Evolut™ FX D-EVOLUTFX-2329 (UDI 00763000365677)Recalls & reported problems

Summary

The FDA's MAUDE database contains 555 adverse event reports that list this exact device (DI 00763000365677), received between Aug 30, 2022 and Jul 30, 2026 — classified as 79 deaths, 270 injuries, 206 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (263 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 555 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Failure to Advance; Patient Device Interaction Problem

  Additional information was received indicating that the injury occurred during insertion and advancement. It was reported that the non-Medtronic sheath was passed through the stenosed/dissected area and that the delivery catheter system (DCS) never passed though it. Dissection was not confirmed. Per the physician, the cause of the injury was unknown. It was noted that the minimum diameter of the access vessel was 5 millimeter (mm) x 6mm.

  Patient problems: Vascular Dissection

  MAUDE report 50077991 ↗
• MalfunctionApr 22, 2026Device Difficult to Setup or Prepare; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED DUE TO THE PATIENT HAVING A BICUSPID AORTIC VALVE. A FLUOROSCOPIC INSPECTION OF THE 29-MILLIMETER (MM) VALVE WAS THEN COMPLETED AFTER LOADING. THIS FLUOROSCOPIC INSPECTION REVEALED THAT A FRAME NODE OVERLAP HAD OCCURRED EXCEEDING THE FOURTH NODE. SUBSEQUENTLY, A NEW 29 MM VALVE WAS PREPARED AND LOADED INTO THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS THEN INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN DEPLOYED AND SUBSEQUENTLY RECAPTURED 3 TIMES DUE TO MOVEMENT DURING DEPLOYMENT TOWARDS THE PATIENT'S VENTRICLE. AFTER THE THIRD RECAPTURE, THE VALVE AND DCS WERE REMOVED FROM THE PATIENT'S BODY. AT REQUEST OF THE ATTENDING PHYSICIAN, A 34 MM VALVE WAS THEN PREPARED, HOWEVER, THE PHYSICIAN THEN CHANGED THEIR MIND AND DECIDED TO MAKE A THIRD ATTEMPT AGAIN WITH A 29 MM VALVE. IN RESPONSE, A NEW 29 MM TRANSCATHETER VALVE WAS PREPARED AND THEN WAS SUCCESSFULLY IMPLANTED AFTER TWO ATTEMPTS. IT WAS NOTED THAT PRIOR TO THE SUCCESSFUL IMPLANT ATTEMPT, THE ATTENDING PHYSICIAN DECIDED TO WAIT FOR 5 MINUTES TO ALLOW THE VAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955668 ↗
• DeathMar 19, 2026Perivalvular Leak; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Patient Device Interaction Problem

  INFORMATION WAS OMITTED FROM THE INITIAL EVENT NARRATIVE INDICATING THAT FOLLOWING THE IMPLANT OF THE SECOND VALVE, THE VALVE WAS CONFIRMED TO BE PROPERLY IMPLANTED AND OTHER COMPLICATIONS WERE RULED OUT BY ECHOCARDIOGRAM AND ANGIOGRAPHY. ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE 29 MM VALVE, 34 MM VALVE AND FIRST DCS DID NOT CAUSE OR CONTRIBUTE TO THE CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Valvular Insufficiency/ Regurgitation

  MAUDE report 24639258 ↗
• InjuryMar 9, 2026Material Separation; Difficult to Advance; Device Dislodged or Dislocated; Patient Device Interaction Problem

  LITERATURE WAS REVIEWED REGARDING A PATIENT WHO UNDERWENT TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH A MEDTRONIC EVOLUT FX SYSTEM (29 MM SIZE VALVE). THE AUTHORS NOTED, ¿FLUOROSCOPY CONFIRMED OPTIMAL BIOPROSTHESIS LOADING AND FLUOROSCOPIC GAP BETWEEN THE CAPSULE AND NOSE CONE (OF THE EVOLUT FX DELIVERY SYSTEM).¿ DURING THE TAVI PROCEDURE, A PRE-IMPLANT DILATION WAS PERFORMED WITH A 22 MM BALLOON, FOLLOWED BY THE FIRST VALVE DEPLOYMENT ATTEMPT, WHICH WAS TOO SHALLOW AND RESULTED IN A DISLODGEMENT WHILE THE VALVE WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THEN, DURING FULL RECAPTURE OF THE EVOLUT FX VALVE, THE OPERATORS PERFORMED OVER-RECAPTURE. THE EVOLUT FX SYSTEM WAS THEN ADVANCED ACROSS THE NATIVE VALVE WITH MILD RESISTANCE. ANGIOGRAPHY AT THE TIME SHOWED AN ¿ABNORMALLY SHARP AORTIC SILHOUETTE.¿ THEN THE VALVE WAS DEPLOYED. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT HEMIPARESIS. COMPUTED TOMOGRAPHY REVEALED AN AORTIC DISSECTION WITH AN ENTRY TEAR AT THE NON-CORONARY SINUS OF VALSALVA, EXTENDING INTO THE BRACHIOCEPHALIC AND DESCENDING AORTA. THE AUTHORS INCLUDED THE FOLLOWING CAUSAL EVALUATION OF THE DISSECTION IN THE ARTICLE: ¿AS THE D ISSECTION OCCURRED B

