Evolut™ FX D-EVOLUTFX-2329 (UDI 00763000942700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 216 adverse event reports that list this exact device (DI 00763000942700), received between Mar 13, 2025 and Sep 29, 2026 — classified as 25 deaths, 126 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (111 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 216 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Unintended Collision

  Patient problems: Foreign Body In Patient

  MAUDE report 50935813 ↗
• InjurySep 2, 2026Patient Device Interaction Problem

  It was reported that prior to the attempted implant of a transcatheter aortic valve, a pre-implant balloon aortic valvuloplasty was performed due to calcification. During the first deployment attempt, inside the patient's native annulus, the valve dislodged and subsequently was recaptured. During the second deployment attempt, the valve was deployed at the target implant depth of 4 millimeter¿s (mm) on the non-coronary cusp (NCC) and 4 mm on the left coronary cusp (LCC). Prior to withdrawing the delivery catheter system (DCS), the nose cone was centered within the frame inflow by slightly retracting the Medtronic guidewire. Following the implant of the valve, as the delivery catheter system (DCS) was withdrawn, the nose cone interacted with the outflow of the valve and subsequently the valve dislodged to the ascending aorta resulting in paravalvular leak (PVL). The dislodged valve was snared and a second system was used to cross the first valve. During the attempted implant of the second valve, an aortic dissection was observed during an aortic root shot. The patient was converted to open heart surgery, and the ascending aorta was repaired to address the dissection. The dislodged v

  Patient problems: Aortic dissection

  MAUDE report 50564533 ↗
• InjurySep 2, 2026Unintended Collision; Perivalvular Leak; Device Dislodged or Dislocated; Patient Device Interaction Problem

  Patient problems: Aortic dissection; Valvular Insufficiency/ Regurgitation

  MAUDE report 50564285 ↗
• MalfunctionSep 1, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550621 ↗
• MalfunctionAug 27, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  It was reported that during the attempted implant of a 29 millimeter (mm) transcatheter aortic valve, the valve would not stay in place. After 4 deployment attempts and recaptures it was decided to size up. The valve was replaced with a larger 34 mm valve. The 34 mm valve was loaded into a new delivery catheter system (DCS), and the valve held in place after 2 attempts. Per the physician, the patient's anatomy and valve size contributed to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476623 ↗
• MalfunctionAug 24, 2026Activation Failure

  It was reported that during the attempted implant of a transcatheter aortic valve, upon the first deployment attempt, the valve was unable to be deployed. Subsequently, the valve was recaptured into the delivery catheter system (DCS). Upon the second deployment attempt, the valve remained unable to be deployed. Subsequently, the valve was recaptured, and the system was withdrawn from the patient. A pre-implant balloon aortic valvuloplasty was performed, and a second valve was opened and used. Per the physician, the patient's heavily calcified anatomy contributed to the inability to fully deploy the valve. No patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410870 ↗
• InjuryAug 17, 2026Unintended Collision

  It was reported that following the successful implant of a transcatheter aortic valve, upon the attempted removal of the delivery catheter system (DCS), the nose cone caught on the frame of the valve, resulting in dislodgement. Subsequently, a second valve was implanted valve-in-valve.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278499 ↗
• MalfunctionAug 6, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163238 ↗
• InjuryAug 5, 2026Device Dislodged or Dislocated

