SAPIEN 3 Ultra RESILIA 9755RSL23Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 00690103215809), received between Feb 27, 2023 and Jun 15, 2026 — classified as 20 deaths, 171 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (45 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 202 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. APPROXIMATELY 1 YEAR AND 8 MONTHS LATER, THE PATIENT UNDERWENT A VALVE IN VALVE (VIV) WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE THE PRE-EXISTING 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO PARAVALVULAR LEAK.

  Patient problems: Insufficient Information

  MAUDE report 25505831 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY APPROXIMATELY 3 MONTHS POST TAVR WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN A PRE-EXISTING EDWARDS SURGICAL VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25350041 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 11 MONTHS, 19 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE CAUSE OF THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25237002 ↗
• DeathMay 13, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 11 MONTHS POST TAVR THE PATIENT PASSED AWAY. THERE IS NO DEATH/DISCHARGE SUMMARY OR CAUSE OF DEATH AVAILABLE IN PATIENT'S CHART REVIEW. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 63-YEAR-OLD FEMALE WITH SIGNIFICANT COMORBIDITIES INCLUDING END-STAGE RENAL DISEASE ON HEMODIALYSIS, SEVERE PROSTHETIC AORTIC STENOSIS STATUS POST TRANSCATHETER AORTIC VALVE REPLACEMENT, CONGESTIVE HEART FAILURE, TYPE 2 DIABETES MELLITUS, PAROXYSMAL ATRIAL FIBRILLATION NOT ANTICOAGULATED DUE TO PRIOR GASTROINTESTINAL BLEEDING, AND CHRONIC GASTROINTESTINAL PATHOLOGY WITH COLOSTOMY, WHO UNDERWENT IMPLANTATION OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION ON (B)(6) 2025. THE PATIENT WAS ADMITTED ON (B)(6) 2026 FOR HYPOTENSION AND ALTERED MENTAL STATUS FOLLOWING DIALYSIS AND WAS FOUND TO BE IN SEPTIC SHOCK WITH LACTIC ACIDOSIS REQUIRING VASOPRESSOR SUPPORT AND INTENSIVE CARE UNIT MANAGEMENT. INFECTIOUS EVALUATION DEMONSTRATED LEUKOCYTOSIS, ELEVATED LACTATE, POSITIVE RESPIRATORY SYNCYTIAL VIRUS POLYMERASE CHAIN REACTION, LEFT LOWER LOBE INFILTRATE, AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS POLYMERASE CHAIN REA

  Patient problems: Septic Shock

  MAUDE report 25162298 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY PATIENT SUPPORT CENTER (PSC), PSC RECEIVED A CALL FROM A CARE ADVOCATE REPORTING THAT THE PATIENT EXPIRED APPROXIMATELY MORE THAN SIX WEEKS FOLLOWING THE TAVR PROCEDURE. THE PATIENT UNDERWENT TAVR WITH A SAPIEN 3 ULTRA RESILIA VALVE AT MEDICAL CITY FORT WORTH APPROXIMATELY 8 MONTHS AND 17 DAYS. PER REPORT, THE PATIENT EXPERIENCED AN INTRA-PROCEDURAL STROKE AND WAS DISCHARGED THE FOLLOWING DAY TO A REHABILITATION FACILITY IN (B)(6). THE PATIENT REPORTEDLY DID NOT FULLY RECOVER AND DEVELOPED COMPLICATIONS, INCLUDING ASPIRATION PNEUMONIA. THE PATIENT WAS TRANSITIONED TO HOSPICE CARE AT A PRIVATE RESIDENCE AND SUBSEQUENTLY EXPIRED. ACCORDING TO THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS LISTED AS CEREBROVASCULAR DISEASE, ATRIAL FIBRILLATION, AND HYPERTENSION.