  Patient problems: Aortic dissection; Ischemia Stroke; Obstruction/Occlusion; Paresis; Thrombosis/Thrombus

  MAUDE report 24551551 ↗
• MalfunctionJan 27, 2026Gradient Increase; Perivalvular Leak; Malposition of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS FIRST COMPLETED DUE TO THE PATIENT'S CALCIFIED ANATOMY. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE THEN ADVANCED INTO THE PATIENT'S BODY THROUGH THE LEFT SUBCLAVIAN ARTERY. THE VALVE WAS THEN POSITIONED AND PARTIALLY DEPLOYED IN THAT IT WAS POSITIONED "EXTREMELY DEEP" IN RELATION TO THE LEFT CORONARY CUSP (LCC) AND 3 MILLIMETER'S (MM) FROM THE NON-CORONARY CUSP (NCC). DUE TO SUBOPTIMAL POSITIONING, THE VALVE WAS THEN RECAPTURED. AFTER TWO MORE DEPLOYMENT ATTEMPTS THAT RESULTED IN RECAPTURE DUE TO SUBOPTIMAL POSITIONING, THE VALVE AND DCS WERE WITHDRAWN FROM THE PATIENT'S BODY. SUBSEQUENTLY, A NEW VALVE AND DCS WERE PREPARED, AND THE PHYSICIAN OPTED TO USE A NON-MEDTRONIC GUIDEWIRE, IN HOPES OF ACHIEVING A MORE COAXIAL DEPLOYMENT OF THE VALVE. UPON DEPLOYMENT OF THE VALVE, IT WAS POSITIONED 10 TO 12 MM FROM THE LCC AND 2 TO 3 MM FROM THE NCC. RESULTINGLY, TRACE PARAVALVULAR LEAK (PVL) WAS OBSERVED AS WELL AS A VALVULAR GRADIENT OF 10 MILLIMETERS OF MERCURY (MM HG). PER THE PHYSICIAN, THE PATIENT'S ROTATED HEART CONTRIBUTED TO THIS EVENT IN ADDITION

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions; Transvalvular Pressure Gradient Increased

  MAUDE report 24190402 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE RIGHT FEMORAL ARTERY WAS USED AS THE ACCESS SITE, WITH A MINIMUM DIAMETER OF 7 MILLIMETERS (MM). UPON ADVANCEMENT OF THE DELIVERY CATHETER SYSTEM (DCS), A PERFORATION OCCURRED AT THE ACCESS SITE. SUBSEQUENTLY, THE SYSTEM WAS REMOVED, AND A COMMON ILIAC TO FEMORAL BYPASS GRAFT WAS PERFORMED. IT WAS NOTED THAT A 3 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: Perforation of Vessels

  MAUDE report 24189564 ↗
• MalfunctionJan 21, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEDTRONIC GUIDEWIRE (CONFIDA) DID NOT CONTRIBUTE TO THE VALVE DISLODGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132291 ↗
• InjuryJan 12, 2026Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, WHEN THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED, A RIGHT FEMORAL ARTERY ACCESS SITE PERFORATION OCCURRED. A STENT WAS PLACED. THE MINIMUM ACCESS DIAMETER WAS 4.6 MM. PER THE PHYSICIAN; THE PERFORATION WAS RELATED TO THE DCS AND PROCEDURE. THE PATIENT¿S CALCIFIED ANATOMY WAS A CONTRIBUTING FACTOR TO THE EVENT. FOLLOWING THE PROCEDURE, A BOWEL OBSTRUCTION DEVELOPED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A GENERAL SURGERY CONSULT AND CORRECTIVE SURGERY WAS PERFORMED.

