Evolut™ FX+ EVFXPLUS-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00763000716127), received between Jul 16, 2024 and Sep 22, 2026 — classified as 12 deaths, 49 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• DeathSep 22, 2026Insufficient Device Problem Information

  It was reported that following the implant of a transcatheter aortic valve into an indwelling surgical aortic valve, the patient died on the operating table due to an unspecified cause.

  Patient problems: Insufficient Information

  MAUDE report 50856075 ↗
• InjurySep 17, 2026Patient Device Interaction Problem

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50810754 ↗
• InjuryJul 1, 2026Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, ECHOCARDIOGRAM ASSESSMENT DETERMINED THAT MILD TO MODERATE PARAVALVULAR LEAK (PVL) WAS PRESENT. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A NON-MEDTRONIC 20 MILLIMETER (MM) BALLOON. PVL WAS STILL PRESENT FOLLOWING THE BAV, SO A SECOND POST-IMPLANT BAV WAS PERFORMED WITH A NON-MEDTRONIC 20 MM BALLOON. UPON REMOVAL OF THE BALLOON FOLLOWING THE SECOND BAV, THE VALVE DISLODGED INTO THE ASCENDING AORTA. SUBSEQUENTLY, THE PATIENT WAS TRANSITIONED TO OPEN HEART SURGERY, THE VALVE WAS EXPLANTED, A ROOT ENLARGEMENT WAS PERFORMED, AND A NON-MEDTRONIC 23 MM SURGICAL AORTIC VALVE WAS IMPLANTED. A 6 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25679149 ↗
• MalfunctionMay 27, 2026Material Invagination; Activation Failure; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE INTO AN INDWELLING SURGICAL AORTIC VALVE (SAV), THE VALVE APPEARED CONSTRAINED IN THE SAV. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS). ON THE SECOND DEPLOYMENT ATTEMPT, THE VALVE ONCE AGAIN APPEARED CONSTRAINED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS OPENED AND USED. IT WAS NOTED THAT DURING ONE OF THE DEPLOYMENT ATTEMPTS, THERE WAS A BRIEF LOSS OF PERFUSION DUE TO THE CONSTRAINED VALVE. A 10 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT. PER THE PHYSICIAN, THE PATIENT'S INDWELLING SAV CONTRIBUTED TO THE EXPANSION ISSUE.

  Patient problems: Low Cardiac Output; Obstruction/Occlusion

  MAUDE report 25306310 ↗
• DeathMay 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ONE DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A STROKE OCCURRED. SUBSEQUENTLY, THE PATIENT DIED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS STROKE. PER THE PHYSICIAN, THE VALVE CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Stroke/CVA

  MAUDE report 25255362 ↗
• DeathMay 14, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE (TAV), THE PATIENT DIED DUE TO AN UNSPECIFIED CAUSE. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT THE TAV IMPLANT WAS A HIGH RISK PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25175092 ↗
• MalfunctionMay 13, 2026Material Invagination

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, A RECAPTURE WAS REQUIRED AS IT WAS OBSERVED THAT THE VALVE WAS POSITIONED TOO HIGH RELATIVE TO THE TARGET IMPLANT DEPTH OF 3 MILLIMETERS (MM). UPON THE SECOND DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED A SECOND TIME, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE OPENED AND USED 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 25162297 ↗
• InjuryApr 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 25050253 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR COMPLETE HEART BLOCK (CHB).

  Patient problems: Heart Block

  MAUDE report 24852162 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE AT 3 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND 3 MM ON THE LEFT CORONARY CUSP (LCC), IT WAS OBSERVED THAT THE VALVE WAS UNDER EXPANDED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. UPON REMOVAL OF THE BALLOON, THE VALVE DISLODGED INTO THE SINUSES. SUBSEQUENTLY, THE VALVE WAS SNARED UP, AND A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. IT WAS NOTED THAT A 2 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24690060 ↗
• InjuryMar 20, 2026Gradient Increase; Thickening of Material