  Patient problems: Stroke/CVA

  MAUDE report 25156421 ↗
• InjuryMay 11, 2026Fluid/Blood Leak; Malposition of Device

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE FIRST 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED 100/0 AND RESULTED IN MODERATE PVL AROUND THE NCC WHERE A LARGE CALCIUM NODULE WAS PRESENT. THE ADDITIONAL 2 CC OF VOLUME CAUSE MORE FORESHORTENING THAN ANTICIPATED. A SECOND 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED INSIDE THE FIRST VALVE SUCCESSFULLY. PATIENT WAS ALIVE AT END OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137389 ↗
• InjuryMay 4, 2026Migration or Expulsion of Device; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT TRANSFEMORAL MITRAL VALVE REPLACEMENT WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN SEVERE NATIVE MITRAL ANNULAR CALCIFICATION (MAC). AS REPORTED, THE FIRST 23MM S3UR VALVE WAS IMPLANTED WITH +2CC. THE PATIENT UNDERWENT BASE TO TIP LAMPOON SO THERE WAS CONCERN OF LVOT OBSTRUCTION. THE 1ST VALVE BEGAN TO MIGRATE ATRIAL. THE TEAM RE-BALLOONED WITH DELIVERY AT +4CC. THE TEAM THEN PREPPED 2ND 23MM S3UR VALVE DUE TO THE INITIAL VALVE HAVING A MILD TO MODERATE PARAVALVULAR LEAK SINCE IT MIGRATED ATRIAL. THE TEAM FELT THE LEAK WAS BETWEEN THE VALVE FRAME AND THE LACERATION FROM THE BASE TO TIP LAMPOON. THE 2ND VALVE WAS IMPLANTED WITH +2CC. A MILD PARAVALVULAR LEAK AT AREA OF LEAFLET MODIFICATION WAS NOTED. THE MITRAL PEAK GRADIENT OF 3 AND NO CHANGE IN LVOT FLOW ACCELERATION. ANNULAR HEMATOMA AT THE AORTOMITRAL CURTAIN WAS NOTED. THE SURGEON STATED THAT THE BASE TO TIP LAMPOON WAS POTENTIALLY TOO DEEP IN THE BASE AND MAY HAVE CREATED THE HEMATOMA OR WHEN THE ADDITIONAL VOLUME WAS ADDED TO KEEP THE VALVE FROM EMBOLIZING THE BASE LACERATION STRETCHED OR INCREASED CAUSING THE DAMAGE. THE TEAM DID NOT TREAT

  Patient problems: Hematoma; Insufficient Information

  MAUDE report 25075134 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT WITH A COMPLEX CONGENITAL AND SURGICAL CARDIAC HISTORY, UNDERWENT TRANSFEMORAL TRANSCATHETER PULMONARY VALVE REPLACEMENT OF A 25MM PULMONARY HOMOGRAFT WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. AS REPORTED, THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA AND SHORTNESS OF BREATH WITHOUT CHEST PAIN. PRE-PROCEDURE ECHOCARDIOGRAPHY DEMONSTRATED SEVERE PULMONIC STENOSIS WITH A PEAK GRADIENT OF 81MMHG AND MEAN GRADIENT OF 32.5MMHG, WITH TRIVIAL PULMONIC REGURGITATION. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA WITH RIGHT FEMORAL VENOUS ACCESS. BASELINE CATHETERIZATION DEMONSTRATED A 40MMHG GRADIENT ACROSS THE PULMONIC VALVE. CORONARY ANGIOGRAPHY CONFIRMED PATENCY OF THE LEFT CORONARY ARTERY, AND A WIRE WAS LEFT IN THE LCA FOR PROTECTION. SERIAL BALLOON ANGIOPLASTY OF THE RIGHT VENTRICULAR OUTFLOW TRACT WAS PERFORMED, FOLLOWED BY PLACEMENT OF A COVERED GARMOR STENT, WHICH WAS POST-DILATED TO A FINAL DIAMETER OF 22MM. THE 23MM SAPIEN 3 ULTRA RESILIA VALVE VALVE WAS DEPLOYED AT NOMINAL VOLUME WITH AN INITIALLY SATISFACTORY RESULT. APPROXIMATELY THREE MINUTES FOLLOWING VALVE DEPLOYMENT, THE PATIENT DEVELOPE