  Patient problems: Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 24035616 ↗
• DeathJan 8, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER VALVE, UPON WITHDRAWING THE WIRE, THE VALVE WAS PULLED AND DISLODGED. A SNARE WAS USED TO STABILIZE THE DISLODGED VALVE IN THE ASCENDING AORTA, AND A SECOND VALVE WAS IMPLANTED. IMMEDIATELY AFTER THE IMPLANT OF THE SECOND VALVE, HYPOTENSION AND BRADYCARDIA WERE OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED A LARGE PERICARDIAL EFFUSION. SUBSEQUENTLY, RESUSCITATION WAS PERFORMED, INCLUDING CARDIAC MASSAGE, TEMPORARY PACING, AND PERICARDIAL DRAINAGE. EMERGENCY SURGERY WAS PERFORMED VIA LEFT ANTERIOR THORACOTOMY IN THE APICAL AREA. AT THE END OF THE PROCEDURE, BLEEDING HAD CEASED AND THE PATIENT WAS HEMODYNAMICALLY STABLE. APPROXIMATELY 5 HOURS FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT DIED. THE PHYSICIAN ASSESSED THAT DURING THE IMPLANT OF THE SECOND VALVE, THE MEDTRONIC (CONFIDA) GUIDEWIRE CAUSED A LEFT VENTRICLE PERFORATION THAT RESULTED IN TAMPONADE AND SUBSEQUENT DEATH. PER THE PHYSICIAN, THE EVENT WAS A PROCEDURE RELATED COMPLICATION, WITH NO CLAIMS AGAINST THE VALVE OR DELIVERY CATHETER SYSTEM (DCS). ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS NOT PERFORMED AND A

  Patient problems: Bradycardia; Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24006153 ↗
• InjuryJan 7, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS FULLY DEPLOYED IN THE PATIENT'S NATIVE ANNULUS. DESPITE FOLLOWING TRAINING GUIDANCE FOR SLOW DEPLOYMENT OF THE VALVE, THE DCS STRUCK A TAB ON THE INNER CURVE OF THE VALVE AS IT BEING RETRACTED. SUBSEQUENTLY, THE VALVE DISLODGED INTO THE PATIENT'S ASCENDING AORTA. AN AORTIC DISSECTION WAS THEN NOTED, SO THE PROCEDURE WAS ABORTED AND TRANSITIONED TO AN OPEN-HEART SURGERY. DURING THE OPEN-HEART SURGERY, THE TRANSCATHETER VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED. ADDITIONALLY, AN AORTIC ARCH GRAFT WAS SUCCESSFULLY PLACED. A 1 HOUR PROCEDURAL DELAYOCCURRED DUE TO THE VALVE DISLODGE AND AORTIC DISSECTION. A NON-MEDTRONIC (SAFARI EXTRA SMALL) GUIDEWIRE WAS UTILIZED FOR THE ATTEMPTED PROCEDURE. PER THE PHYSICIAN, THE NOSECONE OF THE DCS CAUSED THE VALVE TO DISLODGE AFTER IT PULLED ON A TAB OF THE VALVE LOCATED ON THE INNER CURVE.

  Patient problems: Aortic dissection

  MAUDE report 23995988 ↗
• InjuryJan 5, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE WORSENING RESPIRATORY CONDITION WAS UNKNOWN; HOWEVER, THERE WAS NO CAUSAL RELATIONSHIP TO THE VALVE. THE CAUSE OF DEATH WAS SEPSIS. PER THE PHYSICIAN, THE VALVE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. PER THE PHYSICIAN, THE DISSECTION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Aortic dissection; Back pain

  MAUDE report 23964543 ↗
• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, UPON ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) OVER THE MEDTRONIC GUIDEWIRE, RESISTANCE WAS OBSERVED IN THE MIDDLE OF THE DEVICE. SUBSEQUENTLY, A NEW DCS WAS USED. THERE WAS NO RESISTANCE WAS OBSERVED WHEN ADVANCING THE NEW DCS OVER THE GUIDEWIRE, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897059 ↗
• DeathDec 9, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A LEFT VENTRICLE PERFORATION OCCURRED. THE VALVE WAS NOT IMPLANTED. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR SURGERY. THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. THE PHYSICIAN INDICATED THAT THE PROCEDURE CONTRIBUTED TO THE DEATH.

