Evolut™ PRO+ D-EVPROP34USRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00763000207861), received between Jan 7, 2020 and Sep 25, 2026 — classified as 9 deaths, 26 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem

  Patient problems: Foreign Body In Patient

  MAUDE report 50902647 ↗
• InjurySep 25, 2026Device Dislodged or Dislocated

  Additional information was received that surgical treatment was performed where both valves were explanted and a surgical valve was implanted.

  Patient problems: Foreign Body In Patient

  MAUDE report 50902616 ↗
• MalfunctionFeb 16, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE VALVE WAS DEPLOYED UP TO TWO-THIRDS; HOWEVER, A "KINK" WAS OBSERVED ON THE VALVE STENT FRAME. SUBSEQUENTLY, THE VALVE WAS WITHDRAWN FROM THE PATIENT, AND A NEW VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT AN INFOLD DID NOT OCCUR. THE VALVE WAS RECAPTURED AND REDEPLOYED 3 TIMES DUE TO THE VALVE DISLODGING, AND AT TWO-THIRDS DEPLOYMENT, THE VALVE FRAME APPEARED BENT. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED FUSED SPINE CONTRIBUTED TO THE EVENT. IT WAS NOTED THAT A PROCEDURAL DELAY OCCURRED IN RESULT OF THE BENT FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345626 ↗
• MalfunctionJul 18, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THE TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) HANDLE BROKE IN HALF WHILE LOADING THE VALVE ON THE BACK TABLE. THE HANDLE WAS REASSEMBLED, HOWEVER, A DIFFERENT DCS WAS USED FOR THE CASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542607 ↗
• MalfunctionMay 7, 2025Material Invagination; Device Dislodged or Dislocated; Material Invagination; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE LOAD WAS CONFIRMED VIS UALLY, TACTILELY AND UNDER FLUOROSCOPY. THE VALVE WAS LOADED ONE TIME AND NO MISLOAD WAS IDENTIFIED. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON (TRUE) USING HAND INFLATION PRESSURE. UPON THE FIRST DEPLOYMENT, THE VALVE DISLODGED. THE TARGET IMPLANT DEPTH WAS 3 MM AND THE CUSPAL OVERLAP TECHNIQUE WAS USED. THE VALVE WAS RECAPTURED AND DEPLOYED AGAIN HOWEVER AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW SYSTEM WAS USED FOR IMPLANT. PER THE PHYSICIAN, IT WAS POSSIBLE THE PATIENT'S CALCIFICATION MAY HAVE CONTRIBUTED TO THE EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979746 ↗
• 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 PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE LOAD FLUOROSCOPIC CHECK REVEALED MINIMAL CROWN OVERLAP, WHICH DID NOT EXTEND PAST THE THIRD NODE. THE VALVE WAS PARTIALLY DEPLOYED AND AFTER ONE RECAPTURE DUE TO THE VALVE BEING TOO DEEP, AN INFOLD WAS NOTED. IT WAS REPORTED THAT THE VALVE HAD MOVED TOWARDS THE VENTRICLE DURING THE INITIAL DEPLOYMENT ATTEMPT. OF NOTE, MINIMAL CALCIUM WAS REPORTED ON THE NATIVE LEAFLETS. THE IMPLANTING TEAM DID NOT EXPECT AN INFOLD TO OCCUR DUE TO THE LACK OF CALCIUM. THE VALVE WAS WITHDRAWN AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968169 ↗
• 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, THE VALVE WAS LOADED WITHOUT ISSUES. THE LOAD WAS PERFORMED ONCE AND CONFIRMED VIA VISUAL, TACTILE AND FLUOROSCOPIC METHODS. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED. THERE WAS NOT MUCH NATIVE CALCIUM. THE NATIVE VALVE WAS BEING REVISED DUE TO AORTIC INSUFFICIENCY. UPON DEPLOYMENT WITH PACING AROUND 120 BEATS PER MINUTE (BPM), THE VALVE DISLODGED. THE VALVE WAS RECAPTURED AND DEPLOYED AGAIN WITH PACING AROUND 150 BPM AT A GOOD DEPTH AT APPROXIMATELY 4 MILLIMETERS (MM) ON BOTH NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). AT 80% DEPLOYMENT, AN INFOLD WAS NOTED THAT WAS NOT PRESENT ON THE FIRST DEPLOYMENT. THE VALVE WAS RELEASED AND POST DILATED WITH A NON-MEDTRONIC 25 MILLIMETER (MM) BALLOON (TRUE). PER THE PHYSICIAN, THE CALCIFICATION DID NOT CONTRIBUTE TO THE INFOLD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967972 ↗
• 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 PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A NATIVE BICUSPID AORTIC VALVE, FLUOROSCOPIC CHECK DID NOT SHOW ANY ISSUES WITH THE VALVE PRIOR TO USE. DURING THE FIRST DEPLOYMENT, THE VALVE WAS NOT IN A GOOD POSITION IN THE ANNULUS AS IT WAS TOO SHALLOW. IT WAS REPORTED THAT THE VALVE MOVED TOWARDS THE VENTRICLE DURING DEPLOYMENT. THE VALVE WAS RECAPTURED AND NO INFOLD WAS OBSERVED. UPON THE SECOND DEPLOYMENT, AN INFOLD WAS OBSERVED. THE VALVE WAS RECAPTURED AND RETRIEVED FROM THE PATIENT. A SECOND VALVE WAS USED SUCCESSFULLY. PER THE PHYSICIAN, THE PATIENT'S ANATOMY CALCIFICATION TO THE INFOLD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967899 ↗
