Evolut™ PRO+ D-EVPROP2329USRecalls & reported problems

Summary

The FDA's MAUDE database contains 281 adverse event reports that list this exact device (DI 00763000207854), received between Oct 30, 2019 and Aug 10, 2026 — classified as 40 deaths, 161 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (136 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2021Open, Classified

   Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

   Z-2043-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 281 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  It was reported that prior to the attempted implant of a transcatheter aortic valve into an indwelling surgical aortic valve (SAV), a pre-implant balloon aortic valvuloplasty (BAV) was performed with a non-Medtronic 26 millimeter (mm) balloon in order to fracture the indwelling SAV frame. Subsequently, a 29 mm valve was attempted, however the valve would not anchor to the SAV. Subsequently, the valve was recaptured into the delivery catheter system (DCS). 4 subsequent deployment attempts and recaptures were performed, however the valve remained unable to anchor to the SAV. Following the 5th attempt, it was decided to withdraw the system from the patient. The valve was upsized to a 34 mm valve, which was subsequently loaded into a new DCS. The 34 mm valve implant was ultimately successful.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196198 ↗
• MalfunctionMar 20, 2026Difficult or Delayed Activation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A TRANSCATHETER VALVE, PRIOR TO THE IMPLANT OF THE VALVE AND DURING RELEASE, THE VALVE WAS "OUT OF SYNC" LEADING TO VALVE DISLODGEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650145 ↗
• InjuryMar 2, 2026Difficult or Delayed Positioning; Adverse 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), UPON THE FIRST DEPLOYMENT ATTEMPT, CIRCULATORY COLLAPSE AND A DROP IN BLOOD PRESSURE WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED TO ADJUST THE DEPLOYMENT DEPTH. THE VALVE WAS SUCCESSFULLY IMPLANTED ON THE SECOND ATTEMPT, HOWEVER THE PATIENT'S BLOOD PRESSURE DID NOT RECOVER. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. SUBSEQUENTLY, UPON IMAGE REVIEW IT WAS OBSERVED THAT THE VALVE HAD MIGRATED, WITH "SIGNIFICANT" PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS IMPLANTED IN A DEEPER POSITION, AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON, WHICH PROVIDED SIGNIFICANT IMPROVEMENT TO THE PVL.

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

  MAUDE report 24484597 ↗
• MalfunctionJan 7, 2026Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A TRANSCATHETER VALVE, THE DELIVERY CATHETER SYSTEM (DCS) BECAME CONTAMINATED. SUBSEQUENTLY, THE DCS WAS NOT USED, AND A NEW DCS WAS 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 23989767 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING LOADING, THE DEPLOYMENT KNOB OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED. A NEW DCS WAS USED FOR SUCCESSFUL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385907 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE, THE CAPSULE WAS ADVANCED OVER THE TISSUES OF THE SKIRT OF THE INFLOW AND THE HANDLE SEPARATED. A NEW DELIVERY CATHETER SYSTEM (DCS) WAS USED AND THE VALVE WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349881 ↗
• InjuryMay 13, 2025Difficult or Delayed Positioning; Perivalvular Leak; Device Dislodged or Dislocated; Patient Device Interaction Problem; Difficult or Delayed Positioning; Perivalvular Leak; Device Dislodged or Dislocated; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ON THE FIRST AND SECOND DEPLOYMENT ATTEMPTS, THE VALVE DISLODGED AT 80% DEPLOYMENT. ON THE THIRD DEPLOYMENT ATTEMPT, THE VALVE WAS DEPLOYED TO 80% WITH A TARGET DEPTH OF 5 MILLIMETER (MM), BUT THE VALVE APPEARED TOO DEEP. ON THE FOURTH DEPLOYMENT ATTEMPT, THE VALVE WAS FULLY RELEASED AT A DEPTH OF APPROXIMATELY 5MM. APPROXIMATELY 10-15 MINUTES FOLLOWING RELEASE, MODERATE PARAVALVULAR LEAK (PVL) AND A GRADIENT OF 11 MILLIMETERS OF MERCURY (MMHG) WERE OBSERVED. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. AS THE BALLOON WAS WITHDRAWN, THERE WAS INTERACTION WITH THE VALVE FRAME, AND THE VALVE SUBSEQUENTLY DISLODGED TO THE SINUS OF VALSALVA (SOV). THE PATIENT WAS HEMODYNAMICALLY STABLE. THE VALVE WAS SNARED TO THE ASCENDING AORTA, AND A SECOND VALVE WAS ADVANCED TO THE AORTIC VALVE POSITION. ON EACH DEPLOYMENT ATTEMPT, THE VALVE WOULD DISLODGE INTO THE SINUSES OR MOVE VENTRICULAR. THE VALVE WAS EVENTUALLY FULLY DEPLOYED AT A DEPTH OF 5-6MM. FOLLOWING DEPLOYMENT, THE VALVE DISLODGED VENTRICULAR. MODERATE-SEVERE PVL WAS OBSERVED AND THE PATIENT BECAME HYPOTENSIVE. THE PATIE