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 25022679 ↗
• InjuryApr 27, 2026Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT TRANSFEMORAL TAVR WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. 2 MONTHS AND 18 DAYS POST TAVR, THE PATIENT PRESENTED WITH MILD TO MODERATE PARAVALVULAR LEAK (PVL) WITH HEMOLYSIS OF 23 MM S3UR. THE TEAM PERFORMED A BAV WITH 23 COMMANDER DELIVERY SYSTEM AT NOMINAL VOLUME PLUS 2.5 ML. THE PVL WAS NOT PRESENT AFTER THE SECOND INFLATION VIA TTE. THE PATIENT'S FINAL OUTCOME WAS DISCHARGED HOME SAME DAY. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY EDWARDS DEVICES WERE DEFICIENT IN SOME WAY. PER THE FIELD CLINICAL SPECIALIST, THE ROOT CAUSE OF THE PVL WAS THAT THE INFLATING PHYSICIAN DID NOT DELIVER THE FULL VOLUME DUE TO USE ERROR AT THE TIME OF THE INDEX PROCEDURE.

  Patient problems: Hemolysis

  MAUDE report 25001620 ↗
• InjuryApr 24, 2026Insufficient Device Problem Information

  AS REPORTED BY EDWARDS IMPLANT PATIENT REGISTRY (IPR), THE PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE IN WHICH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED IN THE NATIVE AORTIC POSITION. APPROXIMATELY ELEVEN (11) MONTHS AND SEVENTEEN (17) DAYS POST TAVR PROCEDURE, IPR RECEIVED INFORMATION REGARDING A SECOND IMPLANT INDICATING THAT THE PATIENT UNDERWENT A TAVR PROCEDURE AT A DIFFERENT HOSPITAL WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IMPLANTED IN THE AORTIC POSITION. PER THE FIELD CLINICAL SPECIALIST (FCS) CASE NOTES, THE VALVE WAS IMPLANTED IN THE NATIVE AORTIC POSITION. MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAS KNOWN CORONARY DISEASE AND EXPERIENCED ANGINAL QUALITY SYMPTOMS EARLY LAST YEAR, WHICH LED TO CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE MID LEFT ANTERIOR DESCENDING (LAD). PER THE CARDIOLOGIST, THE PATIENT'S "AORTIC VALVE SHOWS SEVERE NARROWING OR STENOSIS. DUE TO THE FACT THAT THE STENOSIS HAS PROGRESSED IN THE PAST 2.5 YEARS FROM MILD TO MODERATE, NOW SEVERE", THE PATIENT WAS REFERRED TO THE VALVE CLINIC FOR EVALUATION. MORE RE

  Patient problems: Insufficient Information

  MAUDE report 24988558 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY (IPR) WHILE DOING A POSITION VERIFICATION ON A SURGICAL DEVICE, THE FCS NOTED THAT 1-DAY POST-IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 23 MM SAPIEN 3 ULTRA RESILIA VALVE WAS EXPLANTED. THE REASON FOR EXPLANT IS UNKNOWN. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT PRESENTED FOR PLANNED TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR SEVERE SYMPTOMATIC AORTIC STENOSIS AND MILD AORTIC INSUFFICIENCY. AFTER THE VALVE WAS DEPLOYED TO NOMINAL INFLATION, A TEE REVEALED MILD PARAVALVULAR LEAK (PVL). IT WAS NOTED THE VALVE LANDED HIGH ABOUT 95/5 AORTIC/VENTRICULAR LIKELY DUE TO A LITTLE BIT OF WATERMELON SEEDING OF THE BALLOON AND PUSH FROM A VERY THICKENED LEFT VENTRICULAR (LV) OUTFLOW TRACT WHICH WAS NOTED TO BE SOMEWHAT UNAVOIDABLE. THE DECISION WAS MADE NOT TO INTERVENE ON THE VALVE AS THE ADDITIONAL FORESHORTENING COULD HAVE CAUSED VALVE EMBOLIZATION. THE PATIENT'S AORTIC INSUFFICIENCY IMPROVED FROM MODERATE TO TRACE/MILD. THE PATIENT ALSO DEVELOPED MILD FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK WHICH IMPROVED BY THE END OF THE PROCEDURE. THERE WERE NO IMMEDIATE COMPLICATIONS DURING THE CASE. THE PATIENT TOLER