• MalfunctionMay 5, 2025Material Invagination; Device Dislodged or Dislocated; Activation Failure; Material Invagination; Device Dislodged or Dislocated; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS LOADED CORRECTLY AND VERIFIED. ON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED AND WAS RECAPTURED. DURING THE SECOND DEPLOYMENT ATTEMPT THE VALVE APPEARED CONSTRAINED. AN INFOLD WAS SUSPECTED INVOLVING THE FIRST THROUGH 8THS NODES, THEREFORE THE VALVE AND DELIVERY CATHETER SYSTEM WERE REMOVED FROM THE PATIENT. A DIFFERENT VALVE AND DIFFERENT DCS WERE USED FOR A SUCCESSFUL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962454 ↗
• MalfunctionMay 5, 2025Material Invagination; Device Dislodged or Dislocated; Material Invagination; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE VIA RIGHT SUBCLAVIAN ACCESS, THE VALVE WAS SUCCESSFULLY LOADED. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON. DURING THE DEPLOYMENT, THE VALVE DISLODGED WHILE POSITIONING. THE VALVE WAS RECAPTURED. FOLLOWING RECAPTURE, AN INFOLD WAS NOTED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE WITHDRAWN FROM THE PATIENT, AND A NEW VALVE AND DCS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962307 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE WOULD NOT STAY IN POSITION. AT 80% DEPLOYED, THE VALVE WOULD DISLODGE UP. 3 ATTEMPTS WERE MADE TO DEPLOY THE VALVE WITHOUT SUCCESS. THE VALVE WAS WITHDRAWN AND THE PROCEDURE WAS ABORTED. THE VALVE WAS NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953161 ↗
• MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS ATTEMPTED TO BE DEPL OYED THREE TIMES, HOWEVER IT WAS REPORTED THAT THE VALVE WOULD NOT REMAIN IN PLACE WHILE 80% DEPLOYED. THE PATIENT PRESENTED WITH PRE-EXISTING SEVERE AORTIC INSUFFICIENCY, WHICH MADE THE DEPLOYMENT ATTEMPTS CHALLENGING. THE VALVE WAS ULTIMATELY RECAPTURE AND RETRIEVED FROM THE PATIENT. THE IMPLANT PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933311 ↗
• MalfunctionNov 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING A PROCEDURE INVOLVING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, AN UNSPECIFIED PROBLEM OCCURRED INVOLVING THE COMPRESSION LOADING SYSTEM AND DELIVERY CATHETER SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762487 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT JUST PRIOR TO DEPLOYMENT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT BECAME APNEIC AND WAS PROFOUNDLY HYPOTENSIVE. A BRIEF PERIOD OF CARDIOPULMONARY RESUSCITATION WAS INITIATED, MEDICATIONS WERE ADMINISTERED VIA INTRAVENOUS THERAPY, AND THE PATIENT WAS INTUBATED. AFTER THE PATIENT WAS STABILIZED, THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND RECEIVED SUPPLEMENTAL OXYGENATION BY FACE MASK. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT WAS DISCHARGED TO HOME THREE DAYS LATER. IT WAS ALSO NOTED DURING REVIEW OF THE PATIENT'S MEDICAL RECORD AND BLOOD TEST RESULTS THE PATIENT'S PLATELET LEVEL AND HEMOGLOBIN (HGB) HAD A DOWNWARD TREND FROM BASELINE. PRE-OPERATIVE PLATELETS WERE 182 THOUSAND; ON THE DAY OF DISCHARGE, PLATELETS WERE AT 68 THOUSAND. PRE-OPERATIVE HGB WAS 12 G/DL AND ON THE DAY OF DISCHARGE HGB WAS 9 G/DL. NO ACTIVE BLEED WAS REPORTED. NO TREATMENT WAS PROVIDED, THE PHYSICIAN RECOMMENDED THE PATIENT REMAIN ON EXISTING MEDICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18880632 ↗
• InjuryMar 5, 2024Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN UNRELATED LEFT HEART CATHETERIZATION REQUIRED A DIAGNOSTIC CATHETER. A NON-MEDTRONIC CLOSURE DEVICE WAS REQUIRED TO CLOSE THE ACCESS SITE. PRIOR TO THE INSERTION OF THE DELIVERY CATHETER SYSTEM (DCS) AND VALVE, A MEDTRONIC SHEATH WAS INSERTED AND USED FOR A PRE-IMPLANT BALLOON AORTIC VALVULOP LASTY AND WAS REMOVED. THE DCS WAS THEN INSERTED USING THE DCS¿S INLINE SHEATH. FOLLOWING THE IMPLANT OF THE VALVE, THE DCS WAS REMOVED FROM THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE. THE SUTURES WERE CINCHED DOWN, AND BLEEDING WAS PRESENT. THREE NON-MEDTRONIC CLOSURE DEVICES WERE UTILIZED IN AN ATTEMPT TO PREVENT FURTHER BLEEDING. ADEQUATE HEMOSTASIS WAS UNABLE TO BE ACHIEVED AND SURGICAL CUTDOWN WAS PERFORMED. THE VESSEL WAS REPAIRED, AND MULTIPLE LAYERS OF SUTURES WERE USED. THE ACCESS SITE MINIMAL LUMEN DIAMETER OF THE VESSEL WAS 6 MILLIMETERS (MM). THE EVENT WAS NOTED AS RESOLVED ON THE SAME DAY. PER THE PHYSICIAN, THE BLEEDING EVENT WAS NOT RELATED TO THE DCS, EXTERNAL SHEATH OR CLOSURE DEVICE. PER THE PHYSICIAN, THE CAUSE OF THE BLEEDING EVENT WAS DUE TO THAT ACCESS SITE OF THE TRANS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscle Weakness/Atrophy; Non specific EKG/ECG Changes; Numbness; Paresthesia; Tachycardia; Valvular Insufficiency/ Regurgitation

