVERE PROSTHETIC VALVE STENOSIS.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24004173 ↗
• InjuryDec 30, 2025Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF A TRANSCATHETER VALVE, THERE WAS POOR VISUALIZATION IN THE NON-CORONARY SINUS DUE TO THE PATIENT'S LOW CALCIFICATION, AND THE VALVE WAS IMPLANTED TOO HIGH. FOLLOWING THE IMPLANT, THE VALVE DISLODGED INTO THE SINUS. SUBSEQUENTLY, THE VALVE WAS PULLED INTO THE ASCENDING AORTA AND A SECOND VALVE WAS IMPLANTED; HOWEVER, THE FIRST VALVE PUSHED THE SECOND VALVE DOWN TO A DEEPER POSITION. THEREFORE, THIRD VALVE WAS IMPLANTED VALVE-IN-VALVE TO "SEAL" THE PARAVALVULAR LEAK (PVL). FOLLOWING THE IMPLANT OF THE THIRD VALVE, A SMALL AMOUNT OF PVL WAS OBSERVED, AND THE PATIENT'S BLOOD PRESSURE WAS 96/65 MILLIMETERS OF MERCURY (MM HG). ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS PERFORMED USING AN 18 MM NON-MEDTRONIC (Z-MED) BALLOON. PRIOR TO IMPLANTING THE THIRD VALVE, THE PVL WAS SEVERE.

  Patient problems: Foreign Body In Patient; Valvular Insufficiency/ Regurgitation

  MAUDE report 23923292 ↗
• MalfunctionDec 9, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, VALVE STENOSIS WAS IDENTIFIED. DUE TO THE VALVULAR STENOSIS, THE PATIENT HAD EXPERIENCED SYNCOPE.

  Patient problems: Aortic Valve Stenosis; Syncope/Fainting

  MAUDE report 23760805 ↗
• InjuryJul 30, 2025Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  IT WAS REPORTED APPROXIMATELY 6 YEARS AND 9 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT REVEALED THE VALVE FAILED DUE TO VALVE STENOSIS. ADDITIONALLY, THROMBUS/PANNUS FORMATION WAS OBSERVED ON THE VALVE LEAFLETS AS WELL. THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE (CHF) THAT WAS ATTRIBUTED TO THE VALVE, AND WAS HOSPITALIZED. SUBSEQUENTLY, A TRANSCATHETER AORTIC VALVE-IN-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED. PER THE PHYSICIAN, THE PATIENT'S SMALL ANATOMY CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body Reaction; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 22664666 ↗
• InjuryJul 18, 2025Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED INTO THE PATIENT, ADVANCED TO THE ANNULUS, AND THE VALVE WAS FULLY DEPLOYED. UPON WITHDRAWAL OF THE DCS, THE VALVE DISLODGED INTO THE ASCENDING AORTA. THE DCS WAS FULLY WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A SECOND VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22542232 ↗
• InjuryJun 13, 2025Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE INVOLVING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING AN 18MM BALLOON. THE VALVE WAS SUCCESSFULLY DEPLOYED FOLLOWED BY A POST-IMPLANT BAV USING A 20 MM BALLOON. DIGITAL SUBTRACTION ANGIOGRAPHY AND ULTRASOUND WERE PERFORMED AND REVEALED MODERATE PARAVALVULAR LEAK ALONG WITH AN UPWARD MOVEMENT OF THE VALVE. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED DUE TO THE DISLODGEMENT OF THE FIRST VALVE.

  Patient problems: Foreign Body In Patient; Valvular Insufficiency/ Regurgitation

  MAUDE report 22205803 ↗
• MalfunctionMay 13, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT DURING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS "KINKED". THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE, DELIVERY CATHETER SYSTEM (DCS) AND COMPRESSION LOADING SYSTEM (CLS) WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THAT THE REPORTED "KINK" WAS REFERRING TO AN INFOLD IN THE VALVE FRAME. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS RECAPTURED INTO THE DCS DUE TO INADEQUATE POSITIONING. THE INFOLD WAS IDENTIFIED DURING THE SECOND DEPLOYMENT ATTEMPT. PER THE PHYSICIAN, THE PATIENT'S "CALCIFIED FUSION RIDGE" CONTRIBUTED TO THE INFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011475 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 21921742 ↗
• InjuryApr 3, 2025Calcified; Patient Device Interaction Problem; Thickening of Material; Calcified; Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED THAT REVEALED THROMBUS/PANNUS FORMATION ON THE VALVE LEAFLETS. ADDITIONALLY, THE VALVE WAS REPORTED TO HAVE FAILED DUE TO CALCIFICATION AFTER THE PATIENT PRESENTED WITH A GASTROINTESTINAL BLEED AND DYSPNEA. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH PALLIATIVE CARE.

