CoreValve™ Evolut™ PRO EVOLUTPRO-23-US (UDI 00643169954434)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169954434), received between May 11, 2017 and Jan 13, 2025 — classified as 2 deaths, 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Thickening of Material; Device Stenosis; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED WHICH CORRECTED THE PREVIOUSLY REPORTED INFORMATION. IT WAS CONFIRMED THAT THE VALVE WAS NOT EXPLANTED, AND NO TREATMENT WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138947 ↗
• InjuryMay 13, 2024Calcified; Gradient Increase; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Calcified; Gradient Increase; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND NINE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE STENOSIS WAS OBSERVED AND PATIENT-PROSTHESIS MISMATCH WAS IDENTIFIED. THROMBUS WAS REPORTED. ROOT ENLARGEMENT SURGERY WAS PERFORMED AND THE VALVE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 19298549 ↗
• MalfunctionFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 8 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE FAILED. THE MODE OF FAILURE IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684244 ↗
• DeathJan 11, 2024Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Device Stenosis; Gradient Increase; Perivalvular Leak; Patient Device Interaction Problem; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 7 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS SCHEDULED FOR A COMPUTED TOMOGRAPHY WORK-UP FOR HYPOATTENUATED LEAFLET THICKENING AND A POSSIBLE INTERVENTION. ECHOCARDIOGRAM SHOWED MILD TRIVIAL PARAVALVULAR LEAK, AS WELL AS A PEAK GRADIENT OF 58 MMHG AND MEAN GRADIENT OF 37MMHG. THERE WAS NO PATIENT ANATOMY THAT CONTRIBUTED TO THE ELEVATED GRADIENT. THE PATIENT WAS REPORTED TO BE ALIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY SIX YEARS AND SIX MONTHS FOLLOWING THE VALVE IMPLANT, VALVE FAILURE DUE TO STENOSIS WAS IDENTIFIED. SUBSEQUENTLY, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS VALVE FAILURE.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 18491393 ↗
• InjuryOct 24, 2023Adverse 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 ON THE DAY OF IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 17999060 ↗
• InjuryOct 24, 2023Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Insufficient Device Problem Information; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT SIX YEARS, FIVE MONTHS, AND FOURTEEN DAYS POST-IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND AORTIC STENOSIS WAS OBSERVED. SUBSEQUENTLY, AN ANTICOAGULANT WAS ADMINISTERED. IT WAS NOTED THE IMPLANTING TEAM WERE NOT 100% SURE THAT THE VALVE WAS AN ISSUE DUE TO THE REPEAT TTE WAS NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998688 ↗
• InjuryOct 24, 2023Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VALVE HAD BEEN IMPLANTED INTO A PREVIOUSLY IMPLANTED NON-MEDTRONIC (EDWARDS) VALVE. THE VALVES WERE EXPLANTED DUE TO AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 17995833 ↗
• InjuryApr 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 14137434 ↗
• InjuryJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR SINUS BRADYCARDIA. ADDITIONAL INFORMATION WAS RECEIVED INFORMATION THAT TWO YEARS AND THREE MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND VALVE WAS IMPLANTED IN THE SAME POSITION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 9618376 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT, THAT FOLLOWING THE IMPLANT OF THIS 23 MM TRANSCATHETER BIOPROSTHETIC VALVE, FOR AN UNKNOWN REASON, A NON-MEDTRONIC PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8773650 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8395003 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THREE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8302029 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, COMPLETE HEART BLOCK INTERMITTENTLY OCCURRED. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 8179178 ↗