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

  MAUDE report 22009029 ↗
• MalfunctionMay 7, 2025Structural Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem; Structural Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A PATIENT WITH AN EXISTING MEDTRONIC SURGICAL AORTIC VALVE, THE TRANSCATHETER VALVE WAS DEPLOYED TO 80%, AND DISLODGED AS A RESULT OF A PREMATURE VENTRICULAR CONTRACTION (PVC). THE VALVE WAS RECAPTURED IN THE ASCENDING AORTA ABOUT THE SURGICAL VALVE. UPON RE-DEPLOYMENT, THE CAMERA ANGLE WAS ADJUSTED AND REPORTED A BENT VALVE STRUT, AT THE INFLOW OF THE VALVE. THE TEAM ELECTED TO FULLY RELEASE THE VALVE. THE VALVE WAS POST DILATED USING A 20 MILLIMETER (MM) NON-MEDTRONIC (TRUE) BALLOON. THE BENT STRUT MOVED SLIGHTLY, BUT DID NOT FULLY RESOLVE. THERE WAS NO RESIDUAL GRADIENT OR PARAVALVULAR LEAK (PVL) REPORTED FOLLOWING THE IMPLANT. THE PATIENT REMAINED STABLE THROUGHOUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 21979261 ↗
• MalfunctionMay 6, 2025Gradient Increase; Device Dislodged or Dislocated; Gradient Increase; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS PLACED IN A GOOD POSITION USING THE CORRECT TECHNIQUE. AS THE PHYSICIAN PULLED THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) OUT OF THE VALVE, THE NOSE CONE MAY HAVE CAUGHT ONTO THE VALVE AND DISLODGED THE VALVE. THE PHYSICIAN WAS UNCERTAIN AS THE NOSE CONE WAS COMPLETELY WITHIN THE FRAME OF THE VALVE AND LEAFLETS. OF NOTE, THE PATIENT HAD VERY MILD CALCIUM ON THEIR LEAFLETS AND IT WAS POSSIBLE THE THE VALVE EJECTED WITHOUT BEING DISTURBED BY THE DCS. THE VALVE STABILIZED AT APPROXIMATELY 10 MILLIMETER (MM) ABOVE THE ANNULUS. THE VALVE PINNED ONE OR MORE OF THE NATIVE AORTIC VALVE LEAFLETS AND A SEAL WAS CREATED. THE VALVE WAS FUNCTIONING AT THE END OF THE CASE WITH A MEAN GRADIENT FROM 40 MILLIMETER OF MERCURY (MMHG) TO 14 MMHG. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970039 ↗
• MalfunctionMay 6, 2025Difficult or Delayed Positioning; Material Invagination; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Material Invagination; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC AORTIC VALVE WITHIN A BICUSPID NATIVE VALVE, THE VALVE WAS SUCCESSFULLY LOADED ON THE FIRST ATTEMPT. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON. THE VALVE WAS DEPLOYED AND RECAPTURED THREE TIMES. IT WAS REPORTED THAT THE FIRST DEPLOYMENT ATTEMPT THE DOCTOR FELT UNEASY, THEREFORE THE VALVE WAS RECAPTURED. ON THE SECOND DEPLOYMENT ATTEMPT, IT WAS REPORTED THAT THE VALVE WAS DEEP, THEREFORE WAS RECAPTURED. ON THE THIRD DEPLOYMENT ATTEMPT, THE IMPLANT TEAM WAS AIMING FOR A HIGHER IMPLANT DEPTH, HOWEVER THE VALVE SLID. THE VALVE WAS RECAPTURED, THE MEDTRONIC FIELD REP NOTED A POSSIBLE INFOLD UPON RECAPTURE. THE IMPLANTING TEAM ELECTED TO ATTEMPT DEPLOYMENT AGAIN. AN ADDITIONAL DEPLOYMENT WAS ATTEMPTED, HOWEVER AN INFOLD WAS NOTED DUE TO THE RECAPTURES AND ANATOMY. IT WAS NOTED THAT THE INFOLD WAS NOT PRESENT AT VALVE LOADING OR OTHER DEPLOYMENTS. PER THE PHYSICIAN, THE BICUSPID ANATOMY CONTRIBUTED TO THE INFOLD. SUBSEQUENTLY, THE SYSTEM WAS REMOVED, AND A NEW SYSTEM WAS USED TO SUCCESSFULLY IMPLANT A DIFFERENT VALVE. IT WAS REPORTED THAT THE ANNULUS SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968266 ↗