  MAUDE report 18837623 ↗
• InjuryMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DC S), A PSEUDOANEURYSM TO THE RIGHT COMMON FEMORAL ARTERY (RCFA) OCCURRED. THE PSEUDOANEURYSM TO THE RCFA WAS DUE TO A PERCUTANEOUS CLOSURE DEVICE FAILURE. THE PSEUDOANEURYSM WAS IDENTIFIED BY A DUPLEX ULTRASOUND. MINOR BLEEDING WITH A HEMATOMA WAS NOTED AT THE ACCESS SITE. MEDICATION WAS ADMINISTERED. A 10-MILLIMETER (MM) BALLOON WAS USED TO TAMPONADE THE RCFA FOR 3 MINUTES. THE PSEUDOANEURYSM, BLEED AND HEMATOMA RESOLVED THE FOLLOWING DAY. 22 DAYS LATER A RIGHT GROIN ACCESS SITE HEMATOMA AND A LEFT GROIN PSEUDOANEURYSM WAS IDENTIFIED ON ULTRASOUND. NO TREATMENT WAS PROVIDED, AND RIGHT GROIN ACCESS SITE HEMATOMA RESOLVED 10 DAYS LATER. THE LEFT GROIN PSEUDOANEURYSM REQUIRED INTRAVENOUS THERAPY (IV) THROMBIN AS TREATMENT. THE LEFT GROIN PSEUDOANEURYSM RESOLVED 10 DAYS AFTER ONSET. ALL ACCESS SITE INJURIES WERE REPORTED AS PROCEDURE RELATED AND NOT RELATED TO ANY MEDTRONIC DEVICES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 18833037 ↗
• InjuryFeb 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT'S PREVIOUSLY IMPLANTED DEFIBRILLATOR DEVICE SHOWED NORMAL VALUES. DURING THE CUT DOWN ACCESS TO THE LEFT FEMORAL ARTERY, CARDIAC ARREST WAS REPORTED. THE CAUSE OF THE CARDIAC ARREST WAS NOT REPORTED. THE ARREST OCCURRED PRIOR TO THE INTRODUCTION OF ANY MEDTRONIC DEVICE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. A FEMORAL ARTERY BLEED WAS ALSO REPORTED DUE TO A CALCIFIED FEMORAL ARTERY. IT WAS REPORTED THAT NO MEDTRONIC DEVICES WERE INVOLVED IN CAUSING THE FEMORAL BLEED. THE BLEED WAS TREATED SURGICALLY. BLOOD PRODUCTS WERE ALSO TRANSFUSED. IT WAS NOTED THAT THE ACCESS SITE ARTERY MEASURED 6.4 MM. FOLLOWING THE VALVE IMPLANT, THE PATIENT'S HEART RATE WAS LOW AND AS THE PHYSICIAN REPORTED PRE-MATURE VENTRICULAR CONTRACTIONS (PVC). THE PATIENT¿S DEFIBRILLATOR WAS ADJUSTED. IT WAS NOT KNOWN IF THE HEART RATE WAS A RESULT OF A PRE-EXISTING CONDITIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Non specific EKG/ECG Changes

