Edwards SAPIEN 3 Ultra Transcatheter Heart Valve 9750TFX20Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00690103201314), received between Mar 11, 2021 and Jun 25, 2026 — classified as 9 deaths, 126 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (32 reports).

3 other recalls cover devices cleared under the same FDA submission (P140031); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 20MM SAPIEN 3 ULTRA VALVE IMPLANTED IN THE AORTIC POSITION FOR 3 YEARS AND 1 MONTH WAS EXPLANTED. A SURGICAL VALVED CONDUIT WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25630378 ↗
• MalfunctionApr 14, 2026Material Integrity Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 20 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE 20 MM SAPIEN 3 ULTRA VALVE WAS SHAPED LIKE A RHOMBUS PREVENTING THE OPERATOR FROM SEEING THE LUCENT LINE DURING VALVE DEPLOYMENT. THE VALVE WAS REMOVED TO CONFIRM VALVE ORIENTATION. A NEW VALVE AND COMMANDER DELIVERY SYSTEM WERE PREPPED AND SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION RECEIVED NOTED THAT CRIMPING WAS MOST LIKELY THE CAUSE OF THE MISSHAPEN VALVE AS THERE WAS NOT A NOTICEABLE AMOUNT OF PUSH FORCE THROUGH THE ESHEATH+. THE UNEVEN CRIMP PROFILE WAS DISCOVERED AFTER INSERTION INTO THE PATIENT. THE OPERATOR DID NOT LIKE HOW IT LOOKED UNDER FLUORO, HOWEVER IT WAS NOT NOTABLE WHEN CRIMPING. THE FCS CRIMPED THE VALVE PER THE IFU WITH NO NOTED ISSUES. THE SAME CRIMPER WAS USED FOR THE SECOND VALVE WITHOUT ISSUE. THERE WAS NO LOSS OF INTEGRITY TO THE SHEATH AND NO DAMAGE TO ANY OTHER DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875957 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY THAT A 20MM SAPIEN 3 ULTRA VALVE, IMPLANTED IN A NON-EW VALVE IN THE AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE YEAR. A NOTE FROM THE INITIAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE STATED "BRIDGE PROCEDURE FOR FUTURE SAVR". A SURGICAL VALVE WAS IMPLANTED AFTER EXPLANT OF THE SAPIEN 3 ULTRA VALVE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24824621 ↗
• InjuryMar 31, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 4 YEARS AND 11 MONTHS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 20MM SAPIEN 3 ULTRA VALVE THE VALVE FAILED DUE TO STENOSIS AND A VALVE IN VALVE WAS PERFORMED USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. THE GRADIENT WAS 35MMHG AND THE VALVE AREA/INDEX WAS 0.6CM^2. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24743274 ↗
• InjuryFeb 25, 2026Gradient Increase; Intravalvular regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS, 2 MONTHS, 24 POST TRANSCAVAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE, THE PATIENT PRESENTED SYNCOPAL DUE TO A FAILING VALVE. THE MODE OF FAILURE WAS UNKNOWN AT THE TIME OF REPORT. HOWEVER, PER MEDICAL RECORDS RECEIVED, TTE REPORT SHOWED A WELL-SEATED BIOPROSTHETIC AORTIC VALVE WITH A PEAK GRADIENT OF 63MMHG, AND A MEAN GRADIENT OF 40MMHG SUGGESTIVE FOR MODERATE TO SEVERE STENOSIS WITH MILD REGURGITATION. A VALVE IN VALVE PROCEDURE IS REQUIRED.