  It was reported that during a non-Medtronic transcatheter valve revision procedure via the left femoral access, a balloon valvuloplasty of the non-Medtronic valve was first performed. The first Medtronic delivery catheter system (DCS) attempted to place the valve two times. However, the valve dislodged with both attempts. The DCS recaptured the valve, and this system was removed from the patient. A new valve was loaded onto a new DCS system. With the first two valve placement attempts of this new system, the valve was positioned low which required valve captures. On the third placement attempt the valve dislodged. This DCS system recaptured the valve, and this system was removed from the patient. Another new valve was loaded onto a new DCS system. Upon the first valve placement attempt with this new system, the valve dislodged. The valve was recaptured and then was successfully deployed and implanted. A balloon valvuloplasty was not performed between the new system uses. As reported, there were no patient symptoms or patient related complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145769 ↗
• InjuryAug 5, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  It was reported that during a non-Medtronic transcatheter valve revision procedure via the left femoral access, a balloon valvuloplasty of the non-Medtronic valve was first performed. The first Medtronic delivery catheter system (DCS) attempted to place the valve two times. However, the valve dislodged with both attempts. The DCS recaptured the valve, and this system was removed from the patient. A new valve was loaded onto a new DCS system. With the first two valve placement attempts of this new system, the valve was positioned low which required valve captures. On the third placement attempt the valve dislodged. This DCS system recaptured the valve, and this system was removed from the patient. Another new valve was loaded onto a new DCS system. Upon the first valve placement attempt with this new system, the valve dislodged. The valve was recaptured and then was successfully deployed and implanted. A balloon valvuloplasty was not performed between the new system uses. As reported, there were no patient symptoms or patient related complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145664 ↗
• DeathJul 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 MONTHS FOLLOWING IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE PATIENT DIED DUE TO EXSANGUINATION FROM THE RUPTURE OF A FEMORAL ARTERY PSEUDOANEURYSM. PER THE PHYSICIAN, THE PROCEDURE CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm; Ruptured Aneurysm

  MAUDE report 25842387 ↗
• InjuryJun 29, 2026Unintended Collision

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO A DIFFICULT ROOT ANGLE AND A TIGHT AORTIC VALVE. FOLLOWING THE SUCCESSFUL IMPLANT OF THE VALVE, UPON REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS), IT WAS NOTED THAT THE NOSE CONE OF THE DCS WAS NOT CENTERED IN THE FRAME OF THE VALVE. THE NOSE CONE SUBSEQUENTLY CAUGHT ON THE VALVE FRAME, RESULTING IN DISLODGEMENT OF THE VALVE INTO THE ASCENDING AORTA. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. A TWO HOUR PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659332 ↗
• MalfunctionMay 29, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED, DURING PREPARATION FOR THE ATTEMPTED IMPLANT OF THIS 29MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV) (R060870), IN A PATIENT WITH A TYPE 0 BICUSPID NATIVE VALVE, AFTER THE TAV WAS LOADED INTO THE DELIVERY CATHETER SYSTEM (DCS) (0013259439) BY AN INEXPERIENCED VALVE LOADER, THE VALVE LOAD WAS REVIEWED VIA FLUOROSCOPIC INSPECTION AND A MISLOAD WAS IDENTIFIED. THE MISLOAD WAS FURTHER CHARACTERIZED AS A BENT STRUT IN THE TAV FRAME WITH NO NODE INVOLVEMENT. THE TAV AND DCS WERE NOT USED FOR THE PROCEDURE. A PRE-IMPLANT BALLOON DILATION WAS PERFORMED AND A SECOND 29MM TAV (R267636) AND DCS (0013259439) WERE LOADED WITHOUT ISSUE. THE DCS WAS INSERTED INTO THE PATIENT¿S VASCULATURE AND ADVANCED TO THE AORTIC ANNULUS. THREE DEPLOYMENT ATTEMPTS WERE MADE; HOWEVER, THE TAV WOULD DISLODGE AND COULD NOT BE IMPLANTED. THE TAV WAS RECAPTURED INTO THE DCS. A DECISION TO ATTEMPT A SMALLER TAV WAS MADE; THEREFORE, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A THIRD, SMALLER 26MM TAV (R234758) WAS LOADED INTO A THIRD DCS (0013092710) WITHOUT ISSUE. THE DCS WAS INSERTED INTO THE PATIENT¿S VASCULATURE AND ADVANCED TO THE AORTIC ANNULUS; HOWEVER, THE TAV ALSO DISLODGED DURING THREE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331333 ↗
• MalfunctionMay 27, 2026Perivalvular Leak; Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, PARAVALVULAR LEAK (PVL) AND MITRAL VALVE (MV) INTERACTION WERE OBSERVED ON THE FIRST DEPLOYMENT ATTEMPT AS THE DELIVERY CATHETER SYSTEM (DCS) REPEATEDLY GOT "SUCKED DOWN VENTRICULARLY". 4-5 DEPLOYMENT ATTEMPTS AND SUBSEQUENT RECAPTURES WERE PERFORMED, HOWEVER THE VALVE WAS UNABLE TO GET TO A HIGH ENOUGH IMPLANT DEPTH TO RELIEVE THE PVL OR MV INTERACTION. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A NON-MEDTRONIC 23 MILLIMETER (MM) VALVE WAS IMPLANTED SUCCESSFULLY. PER THE PHYSICIAN, THE SUCTION PHENOMENON CAUSED BY THE USE OF THE CAROTID ARTERY AS THE ACCESS SITE, AND THE INABILITY TO CHANGE GUIDEWIRES TO A STIFF WIRE DUE TO THE PATIENT'S AORTIC INSUFFICIENCY CONTRIBUTED TO THE REPEATED DCS DISLODGEMENT. A 1 HOUR PROCEDURAL DELAY OCCURRED AS A RESULT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25306124 ↗
• InjuryMay 26, 2026Unintended Collision; Malposition of Device