• InjuryOct 31, 2018Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS 23 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, INTO A 19 MM NON-MEDTRONIC SURGICAL VALVE, MINIMAL PARAVALVULAR LEAK (PVL) AND A MEAN AORTIC VALVE GRADIENT OF 25 MM HG WERE NOTED. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. AS THE BALLOON WAS DEFLATED AND RAPID PACING WAS TERMINATED, THE VALVE DISLODGED INTO THE AORTA. SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE SINOTUBULAR JUNCTION AND A SECOND VALVE WAS IMPLANTED SUCCESSFULLY. IT WAS REPORTED THAT THE MEAN AORTIC VALVE GRADIENT PRIOR TO IMPLANT OF THE TRANSCATHETER VALVES WAS 90 MM HG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026293 ↗
• InjuryOct 11, 2018Perivalvular Leak; Device Dislodged or Dislocated; Activation Failure; Perivalvular Leak; Device Dislodged or Dislocated; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT AN IMPLANT DEPTH OF 4 MILLIMETER (MM), ANGIOGRAPHY INDICATED MILD PARAVALVULAR LEAK (PVL) AND ECHOCARDIOGRAM INDICATED A LEFT VENTRICLE (LV) PRESSURE OF 160/10 MMHG AND AN AORTIC (AO) PRESSURE OF 160/65 MMHG WITH A MEAN AORTIC VALVE GRADIENT OF 5-8 MMHG. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY(BAV) WAS PERFORMED USING A 20 MM BALLOON AND 2 INFLATIONS. ON THE SECOND INFLATION, VALVE EXPANSION WAS NOTED, AND THE VALVE DISLODGED INTO THE SINUS OF VALSALVA (SOV). AN ECHOCARDIOGRAM INDICATED MODERATE PVL AND ANGIOGRAPHY INDICATED THE VALVE HAD SHIFTED TOWARD THE AORTA. SUBSEQUENTLY, A SECOND VALVE WAS DEPLOYED SUCCESSFULLY AT A DEPTH OF 4 MM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955478 ↗
• InjuryAug 7, 2018Failure to Capture; Malposition of Device; Deformation Due to Compressive Stress; Material Deformation; Positioning Problem; Malposition of Device; Deformation Due to Compressive Stress; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER LOADING WAS CONFIRMED WITH FLUOROSCOPY, ANGIOGRAPHY SHOWED THE VALVE ABOVE THE AORTIC ROOT ANNULUS AT 80% DEPLOYMENT. THE ASCENDING AORTA WAS SHORT AND CAUSED AN ACUTE ANGLE IN THE VALVE FRAME. A RECAPTURE WAS ATTEMPTED, BUT WAS UNSUCCESSFUL, AS THE CAPSULE OF THE DELIVERY CATHETER SYSTEM DUG INTO THE SIDE OF THE VALVE FRAME AND FOLDED THE FRAME OVER ON ITSELF. THE DCS CAPSULE WAS REDEPLOYED TO 80% AND A SECOND RECAPTURE WAS ATTEMPTED WITH THE SAME RESULT. THE VALVE WAS REPOSITIONED IN THE DESCENDING AORTA TO ALLOW THE VALVE FRAME TO STRAIGHTEN OUT. ANGIOGRAPHY ROOT SHOT CONFIRMED THE VALVE FRAME WAS BELOW THE GREAT VESSELS. THE VALVE FRAME WAS IN A MORE COAXIAL POSITION IN RELATION TO THE DCS CAPSULE. FRAME RECAPTURE WAS ATTEMPTED FOR THE THIRD TIME WITH THE FRAME FOLDING OVER ON ITSELF. THE PHYSICIANS CHOSE TO DEPLOY THE VALVE AT ITS PRESENT POSITION IN THE DESCENDING AORTA. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. THE AORTIC/LEFT VENTRICULAR (AO/LV) GRADIENT DECREASED FROM 105MMHG TO 8MMHG VIA CATHETER HEMODYNAMICS. NO ADDITIONAL ADVERSE PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758006 ↗
• InjuryMay 25, 2018Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, INTO A PRE-EXISTING AORTIC ROOT BIOPROSTHESIS, WHEN AT 80% DEPLOYMENT, IT WAS DETERMINED TO BE TOO DEEP. THE VALVE WAS RECAPTURED AND DEPLOYED TO 80% A SECOND TIME, BUT DISLODGED AND WAS RECAPTURED. THE VALVE WAS DEPLOYED A THIRD TIME, BUT DURING RELEASE, A PADDLE WAS STILL ATTACHED TO THE CATHETER. ATTEMPTS WERE MADE TO FREE THE PADDLE BY PULLING THE WIRE BACK AND TWISTING THE CATHETER AWAY FROM THE PADDLE WITH NEUTRAL PRESSURE. THE PADDLE RELEASED WITH A GENTLE PUSH FORWARD AND IT WAS NOTED THAT THE VALVE DISLODGED INTO THE VENTRICLE AND INTERFERED WITH THE ANTERIOR MITRAL VALVE LEAFLET, WHICH CAUSED MODERATE TO SEVERE MITRAL REGURGITATION (MR). AN ATTEMPT WAS MADE TO SNARE THE VALVE INTO A HIGHER POSITION, WHICH IMPROVED MR