  Patient problems: Syncope/Fainting

  MAUDE report 24446553 ↗
• InjuryFeb 20, 2026Degraded; Patient-Device Incompatibility; Intravalvular regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 2 YEARS, 1 MONTH, AND 18 DAYS AFTER IMPLANTATION OF A 20 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION WITHIN A NON EDWARDS SURGICAL BIOPROSTHESIS, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND EVIDENCE OF ELEVATED GRADIENTS CONSISTENT WITH VALVE STENOSIS. A VALVE FRACTURE PROCEDURE WAS PERFORMED USING A 22 MM TRUE BALLOON. FOLLOWING THE FRACTURE, THE PATIENT DEVELOPED CENTRAL AORTIC REGURGITATION. A VALVE IN VALVE (VIV) TRANSCATHETER VALVE REPLACEMENT WAS SUBSEQUENTLY PERFORMED, WHICH RESOLVED THE REGURGITATION. THE PATIENT WAS DISCHARGED HOME IN IMPROVED CONDITION. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD UNDERLYING AORTIC STENOSIS AND HAD PREVIOUSLY RECEIVED A 23 MM SAPIEN 3 ULTRA VALVE INSIDE A 21 MM SURGICAL VALVE, RESULTING IN PATIENT'PROSTHESIS MISMATCH AND RECURRENT HYPOATTENUATED LEAFLET THICKENING (HALT). DURING THE CORRECTIVE PROCEDURE, THE PRIOR VIV CONSTRUCT WAS FRACTURED WITH A 22 MM TRUE BALLOON, WHICH LED TO MODERATE AORTIC INSUFFICIENCY AND DIFFICULTY REMOVING THE BALLOON THROUGH A PREVIOUSLY IMPLANTED ENDOGRAFT IN THE LEFT ILIAC ARTERY. ADDITIONAL VASCULAR INTERVENTIONS WERE REQUIRED,

  Patient problems: Dyspnea

  MAUDE report 24400214 ↗
• InjuryFeb 6, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 4 AND A HALF YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 20MM SAPIEN 3 ULTRA VALVE, IT WAS NOTED "THE VALVE HAS FAILED. PATIENT IS CURRENTLY IN OUR CCU [CRITICAL CARE UNIT]." PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT PRESENTED WITH PROGRESSIVE SYMPTOMS OF DYSPNEA ON EXERTION AND FATIGUE OVER 4 WEEKS, AND MYOCARDIAL INFARCTION. THE VALVE WAS NOTED TO EXHIBIT STENOSIS WITH INCREASED GRADIENTS. IT WAS NOTED THAT INTERVENTION IS "PENDING SAVR [SURGICAL AORTIC VALVE REPLACEMENT] WITH CT [CARDIOTHORACIC] SURGERY."

  Patient problems: Dyspnea

  MAUDE report 24279369 ↗
• InjuryFeb 3, 2026Gradient Increase

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 3 YEARS AND 6 MONTHS POST IMPLANTAITON OF A 20MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE VALVE WAS EXPLANTED. PATIENT WAS SYMPTOMATIC WITH DYSPNEA ON EXERTION AND MILD SUBSTERNAL CHEST PRESSURE. ECHO SHOWED SEVERE PROSTHETIC AORTIC VALVE STENOSIS WITH A MEAN GRADIENT OF 45MMHG ACROSS THE AORTIC VALVE.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 24247771 ↗
• InjuryJan 15, 2026Degraded; Insufficient Device Problem Information; Device Stenosis

  AS REPORTED THROUGH EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY 3 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA (S3U) VALVE IN A PRE-EXISTING SURGICAL VALVE, THE S3U VALVE WAS EXPLANTED DUE TO AN UNKNOWN CAUSE. A 21MM SURGICAL VALVE WAS IMPLANTED IN THE AORTIC POSITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24085385 ↗
• InjuryDec 24, 2025Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis; Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis

  PER MEDICAL RECORD REVIEW, APPROXIMATELY 2 YEARS AND 2 MONTHS LATER, THE VALVE WAS EXPLANTED DUE TO A LARGE PARAVALVULAR DEFECT NEAR THE LEFT NONCORONARY COMMISSURE CORRESPONDING TO AN AORTIC INSUFFICIENCY JET OBSERVED ON PREOPERATIVE TEE. INTRAOPERATIVE TEE NOTED MODERATE AORTIC VALVE STENOSIS WITH A MEAN GRADIENT OF 13 MMHG; AVA WAS NOT MEASURED. THE PATIENT UNDERWENT LEFT ATRIAL APPENDAGE OCCLUSION, ASCENDING AORTA REPLACEMENT FOR ANEURYSM, AND AORTIC VALVE REPLACEMENT FOLLOWING ROOT ENLARGEMENT TO ACCOMMODATE A 23 MM VALVE AND REINFORCE THINNING SUBANNULAR TISSUE IDENTIFIED AFTER CALCIUM DEBRIDEMENT. PATHOLOGY REVEALED PLIABLE LEAFLETS WITHOUT TEARS, VEGETATIONS, PERFORATIONS, OR CALCIFICATION, WITH ONLY MILD PANNUS FORMATION CONSIDERED NON-SIGNIFICANT.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23888145 ↗
• InjuryDec 19, 2025Gradient Increase; Gradient Increase