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ELEVATED GRADIENTS WERE OBSERVED ON ECHOCARDIOGRAPHY WITH A PEAK GRADIENT OF 39 MMHG AND A MEAN GRADIENT OF 24 MMHG. A COMPUTED TOMOGRAPHY WAS PERFORMED AND SHOWED THICKENING ALONG THE INNER VALVE AND ON THE LEAFLETS 1-2 MM THICK WITH MILD RESTRICTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 24650351 ↗
• DeathMar 18, 2026Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO AN UNSPECIFIED CAUSE. IT WAS NOTED THAT VALVE FAILURE OCCURRED AND THE PATIENT SUFFERED A BLOOD CLOT IN THE PROCESS.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Pulmonary Hypertension; Pulmonary Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24630787 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE TRANSCATHETER AORTIC VALVE EVFXPLUS-23, THE PATIENT EXPERIENCED A BRIEF EPISODE OF PULSELESS ELECTRICAL ACTIVITY DURING INITIAL VALVE DEPLOYMENT. TEMPORARY PACING AND ADMINISTRATION OF EPINEPHRINE WERE REQUIRED, AND THE RHYTHM RECOVERED. VALVE DEPLOYMENT WAS SUCCESSFUL. ON THE FIRST POST-OPERATIVE DAY, VALVE THROMBOSIS WAS REPORTED, WHICH LED TO A SWITCH FROM ELIQUIS TO WARFARIN. SUBSEQUENT INTERNATIONAL NORMALIZED RATIO (INR) TESTING SHOWED SUPRATHERAPEUTIC VALUES OF 4.4 AND 5.2 AFTER THE MEDICATION CHANGE. THESE ADVERSE EVENTS RESULTED IN PROLONGATION OF THE EXISTING HOSPITALIZATION. PER THE PHYSICIAN, THE VALVE THROMBOSIS WAS POSSIBLY RELATED TO THE VALVE AND THE IMPLANT PROCEDURE. THE PATIENT WAS RECOVERING FROM VALVE THROMBOSIS AND SUPRATHERAPEUTIC INR, AND THE PULSELESS ELECTRICAL ACTIVITY EPISODE RESOLVED DURING THE PROCEDURE.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 24592735 ↗
• InjuryMar 12, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, AN UNSPECIFIED VALVE FAILURE OCCURRED THAT NECESSITATED THE IMPLANT OF A SECOND TRANSCATHETER VALVE. THE SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE.

  Patient problems: Insufficient Information; Non specific EKG/ECG Changes

  MAUDE report 24583935 ↗
• MalfunctionMar 6, 2026Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE VALVE BECAME CONTAMINATED AND WAS SUBSEQUENTLY NOT USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PACKAGING OF THE VALVE WAS NOT DAMAGED OR COMPROMISED. THE VALVE BECAME CONTAMINATED DUE TO USER ERROR WHEN THE TECHNICIAN HIT THE OPERATING ROOM LIGHT WITH THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536851 ↗
• InjuryMar 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED, DURING THE IMPLANTATION OF THIS 23MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV) ((B)(6)), IN A PATIENT WITH TWO PREVIOUS SURGICAL AORTIC VALVES (SAV) AND AORTIC STENOSIS AT BASELINE, THE BOTTOM OF THE SAV WAS USED AS A MARKER FOR THE DEPLOYMENT STARTING POINT; A PIGTAIL WAS NOT USED. THE MEDTRONIC TAV WAS DEPLOYED AT AN IMPLANT DEPTH OF 3MM ON THE NON-CORONARY CUSP (NCC) AND 3MM ON THE LEFT CORONARY CUSP (LCC). FOLLOWING IMPLANT, A POST-IMPLANT BALLOON DILATION WAS PERFORMED DUE TO THE PHYSICIAN¿S PREFERENCE FOLLOWING A VALVE-IN-VALVE (VIV) PROCEDURE AND WITH AN INTENTION TO FRACK THE SAV. HOWEVER, THE BALLOON DID NOT FRACK THE SAV, BUT IT DISLODGED THE TAV AORTIC TO A DEPTH OF -2MM ON THE NCC AND -2MM ON THE LCC. SUBSEQUENTLY, A SECOND VALVE ((B)(6)) WAS SUCCESSFULLY IMPLANTED VIV. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520018 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV), THE PATIENT'S HEMODYNAMICS BECAME UNSTABLE. IT WAS OBSERVED THAT THE PATIENT'S SYSTOLIC PRESSURE DROPPED FROM 140 MILLIMETERS OF MERCURY (MMHG) TO 60 MMHG. SUBSEQUENTLY, VASOPRESSORS WERE ADMINISTERED TO TREAT THE HYPOTENSION.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508523 ↗
• MalfunctionFeb 26, 2026Material Invagination