  Patient problems: Insufficient Information

  MAUDE report 24873040 ↗
• InjuryApr 9, 2026Calcified

  AS REPORTED TO THE IMPLANT PATIENT REGISTRY (IPR), 1 YEAR, 3 MONTHS, AND 12 DAYS POST-IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 23 MM SAPIEN 3 ULTRA VALVE REQUIRED INTERVENTION DUE TO CALCIFICATION AND A VALVE IN VALVE PROCEDURE (VIV) WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE MEDICAL RECORDS, AN ECHO WAS PERFORMED THAT SHOWED EJECTION FRACTION (EF) 60-65%, SEVERE AORTIC STENOSIS, AORTIC VALVE AREA VELOCITY TIME INTEGRAL (AVA VTI) 0.74CM^2, MEAN GRADIENT OF 38.5MMHG, NO REGURGITATION, AND THE LEAFLETS WERE SEVERELY CALCIFIED. THE PATIENT WAS ADMITTED FOR THE VIV. THE VALVE WAS SUCCESSFULLY DEPLOYED UNDER RAPID PACING, USING SINGLE INFLATION AND NO APPARENT COMPLICATIONS. THE POST VIV ECHO SHOWED A WELL-SEATED 26MM SAPIEN 3 IN THE AORTIC POSITION, WITH A MEAN GRADIENT OF 3MMHG, AND TRIVIAL PERIVALVULAR LEAK. THE PATIENT WAS DISCHARGED HOME ON POST OP DAY 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830939 ↗
• InjuryApr 7, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 8 MONTHS POST-IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED DUE TO SEVERE PARAVALVULAR LEAK (PVL). STARTING ECHO GRADIENT DURING PROCEDURE WAS 17MMHG. A 23MM DELIVERY SYSTEM WAS USED AND POST-DILATED WITH AN ADDITIONAL 2CC AT 8ATM; HOWEVER, THE VALVE CONTINUED TO EXHIBIT SIGNIFICANT PARAVALVULAR LEAK WITH AN ECHO-DERIVED MEAN GRADIENT OF 9MMHG. THE TEAM THEN DEPLOYED A 26MM S3UR VALVE WITH AN ADDITIONAL 1CC AT 10ATM AND PERFORMED POST-DILATION USING A 24MM TRUE BALLOON. FINAL MEASUREMENTS SHOWED AN INVASIVE GRADIENT OF 3MMHG AND AN ECHOCARDIOGRAPHIC MEAN GRADIENT OF 6MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808601 ↗
• InjuryApr 6, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY APPROXIMATELY 2 YEARS AND 7 MONTHS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24792915 ↗
• InjuryApr 3, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 2 YEARS, 10 MONTHS, 7 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE PRESENTED ELEVATED GRADIENT AND SEVERE AORTIC STENOSIS. THE PEAK GRADIENTS WERE 48.27 MMHG AND PEAK VELOCITY 4.97 M/S. THE PATIENT IS BEING WORKED UP FOR A VALVE IN VALVE PROCEDURE. ACCORDING TO THE MEDICAL RECORD A TEE PERFORMED APPROXIMATELY 2 YEARS AND 8 MONTHS POST IMPLANT NOTED SEVERE AORTIC STENOSIS WITH A MEAN GRADIENT OF 48.27MMHG, PEAK GRADIENT OF 98.86MMHG AND AN AVA OF 0.75CM2. TRIVIAL REGURGITATION WAS ALSO OBSERVED. THE EVALUATION WAS PERFORMED POST-WATCHMAN PROCEDURE. THE PATIENT DID REPORT EXPERIENCING SEVERE FATIGUE AND SHORTNESS OF BREATH. AFTER REVIEW OF THE MEDICAL RECORD, THE RECOMMENDATION IS TO UPDATE THE CODE FOR POST IMPLANTATION STENOSIS. OUTCOME 1 TO BE UPDATED TO DYSPNEA. OUTCOME 2 CODE TO REMAIN UNCHANGED.