• MalfunctionMay 6, 2025Material Invagination; Device Dislodged or Dislocated; Material Invagination; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH A LARGE CALCIUM BURDEN IN THE ANNULUS, THE VALVE WAS PARTIALLY DEPLOYED AND DISLODGED TOWARD THE AORTA. THE VALVE WAS RECAPTURED AND AN INFOLD WAS NOTED. THE VALVE WAS REMOVED. A NEW VALVE WAS LOADED WITH A NEW DELIVERY CATHETER SYSTEM (DCS) AND SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, CALCIUM IN THE ANNULUS CONTRIBUTED TO THE INFOLD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967758 ↗
• MalfunctionMay 5, 2025Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE WOULD MOVE VENTRICULAR WHILE THE VALVE WAS DEPLOYED OUT TO 80%. MULTIPLE ATTEMPTS WERE MADE TO LAND THE VALVE AT AN APPROPRIATE DEPTH, HOWEVER DESPITE MITIGATION, THE VALVE WOULD STAY STAY AT A REASONABLE DEPTH. THE VALVE WAS RECAPTURED AND WITHDRAWN. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE REPLACED. THE REPLACEMENT VALVE WAS ULTIMATELY IMPLANTED AT AN APPROPRIATE DEPTH. OF NOTE, THE PATIENT HAD SEVERE AORTIC STENOSIS, A MEAN GRADIENT OF GREATER THAN 40 MMHG AND A CALCIUM SCORE OF 150. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959993 ↗
• MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, ON THE FIRST DEPLOYMENT VIA THE DELIVERY CATHETER SYSTEM (DCS) OF THIS 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WOULD NOT STAY IN ANNULAR POSITION AT 80% DEPLOYED. THIS SYSTEM WAS REMOVED FROM THE PATIENT. A NEW DCS AND A 29MM VALVE WERE THEN ATTEMPTED. AT 80% DEPLOYMENT, THIS VALVE ALSO WOULD NOT STAY IN ANNULAR POSITION. THE SYSTEM WAS REMOVED FROM THE PATIENT. OF NOTE, NO PRE BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. A SIZING ISSUE WITH BOTH THE 26 MM AND THE 29 MM VALVE WAS CONSIDERED TO BE THE POSSIBLE CAUSE. ALSO, THE PATIENT'S ROOT ANGLE WAS 69 AND WAS NOTED TO POSSIBLY HAVE CONTRIBUTED TO THE DISLODGEMENTS. THE PHYSICIAN ELECTED TO SWITCH TO BALLOON EXPANDABLE VALVE FOR THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959860 ↗
• MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, ON THE FIRST DEPLOYMENT VIA THE DELIVERY CATHETER SYSTEM (DCS) OF THIS 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WOULD NOT STAY IN ANNULAR POSITION AT 80% DEPLOYED. THIS SYSTEM WAS REMOVED FROM THE PATIENT. A NEW DCS AND A 29MM VALVE WERE THEN ATTEMPTED. AT 80% DEPLOYMENT, THIS VALVE ALSO WOULD NOT STAY IN ANNULAR POSITION. THE SYSTEM WAS REMOVED FROM THE PATIENT. OF NOTE, NO PRE BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. A SIZING ISSUE WITH BOTH THE 26 MM AND THE 29 MM VALVE WAS CONSIDERED TO BE THE POSSIBLE CAUSE. ALSO, THE PATIENT'S ROOT ANGLE WAS 69 AND WAS NOTED TO POSSIBLY HAVE CONTRIBUTED TO THE DISLODGEMENTS. THE PHYSICIAN ELECTED TO SWITCH TO BALLOON EXPANDABLE VALVE FOR THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959854 