  IT WAS REPORTED, DURING PREPARATION FOR A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE PROCEDURE, IN A PATIENT WITH AN EXISTING FAILED MEDTRONIC MOSAIC VALVE, THE VALVE WAS LOADED INTO THE DELIVERY CATHETER SYSTEM (DCS) WITHOUT ISSUE. THE DCS AND LOADED VALVE WERE INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. DURING THE FIRST DEPLOYMENT ATTEMPT, THE DEPTH OF THE VALVE WAS SHALLOW. THE VALVE WAS RECAPTURED INTO THE DCS; HOWEVER, UPON THE SECOND DEPLOYMENT ATTEMPT, THE DEPTH OF THE VALVE WAS DEEP AT 0MM AND AN INFOLD WAS OBSERVED IN THE VALVE FRAME. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND THE DCS WAS WITHDRAWN FROM THE PATIENT. A NEW SYSTEM WAS USED FOR VALVE IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457303 ↗
• MalfunctionFeb 24, 2026Material Invagination

  IT WAS REPORTED THAT DURING A VALVE-IN-VALVE PROCEDURE FOR A PATIENT WITH SEVERE AORTIC STENOSIS AND A PREVIOUSLY IMPLANTED 19-MILLIMETER MOSAIC SURGICAL VALVE, A 23-MILLIMETER EVOLUT TRANSCATHETER AORTIC VALVE WAS FIRST INSPECTED VIA FLUOROSCOPY. THIS INSPECTION REVEALED NO ABNORMALITIES TO THE VALVE, SO THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED INTO THE PATIENT. DUE TO A CHALLENGING IMPLANTATION ANGLE, PROPER COAXIAL ALIGNMENT BETWEEN THE TRANSCATHETER VALVE AND THE SURGICAL BIOPROSTHESIS COULD NOT BE ACHIEVED, RESULTING IN SIGNIFICANT DIFFICULTY IN POSITIONING THE VALVE AT THE DESIRED IMPLANTATION DEPTH. FIVE DEPLOYMENT ATTEMPTS WERE MADE, AND IN EACH ATTEMPT, UPON REACHING APPROXIMATELY 80% DEPLOYMENT, THE IMPLANTATION DEPTH WAS DEEMED SUBOPTIMAL. AFTER EACH ATTEMPT, THE VALVE WAS FULLY RECAPTURED AND REDEPLOYED USING THE SAME DEVICE. DURING THE FIFTH DEPLOYMENT ATTEMPT, AT APPROXIMATELY 80% DEPLOYMENT, INFOLDING OF THE VALVE FRAME WAS OBSERVED, WHICH HAD NOT BEEN NOTED IN PREVIOUS ATTEMPTS. THE VALVE WAS SUBSEQUENTLY RETRIEVED FROM THE PATIENT¿S BODY. A NEW VALVE WAS PREPARED AND SUCCESSFULLY IMPLANTED AT THE DESIRED IMPLANT DEPTH ON THE SECOND DEPLOYMENT ATTEMPT WITH TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434521 ↗
• MalfunctionFeb 19, 2026Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF A TRANSCATHETER VALVE, THE VALVE WAS CONTAMINATED. SUBSEQUENTLY, THE VALVE WAS NOT USED AND A NEW VALVE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT A MEDTRONIC REPRESENTATIVE CAUSED THE VALVE TO COME INTO CONTACT WITH A NON-STERILE SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389121 ↗
• InjuryFeb 16, 2026Fluid/Blood Leak; Gradient Increase; Perivalvular Leak; Migration