  Patient problems: Dyspnea

  MAUDE report 24782315 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR AND 6 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 24735612 ↗
• InjuryMar 30, 2026Migration or Expulsion of Device; Malposition of Device

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS UNINTENTIONALLY DEPLOYED 60:40 AORTIC/VENTRICLE POSITION AND AN ATTEMPT WAS MADE TO POST DILATATE DUE TO MINIMAL UNDER-EXPANSION. FOLLOWING POST DILATION, IT WAS OBSERVED THAT THE VALVE HAD MIGRATED TOWARD THE VENTRICLE. A SECOND VALVE WAS PREPARED, AND AN ATTEMPT WAS MADE TO DEPLOY THIS VALVE JUST ABOVE THE PREVIOUSLY IMPLANTED VALVE TO PREVENT FURTHER MIGRATION. DURING ADVANCEMENT OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM NOSECONE DISLODGED THE FIRST VALVE, RESULTING IN MIGRATION OF THE VALVE INTO THE LEFT VENTRICLE. A 22 MM BALLOON WAS ADVANCED WITHIN THE MIGRATED VALVE AND INFLATED, AND AN ATTEMPT WAS MADE TO PULL THE VALVE BACK INTO THE ANNULUS; HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE SECOND VALVE WAS NEVER DEPLOYED, AS IT WAS SAFELY REMOVED WITH THE DELIVERY SYSTEM. A DECISION WAS THEN MADE TO PROCEED WITH AN OPEN SURGICAL PROCEDURE TO RESCUE THE EMBOLIZED VALVE AND IMPLANT A SURGICAL VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED TO BE INTUBATED FOLLOWING THE I

  Patient problems: Foreign Body Embolism

  MAUDE report 24716751 ↗
• InjuryMar 26, 2026Migration or Expulsion of Device; Perivalvular Leak

  AS REPORTED BY PATIENT SUPPORT, APPROXIMATELY 2 WEEKS POST TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE, A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) IDENTIFIED A PARAVALVULAR LEAK AROUND THE VALVE, WHICH ORIGINATED AROUND THE VALVE FRAME. THE PATIENT IS EXPERIENCING INCREASED FATIGUE WITH MINIMAL EXERTION. ACCORDING TO THE MEDICAL RECORD, AN ECHOCARDIOGRAM PERFORMED APPROXIMATELY ONE MONTH FOLLOWING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE NOTED A MEAN GRADIENT OF 14 MMHG, MILD TO MODERATE PARAVALVULAR LEAK (PVL), AND A VALVE AREA OF 1.45 CM2. THE PATIENT WAS ADVISED TO FOLLOW UP WITH A CARDIOLOGIST FOR A ONE-YEAR EVALUATION AND TO REMAIN ON ASPIRIN THERAPY. IT WAS NOTED THAT THE PATIENT DECLINED MOST MEDICATIONS AND PREFERRED NATURAL SUPPLEMENTS, INCLUDING REFUSAL OF STATIN AND ANTIHYPERTENSIVE THERAPIES. THE PATIENT WAS SUBSEQUENTLY SEEN IN CONSULTATION WITH OUTPATIENT STRUCTURAL HEART DISEASE FOR FOLLOW-UP AND REPORTED DYSPNEA ON EXERTION AND WORSENING FATIGUE. LABORATORY STUDIES SHOWED NO EVIDENCE OF HEMOLYSIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED WITH ANESTHESIA IDENTIFIED TWO JETS OF PVL ORIGINATING FROM