TO MILD. A BALLOON WAS USED IN ATTEMPT TO PULL THE VALVE INTO A MORE PROXIMAL POSITION, WITHOUT SUCCESS. IT WAS DECIDED TO END THE PROCEDURE. IT WAS REPORTED THAT BOTH THE SINO-TUBULAR JUNCTION AND AORTA WERE NARROW, WHICH MIGHT HAVE CONTRIBUTED TO THE DIFFICULTY POSITIONING AND RELEASING THE VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7544944 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR SECOND DEGREE, MOBITZ II ATRIO-VENTRICULAR (AV) BLOCK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 7465274 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, NO COMPLICATIONS OCCURRED. IMMEDIATELY FOLLOWING THE IMPLANT OF THE VALVE, A STROKE WAS IDENTIFIED. AN ATTEMPT TO IMPLANT A SENTINEL DISTAL EMBOLIC PROTECTION DEVICE VIA RIGHT RADIAL ACCESS WAS UNSUCCESSFUL AND RESIDUAL HEMIPARESIS RESULTED WITH NO IMPROVEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 7464936 ↗
• InjuryMar 19, 2018Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS IMPLANTED AT A DEPTH OF 4-5 MILLIMETER (MM). AN ANGIOGRAM REVEALED MODERATE PARAVALVULAR LEAK (PVL) FROM THE LEFT CUSP. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH NO CHANGE IN PVL. THE SAME BALLOON WAS INTRODUCED AND WENT THROUGH ONE OF THE TOP STRUTS OF THE VALVE, CAUSING IT TO DISLODGE INTRA ANNULAR. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED WHILE A SNARE HELD THE FIRST VALVE IN PLACE. THE PVL WAS REDUCED TO MILD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7348961 ↗
• DeathFeb 7, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VALVE-IN-VALVE WITH A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL VALVE, THE VALVE WAS CONSTRAINED. THE PHYSICIAN WAS CONCERNED THAT A HIGH GRADIENT COULD RESULT, SO A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH ONE INFLATION, FOR 30 SECONDS. THE BAV FRACTURED THE SURGICAL VALVE, BUT NO ANNULAR RUPTURE OR DISSECTION OCCURRED. THE SICK LEFT VENTRICLE DID NOT RECOVER AFTER THE RAPID PACING OF THE BAV. THE PATIENT CODED FOR 20 MINUTES AND RESULTED IN DEATH. IT WAS REPORTED THAT THE PATIENT DIED DUE TO THE BAV PACING RUN. THE CAUSE OF DEATH WAS REPORTED AS SUDDEN CARDIAC ARREST, WAS RELATED TO THE PROCEDURE AND NOT RELATED TO THE VALVE. NO AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7248567 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIFTY-NINE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED FOR AN UNKNOWN REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7173623 ↗
• InjuryNov 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS FULLY DEPLOYED AND THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED. THE NON-MEDTRONIC GUIDEWIRE WAS THEN REMOVED FROM THE VENTRICLE AND CAUGHT ON THE INFLOW PORTION OF THE VALVE FRAME, CAUSING THE VALVE TO THEN DISLODGED INTO THE ASCENDING AORTA. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041894 ↗
• InjuryJul 3, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A FAILED NON-MEDTRONIC SURGICAL VALVE, THE VALVE DISLODGED AFTER DEPLOYMENT INTO THE ASCENDING AORTA. THE VALVE WAS SNARED TO KEEP IT STATIONARY AND A SECOND VALVE WAS SUCCESSFULLY IMPLANTED. THE FIRST VALVE WAS LEFT IMPLANTED IN THE ASCENDING AORTA. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6684869 ↗
• InjuryMay 11, 2017Migration or Expulsion of Device; Activation Failure; Migration or Expulsion of Device; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED INTO A FAILED NON-MEDTRONIC SURGICAL AORTIC VALVE. THE VALVE DID NOT FULLY EXPAND AND A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. SUBSEQUENTLY, THE BAV EMBOLIZED THE VALVE INTO THE AORTA. THE VALVE WAS SNARED AND STABILIZED. A SECOND VALVE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562048 ↗

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-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-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-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