  Patient problems: Cardiac Perforation; Perforation of Vessels

  MAUDE report 23760981 ↗
• InjuryDec 3, 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, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO CROSS THE RIGHT AXILLARY ACCESS SITE. IT WAS NOTED THAT THE MINIMUM DIAMETER OF THE ACCESS VESSEL WAS 6 MILLIMETERS (MM). DILATION WAS PERFORMED USING A 16 FRENCH (FR) AND 18 FR DILATOR; HOWEVER, THE DCS WAS STILL UNABLE TO ADVANCE. A 14 FR NON-MEDTRONIC INTRODUCER SHEATH WAS INSERTED. UPON REMOVAL OF THE DCS, A KINK WAS OBSERVED ON THE DISTAL END PROXIMAL TO THE CAPSULE OF THE DCS. THEREFORE, A NEW VALVE WAS LOADED INTO A NEW DCS, AND THE NEW DCS WAS SUCCESSFULLY ADVANCED THROUGH THE NON-MEDTRONIC SHEATH. THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED TWO TIMES. UPON 80% DEPLOYMENT OF EACH DEPLOYMENT ATTEMPT, THE POSITION OF THE VALVE WAS UNABLE TO BE CORRECTED. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED. UPON REMOVING THE NON-MEDTRONIC SYSTEM, A DISSECTION WAS NOTED AT THE RIGHT AXILLARY ACCESS SITE. SUBSEQUENTLY, A STENT WAS PLACED TO ADDRESS THE DISSECTION. PER THE PHYSICIAN, THE PATIENT'S ANATOMY AND IMPLANT PROCEDURE CONTRIBUTED TO THE DISSECTION. IT WAS NOTED THAT A 2 HOUR PR OCEDURAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 23709818 ↗
• DeathDec 2, 2025Difficult to Insert; Deformation Due to Compressive Stress; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Difficult to Insert; Deformation Due to Compressive Stress; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT HAD AN ILIAC VESSEL DIAMETER OF 5.1 MILLIMETERS (MM) WITH SEVERE CALCIFICATION, AND INSERTION OF THE 14 FRENCH (FR) NON-MEDTRONIC INTRODUCER SHEATH WAS DIFFICULT. UPON ATTEMPTING TO EXCHANGE THE SHEATH FOR THE DELIVERY CATHETER SYSTEM (DCS), THE SHEATH WAS UNABLE TO ADVANCE. AN ATTEMPT WAS MADE TO ADVANCE ONLY THE SHEATH; HOWEVER, THE SHEATH WAS STILL UNABLE TO ADVANCE. AFTER SEVERAL ATTEMPTS TO ADVANCE THE DCS, THE WIRE LUMEN BECAME "OCCLUDED" AND A KINK IN THE CAPSULE WAS NOTED. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. THE SAME VALVE WAS LOADED INTO A NEW DCS, AND DILATION WAS PERFORMED USING A 6 MM BALLOON. A DIFFERENT NON-MEDTRONIC INTRODUCER SHEATH WAS INSERTED AND THE DCS WAS ADVANCED THROUGH THE SHEATH. SUBSEQUENTLY, THE VALVE WAS IMPLANTED WITHOUT RECAPTURE. UPON WITHDRAWING THE DCS, THE DCS WAS UNABLE TO BE PULLED INTO THE INTRODUCER SHEATH. THEREFORE, THE SHEATH WAS REMOVED WITH THE DCS. A 14 FR NON-MEDTRONIC SHEATH WAS INSERTED, AND CONTRAST IMAGING WAS PERFORMED THAT REVEALED SIGNIFICANT BLEEDING IN THE ILIAC ARTERY. HEMOSTASIS WAS PERFORMED WITH A BALLOON FROM THE SAME SIDE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23698048 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Fracture; Packaging Problem; Fluid/Blood Leak; Fracture; Packaging Problem