  Patient problems: Dyspnea; Fatigue

  MAUDE report 24701513 ↗
• InjuryMar 26, 2026Malposition of Device

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE, DURING INFLATION THERE WAS TOO MUCH FORWARD PRESSURE ON COMMANDER SYSTEM AND ADVANCED THE VALVE VENTRICULAR RESULTING IN A FINAL POSITION OF 50/50. THE PERCEIVED ROOT CAUSE OF THE VALVE MOVEMENT WAS REPORTED TO BE EXCESSIVE FORWARD PRESSURE APPLIED TO THE COMMANDER DELIVERY SYSTEM. DUE TO THE SUBOPTIMAL POSITION OF THE FIRST VALVE, A SECOND VALVE WAS IMPLANTED SUCCESSFULLY, WHILE THE FIRST VALVE REMAINED IN SITU. DURING DEPLOYMENT OF THE SECOND VALVE, A BALLOON RUPTURE OF THE SECOND COMMANDER DELIVERY SYSTEM WAS OBSERVED AND POST DILATED WITH A 22MM NON-EDWARDS BALLOON. DESPITE THIS ADDITIONAL EVENT, THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24700209 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information; Device Stenosis

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 4 MONTHS POST-TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED. BASED ON THE MEDICAL RECORD REVIEW, IT WAS NOTED THE PATIENT UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM APPROXIMATELY 4 MONTHS POST IMPLANT TO EVALUATE FOR HYPO-ATTENUATING LEAFLET THICKENING (HALT). RESULTS OF THE EXAM NOTED PEAK/MEAN GRADIENTS OF 47.9/24.5 MMHG, AND AN AVA OF 0.98 CM2. BIOPROSTHETIC LEAFLETS ARE NOT WELL VISUALIZED. THERE IS CONCERN THAT THE VALVE IS CONSTRAINED BY THE PREVIOUSLY PLACED SURGICAL VALVE. NO OBVIOUS HYPOATTENUATING LEAFLET THROMBOSIS. APPROXIMATELY 4 MONTHS AND 13 DAYS POST IMPLANT THE PATIENT WAS SEEN FOR A CARDIAC SURGERY CONSULTATION. THE ASSESSMENT NOTED SEVERE AORTIC VALVE STENOSIS. ONE MONTH LATER, THE PATIENT UNDERWENT EXPLANTATION OF THE SURGICAL AND TAVR VALVES AND IMPLANTATION OF A 21 MM INSPIRIS RESILIA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24650850 ↗
• MalfunctionMar 19, 2026Material Deformation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE, A BENT TINE WAS OBSERVED ON THE NC SIDE OF THE THV BEFORE DEPLOYMENT. IMPLANTER CHOSE TO SLOWLY DEPLOY AND THE TINE MOSTLY STRAIGHTENED OUT AND DEPLOYMENT/IMPLANT WAS A SUCCESS. IT WAS SUGGESTED THAT THE CRIMPED VALVE INTERACTED WITH THE PIGTAIL CATHETER. THE SHEATH AND DELIVERY SYSTEM WERE REMOVED AS A SINGLE UNIT. PER ADDITIONAL INFORMATION PROVIDED BY THE FCS, THERE WERE DIFFICULTIES DURING THE CRIMPING PHASE. THE PATIENT HAD MILD TORTUOSITY, AND MILD CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643607 ↗
• InjuryMar 19, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 1 MONTH POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 ULTRA RESILIA (S3UR) IMPLANTED THE PATIENT PRESENTED WITH MODERATE PVL AND SYMPTOMATIC HEMOLYSIS. IT WAS BELIEVED THE INDEX VALVE WAS NOT DELIVERED WITH IT'S FULL INTENDED VOLUME, INDEX PROCEDURAL TTE WAS NON-DIAGNOSTIC. THE PHYSICIAN ATTEMPTED TO RESOLVE PVL WITH A BAV UTILIZING COMMANDER. FIRST +1.5 CC'S, THEN 2.5 CC'S, THEN 3 CC'S WERE ADDED TO THE DELIVERY SYSTEM. MILD TO MODERATE PVL REMAINED SO THE DECISION WAS MADE TO PUT A SECOND VALVE IN. A SECOND 23MM S3U WAS IMPLANTED AT 70/30 WITH 2 ADDITIONAL CC'S TO RESOLVE THE PVL. TRACE CENTRAL WAS OBSERVED AT PROCEDURAL END WITH TEE. IMPLANTER CONSIDERED THIS A PROCEDURAL SUCCESS. UPON FOLLOW UP, THE FCS ADVISED THAT THE PHYSICIAN WHO DEPLOYED THE VALVE STRUGGLES TO GET ALL THE VOLUME IN SOMETIMES. IT WAS BELIEVED THIS WAS THE CAUSE OF THE VALVE BEING UNDER EXPANDED, BUT IS NOT CONFIRMED.