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE PADDLE HOUSING OF THE DELIVERY CATHETER SYSTEM (DCS) CAUGHT ON THE OUTFLOW PORTION OF THE VALVE WHILE WITHDRAWING THE DCS, RESULTING IN DISLODGEMENT. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED IN THE NATIVE ANNULUS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 25278576 ↗
• MalfunctionMay 22, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE, AND THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. AFTER THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS RECAPTURED DUE TO THE VALVE MOVING AORTIC. PRIOR TO DISLODGEMENT, THE DEPTH ON THE NON-CORONARY CUSP (NCC) WAS 3 MM, AND THE IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC) WAS 1 MM. AFTER VALVE DISLODGEMENT, THE DEPTH WAS 4 MM ON THE NCC AND 5 MM ON THE LCC. AFTER THE SECOND AND THIRD DEPLOYMENT ATTEMPTS, THE VALVE WAS RECAPTURED DUE TO THE IMPLANT DEPTH BEING TOO SHALLOW ON THE LEFT CORONARY CUSP (LCC). PER THE PHYSICIAN, THE ANATOMICAL REPORT DID NOT PROVIDE INCORRECT VALVE SIZING RECOMMENDATIONS. IT WAS NOTED THAT THE PATIENT HAD PRE-EXISTING SUICIDE VENTRICLE AND THICKENED LEFT VENTRICLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257669 ↗
• DeathMay 14, 2026Difficult or Delayed Positioning; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, IT WAS DECIDED TO USE THE LEFT COMMON CAROTID ARTERY AS THE ACCESS SITE DUE TO TORTUOSITY IN THE ABDOMINAL AORTA. SUBSEQUENTLY, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A NON-MEDTRONIC 23 MILLIMETER (MM) BALLOON. UPON THE FIRST DEPLOYMENT ATTEMPT, IT WAS OBSERVED THAT THE POSITIONING OF THE VALVE WAS "CATASTROPHICALLY" DEEP. SUBSEQUENTLY, THE DEVICE WAS PULLED BACK INTO THE PATIENT'S ASCENDING AORTA TO INCREASE THE PATIENT'S BLOOD PRESSURE. LEVOPHED WAS ADMINISTERED, WITH NO INCREASE TO THE PATIENT'S BLOOD PRESSURE. IT WAS OBSERVED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT A CIRCUMFERENTIAL PERICARDIAL EFFUSION HAD OCCURRED, WITH HEMODYNAMIC CHANGES THAT CORRESPONDED TO CARDIAC TAMPONADE. CPR WAS INITIATED AND PERICARDIAL WINDOW WAS ATTEMPTED, HOWEVER THE EFFUSION AND BLOOD PRESSURE DID NOT IMPROVE AFTER 30 MINUTES, AND THE PATIENT ULTIMATELY DIED. AN ANNULAR RUPTURE WAS SUSPECTED, BUT WAS UNABLE TO BE CONFIRMED. PER THE PHYSICIAN, THE USE OF THE LEFT COMMON CAROTID ARTERY AS THE ACCESS SITE CONTRIBUTED TO THE EVENT. A 30 MINUTE PROCEDURAL DELAY OCCURRED AS A RESULT.