  MAUDE report 18645923 ↗
• InjuryOct 29, 2022Failure to Advance; Patient Device Interaction Problem; Failure to Advance; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS 34 MM TRANSCATHETER BIOPROSTHETIC VALVE USING THIS DELIVERY CATHETER SYSTEM (DCS), IT WAS REPORTED THAT THE DCS WAS NOT ABLE TO ADVANCE THE RIGHT ILIAC ARTERY. A COMMON FEMORAL DISSECTION WITHIN THE RIGHT FEMORAL ARTERY WAS REPORTED. THE DISSECTION LIKELY OCCURRED AT INSERTION OF THE INITIAL SHEATH, OR DURING SHEATH EXCHANGE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE DISSECTION WAS THE SMALL SIZE OF THE VESSEL. THE LARGE BORE SHEATH OR DCS LIKELY CONTRIBUTED. A STENT WAS PLACED AT THE FEMORAL ARTERY HEAD. THE 34 MM VALVE WAS NOT USED AND A DIFFERENT, 29 MM VALVE WAS IMPLANTED. OF NOTE, THE MINIMUM DIAMETER OF THE ACCESS VESSEL WAS 5.7 MM. A DISCUSSION WAS HAD PRIOR TO THE START OF THE IMPLANT OVER THE FEMORAL VESSEL SIZE AND THE RISK. THE IMPLANTING TEAM ELECTED TO INITIALLY USE THE 34 MM PER THEIR SIZING MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15695300 ↗
• MalfunctionSep 9, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A SEVERELY CALCIFIED ANNULUS WAS NOTED. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED THREE TIMES USING 20 MM AND 25 MM NON-MEDTRONIC BALLOONS. THE ANNULUS NEEDED TO BE RE-WIRED SEVERAL TIMES DUE TO THE TIGHT AND CALCIFIED VALVE. THE NOSE CONE OF THIS DELIVERY CATHETER SYSTEM (DCS) WOULD NOT CROSS THE ANNULUS. THE NOSE CONE WAS PUSHED MULTIPLE TIMES AND THE CAPSULE BUCKLED. THE DCS WOULD NOT THEN TRACK OVER THE NON-MEDTRONIC GUIDEWIRE. THE SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED AS THE BAVS WERE HELPFUL TO THE PATIENT. PER THE PHYSICIAN, THE DCS MAY HAVE BEEN KINKED WHEN TRYING TO PUSH THROUGH CALCIUM. PER THE PHYSICIAN, THERE WAS NO FAILURE OF THE DCS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393353 ↗
• DeathAug 25, 2022Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A PATIENT WITH TYPE 0 BICUSPID SIEVERS VALVE WITH STENOSIS AND AORTIC TORTUOSITY, THE VALVE WAS LOADED SUCCESSFULLY. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20 MILLIMETER (MM) BALLOON. THE BALLOON HAD TO BE POSITIONED TWICE FOR OPTIMIZATION. THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED OVER THE AORTIC ARCH WITH SOME RESISTANCE HOWEVER TRACKING APPEARED REASONABLE TO ADVANCE AND POSITION INTO THE ASCENDING AORTA JUST SUPERIOR TO THE ANNULUS. THE VALVE WAS ADVANCED TO THE ANNULUS WITH AN ATTEMPT TO CROSS HOWEVER RESISTANCE WAS MET AS THE NOSE CONE WAS TRYING TO NEGOTIATE A MILD/MODERATE TURNING COURSE AT THE ANNULUS WITHOUT TRACKING SUCCESS AND CREATED TENSION IN THE CATHETER. MULTIPLE FORWARD ATTEMPTS WERE MADE WITHOUT SUCCESS. THE VALVE WAS WITHDRAWN FROM THE ANNULUS AND BACK ACROSS THE AORTIC ARCH. THE VALVE WAS POSITIONED INTO THE DESCENDING AORTA AND FLUOROSCOPY VISUALLY INSPECTED THE VALVE AND NOSE CONE WHICH APPEARED NORMAL. THE PATIENT REMAINED STABLE. THE DCS WAS ROTATED 90 DEGREES AND RE-ADVANCED. MULTIPLE FORWARD ATTEMPTS WERE MADE AGAIN W WITHOUT SUC

