Evolut™ FX D-EVOLUTFX-34 (UDI 00763000365684)Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00763000365684), received between Sep 14, 2022 and Feb 27, 2026 — classified as 16 deaths, 66 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (59 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 142 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE RIGHT FEMORAL ARTERY, WITH A MINIMUM DIAMETER OF 8.4 MILLIMETERS (MM) WAS USED AS THE ACCESS SITE. UPON ADVANCEMENT OF THE DELIVERY CATHETER SYSTEM (DCS) THROUGH THE ACCESS SITE, IT WAS NOTED THAT THE WIRE WAS NOT HELD TIGHT TO PROVIDE A "RAIL" FOR THE DCS TO ADVANCE, RESULTING IN A PERFORATION OF THE ACCESS SITE. SUBSEQUENTLY, A STENT WAS PLACED TO ADDRESS THE INJURY. IT WAS NOTED THAT A 50 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT, AND THE PROCEDURE WAS ULTIMATELY ABORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 24475540 ↗
• InjuryFeb 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING LOADING OF A TRANSCATHETER VALVE, AN INFLOW FRAME NODE OVERLAP EXTENDING TO NODE 3 WAS OBSERVED. UPON THE FIRST DEPLOYMENT ATTEMPT TO THE POINT OF NO RECAPTURE (PONR), THE PATIENT'S BLOOD PRESSURE WAS 20-30 MILLIMETERS OF MERCURY (MM HG), AND AN INFOLD WAS OBSERVED. AT THIS POINT, CARDIAC ARREST OCCURRED AND THE SYSTEM WAS WITHDRAWN. A NEW VALVE WAS IMMEDIATELY DEPLOYED AND IMPLANTED; HOWEVER, THE PATIENT'S BLOOD PRESSURE DID NOT RECOVER. THE PROCEDURE ENDED WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 24293835 ↗
• MalfunctionJan 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT HAD TWO NON-MEDTRONIC TRANSCATHETER VALVES IMPLANTED THAT DISLODGED. FOLLOWING THE IMPLANT OF THE MEDTRONIC TRANSCATHETER VALVE, IT WAS OBSERVED THAT THE MEDTRONIC DELIVERY CATHETER SYSTEM (DCS) AND COMPRESSION LOADING SYSTEM (CLS) USED DURING THE PROCEDURE WERE EXPIRED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026915 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO PATIENT CALCIFICATION. UPON 80% DEPLOYMENT OF THE VALVE, IT WAS REPORTED THAT THE SYSTEM DISLODGED AORTIC. THE VALVE WAS SUBSEQUENTLY RECAPTURED. IT WAS REPORTED THAT DISLODGEMENT CONTINUED TO OCCUR MULTIPLE TIMES AT 80% DEPLOYMENT, SO THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. ANOTHER PRE-IMPLANT BAV WAS PERFORMED DUE TO THE PRIOR DISLODGEMENTS. UPON 80% DEPLOYMENT OF THE SECOND VALVE, IT WAS DETERMINED THAT THE POSITIONING WAS TOO HIGH RELATIVE TO THE TARGET IMPLANT DEPTH OF 0-1 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND ABOVE THE ANNULAR PLANE ON THE LEFT CORONARY CUSP (LCC), IT WAS DETERMINED NECESSARY TO RECAPTURE THE VALVE. UPON THE ATTEMPTED RECAPTURE, THE DEPLOYMENT KNOB WAS TURNED TOO QUICKLY, RESULTING IN INADVERTENT DEPLOYMENT OF THE VALVE. THE VALVE ULTIMATELY DISLODGED TO ABOVE THE SINOTUBULAR JUNCTION (STJ) ON THE NCC AND 1-2 MM BELOW THE STJ ON THE LCC, RESULTING IN EMBOLIZATION. SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE ASCENDING AORTA. A THIRD VALVE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT A 90 MINUTE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783136 ↗
• InjuryDec 11, 2025Difficult or Delayed Positioning; Malposition of Device; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO PATIENT CALCIFICATION. UPON 80% DEPLOYMENT OF THE VALVE, IT WAS REPORTED THAT THE SYSTEM DISLODGED AORTIC. THE VALVE WAS SUBSEQUENTLY RECAPTURED. IT WAS REPORTED THAT DISLODGEMENT CONTINUED TO OCCUR MULTIPLE TIMES AT 80% DEPLOYMENT, SO THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. ANOTHER PRE-IMPLANT BAV WAS PERFORMED DUE TO THE PRIOR DISLODGEMENTS. UPON 80% DEPLOYMENT OF THE SECOND VALVE, IT WAS DETERMINED THAT THE POSITIONING WAS TOO HIGH RELATIVE TO THE TARGET IMPLANT DEPTH OF 0-1 MILLIMETERS (MM) ON THE NON-CORONARY CUSP (NCC) AND ABOVE THE ANNULAR PLANE ON THE LEFT CORONARY CUSP (LCC), IT WAS DETERMINED NECESSARY TO RECAPTURE THE VALVE. UPON THE ATTEMPTED RECAPTURE, THE DEPLOYMENT KNOB WAS TURNED TOO QUICKLY, RESULTING IN INADVERTENT DEPLOYMENT OF THE VALVE. THE VALVE ULTIMATELY DISLODGED TO ABOVE THE SINOTUBULAR JUNCTION (STJ) ON THE NCC AND 1-2 MM BELOW THE STJ ON THE LCC, RESULTING IN EMBOLIZATION. SUBSEQUENTLY, THE VALVE WAS SNARED INTO THE ASCENDING AORTA. A THIRD VALVE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT A 90 MINUTE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783103 ↗
• MalfunctionNov 24, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE PROCEDURE, AS THE FIRST DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE THROUGH THE PATIENT'S CALCIFIED ANATOMY. SCRATCHES APPROXIMATELY 1 CENTIMETER ON THE FIRST DCS WAS NOTED AROUND THE MIDDLE OF THE CAPSULE. SUBSEQUENTLY, A NEW VALVE AND DCS WERE USED THROUGH DIRECT AORTIC ACCESS RESULTING IN A PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634295 ↗
• InjuryNov 10, 2025Difficult or Delayed Positioning; Patient Device Interaction Problem; Difficult or Delayed Positioning; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS RECAPTURED DUE TO THE IMPLANT DEPTH BEING TOO HIGH. UPON RECAPTURE, AN INFOLD WAS OBSERVED. A SECOND DEPLOYMENT ATTEMPT WAS PERFORMED, AND THE INFOLD WAS STILL PRESENT. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 2 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT, AND A NEW TRANSCATHETER VALVE AND NEW DELIVERY CATHETER SYSTEM (DCS) WERE USED. UPON DEPLOYMENT OF THE NEW VALVE, THE IMPLANT DEPTH WAS 3 MM ON THE NON-CORONARY CUSP (NCC) AND 3 MM ON THE LEFT CORONARY CUSP (LCC). SUBSEQUENTLY, THE VALVE WAS FULLY DEPLOYED; HOWEVER, "SOME" PARAVALVULAR LEAK (PVL) WAS NOTED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 26 MM NON-MEDTRONIC BALLOON WHILE THE PATIENT WAS RAPIDLY PACED OFF THE MEDTRONIC GUIDEWIRE AS VENOUS ACCESS WAS UNABLE TO BE OBTAINED. DURING THE POST-IMPLANT BAV, PREMATURE VENTRICULAR CONTRACTION (PVC) WAS OBSERVED, AND THE VALVE DISLODGED AORTIC BEFORE THE BALLOON WAS DOWN. SUBSEQUENTLY, THE VALVE WAS SNARED IN PLACE ABOVE THE SINOTUBULAR JUN CTION (STJ) W