  Patient problems: Calcium Deposits/Calcification; Dyspnea; Gastrointestinal Hemorrhage; Thrombosis/Thrombus

  MAUDE report 21765839 ↗
• MalfunctionMar 19, 2025Material Invagination; Patient Device Interaction Problem; Material Invagination; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE INVOLVING A 23 MM EVOLUT PRO SYSTEM, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH AN 18 MM BALLOON. ACCORDING TO THE REPORTER, DUE TO CALCIFICATION, THE 23 MM VALVE WAS RECAPTURED AND INFOLDED. THEN, ON THE SUBSEQUENT DEPLOYMENT OF THE VALVE, THE FRAME WAS STILL INFOLDED, AND THE RIGHT SINUS ON THE GREATER CURVATURE WAS "DAMAGED." NO CLINICAL SYMPTOMS OR INTERVENTIONAL ACTIONS WERE RECOUNTED FOR THIS VESSEL DAMAGE. THE 23 MM VALVE SYSTEM WAS WITHDRAWN AND DISCARDED, AND A 26 MM VALVE SYSTEM WAS SUCCESSFULLY USED FOR IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE INFOLD OCCURRED AFTER THE FIRST RECAPTURE. PER THE PHYSICIAN, THE PATIENT'S NATIVE ANNULUS HAD "LUMPY" CALCIFICATION WHICH CONTRIBUTED TO THE INFOLD. IT WAS CLARIFIED NO VASCULAR DAMAGE OCCURRED; IT WAS NOTED A SUBSEQUENT ULTRASOUND MAY HAVE REVEALED CALCIFICATION/VEGETATION ON THE NATIVE VALVE LEAFLET. A PROCEDURAL DELAY DID NOT OCCUR AS A RESULT OF CHANGING TO A NEW SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21646807 ↗
• InjuryMar 14, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE VALVE FAILURE WAS SEVERE CENTRAL AORTIC REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607645 ↗
• InjuryMar 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ONE DAY FOLLOWING THE VALVE IMPLANT PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED FOR ATRIO-VENTRICULAR (AV) BLOCK.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21527959 ↗
• MalfunctionFeb 26, 2025Material Invagination; Material Invagination

  IT WAS REPORTED DURING THIS TRANSCATHETER BIOPROSTHETIC VALVE IMPLANT PROCEDURE, THE VALVE WAS POSITIONED TOO LOW ON THE FIRST DEPLOYMENT ATTEMPT. DURING THE RECAPTURE, THE VALVE INFOLDED INWARD. THE VALVE WAS REMOVED FROM THE PATIENT. A NEW SYSTEM WAS USED FOR IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE PATIENT'S NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED WHICH CONTRIBUTED TO THE INFOLD OF THE VALVE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470263 ↗
• MalfunctionFeb 6, 2025Structural Problem; Activation Failure; Structural Problem; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT'S UNDERLYING HEART FUNCTION WAS NOTED TO BE POOR AND THAT CIRCULATORY COLLAPSE COULD OCCUR AT ANY TIME. ACCORDING THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) AND MEDTRONIC VALVE SELECTION PRINCIPLES, A 26 MILLIMETER (MM) VALVE WAS SELECTED. AFTER BALLOON PRE-DILATION, THE ANNULAR CALCIFICATION WAS NOTED TO BE HEAVIER THAN THE CT HAD SHOWED AND THE ANNULAR DIAMETER WAS ALSO SMALLER. THEREFORE, THE 26 MM VALVE WAS SWITCHED OUT WITH A 23 MM VALVE. DURING THE IMPLANT, IT WAS NOTED THAT THE 23 MM VALVE FRAME WAS "SQUEEZED" BY CALCIFICATION AND WAS KINKED. THE IMPLANTING PHYSICIAN REQUESTED THE VALVE BE REPLACED WITH A DIFFERENT 23 MM VALVE. THE SECOND 23 MM VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322106 ↗
• InjuryDec 9, 2024Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Gradient Increase; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT AN EVOLUTPRO-23-US DEVICE WAS ASSOCIATED WITH A POSSIBLE THROMBUS ON THE NON-CORONARY CUSP LEAFLET AND VALVE STENOSIS. THE PATIENT REQUIRED AN INTERVENTION DUE TO THE DEVICE ISSUES. THE SPECIFIC DETAILS OF THE INTERVENTION OR TREATMENT PROVIDED WERE NOT SPECIFIED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20885474 ↗

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-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
• 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, Labele
• 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
• 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