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS ATTEMPTED TO BE IMPLANTED HOWEVER BASED ON THE ANATOMY, THE VALVE WOULD NOT STAY IN PLACE AND DISLODGED UP FROM THE ANNULUS OF THE AORTIC VALVE AREA. THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WAS CONICAL IN SHAPE AND A SEPTAL BULGE WAS PRESENT. THESE CREATED MUCH MORE PRESSURE ON THE ANNULUS OF THE NATIVE AORTIC VALVE AREA. THIS IN TURN DID NOT ALLOW THE TRANSCATHETER VALVE TO ADHERE TO THE ANATOMY WALL AND HOLD ITS PLACE. THE VALVE WAS REMOVED FROM THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954168 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED OUT OF THE ANNULUS AT 80% DEPLOYMENT. THE VALVE DISLODGED WHEN ATTEMPTED DEEPER THAN 3 MM. THE VALVE WAS RECAPTURED AND REMOVED. A 29MM VALVE WAS IMPLANTED. ECHOCARDIOGRAM AND ANGIOGRAM WERE PERFORMED, THE VALVE WAS RELEASED WITHOUT ANY ISSUES. NO PARAVALVULAR LEAK (PVL) WAS NOTED ON ECHOCARDIOGRAM AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954145 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED FOUR TIMES. THE VALVE WAS RECAPTURED AND REMOVED. IT WAS REPORTED THAT THE NATIVE VALVE HAD 17% OVERSIZING AND MINIMAL AORTIC ROOT CALCIFICATION. A 29 MM VALVE WAS ATTEMPTED. THE VALVE WAS DEPLOYED AT 4 MM AND HELD AT 80% FOR APPROXIMATELY TWO MINUTES. THE VALVEMOVED AORTIC AND DISLODGED. THE VALVE WAS RECAPTURED AND REMOVED AND THE PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953971 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED FOUR TIMES. THE VALVE WAS RECAPTURED AND REMOVED. IT WAS REPORTED THAT THE NATIVE VALVE HAD 17% OVERSIZING AND MINIMAL AORTIC ROOT CALCIFICATION. A 29 MM VALVE WAS ATTEMPTED. THE VALVE WAS DEPLOYED AT 4 MM AND HELD AT 80% FOR APPROXIMATELY TWO MINUTES. THE VALVE MOVED AORTIC AND DISLODGED. THE VALVE WAS RECAPTURED AND REMOVED AND THE PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953948 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A SIEVERS TYPE 1 BICUSPID VALVE, NO PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE WAS DEPLOYED THREE TIMES AND DISLODGED EACH TIME. EACH ATTEMPT WAS ATTEMPTED SLIGHTLY DEEPER. THE FIRST ATTEMPT WAS AT 3 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC), THE SECOND ATTEMPT AT 4-5 MM ON THE NCC AND THE THIRD ATTEMPT AT 6 MM ON THE NCC. THE THIRD ATTEMPT APPEARED TO STAY IN PLACE HOWEVER AFTER APPROXIMATELY 15 SECONDS, FLUOROSCOPY REVEALED THE VALVE HAD DISLODGED INTO THE ASCENDING AORTA AGAIN. THE VALVE WAS REMOVED AND A NON-MEDTRONIC VALVE WAS ULTIMATELY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953287 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED THREE TIMES DUE TO THE VALVE DISLODGING VENTRICULAR. THE SYSTEM WAS REMOVED AND REPLACED. THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED ON THE FIRST ATTEMPT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952887 ↗