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23512677 ↗
• MalfunctionSep 10, 2025Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROCEDURE, THE VALVE WAS DEPLOYED AND RECAPTURED A COUPLE TIMES AND AN INFOLD WAS THEN IDENTIFIED. THE VALVE WAS RECAPTURED AND REMOVED AND A NEW SYSTEM WAS USED FOR IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VALVE WAS RECAPTURED TWICE DURING DEPLOYMENT DUE TO DISLODGMENTS WHILE ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). THERE WAS A PROCEDURAL DELAY AS THE IMPLANTING PHYSICIANS HAD TO WAIT FOR THE NEW VALVE TO BE OPENED AND PREPARED. OFNOTE, THE PATIENT HAD TWO CALCIUM SPURS EXTENDING INTO LEFT VENTRICULAR OUTFLOW TRACT THAT WERE APPROXIMATELY 11 MM FROM THE BASAL PLANE. AORTIC VALVE CALCIUM MEASURED AT 725 MM CUBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016801 ↗
• InjurySep 8, 2025Difficult or Delayed Positioning; Difficult to Open or Close; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Difficult to Open or Close; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF A TRANSCATHETER VALVE IN A PATIENT WITH PRE-EXISTING PURE AORTIC INSUFFICIENCY (AI), FOLLOWING THE THIRD DEPLOYMENT ATTEMPT, THE VALVE DISLODGED FROM THE PADDLE ATTACHMENT POCKET AND WAS SUBSEQUENTLY RECAPTURED. THE DELIVERY CATHETER SYSTEM (DCS) WAS RETRIEVED TO THE ABDOMINAL AORTA AND THE VALVE WAS FULLY DEPLOYED. SUBSEQUENTLY, A SECOND TRANSCATHETER VALVE WAS IMPLANTED IN THE AORTIC POSITION. IT WAS NOTED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 1.5 HOURS AS A RESULT OF THE DISLODGE. PER THE PHYSICIAN, THE PATIENT'S PURE AI CONTRIBUTED TO THE DISLODGE. ADDITIONAL INFORMATION WAS RECEIVED THAT A MEDTRONIC (CONFIDA) GUIDEWIRE WAS USED FOR THE PROCEDURE. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. DURING THE FIRST DEPLOYMENT ATTEMPT, THE POSITION WAS TOO SHALLOW AND THE VALVE WAS RECAPTURED. ON THE SECOND DEPLOYMENT ATTEMPT, THE VALVE WAS POSITIONED TOO DEEPLY, AND WAS RECAPTURED. DURING THE THIRD DEPLOYMENT ATTEMPT, THE VALVE DISLODGED INTO THE AORTA NECESSITATING A THIRD RECAPTURE, BUT IT WAS THEN NOTICED THAT LIKELY ONE VALVE PADDLE WAS NOT CONNECTED WITH THE ATTACHMENT POCKETS ANYMORE, AND ONLY A PARTIA