  Patient problems: Hemolytic Anemia

  MAUDE report 24639083 ↗
• InjuryMar 17, 2026Migration or Expulsion of Device

  PER THE FIELD CLINICAL SPECIALIST, DURING TRANSCATHETER MITRAL VALVE REPLACEMENT VALVE DEPLOYMENT USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE IMPLANTED INSIDE A PRE-EXISTING SURGICAL VALVE, THE SAPIEN VALVE MIGRATED VENTRICULARLY AND FULLY EMBOLIZED INTO THE LEFT VENTRICLE DURING MID-INFLATION. THE SAFARI WIRE REMAINED IN PLACE. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL VALVE REPLACEMENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PERCEIVED ROOT CAUSE WAS ATTRIBUTED TO A POSITIONING ISSUE BY THE IMPLANTER.

  Patient problems: Insufficient Information

  MAUDE report 24617135 ↗
• InjuryMar 16, 2026Fluid/Blood Leak; Migration

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIAMTELY 1 YEAR AND 1 MONTH POST IMPLANTATION OF A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, PATIENT CAME IN URGENTLY WITH SEVERE PVL. TWO PLUGS AND POST DILATION WAS PERFORMED. NO LEAK POST INTERVENTIONS. VALVE WAS UNDERSIZED AND IN A LOW POSITION. PER CINE, THE INITIAL IMPLANT DID NOT APPEAR TO BE POSITIONED AS LOW AS THE CURRENT POSITION THE VALVE, INDICATING THAT VALVE MIGRATION LIKELY OCCURRED. PATIENT SYMPTOMS NOT PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24606443 ↗
• InjuryMar 13, 2026Degraded; Perivalvular Leak; Malposition of Device; Difficult to Open or Close

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 11 MONTHS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE VALVE FAILED DUE TO PARAVALVULAR LEAK (PVL). THE PATIENT IS BEING EVALUATED FOR INTERVENTION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) 11 MONTHS POST PROCEDURE REPORTED: THERE IS A 23MM SAPIEN 3 ULTRA RESILIA AORTIC VALVE WITH MODERATE PARAVALVULAR AORTIC INSUFFICIENCY, MEAN GRADIENT 18 MMHG, PEAK GRADIENT 42 MMHG. PROCTOR REVIEW STATED, THE TEE SHOWS SEVERE PVL EXTENDING ANTERIORLY FROM MEDIAL TO LATERAL. THERE IS THICKENING OF THE ANTERIOR LEAFLET. THE CT SHOWS THAT THIS 23MM VALVE IS UNDER-EXPANDED AT THE WAIST MEASURING 20.9MM (0.5MM ADDED FOR OUTER DIAMETER). ALSO, THIS VALVE IS SITTING 50% IN THE LV AND 50% IN THE AORTA, AND THERE IS PROBABLY NO SKIRT COVERAGE AT THIS LEVEL. THIS WOULD BE THE CAUSE OF THIS SIGNIFICANT PVL. THERE IS NO EVIDENCE SEEN OF VALVE THROMBOSIS ON CT OR TEE. HYPO ATTENUATED LEAFLET THICKENING (HALT) WAS IDENTIFIED ON THE RIGHT FACING CUSP. ON ECHO THE RIGHT CUSP DID NOT MOVE AS WELL AS THE OTHER TWO. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED: EJECTION FRACTION= 55-60%. AORTIC VALVE S3 ULTRA 23 MM VALVE WITH

  Patient problems: Insufficient Information

  MAUDE report 24598328 ↗

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