  IT WAS REPORTED THAT THE D-EVOLUTFX-2329 SYSTEM¿S PACKAGING WAS FRACTURED AND, DURING PREPARATION, SALINE LEAKED FROM THE DEVICE ONTO THE TABLE SEVERAL TIMES WHEN FILLING IT WITH SALINE SOLUTION FOR VALVE ASSEMBLY. A DIFFERENT DELIVERY CATHETER SYSTEM (DCS) WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS A CRACK IN THE DCS WHICH CAUSED THE SALINE TO LEAK. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THE CRACK WAS NOT IN THE DCS BUT WAS IN THE PLASTIC PACKAGING OF THE DCS WHICH IS USED FOR SYSTEM PREPARATION. THE CRACK WAS NOT VISIBLE BUT SALINE SOLUTION WAS LEAKING WHICH PREVENTED THE SYSTEM FROM BEING ASSEMBLED. FOR SAFETY REASONS, IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541632 ↗
• DeathNov 12, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20 MILLIMETER (MM) NON-MEDTRONIC BALLOON IN AN ATTEMPT TO "FRACK" THE PREVIOUSLY IMPLANTED SURGICAL AORTIC VALVE. DURING THE PROCEDURE, PERICARDIAL EFFUSION WAS OBSERVED, AND THE CAUSE WAS UNKNOWN. THE VALVE WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE PATIENT BECAME HYPOTENSIVE AND COULD NOT BE RESUSCITATED. IT WAS NOTED THAT THE PATIENT HAD A POSTERIOR EFFUSION WHICH WAS DETERMINED TO BE TOO HIGH RISK TO TREAT DUE TO THE PATIENT'S FRAILTY AND PREVIOUS RE-DO STERNOTOMY. SUBSEQUENTLY, THE PATIENT DIED. PER THE PHYSICIAN, PERICARDIAL EFFUSION WAS THE CAUSE OF DEATH. IT WAS NOTED THAT THE PATIENT WAS DEEMED HIGH RISK FOR CORONARY OCCLUSION; THEREFORE, LEAFLET MODIFICATION WAS ATTEMPTED PRE-OPERATIVELY BUT UNSUCCESSFUL. IN RESULT, CORONARY STENTS WERE PLACED IN THE PATIENTS LEFT CORONARY ARTERY (LCA) AND RIGHT CORONARY ARTERY (RCA), WHICH WERE REPORTED AS CONTRIBUTING FACTORS TO THE EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23532822 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, IMAGING OF THE RIGHT LEG REVEALED AN OCCLUSION FROM THE COMMON ILIAC ARTERY (CIA) TO THE EXTERNAL ILIAC ARTERY (EIA). SUBSEQUENTLY, ENDOVASCULAR THERAPY (EVT) WAS PERFORMED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23526311 ↗
• InjuryOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT SIDE WAS USED AS THE ACCESS SITE FOR THE DCS. PER THE PHYSICIAN, THE DCS WAS TOO LARGE FOR THE ACCESS VESSEL, AND THERE WAS A "SNAG" AT THE CURVED SECTION WHICH CAUSED THE RUPTURE. ADDITIONALLY, IT WAS REPORTED THAT THE NON-MEDTRONIC INTRODUCER SHEATH AND NON-MEDTRONIC GUIDEWIRE CONTRIBUTED TO THE RUPTURE. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY THAT CONTRIBUTED TO THE RUPTURE AS WELL.

  Patient problems: Rupture

  MAUDE report 23405230 ↗
• InjuryOct 28, 2025Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION. FOLLOWING IMPLANT OF THE VALVE IN THE PATIENT¿S NATIVE ANNULUS, UPON WITHDRAWING THE DELIVERY CATHETER SYSTEM (DCS), THE NOSECONE CAUGHT ON THE OUTFLOW OF THE VALVE DESPITE THE NOSECONE OF THE DCS BEING CENTERED WHILE RETRACTING THE DCS THROUGH THE VALVE INFLOW. SUBSEQUENTLY, THE VALVE DISLODGED, RESULTING IN A FINAL VALVE IMPLANT DEPTH OF -5 MILLIMETER'S (MM) ON THE NON-CORONARY CUSP (NCC) AND 0 MM'S ON THE LEFT CORONARY CUSP (LCC). IT WAS NOTED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE. TRACE PARAVALVULAR LEAK (PVL) WAS OBSERVED IN THE VALVE, AS WELL AS A GRADIENT OF 8 MILLIMETERS OF MERCURY (MM HG). AS A RESULT, THE PATIENT WAS MONITORED IN THE HOSPITAL, AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 23402274 ↗
• InjuryOct 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, WHICH WAS STANDARD FOR THE IMPLANTING PHYSICIAN. DURING INSERTION OF THE DELIVERY CATHETER SYSTEM (DCS) THROUGH THE RIGHT FEMORAL ARTERY, DIFFICULTY INSERTING AND ADVANCING THE DCS OCCURRED. SUBSEQUENTLY, A MATERIAL PROTRUSION WAS OBSERVED. IT WAS NOTED THAT THE MINIMUM DIAMETER OF THE VESSEL WAS 5 MILLIMETER¿S (MM). THE DCS WAS WITHDRAWN FROM THE PATIENT OVER THE GUIDEWIRE. A NEW VALVE AND DCS WERE PREPARED. WHILE ADVANCING THE DCS THROUGH THE RIGHT FEMORAL ARTERY, AN ILIAC RUPTURE WAS IDENTIFIED. SUBSEQUENTLY, SURGICAL REPAIR OF THE VESSEL WAS PERFORMED. PER THE PHYSICIAN, THE CAUSE OF THE ILIAC RUPTURE WAS DUE TO THE PATIENT'S ILIAC DISEASE.