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

  MAUDE report 22998884 ↗
• InjuryAug 19, 2025Failure to Advance; Patient Device Interaction Problem; Failure to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO A BICUSPID AORTIC VALVE. DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, AFTER ADVANCEMENT OF A NON-MEDTRONIC SHEATH, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE THROUGH THE LEFT EXTERNAL ILIAC ARTERY (EIA). SUBSEQUENTLY, AN ACCESS SITE DISSECTION AND PERFORATION OCCURRED AT THE LEFT EIA, AND THE PATIENT¿S BLOOD PRESSURE DROPPED. SURGICAL REPAIR WAS THEN INITIATED WITH THE PLACEMENT OF A STENT, AND THE PATIENT WAS HOSPITALIZED. PER THE PHYSICIAN, THE DCS CAPSULE OR INLINE SHEATH CAUSED THE DISSECTION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT, PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE VASCULAR INJURYWAS THE DCS CAPSULE. THE GUIDEWIRE DID NOT CONTRIBUTE TO THE INJURY. THE PROCEDURE WAS NOT COMPLETED AND A NEW VALVE WAS NOT PLACED AT THAT TIME.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Vascular Dissection

  MAUDE report 22846139 ↗
• InjuryAug 12, 2025Failure to Advance; Patient Device Interaction Problem; Failure to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE THROUGH THE ASCENDING AORTA. SUBSEQUENTLY, AN ABDOMINAL AORTA DISSECTION EXTENDING TO THE AORTIC VALVE WAS OBSERVED, AND THE VALVE WAS NEVER IMPLANTED. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE EVENT.

  Patient problems: Aortic dissection

  MAUDE report 22784583 ↗
• InjuryAug 8, 2025Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE IN THE NATIVE ANNULUS, UPON WITHDRAWING THE DELIVERY CATHETER SYSTEM (DCS), THE NOSECONE OF THE DCS CAUGHT ONTO THE INFLOW OF THE VALVE AND THE VALVE DISLODGED. SUBSEQUENTLY, A SECOND TRANSCATHETER VALVE WAS IMPLANTED, AND THE DISLODGED VALVE WAS SNARED ABOVE THE SECOND VALVE. IT WAS REPORTED THAT THE DCS WAS NOT TWISTED OR TORQUED AT ANY POINT DURING DEPLOYMENT. IT WAS NOTED THAT A 5 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT OF THE DISLODGE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE RIGHT FEMORAL ACCESS SITE WAS USED. THE VALVE AND DCS WERE ADVANCED OVER A N ON-MEDTRONIC GUIDEWIRE TO THE NATIVE ANNULUS. THE VALVE WAS SLOWLY DEPLOYED USING THE CUSP OVERLAP TECHNIQUE. THE DCS WAS NOT TWISTED OR TORQUED DURING DEPLOYMENT. FOLLOWING DEPLOYMENT, TENSION IN THE GUIDEWIRE WAS NOTED MAKING IT DIFFICULT TO CENTER THE DCS NOSE CONE WITHIN THE INFLOW OF THE VALVE. PER THE PHYSICIAN, THE WIRE WAS "CAUGHT" ON SOMETHING. THE DCS WAS PULLED BEFORE THE GUIDEWIRE COULD BE LOOSENED, CAUSING THE VALVE TO DISLODGE. PER THE PHYSICIAN, THE ISSUE WITH THE GUIDEWIRE CAUSED THE DISLODGE.