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

  MAUDE report 25176744 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED. AFTER COMPLETION OF THE PRE-IMPLANT BAV, THE PATIENT EXPERIENCED AORTIC REGURGITATION. DUE TO THE AORTIC REGURGITATION, THE TRANSCATHETER AORTIC VALVE WAS PREPARED AND DEPLOYED IN A FAST MANNER. HOWEVER, UPON INITIAL DEPLOYMENT, THE VALVE DEPTH WAS NOT "STABLE" DURING DEPLOYMENT. SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND REPOSITIONED BEFORE IT WAS FULLY IMPLANTED. AFTER IMPLANTATION OF THE VALVE, CONTRAST LEAKAGE INDICATING DISSECTION WAS NOTED NEAR THE SINOTUBULAR JUNCTION (STJ) DURING FINAL ANGIOGRAPHY. AN ECHOCARDIOGRAM WAS THEN OBTAINED AS WELL AS OTHER ASSESSMENTS, WHICH REVEALED THAT A TYPE A DISSECTION HAD OCCURRED. IN RESPONSE, THE PROCEDURE WAS CONVERTED TO SURGICAL REPAIR. THE TRANSCATHETER AORTIC VALVE WAS SURGICALLY EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED. ADDITIONALLY, ASCENDING AORTIC REPLACEMENT TOOK PLACE.

  Patient problems: Aortic dissection

  MAUDE report 25156649 ↗
• InjuryMay 6, 2026Unintended Collision

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE NATIVE AORTIC ANNULUS. DESPITE FOLLOWING TRAINING GUIDANCE FOR SLOW DEPLOYMENT OF THE VALVE AND CENTERING THE NOSECONE OF THE DCS BE RETRACTING THE GUIDEWIRE, THE NOSECONE OF THE DCS INTERACTED WITH THE MIDDLE OF THE VALVE FRAME. SUBSEQUENTLY, THE VALVE DISLODGED INTO THE ASCENDING AORTA ABOVE THE SINOTUBULAR JUNCTION (STJ). THE VALVE WAS THEN SNARED AND HELD IN PLACE AS A SECOND DCS AND VALVE WERE PREPARED. THE SECOND DCS WAS THEN INSERTED INTO THE PATIENT, AND THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED. A 30-MINUTE PROCEDURAL DELAY OCCURRED DUE TO THE VALVE DISLODGEMENT. PER THE PHYSICIAN, THE CAUSE OF DISLODGEMENT WAS THE NOSECONE OF THE DCS INTERACTING WITH THE VALVE FRAME.

  Patient problems: Foreign Body In Patient

  MAUDE report 25107091 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE SUCCESSFUL IMPLANT OF A TRANSCATHETER AORTIC VALVE, DURING REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS) FROM THE RIGHT FEMORAL ARTERY WITH A MINIMUM DIAMETER OF 6.7 MILLIMETERS (MM), A PERFORATION OCCURRED. SUBSEQUENTLY, A NON-MEDTRONIC COVERED STENT WAS PLACED.