  Patient problems: Rupture

  MAUDE report 23367162 ↗
• InjuryOct 23, 2025Difficult to Advance; Material Protrusion/Extrusion; Patient Device Interaction Problem; Difficult to Advance; Material Protrusion/Extrusion; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, WHICH WAS STANDARD FOR THE IMPLANTING PHYSICIAN. DURING INSERTION OF THE DELIVERY CATHETER SYSTEM (DCS) THROUGH THE RIGHT FEMORAL ARTERY, DIFFICULTY INSERTING AND ADVANCING THE DCS OCCURRED. SUBSEQUENTLY, A MATERIAL PROTRUSION WAS OBSERVED. IT WAS NOTED THAT THE MINIMUM DIAMETER OF THE VESSEL WAS 5 MILLIMETER¿S (MM). THE DCS WAS WITHDRAWN FROM THE PATIENT OVER THE GUIDEWIRE. A NEW VALVE AND DCS WERE PREPARED. WHILE ADVANCING THE DCS THROUGH THE RIGHT FEMORAL ARTERY, AN ILIAC RUPTURE WAS IDENTIFIED. SUBSEQUENTLY, SURGICAL REPAIR OF THE VESSEL WAS PERFORMED. PER THE PHYSICIAN, THE CAUSE OF THE ILIAC RUPTURE WAS DUE TO THE PATIENTS ILIAC DISEASE.

  Patient problems: Rupture

  MAUDE report 23367148 ↗
• InjuryOct 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT OF A TRANSCATHETER VALVE, A HEMATOMA AND HEMORRHAGING WERE OBSERVED AT THE ACCESS SITE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEFT FEMORAL ARTERY WAS USED AS A SECONDARY ACCESS SITE WITH A MINIMUM DIAMETER OF 6.0 MM. THE PRIMARY ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. A SHEATH-IN-SHEATH WITH AN 18 FR SHEATH STRATEGY WAS USED AT THE PRIMARY ACCESS SITE. A PRE-IMPLANT BALLOON DILATION WAS PERFORMED USING A 20 MM BALLOON. FOLLOWING FULL RELEASE OF THE VALVE, MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. A POST IMPLANT BALLOON DILATION WAS PERFORMED USING A 20 MM BALLOON TO RESOLVE THE PVL. THE HEMORRHAGE WAS OBSERVED A FEW DAYS AFTER THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE HEMORRHAGE WAS A PSEUDOANEURYSM FORMED DUE TO THE 5 FR NON-MEDTRONIC SHEATH. PER THE PHYSICIAN, THE GUIDEWIRE AND DELIVERY CATHETER SYSTEM DID NOT CONTRIBUTE TO THE HEMORRHAGE. IT IS UNKNOWN WHETHER ANATOMY WAS A CONTRIBUTING FACTOR. THE HEMORRHAGE WAS STOPPED USING THROMBIN. THE PATIENT WAS LATER DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23360079 ↗
• MalfunctionOct 15, 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 A 29 MILLIMETER (MM) TRANSCATHETER VALVE IN A PATIENT WITH AN ANNULUS MEASURING 79 MM TO 80 MM, THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED 3 TIMES; HOWEVER, THE VALVE WOULD NOT STAY IN PLACE. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A 34 MM TRANSCATHETER VALVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S ANNULUS SIZE CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291904 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED 23 MILLIMETER (MM) SURGICAL AORTIC VALVE, THE PATIENT BECAME HYPOTENSIVE AND REQUIRED TREATMENT. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE, AND A REDO SURGICAL AORTIC VALVE REPLACEMENT WITH CORONARY ARTERY BYPASS GRAFT (CABG) WERE PERFORMED. PER THE PHYSICIAN, THE PATIENT'S SIGNIFICANT CORONARY ARTERY DISEASE (CAD) AND DEPTH OF IMPLANT CONTRIBUTED TO THE HYPOTENSION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23278973 ↗

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