• MalfunctionMay 1, 2025Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC AORTIC VALVE, THE INITIAL NON-MEDTRONIC GUIDEWIRE DID NOT SIT WELL THE APEX AND DID NOT ALIGN BIAS THE VALVE TOWARD THE GREATER CURVATURE OF THE AORTA. THEREFORE, THE VALVE WAS RESHEATHED VIA THE DELIVERY CATHETER SYSTEM (DCS) TO ALLOW FOR WIRE EXCHANGE WITH A DIFFERENT NON-MEDTRONIC GUIDEWIRE. ADDITIONALLY, THE DCS RECAPTURED THE VALVE 2 TIMES DUE TO VALVE BEING PLACED TOO LOW AND VALVE DISLODGMENT. ULTIMATELY THE VALVE WAS SUCCESSFULLY IMPLANTED. ADDITIONALLY, DURING THE IMPLANT PROCEDURE, A COMPLETE HEART BLOCK (CHB) WITH ESCAPE RHYTHM WITH A RATE OF 50 BEATS PER MINUTE (BPM) WAS IDENTIFIED. IN TURN, A TEMPORARY PACEMAKER WAS LEFT IN PLACE AND THE ELECTROPHYSIOLOGIST WAS CONSULTED. WITHIN 1-2 HOURS POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT RETURNED TO HER NATIVE RHYTHM OF RIGHT BUNDLE BRANCH BLOCK (RBBB). THE PATIENT CONTINUED TO BE MONITORED VIA A TEMPORARY PACEMAKER WHICH WAS DISCONTINUED THE FOLLOWING DAY. AT DISCHARGE, ELECTROCARDIOGRAM (ECG) SHOWED THE PATIENT REMAINED IN NORMAL SINUS RHYTHM WITH RBBB. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944059 ↗
• MalfunctionMay 1, 2025Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) NOSE CONE WAS NOT CENTERING. THE DCS WAS GETTING STUCK ON THE INFLOW OF THE VALVE. THE VALVE DISLODGED UP TOWARDS THE AORTA 1-2 MM. NO TREATMENT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943014 ↗
• MalfunctionMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THREE ATTEMPTS WERE MADE TO DEPLOY THE VALVE. HOWEVER, DUE TO SEVERITY OF THE EXISTING AORTIC STENOSIS, THE VALVE WAS UNABLE TO BE SECURED ENOUGH TO HOLD THE VALVE IN PLACE AND DISLODGED AT 80% DEPLOYMENT. AFTER THE THIRD RECAPTURE, THE VALVE WAS WITHDRAWN FROM THE PATIENT AND A SECOND VALVE WAS LOADED ON A NEW DELIVERY CATHETER SYSTEM (DCS). THE NEW SYSTEM WAS INSERTED INTO THE PATIENT AND THREE DEPLOYMENT ATTEMPTS WERE MADE WITH THE SECOND VALVE, HOWEVER, DISLODGED AS WELL AT 80% DEPLOYMENT. AFTER THE THIRD RECAPTURE, THE SECOND VALVE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942711 ↗
• MalfunctionMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THREE ATTEMPTS WERE MADE TO DEPLOY THE VALVE. HOWEVER, DUE TO SEVERITY OF THE EXISTING AORTIC STENOSIS, THE VALVE WAS UNABLE TO BE SECURED ENOUGH TO HOLD THE VALVE IN PLACE AND DISLODGED AT 80% DEPLOYMENT. AFTER THE THIRD RECAPTURE, THE VALVE WAS WITHDRAWN FROM THE PATIENT AND A SECOND VALVE WAS LOADED ON A NEW DELIVERY CATHETER SYSTEM (DCS). THE NEW SYSTEM WAS INSERTED INTO THE PATIENT AND THREE DEPLOYMENT ATTEMPTS WERE MADE WITH THE SECOND VALVE, HOWEVER, DISLODGED AS WELL AT 80% DEPLOYMENT. AFTER THE THIRD RECAPTURE, THE SECOND VALVE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942682 ↗
• MalfunctionMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL AORTIC VALVE (SAV), THE PHYSICIAN MADE THREE ATTEMPTS TO POSITION THE TRANSCATHETER VALVE WITHIN THE EXISTING SAV. HOWEVER, ON EACH ATTEMPT, THE VALVE DISLODGED. AFTER THREE UNSUCCESSFUL ATTEMPTS, THE VALVE WAS WITHDRAWN FROM THE PATIENT AND REPLACED. THE REPLACEMENT TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942638 ↗

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