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

  MAUDE report 22754851 ↗
• MalfunctionJul 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE LOADING OF A TRANSCATHETER AORTIC VALVE, A CAPSULE TEAR APPEARED TO HAVE OCCURRED WHEN THE VALVE WAS BROUGHT INTO THE INFLOW CONE. SUBSEQUENTLY, WHEN LOADING WAS COMPLETED, THE TEAR WAS PROMINENTLY SEEN AND CONFIRMED. THE EXISTING VALVE THEN WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS) AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666743 ↗
• InjuryJul 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT WAS CONSIDERED TO BE AT HIGH-RISK FOR A CONDUCTION BLOCK DUE TO A MEMBRANOUS SEPTUM LENGTH OF 1.4 MILLIMETERS (MM). UPON DEPLOYMENT OF THE VALVE TO THE POINT OF NO RECAPTURE (PONR), A LEFT BUNDLE BRANCH BLOCK (LBBB) WAS OBSERVED. THE VALVE WAS FULLY DEPLOYED, HOWEVER, THE LBBB CONTINUED FOLLOWING THE IMPLANT OF THE VALVE. SUBSEQUENTLY, THE PATIENT LEFT THE PROCEDURE WITH TEMPORARY PACING INSERTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22636687 ↗
• MalfunctionJul 25, 2025Difficult or Delayed Positioning; Material Invagination; Device Dislodged or Dislocated; Positioning Problem; Difficult or Delayed Positioning; Material Invagination; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, A PRE-BALLOON DILATION WAS PERFORMED WITH A 23 MM BALLOON. THE VALVE WAS INITIALLY POSITIONED TOO HIGH AND REQUIRED PARTIAL RECAPTURE AND REPOSITIONING. UPON RECAPTURE, THE STIFF WIRE WAS MOVED, CAUSING THE VALVE TO DISLODGE UP AND NECESSITATE A FULL RECAPTURE. DURING THE SECOND DEPLOYMENT, AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED. A NEW VALVE WAS SUBSEQUENTLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612407 ↗
• MalfunctionJul 24, 2025Packaging Problem; No Apparent Adverse Event; Packaging Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT UPON OPENING THE DELIVERY CATHETER SYSTEM (DCS), THE DEVICE WAS CONTAMINATED. SUBSEQUENTLY, A NEW DCS WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588598 ↗
• MalfunctionJul 24, 2025Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING LOADING OF A TRANSCATHETER AORTIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS DIFFICULT TO LOAD. SPECIFICALLY, THE END CAPSULE CAUGHT ON THE VALVE METAL. ADDITIONALLY, THE CAPSULE BECAME WRINKLED AND WAS PUNCTURED. A NEW VALVE WAS LOADED INTO A NEW DCS AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588510 ↗
• MalfunctionJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A 34 MILLIMETER (MM) TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION WHICH WAS STANDARD FOR THE IMPLANTING PHYSICIAN. UPON 80% DEPLOYMENT, THE VALVE DISLODGED AORTIC AND WAS SUBSEQUENTLY RECAPTURED. UPON THE SECOND DEPLOYMENT ATTEMPT AT 80% DEPLOYMENT, AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A 29 MM TRANSCATHETER VALVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY AND BORDERLINE PRE-CASE MEASUREMENTS CONTRIBUTED TO THE INFOLD/DISLODGE. IT WAS NOTED THAT A 5 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD/DISLODGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544196 ↗
• MalfunctionJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A 29 MILLIMETER (MM) TRANSCATHETER VALVE IN A PATIENT WITH PRE-EXISTING SEVERE AORTIC INSUFFICIENCY AND NO LEAFLET CALCIFICATION, THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED 3 TIMES. PRIOR TO FINAL DEPLOYMENT ON EACH DEPLOYMENT ATTEMPT, THE VALVE DISLODGED. PRIOR TO VALVE DISLODGEMENT, THE IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) WAS 5 MM, AND THE IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC) WAS 6 MM. SUBSEQUENTLY, THE VALVE WAS WITHDRAWN FROM THE PATIENT AND WAS UPSIZED TO A 34 MM TRANSCATHETER VALVE. THE 34 MM VALVE WAS SUCCESSFULLY IMPLANTED AT AN IMPLANT DEPTH OF 5 MM ON THE NCC AND 8 MM ON THE LCC. PER THE PHYSICIAN, THE PATIENT'S ANATOMY AND AORTIC INSUFFICIENCY CAUSED THE VALVE TO DISLODGE. FOLLOWING THE IMPLANT PROCEDURE, THE INCORRECT VALVE SERIAL NUMBER WAS PROVIDED TO THE PATIENT ON THEIR IDENTIFICATION (ID) CARD, WITH TWO AORTIC VALVES REGISTERED TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BOTTOM OF PIGTAIL DEPLOYMENT STARTING POSITION WAS USED. THE VALVE DISLODGED IN THE AORTIC DIRECTION TO A DEPTH OF +5 MM ON THE NCC AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534129 ↗