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 9750TFX 20MM SAPIEN 3 ULTRA VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR AND 3 MONTHS. PER THE MEDICAL RECORDS, THE PATIENT PRESENTED WITH ELEVATED PROSTHETIC GRADIENTS (MEAN 55MMHG) ON ECHO. UNDER GENERAL ANESTHESIA, THE PATIENT HAD AN AORTIC VALVE REPLACEMENT AND EXPLANT OF THE TAVR VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857089 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Device Stenosis; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A 20MM SAPIEN 3 ULTRA AORTIC VALVE IMPLANTED FOR APPROXIMATELY 5 YEARS AND 2 MONTHS WAS EXPLANTED DUE TO STENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 23780697 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 20MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION APPROXIMATELY 3 YEARS AND 10 MONTHS POST TAVR PROCEDURE. THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON AND REPLACED WITH AN EDWARDS SURGICAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23423092 ↗
• InjuryOct 28, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY THE CLINICAL SPECIALIST, DURING A TRANSFEMORAL PULMONIC PROCEDURE THE TEAM ATTEMPTED TO IMPLANT A 20MM SAPIEN 3 ULTRA VALVE (S3U) INTO THE PRE-EXISTING CONDUIT. POST IMPLANT THE VALVE EMBOLIZED INTO THE RIGHT VENTRICLE. THE PHYSICIANS RESCUED THE VALVE AND MANEUVERED IT INTO THE INFERIOR VENA CAVA (IVC) WHERE THEY USED ANOTHER STENT TO PIN IT IN THE VESSEL. A 23MM SAPIEN 3 ULTRA (S3U) VALVE WAS THEN SUCCESSFULLY IMPLANTED INTO THE MPA TARGET AREA WHERE THERE WERE ALREADY THREE PRIOR STENTS PLACED THAT DAY. THE ROOT CAUSE OF THE EMBOLIZATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405947 ↗
• InjuryOct 20, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 9750TFX 20MM SAPIEN 3 ULTRA VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF 5 MONTHS AND 22 DAYS DUE TO UNKNOWN REASONS. A 23MM EDWARDS SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343775 ↗
• InjurySep 15, 2025Degraded; Gradient Increase; Difficult to Open or Close; Degraded; Gradient Increase; Difficult to Open or Close

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 20MM SAPIEN 3 ULTRA AORTIC VALVE IMPLANTED FOR 3 YEARS AND 4 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE USING A NON-EDWARDS VALVE DUE TO HYPO ATTENUATED LEAFLET THICKENING (HALT), HYPO-ATTENUATION AFFECTING MOTION, AND INCREASED GRADIENTS. HALT WAS DESCRIBED AS INVOLVING > 75% OF THE RIGHT AND LEFT LEAFLETS AND THERE WAS MODERATE RESTRICTION OF MOTION INVOLVING THE RIGHT AND LEFT LEAFLETS. THE PATIENT HAD BEEN PLACED ON ELIQUIS AND APIXABAN, WHICH IMPROVED THE GRADIENT FROM 45 MMHG DOWN TO 30 MMHG; HOWEVER, THE MEDICATION PROVED TOO COSTLY FOR THE PATIENT. THE PATIENT BECAME SYMPTOMATIC WITH DYSPNEA, LOWER EXTREMITY EDEMA, AND HOSPITALIZATION. A CATH GRADIENT PROVED TO BE 60 MMHG ACROSS THE AORTIC VALVE WHICH WAS A COMBINATION OF LVOT OBSTRUCTION WITH MID CAVITY GRADIENT. THE PATIENT'S AORTIC VALVE AREA WAS NOTED AT 1.3 CM2.