  Patient problems: Perforation

  MAUDE report 25083566 ↗
• InjuryMay 1, 2026Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE USING A LEFT TRANS CAROTID APPROACH, RESISTANCE WAS FELT WHILE ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) TOWARDS THE AORTIC ARCH. BLEEDING WAS IDENTIFIED, AND A COMPLETE RUPTURE OF THE LEFT CAROTID ARTERY AS IDENTIFIED. SUBSEQUENTLY, THE DCS WAS WITHDRAWN FROM THE PATIENT, AND VASCULAR REPAIR WAS PERFORMED. SUBSEQUENTLY, A NEW VALVE AND DCS WERE OPENED AND LOADED, AND THE 14 FRENCH (FR) SENTRANT SHEATH WAS INSERTED INTO THE PATIENT. PRIOR TO ADVANCING THE DCS, THE OPERATOR WAS UNABLE TO WITHDRAW THE SHEATH. ROTATIONAL MANEUVERS AND INCREASED FORCE WERE ATTEMPTED, HOWEVER THE SHEATH REMAINED STUCK IN THE RIGHT ILIAC ARTERY. SUBSEQUENTLY, THE PROCEDURE WAS ABORTED DUE TO RISK OF ILIAC RUPTURE. IT WAS LATER IDENTIFIED THAT THE SHEATH HAD TORN UPON REMOVAL, AND AN EXTERNAL ILIAC ARTERY RUPTURE OCCURRED. A BALLOON WAS INFLATED IN THE AORTA TO MAINTAIN HEMODYNAMIC CONTROL, AND VASCULAR REPAIR WAS PERFORMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 25056197 ↗
• MalfunctionApr 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE, IN A PATIENT WITH A PREVIOUSLY IMPLANTED NON-MEDTRONIC T RANSCATHETER AORTIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED TO THE AORTIC ANNULUS. THE VALVE WAS THEN DEPLOYED THREE TIMES AND SUBSEQUENTLY RECAPTURED THREE TIMES DUE TO THE VALVE NOT STAYING IN THE INTENDED POSITION. SUBSEQUENTLY, THE DCS AND VALVE WERE REMOVED FROM THE PATIENT, AND A NON-MEDTRONIC VALVE WAS PREPARED AND THEN SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE PATIENT'S HORIZONTAL ROOT ANATOMY 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 24987888 ↗
• InjuryApr 20, 2026Unintended Collision

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CUSP OVERLAP TECHNIQUE WAS USED. THE VALVE WAS NOT INADVERTENTLY DEPLOYED TO AN UNINTENDED POSITION. PER THE PHYSICIAN, THERE WERE NO ADDITIONAL PROCEDURAL OBSERVATIONS, OR ANYTHING IN TERMS OF PATIENT ANATOMY THAT CONTRIBUTED TO THE DISLODGEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24933331 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE PRE-IMPLANT BAV AND BEFORE THE AORTIC DISSECTION WAS IDENTIFIED, THE FIRST DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO PATIENT; HOWEVER, THE DCS WAS UNABLE TO CROSS THE AORTIC VALVE. SUBSEQUENTLY, THE DCS WAS WITHDRAWN FROM THE PATIENT, AND THE PRE-IMPLANT BAV WAS PERFORMED TO HELP STEER THE DCS THROUGH THE VALVE. A DECISION WAS MADE TO USE A NEW VALVE AND NEW DCS DUE TO THE DIFFICULTY CROSSING THE VALVE, AND THE AMOUNT OF PRESSURE THAT WAS BEING APPLIED TO THE SYSTEM. PER THE PHYSICIAN, BOTH DCS AND BOTH VALVES DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION AS THE DISSECTION OCCURRED AFTER THE PRE-IMPLANT BAV.

  Patient problems: Aortic dissection

  MAUDE report 24928001 ↗
• InjuryApr 20, 2026Failure to Advance; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE PRE-IMPLANT BAV AND BEFORE THE AORTIC DISSECTION WAS IDENTIFIED, THE FIRST DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO PATIENT; HOWEVER, THE DCS WAS UNABLE TO CROSS THE AORTIC VALVE. SUBSEQUENTLY, THE DCS WAS WITHDRAWN FROM THE PATIENT, AND THE PRE-IMPLANT BAV WAS PERFORMED TO HELP STEER THE DCS THROUGH THE VALVE. A DECISION WAS MADE TO USE A NEW VALVE AND NEW DCS DUE TO THE DIFFICULTY CROSSING THE VALVE, AND THE AMOUNT OF PRESSURE THAT WAS BEING APPLIED TO THE SYSTEM. PER THE PHYSICIAN, BOTH DCS AND BOTH VALVES DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION AS THE DISSECTION OCCURRED AFTER THE PRE-IMPLANT BAV.

  Patient problems: Aortic dissection

  MAUDE report 24927373 ↗

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-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-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