  IT WAS REPORTED THAT PRIOR TO THE IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE PATIENT HAD A MEAN AORTIC VALVE GRADIENT OF 42 MILLIMETERS OF MERCURY (MM HG). AFTER INITIAL IMPLANT OF THE VALVE INTO THE PATIENT'S NATIVE ANNULUS, IT WAS NOTED THAT THE PATIENT HAD A MEAN VALVULAR GRADIENT OF 20 MM HG. AN ECHOCARDIOGRAM WAS THEN OBTAINED 30 DAYS FOLLOWING IMPLANT OF THE TRANSCATHETER AORTIC VALVE, WHICH REVEALED A MEAN VALVULAR GRADIENT OF 45 MM HG. SUBSEQUENTLY, THE PATIENT RECEIVED INTERVENTION IN THE FORM OF SURGICAL AORTIC VALVE REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED MODERATE AORTIC REGURGITATION (AR), AND THE PHYSICIAN BELIEVES THE VALVE MAY HAVE MIGRATED AORTIC. THERE WAS NO EVIDENCE OF THROMBUS ON THE VALVE, AND THERE WAS NO PATIENT FACTORS THAT COULD HAVE CONTRIBUTED TO THE ELEVATED GRADIENT. SUBSEQUENTLY, THE SURGICAL AORTIC VALVE REPLACEMENT WAS PLANNED BUT NOT PERFORMED YET.

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

  MAUDE report 24345737 ↗
• InjuryFeb 10, 2026Device Markings/Labelling Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS EXPLANTED DUE TO AN UNSPECIFIED CAUSE. SUBSEQUENTLY, THE PATIENT WAS SENT AN IDENTIFICATION CARD WITH THE EXPLANTED VALVE SERIAL NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 24307626 ↗
• DeathFeb 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEW HOURS FOLLOWING THE IMPLANT PROCEDURE OF A TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED SURGICAL AORTIC VALVE, CARDIAC ARREST OCCURRED, AND THE PATIENT DIED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO CARDIAC ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 24304547 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE LEFT BUNDLE BRANCH BLOCK (LBBB) AND ATRIAL FIBRILLATION EVENT RESOLVED WITH SEQUELAE.

  Patient problems: Atrial Fibrillation; Bradycardia; Dizziness; Dyspnea; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Swelling/ Edema

  MAUDE report 24189072 ↗
• MalfunctionJan 8, 2026Activation Failure

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED BETWEEN 0 MILLIMETERS (MM) AND -1 MM ON THE NON-CORONARY CUSP (NCC) FROM THE TARGET IMPLANT DEPTH OF 3 MM. SUBSEQUENTLY, THE VALVE WAS RECAPTURED. TWO ADDITIONAL REDEPLOYMENTS AND RECAPTURES WERE MADE, WITH THE VALVE DISLODGING TO THE SAME LOCATION ON THE NCC. ON THE 4TH DEPLOYMENT ATTEMPT, THE VALVE WAS POSITIONED AT 1 MM ON THE NCC AND 3 MM ON THE LEFT CORONARY CUSP (LCC). A MEAN GRADIENT OF 40 MILLIMETERS OF MERCURY (MM HG) WAS OBSERVED, AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 21 MM NON-MEDTRONIC (BECTON DICKSON TRUE) BALLOON. SUBSEQUENTLY, THE VALVE EMBOLIZED TO THE AORTA. 2 SNARES WERE UTILIZED TO REPOSITION THE VALVE ABOVE THE SINOTUBULAR JUNCTION (STJ). ANOTHER VALVE WAS OPENED AND USED TO PLACE THE VALVE AT 5 MM ON THE NCC AND 8 MM ON THE LCC. ANOTHER POST-IMPLANT BAV WAS PERFORMED WITH A 22 MM NON-MEDTRONIC (BECTON DICKSON TRUE) BALLOON. A 1 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIRST POST-IMPLANT BAV WAS PERFORMED DUE TO FRAME UNDER-EXPANSION, AND A MEAN GRADIENT OF 40 MM HG. ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003680 ↗

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
• 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-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