  Patient problems: Dyspnea

  MAUDE report 23059571 ↗
• InjurySep 4, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 5 YEARS AND 1 MONTH AFTER IMPLANT OF A 20 MM SAPIEN 3 ULTRA VALVE VIA TRANSFEMORAL TAVR PROCEDURE, A VALVE IN VALVE PROCEDURE IS BEING PLANNED. THE PEAK GRADIENTS WERE 92.03 MMHG AND MEAN GRADIENTS WERE 62 MMHG. THE VALVE AREA INDEX WAS 0.49 CM2. THE LEAFLETS WERE NOTED TO BE THICKENED. PER MEDICAL RECORDS RECEIVED FOR THE PATIENT, ON THE FOLLOW UP VISIT POST TAVR THE PATIENT HAS HEART FAILURE NYHA CLASS 1 SYMPTOMS AND POSSIBLE SYNCOPE EPISODE OF UNKNOWN ETIOLOGY AND PRESERVED EJECTION FRACTION. THE PATIENT WAS FOUND TO HAVE SEVERE PROSTHETIC AORTIC STENOSIS. PER THE CARDIOLOGY CONSULT, THE "PATIENT NEEDS INTERVENTION FOR THE AORTIC VALVE." THE PATIENT IS BEING EVALUATED FOR TAVR OR SAVR.

  Patient problems: Insufficient Information

  MAUDE report 22966541 ↗
• InjuryAug 22, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 ULTRA VALVE, THE VALVE WAS EXPLANTED, AND A SURGICAL VALVE WAS IMPLANTED. THE CAUSE OF THE EXPLANT IS UNKNOWN.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22874701 ↗
• InjuryAug 17, 2025Device Stenosis; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 8 MONTHS POST-IMPLANT OF A 20 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED DUE TO STENOSIS. A VALVE A VALVE WAS SUCCESSFULLY PERFORMED. POST-VALVE DEPLOYMENT TEE MILD LEAK AND MEAN GRADIENT WAS 11 MMHG. A POST DILATION WAS PERFORMED WITH +1CC COMMANDER DELIVERY SYSTEM AND MG WAS 8 MMHG AND ZERO LEAK.

  Patient problems: Insufficient Information

  MAUDE report 22824194 ↗
• InjuryAug 14, 2025Degraded; Gradient Increase; Difficult to Open or Close; Intravalvular regurgitation; Degraded; Gradient Increase; Difficult to Open or Close; Intravalvular regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 4 YEARS AND 6 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA (S3U) VALVE IN THE NATIVE AORTIC POSITION, THE PATIENT PRESENTED WITH RECURRENT HEART FAILURE ADMISSIONS, DYSPNEA ON EXERTION, AND FATIGUE. THE S3U VALVE SHOWED MILD AORTIC INSUFFICIENCY, SEVERE PROSTHETIC AORTIC STENOSIS, A MEAN GRADIENT OF 36 TO 42MMHG, AND RESTRICTION OF MOBILITY WITH THICKNESS OF THE LEAFLETS. AS TREATMENT, THE PATIENT WAS PUT ON ELIQUIS FOR 3 MONTHS, BUT PER REPORT, THE VALVE IS STILL DEFICIENT. THE PHYSICIAN REQUESTED A PROCTOR REVIEW. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22810633 ↗
• DeathAug 12, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR, 4 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. AN EDWARDS SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22783822 ↗
• InjuryJul 28, 2025Calcified; Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 ULTRA (S3U) VALVE, THE PATIENT IS PRESENTING WITH ELEVATED GRADIENTS WITH NO SYMPTOMS. THE PHYSICIAN DETERMINED THAT THE INCREASED GRADIENT WAS DUE TO CALCIFICATION. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH THE 20 MM S3U VALVE INSIDE A 26 MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637609 ↗
• InjuryJul 18, 2025Thickening of Material; Device Stenosis; Thickening of Material; Device Stenosis