• MalfunctionJul 11, 2025Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOP LASTY WAS PERFORMED DUE TO CALCIFICATION. FOLLOWING INITIAL DEPLOYMENT, THE VALVE WAS RECAPTURED AS THE VALVE WAS PLACED TOO SHALLOW AND IT DISLODGED IN THE AORTIC DIRECTION. UPON RECAPTURE, AN INFOLD WAS OBSERVED IN THE VALVE FRAME AT A DEPTH OF APPROXIMATELY 3 MM TO 5 MM. A SECOND DEPLOYMENT ATTEMPT WAS MADE, BUT THE VALVE WAS POSITIONED TOO DEEP. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM AND SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WAS A 5-MINUTE PROCEDURAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480824 ↗
• InjuryJul 7, 2025Difficult or Delayed Activation; Device Dislodged or Dislocated; Difficult or Delayed Activation; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THE FIRST VALVE, AT THE MOMENT OF FINAL RELEASE, THE VALVE DID NOT RELEASE CAUSING IT TO DISLODGE. SUBSEQUENTLY A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22425578 ↗
• MalfunctionJun 10, 2025Perivalvular Leak; Device Dislodged or Dislocated; No Apparent Adverse Event; Perivalvular Leak; Device Dislodged or Dislocated; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO A BICUSPID AORTIC VALVE. DURING THE DEPLOYMENT OF THE VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, AND A TRACE LEAK OCCURRED. APPROXIMATELY 16 DAYS FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, THE PATIENT WAS HOSPITALIZED AND AN ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH REVEALED THE VALVE HAD FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL) AND HAD MIGRATED, CAUSING SEVERE CIRCUMFERENTIAL AORTIC INSUFFICIENCY (AI). PER THE PHYSICIAN, THE DEPTH OF THE IMPLANT CONTRIBUTED TO THE EVENT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22177760 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE LOAD PROCEDURE WAS PERFORMED BY AN INDIV IDUAL IN TRAINING. THE VALVE LOAD WAS REVIEWED VIA VISUAL AND TACTILE INSPECTION WITH NO ISSUES NOTED. HOWEVER, UPON FLUOROSCOPIC INSPECTION A MISLOAD WAS IDENTIFIED AND DESCRIBED AS A FRAME NODE OVERLAP EXTENDING BEYOND THE FOURTH NODE OF THE VALVE FRAME. THE MIS LOADED VALVE WAS REMOVED FROM THE DELIVERY CATHETER SYSTEM (DCS) AND THE VALVE FRAME WAS VISUALLY INSPECTED. SUBSEQUENTLY, A NEW VALVE WAS LOADED INTO A NEW DCS AND IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS A PLANNED COMBINED TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) AND ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE FOR A PRE-EXISTING ABDOMINAL AORTIC ANEURYSM (AAA). FOLLOWING THE VALVE IMPLANT, PARAVALVULAR LEAK (PVL) WAS OBSERVED.

  Patient problems: Aneurysm

  MAUDE report 22118806 ↗
• MalfunctionMay 20, 2025Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A 29 MILLIMETER (MM) TRANSCATHETER VALVE, THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED 2 TIMES. DURING EACH DEPLOYMENT ATTEMPT, THE VALVE WAS DIFFICULT TO "LAND" AND THE VALVE APPEARED "UNSTABLE". SUBSEQUENTLY, THE SYSTEM WAS REMOVED FROM THE PATIENT AND A 34 MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE POSITIONING DIFFICULTIES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056136 ↗
• InjuryMay 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. HEART BLOCK WAS OBSERVED. THE VALVE AND DCS WERE WITHDRAWN FROM THE PATIENT AND THE CASE WAS ABORTED. PATIENT ANATOMY AND INADEQUATE DIAGNOSTIC COMPUTED TOMOGRAPHY SCANS WERE LISTED AS CONTRIBUTING FACTORS. A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21996045 ↗

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-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-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