  Patient problems: Cardiac Arrest; Perforation

  MAUDE report 15297310 ↗
• InjuryAug 23, 2022Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS PARTIALLY DEPLOYED UNDER RAPID PACING, BUT WAS TOO DEEP. THE VALVE WAS RECAPTURED AND RE-DEPLOYED TO 80% AT A PROPER DEPTH. WHEN PACING WAS CEASED, VENTRICULAR TACHYCARDIA WAS NOTED AND PROGRESSED TO VENTRICULAR FIBRILLATION. WHILE DEFIBRILLATION AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PROVIDED, THE VALVE WAS RECAPTURED. THE VALVE WAS NOT IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 15279506 ↗
• DeathJun 29, 2022Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT EXPERIENCED SIGNIFICANT CHEST PAIN. SEVERAL HOURS FOLLOWING IMPLANT, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, WHICH REVEALED A TYPE B AORTIC DISSECTION WITH RUPTURE. A STENT GRAFT PROCEDURE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT WAS PLACED ON COMFORT MEASURES AND DIED THE MORNING AFTER THE IMPLANT PROCEDURE.

  Patient problems: Chest Pain; Rupture; Vascular Dissection

  MAUDE report 14854459 ↗
• MalfunctionJun 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE THIS TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY LOADED AND CONFIRMED VIA FLUOROSCOPY. THE SYSTEM WAS INSERTED AND AT 50% DEPLOYMENT THE TIP RETRIEVAL MECHANISM WAS ACTIVATED. IT WAS UNKNOWN IF THE HEALTH CARE PROFESSIONAL PRESSED THE BUTTON TO ACTIVATE OR IF THE TORTUOUS ANATOMY BUILT UP ENOUGH TENSION TO ENGAGE THE MECHANISM. IT WAS REPORTED THAT THE ACTUATOR SEPARATED. THE VALVE WAS RECAPTURED SUCCESSFULLY. A NEW SYSTEM WAS USED FOR IMPLANT AND A VALVE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788850 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (B)(4), A DISSECTION WAS NOTED IN THE RIGHT FEMORAL ARTERY; STENTS WERE PLACED TO TREAT THE DISSECTION. THE CAUSE OF THE DISSECTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 14694976 ↗
• InjuryJun 1, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE LOADING CHECK REVEALED NO CROWN OVERLAP BEYOND THE FOURTH NODE. DURING ATTEMPTED DEPLOYMENT, THE VALVE WAS NOT FULLY EXPANDED. THE VALVE WAS RECAPTURED AND A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MM NON-MEDTRONIC BALLOON. DURING THE SECOND DEPLOYMENT ATTEMPT, THE VALVE WAS NOT FULLY EXPANDED. THE VALVE WAS RECAPTURED AND WITHDRAWN TO THE DESCENDING AORTA. BLOOD PRESSURE RECOVERED BRIEFLY AND THEN BEGAN TO DROP. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED NO INJURIES. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AND PRESSURE RECOVERED QUICKLY. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED VIA THE CAROTID APPROACH DUE TO VASCULAR CONCERNS WITH ECMO IN PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 14567877 ↗

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-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-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-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