  AS REPORTED FROM FCS, APPROXIMATELY 4 YEARS AND 8 MONTHS POST TAV IN SAV WITH A 20MM SAPIEN ULTRA VALVE, A PROCTOR REVIEW HAS BEEN REQUESTED FOR PATIENT AS ECHO SHOWS STENOSIS. A REVIEW OF THE MEDICAL RECORDS CONFIRMED STENOSIS OF THE EWS BIOPROSTHETIC VALVE PREVIOUSLY IMPLANTED IN THE AORTIC POSITION WITHIN AN EXISTING VALVE. TTE FINDINGS INCLUDED AN AOV PEAK VEL OF 4.1 M/S, AVA (CONT EQ VTI) OF 0.6 CM', DI OF 0.23 & AVMG OF 39 MMHG. THE PATIENT PRESENTED WITH SYMPTOMS OF SYNCOPE. UPON FOLLOW UP, AN IMAGING REVIEW WAS PERFORMED AND THE CT SHOWS THAT THIS 20MM S3U IS UNDER EXPANDED. AT THE LEVEL OF THE SURGICAL VALVE, THE S3 MEASURES 17.5MM (0.5MM ADDED FOR OUTER DIAMETER). THE LEAFLETS SHOW HALT AT BOTH THE RCC AND NCC, AND COMMISSURAL THICKENING. THERE IS SOME EVIDENCE OF LCC THICKENING AS WELL. THE ECHO REPORT FROM 4/17/25 CONFIRMS STENOSIS WITH HIGH MEAN GRADIENT, HIGH VELOCITIES, SMALL AREA, AND LOW DIMENSIONLESS INDEX. BASED ON A CLINICAL RE-REVIEW OF THE INFORMATION PROVIDED (ECHO REPORT AND IMAGE REVIEW), INTERVENTION IS LIKELY DUE TO THE SEVERITY OF THE STENOSIS. UPON FOLLOW UP, THE VCC ADVISED THAT THE PATIENT IS CURRENTLY UNDERGOING RE-EVALUATION BY THE MEDICAL TEAM TO D

  Patient problems: Syncope/Fainting

  MAUDE report 22545797 ↗
• DeathJul 10, 2025Adverse Event Without Identified Device or Use Problem; Device Stenosis; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  AS REPORTED FROM PATIENT SUPPORT, ON THE SAME DAY FOLLOWING A TRANSFEMORAL AORTIC VALVE REPLACEMENT INVOLVING A 20MM SAPIEN 3 ULTRA VALVE IMPLANTED WITHIN A MECHANICAL VALVE, THE PATIENT PASSED AWAY. THE PATIENT PREVIOUSLY HAD AN AORTIC VALVE REPLACEMENT WITH THE PERIMOUNT MAGNA EASE 9 YEARS AND 6 MONTHS PRIOR AND WENT FOR A SCHEDULED VALVE-IN-VALVE TAVR WITH THE IMPLANTATION OF THE SAPIEN 3 ULTRA AT THE SAME HOSPITAL. AFTER THE PATIENT CAME OUT OF THE PROCEDURE AND WAS IN THE RECOVERY UNIT, THE PATIENT WENT ACUTELY UNRESPONSIVE AND WAS RUSHED TO THE OPERATING ROOM. PER THE CARE ADVOCATE, 'THEY WORKED ON HER FOR A WHILE BUT WERE UNABLE TO BRING HER BACK'. EVENTUALLY, THE PATIENT PASSED AWAY IN THE HOSPITAL THAT SAME DAY. AFTERWARDS, THE HEART TEAM TOLD THE CARE ADVOCATE THAT THEY BELIEVE 'A PIECE OF PLAQUE WAS DISLODGED FROM THE PRIOR VALVE AND CAUSED HER TO HAVE A HEART ATTACK'. ACCORDING TO PATIENT'S CERTIFICATE, CAUSE OF DEATH STATES 'LEFT MAIN CORONARY ARTERY OCCLUSION DUE TO SEVERE AORTIC STENOSIS'.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 22475067 ↗
• InjuryJun 27, 2025Fluid/Blood Leak; Perivalvular Leak; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Perivalvular Leak; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE THE INITIAL VALVE MIGRATED INTO THE LVOT DURING INFLATION. THE INITIAL CAUSE WAS THOUGHT TO BE UNRESOLVED FORWARD TENSION ON THE DELIVERY SYSTEM COMBINED WITH A RAPID INFLATION OF THE BALLOON. A SECOND VALVE WAS DEPLOYED IN 80/20 POSITION, ANCHORING THE FIRST VALVE AND RESOLVING ANY PVL/CENTRAL LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346711 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2019 · Jan 22, 2019 · Terminated
  Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS
• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive