SAPIEN 3 Ultra RESILIA 9755RSL29Recalls & reported problems

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 00690103215823), received between Jan 12, 2023 and Sep 3, 2026 — classified as 35 deaths, 232 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (94 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 321 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Perivalvular Leak

  As reported by the Field Clinical Specialist (FCS), during off label implant of a 29 mm Sapien 3 Ultra Resilia valve in the MAC position, the team started with a 16f eSheath+ in the right femoral vein. There was a problem crossing the septum when the 29mm Commander Delivery System (DS) with the valve were inserted. The team decided to pull the DS and 16f eSheath+ as one unit. The first valve was wasted. Another 29mm DS and 29mm Sapien 3 Ultra Resilia were prepped. This time though, the team decided to use a 26f Gore Dry Seal Sheath to deliver the valve. It was able to successfully cross the septum with valve. The valve was deployed with nominal volume. Post dilatation was performed with +3cc. The team decided to do another post dilation but the DS was not able to go through the Gore Dry Seal Sheath, so another 29mm DS was prepped for post dilatation with +5cc. The operator also asked to attach an Atrion inflation device to the System for Pressure Monitoring. The post dilatation was successful with Mild-Moderate PVL remaining. The 29mm DS was removed from the patient and they were stable after the case.An update from the FCS noted that 2 days post implant, the patient had a valve in

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50590787 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000322 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE ARTICLE, 'BUDDY WIRE TECHNIQUE FOR RESCUING AN EMBOLIZED TAVR VALVE', DURING A RIGHT TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, RAPID PACING AT 180 BEATS/MIN WAS INITIATED USING A TEMPORARY RIGHT VENTRICULAR PACEMAKER, AND THE VALVE WAS DEPLOYED. DURING DEPLOYMENT, THE PATIENT DEVELOPED PREMATURE VENTRICULAR CONTRACTIONS AND LOSS OF CAPTURE, LEADING TO EMBOLIZATION OF THE PARTIALLY DEPLOYED VALVE INTO THE ASCENDING AORTA. USING THE DELIVERY BALLOON, THE VALVE WAS RETRIEVED INTO THE DESCENDING AORTA; HOWEVER, A CORNER OF THE VALVE CAUGHT THE LESSER CURVATURE OF THE AORTA, CAUSING THE BALLOON TO SLIP THROUGH THE VALVE. TROUBLESHOOTING WAS DONE BUT WAS UNSUCCESSFUL. THE TEAM THEN USED A BUDDY WIRE TECHNIQUE WITH 2 WIRES IN A SINGLE CATHETER WHICH ENABLING PARTIAL EXPANSION OF THE EMBOLIZED VALVE AND FACILITATING COAXIAL REPOSITIONING WITHIN THE AORTA. POSITIONING WAS CONFIRMED WITH ANGIOGRAPHY, AND THE VALVE WAS BALLOONED FOR FURTHER EXPANSION IN THE ASCENDING AORTA, FOLLOWED BY FULL EXPANSION IN THE DESCENDING AORTA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. A SECOND 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS THEN FULLY DEPLOYED ACROSS THE

  Patient problems: Foreign Body In Patient

  MAUDE report 25509227 ↗
• InjuryJun 8, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 3 YEARS POST TAVR WITH A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25430748 ↗
• InjuryJun 5, 2026Migration or Expulsion of Device; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) IN A PREVIOUSLY IMPLANTED NON-EDWARDS ANNULOPLASTY RING VIA THE RIGHT JUGULAR VEIN APPROACH. AS REPORTED, THE FIRST 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED AND WAS UNABLE TO CROSS INTO THE RIGHT ATRIUM (RA) VIA TRANSFEMORAL (TF) APPROACH. THE S3UR VALVE WAS REMOVED. A SECOND 29MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED AND ADVANCED INTO THE TRICUSPID SURGICAL RING VIA THE RIGHT JUGULAR VEIN. THE VALVE WAS DEPLOYED 50/50. MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED. A 28MM TRUE BALLOON WAS USED TO POST DILATE WITH X2 INFLATIONS. THE TAVR VALVE APPEARED TO MIGRATE TOWARDS THE RA AFTER SECOND INFLATION. THE PVL WAS NOW SEVERE. THE DECISION WAS MADE TO GO TO SURGERY. THE PATIENT'S VITALS WERE STABLE THE ENTIRE CASE. THE PATIENT LEFT THE PROCEDURE AREA WITH STABLE VITALS. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY OF THE EW DEVICES WERE DEFICIENT IN SOME WAY.

  Patient problems: Insufficient Information

  MAUDE report 25410780 ↗
• InjuryMay 29, 2026Expulsion

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 VALVE, WHILE DELIVERING THE VALVE FOR IMPLANTATION, A PREMATURE VENTRICULAR CONTRACTION (PVC) BROKE THROUGH THE PACING RUN; WHICH RESULTED IN THE VALVE EMBOLIZING AND BEING IMPLANTED IN THE DESCENDING AORTA. A SECOND VALVE WAS PREPPED AND DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. POST PROCEDURE, THE PATIENT WAS REPORTED TO BE IN THE POST ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 25337685 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM EDWARDS LIFESCIENCES PATIENT SUPPORT DEPARTMENT, REGARDING IMPLANTATION OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. CARE ADVOCATE CALLED AND STATED DURING THE TIME OF THE TAVR, THE PATIENT WAS ALSO IMPLANTED WITH A PACEMAKER. NO ADDITIONAL DETAILS OF THE PACEMAKER IMPLANATATION WAS PROVIDED.

  Patient problems: Heart Block

  MAUDE report 25280382 ↗
• InjuryMay 22, 2026Migration or Expulsion of Device; Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), 3 DAYS POST TAVR PROCEDURE WITH A 29 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE MITRAL POSITION FOR MAC, ANOTHER 29 S3UR PLACED IN EXISTING 29 S3UR, AS THE FIRST S3UR MIGRATED MORE ATRIAL, SIGNIFICANT PARAVALVULAR LEAK (PVL) AND HEMOLYSIS WAS NOTED. NO PVL WAS NOTED POST PROCEDURE.

  Patient problems: Hemolysis

  MAUDE report 25259596 ↗
• InjuryMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY IMPLANT PATIENT REGISTRY, THAT APPROXIMATELY 4 MONTHS, 10 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED. THE REASON FOR EXPLANT IS UNKNOWN AT THE TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25244144 ↗
• InjuryMay 19, 2026Migration or Expulsion of Device; Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), THE PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE VIA THE RIGHT SIDE DUE TO AORTIC INSUFFICIENCY. THE PATIENT BEGAN HAVING SYMPTOMS OF HEART FAILURE AND PERIVALVULAR LEAK AND UNDERWENT AN ANGIOGRAPHY TO INVESTIGATE. THE ANGIOGRAPHY SHOWED THAT THE VALVE APPEARED TO BE SITTING APPROXIMATELY 50/50 (AORTIC/ VENTRICLE) RESPECTIVELY. THE 29MM SAPIEN 3 ULTRA RESILIA VALVE HAD ORIGINALLY BEEN INITIALLY IMPLANTED IN THE AORTIC ANNULUS AT A 70/30 (AORTIC/VENTRICLE) RESPECTIVELY. POSITION AND APPEARS TO HAVE MIGRATED TO ITS CURRENT POSITION. APPROXIMATELY 4 MONTHS AND SIX DAYS POST IMPLANTATION IT WAS DECIDED TO DO A VALVE IN VALVE PROCEDURE WITH ANOTHER 29MM SAPIEN 3 ULTRA RESILIA VALVE. THE NEW VALVE PLACED INSIDE IS ESTIMATED TO BE 5-7MM HIGHER THAN THE OLD VALVE. MEAN GRADIENT IS ESTIMATED AT 7-10 MMHG. THE VALVE IN VALVE PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25222384 ↗
• MalfunctionMay 15, 2026Material Deformation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING THE PROCEDURE, THE DELIVERY SYSTEM BECAME STUCK AT THE WHITE PORTION OF THE ESHEATH. DUE TO TORTUOUS ANATOMY, A BENT STRUT PARTIALLY PIERCED THE EXPANDABLE PORTION OF THE SHEATH. THE DELIVERY SYSTEM AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. A NEW SHEATH, VALVE, AND DELIVERY SYSTEM WERE PREPARED, AND THE VESSEL WAS PREDILATED PRIOR TO ADVANCEMENT OF THE NEW SHEATH. THE NEW VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185520 ↗
• MalfunctionMay 11, 2026Material Deformation

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT RIGHT SIDE TRANSFEMORAL TAVR. AS REPORTED, DURING THE 1ST ATTEMPT, UPON ENTERING THE 29MM SAPIEN 3 ULTRA RESILIA VALVE INTO THE 16FR ESHEATH+, THERE WAS RESISTANCE NOTED AT THE FEMORAL HEAD AND THE 29MM COMMANDER SYSTEM WAS UNABLE TO BE ADVANCED. A TINE WAS SEEN "BOWING" ON FLUOROSCOPY AND AT THIS POINT THE SYSTEM AND SHEATH WAS REMOVED AS A UNIT. THE DELIVERY SYSTEM DID AND VALVE DID NOT EXIT THE TIP OF THE SHEATH. THE SHEATH HAD A VISIBLE WHAT APPEARED TO BE A PERFORATION WITH A STRUT JUST AT THE BEGINNING OF THE BLUE PORTION. A NEW 16FR ESHEATH+/29MM COMMANDER/29MM S3UR VALVE WERE PREPPED IN STANDARD FASHION AND IMPLANTED. ON THE SECOND ATTEMPT THERE WAS A LITTLE RESISTANCE BUT DELIVERY SYSTEM WAS ABLE TO TRACK AND PROCEDURE COMPLETED. ON REMOVAL OF THE SECOND SHEATH THE TIP WAS NOTED TO BE TORN. PER THE FIELD CLINICAL SPECIALIST, THE DAMAGE WAS CONSISTENT WITH SHEATH DISTAL TIP DAMAGE. THERE WAS NO WITHDRAW DIFFICULTY NOTED. ANGIOGRAM AFTER IMPLANT SHOWED NO VASCULAR INJURY PER THE INTERVENTIONAL CARDIOLOGIST. THE ORIGINAL COMMANDER/ SHEATH/ VALVE SYSTEM WILL BE RETURNED; THE SECOND SHEATH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143128 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 5 MONTHS, 23 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29MM 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 25126867 ↗
• InjuryApr 27, 2026Perivalvular Leak

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT APPROXIMATELY 8 MONTHS AND 22 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT THAT THE VALVE HAS MODERATE TO SEVERE PARAVALVULAR LEAK AND IS EXPERIENCING ANEMIA. MEDICAL RECORDS WERE RECEIVED AND REVIEWED; THE PATIENT UNDERWENT A SUCCESSFUL IMPLANTATION OF 29 MM EDWARDS SAPIEN-3 BIOPROSTHETIC VALVE VIA RIGHT COMMON FEMORAL ARTERY. POST DEPLOYMENT TRANSTHORACIC ECHOCARDIOGRAM SHOWED A WELL-POSITIONED VALVE WITH NO PVL AND WITH A MEAN GRADIENT OF 3 MMHG. POST OPERATIVE (POD) 1 ECHOCARDIOGRAM: THE TAVR AORTIC VALVE IS STRUCTURALLY AND FUNCTIONALLY NORMAL BY TWO-DIMENSIONAL, COLOR FLOW DOPPLER AND DOPPLER INTERROGATION. THERE IS MILD PERI-VALVULAR REGURGITATION OF THE TAVR AORTIC VALVE. THERE IS NO AORTIC VALVE STENOSIS AND NO CENTRAL REGURGITATION. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT IS SCHEDULED FOR PVL LEAK CLOSURE.

  Patient problems: Anemia

  MAUDE report 25007488 ↗
• DeathApr 24, 2026Patient Device Interaction Problem

  PER MEDICAL RECORD REVIEW THE PATIENT UNDERWENT A SUCCESSFUL TAVR PROCEDURE WITH A SAPIEN 3 ULTRA RESILIA VALVE, HOWEVER THE PATIENT EXPERIENCED A LEFT BUNDLE BRANCH BLOCK (LBBB), WHICH GRADUALLY IMPROVED. AT THE CONCLUSION OF THE TAVR PROCEDURE, THE PATIENT DEVELOPED ACUTE RESPIRATORY ACIDOSIS WITH SEVERE CO2 RETENTION, PROMPTING INITIATION OF BIPAP. DESPITE BEING AWAKE AND ALERT, THE PATIENT REMAINED HYPOTENSIVE WITH MINIMAL RESPONSE TO INTRAVENOUS ALBUMIN, NECESSITATING TRANSFER TO THE ICU FOR CLOSER MONITORING AND MANAGEMENT OF PERSISTENT RESPIRATORY AND HEMODYNAMIC INSTABILITY. THE PATIENT RECEIVED ADDITIONAL FLUID RESUSCITATION IN THE MICU WITH SUBSEQUENT STABILIZATION OF BLOOD PRESSURE. THE PATIENT SUBSEQUENTLY PASSED AWAY.

  Patient problems: Heart Block

  MAUDE report 24983889 ↗
• InjuryApr 22, 2026Perivalvular Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM SAPIEN 3 ULTRA RESILIA VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT REINTERVENTION AFTER AN IMPLANT DURATION OF 1 YEAR AND 8 MONTHS. ACCORDING TO CASE INFORMATION CAPTURED AT THE TIME OF INITIAL IMPLANT OF THE 29MM SAPIEN 3 ULTRA RESILIA VALVE, THERE WAS "NONE/TRACE" PARAVALVULAR LEAK (PVL) AT THE END OF THE PROCEDURE. THE VALVE NOW HAS PVL, WHICH WAS HYPOTHESIZED TO BE DUE TO UNDER EXPANSION OF THE VALVE. THE PATIENT WAS SYMPTOMATIC WITH HEMOLYSIS. THE VALVE UNDERWENT VALVE-IN-VALVE PROCEDURE WITH AN UNKNOWN 29MM SAPIEN VALVE. THE DAY FOLLOWING THE VALVE-IN-VALVE PROCEDURE, THE HEART TEAM NOTICED MODERATE PVL THAT REMAINED BETWEEN THE NATIVE VALVE AND THE INDEX 29MM SAPIEN 3 ULTRA RESILIA VALVE. THE TEAM POST DILATED THE VALVES, WHICH RESOLVED THE PVL. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY OF THE EW DEVICES WERE DEFICIENT.

  Patient problems: Hemolysis

  MAUDE report 24957833 ↗
• InjuryApr 22, 2026Perivalvular Leak

  AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST REPORTED THAT A PATIENT IMPLANTED WITH A 29 MM SAPIEN 3 VALVE IS NOW EXPERIENCING SEVERE PARAVALVULAR LEAK (PVL) APPROXIMATELY 2 YEARS AND 9 MONTHS POST-IMPLANT, REPRESENTING AN INCREASE FROM THE MILD PVL OBSERVED AT THE TIME OF THE ORIGINAL PROCEDURE. THE PATIENT IS CURRENTLY EXPERIENCING HEART FAILURE SYMPTOMS. POST-DILATION OF THE VALVE WAS PERFORMED, RESULTING IN A REDUCTION OF PVL SEVERITY FROM SEVERE TO MILD-TO-MODERATE. THE PERCEIVED ROOT CAUSE INITIALLY REPORTED WAS THAT THE VALVE HAD BEEN FULLY EXPANDED AT DEPLOYMENT BUT MAY HAVE SUBSEQUENTLY "RECOILED" OR COLLAPSED SLIGHTLY OVER TIME DUE TO CARDIAC REMODELING AND CARDIAC MOTION DURING THE CARDIAC CYCLE. A REVIEW OF PRE-TAVR CT IMAGING BY AN EDWARDS LIFESCIENCES CLINICAL IMAGER IDENTIFIED THE NATIVE ANATOMY AS BICUSPID, WITH PROBABLE FUSION OF THE RIGHT AND LEFT CUSPS. THE ANNULUS WAS NOTED TO BE ELLIPTICAL AND VERY LARGE (699 MM2). SIGNIFICANT CALCIUM BURDEN WAS PRESENT, WITH LARGE CALCIFIC DEPOSITS AT ALL THREE NATIVE COMMISSURES EXTENDING INTO THE LVOT. FLUOROSCOPIC IMAGING AND ECHOCARDIOGRAPHY FROM THE INDEX PROCEDURE WERE REVIEWED. THE TRANSTHORACIC ECHO DEMONSTRATED A

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24956670 ↗
• InjuryApr 15, 2026Migration or Expulsion of Device; Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE MITRAL POSITION WITHIN AN INCOMPLETE RING WITH PASCAL IN PLACE, A SUCCESSFUL LAMPOON PROCEDURE OF THE ANTERIOR LEAFLET WAS PERFORMED. THE FIRST S3UR DEPLOYED WELL USING +3 CC OF ADDITIONAL VOLUME (30/70 POSITION). THE INITIAL PLACEMENT WAS IN A GOOD POSITION AND HAD SEAL ALL AROUND THE SKIRT. THE VALVE SLOWLY MOVED ATRIAL RESULTING IN PARAVALVULAR LEAK (PVL) THROUGH THE OPEN CELLS (90/10). A SECOND TMVR VALVE WAS THEN PREPPED, THIS TIME A 29MM SAPIEN 3. THE VALVE WAS DEPLOYED WITH +3 CC OF ADDITIONAL VOLUME AGAIN. THE PVL APPEARED TO BE TAKEN CARE OF, HOWEVER, BOTH VALVES CONTINUED TO MOVE MORE ATRIAL AND EVENTUALLY FELL INTO THE ATRIUM. AT THIS POINT, THE PATIENT WAS PUT ON ECMO FOR SUPPORT AND REMAINED STABLE THROUGHOUT. WHILE THE INITIAL TWO TMVR VALVES REMAINED ON THE WIRE IN THE ATRIUM, A THIRD VALVE, ANOTHER 29MM S3 WAS PREPPED AND DEPLOYED, LOCKING IT INTO PLACE WITH APPROXIMATELY +8 CC OF VOLUME ADDED TO THE COMMANDER DELIVERY SYSTEM. THE INITIAL TWO TAVR VALVES WERE PULLED BACK ONTO THE SEPTAL WALL AND

  Patient problems: Foreign Body In Patient

  MAUDE report 24885057 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS 29MM SAPIEN 3 ULTRA RESILIA VALVE IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER 6 MONTHS DUE TO UNKNOWN REASON. A SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24809170 ↗
• DeathApr 6, 2026Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TMVR (TRANSCATHETER MITRAL VALVE REPLACEMENT) PROCEDURE WITH A 29 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE MITRAL POSITION, THERE WAS A SEVERE PARAVALVULAR LEAK (PVL) WITH AN AORTIC PRESSURE GRADIENT-TO-LEFT VENTRICULAR OF 30 MMHG POST VALVE DEPLOYMENT. IN RESPONSE, THE OPERATING TEAM PERFORMED AN ALCOHOL SEPTAL ABLATION AND IMPLANTED AN ADDITIONAL 29 MM S3UR VALVE. THE PVL HAD REDUCED TO MILD AND THE PATIENT WAS STABLE. IT WAS NOTED THAT DURING THE INITIAL TMVR, A LAMPOON PROCEDURE WAS PERFORMED. IN ADDITION, THIS IS AN OFF-LABEL CASE DUE TO THE NATIVE MITRAL POSITION. THE PERCEIVED ROOT CAUSE OF THE PVL WAS THAT THE FIRST VALVE WAS DEPLOYED TOO ATRIAL. ADDITIONAL INFORMATION PROVIDED PER FCS INDICATING THE PATIENT PASSED AWAY. DURING THE TAVR PROCEDURE, TWO SAPIEN VALVES WERE PLACED IN THE MITRAL POSITION, AND THERE WAS TRACE PARAVALVULAR LEAK NOTED. THE FOLLOWING DAY, THE SAPIEN VALVES MIGRATED INTO THE LEFT ATRIUM AND WERE FREELY MOBILE, WHICH CAUSED HEMODYNAMIC COMPROMISE AND INCREASING OXYGEN REQUIREMENTS WITH EVIDENCE OF END ORGAN MALPERFUSION. THE PATIENT ALSO HAD SEVERE MITRAL

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24793521 ↗
• MalfunctionApr 2, 2026Material Deformation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A RIGHT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 29MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE BEING PLACED IN A NON-EDWARDS SURGICAL VALVE WHEN THE 29MM COMMANDER DELIVERY SYSTEM (DS) WAS BEING INSERTED INTO THE 16F ESHEATH+ THE INSERTION TRACK WAS TOO TIGHT AND HAD RESISTANCE AT THE STRAIN RELIEF PORTION AND THOUGHT TO BE DAMAGED. ONCE AN INCISION WAS MADE THE DS WAS DELIVERED EASIER. DUE TO THE FORCE GOING THROUGH THE SHEATH THE STRUT WAS BENT HAD EXITED THE SHEATH AND WAS DEPLOYED IN THE ANNULUS. THE SYSTEM CAME OUT THROUGH THE SHEATH POST DEPLOYMENT. THE SHEATH AND DS WERE REMOVED, AND A NEW SHEATH WAS PREPPED AND USED FOR POSSIBLE POST DILATION. THERE WAS NO DIFFICULTY WITHDRAWING THE SHEATH. THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PERCEIVED ROOT CAUSE OF THE RESISTANCE WAS THE INSERTION TRACK WAS NOT DILATED ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769936 ↗
• InjuryMar 31, 2026Perivalvular Leak; Malposition of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE MITRAL POSITION (MAC) VIA OPEN SURGICAL ACCESS, VISIBILITY WAS POOR AND POSITIONING WAS DIFFICULT AND THE VALVE WAS POSITIONED TOO DEEP IN THE VENTRICLE. PARAVALVULAR LEAK (PVL) WAS NOTICED. THE FIRST VALVE WAS ABLE TO BE REMOVED WHILE THE FCS WAS PREPPING THE SECOND VALVE. THE SECOND 29MM S3UR VALVE WAS IMPLANTED SUCCESSFULLY (STILL IN THE NATIVE MAC) WHICH REDUCED THE PVL AND STABILIZED THE INITIAL VALVE. THE AMOUNT OF PVL IS UNKNOWN AS THIS WAS A SURGICAL PROCEDURE AND THE PATIENT WAS ON A PUMP. THE PATIENT WAS IN STABLE CONDITION FOLLOWING IMPLANT. IT'S NOTED THAT AT THE TIME OF PROCEDURE, THE PATIENT ALSO HAD A CABG AND AORTIC VALVE REPLACEMENT (AVR). VERIFICATION WAS RECEIVED THAT THERE WERE NO ALIGNMENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746435 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Gradient Increase; Intravalvular regurgitation

  AS REPORTED BY AN EDWARDS CLINICAL SAFETY OFFICER, APPROXIMATELY 1 YEAR AND 8 MONTHS FOLLOWING IMPLANTATION OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL POSITION WITHIN A SAPIEN M3 VALVE SYSTEM, THE PATIENT REQUIRED REHOSPITALIZATION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED MODERATE TRANSPROSTHETIC MITRAL REGURGITATION WITH A MEAN MITRAL GRADIENT (MG) OF 17 MMHG.

  Patient problems: Insufficient Information

  MAUDE report 24746338 ↗
• InjuryMar 30, 2026Migration or Expulsion of Device; Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 1 YEAR AND 1 MONTH POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE THE PATIENT WAS BROUGHT BACK FOR A BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO SEVERE PARAVALVULAR LEAK (PVL) AND BEING SYMPTOMATIC. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, HYPOXIA, AND WEIGHT GAIN. THE PVL WENT FROM SEVERE TO NONE/TRACE. THE PATIENT IS IN STABLE CONDITION. THERE WAS NO AORTIC INSUFFICIENCY OR PVL AFTER POST INITIAL IMPLANT. THE INITIAL IMPLANT WAS UNDER EXPANDED WITH SOME DEGREE OF MIGRATION INTO THE VENTRICLE. ECHO LESS 16 DAYS PRIOR TO BAV SHOWED MILD TO MODERATE AORTIC VALVE REGURGITATION, A PEAK VELOCITY OF 255 CM/S, MEAN GRADIENT OF 15 MMHG AND AN AORTIC VALVE AREA OF 1.7 CM2.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24734331 ↗
• InjuryMar 26, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 1 YEAR, 5 MONTHS, AND 25 DAYS POST-IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 29 MM SAPIEN 3 ULTRA RESILIA VALVE REQUIRED INTERVENTION DUE TO CALCIFIED AORTIC STENOSIS. THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH. AA VALVE IN VALVE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION AFTER THE PROCEDURE. PER THE PROCTOR REVIEW, THE PATIENT WAS PRESENTING WITH ELEVATED GRADIENTS, WITH HALT VS EARLY STRUCTURAL VALVE DEGENERATION. BASED ON THE AVAILABLE IMAGING AND THE VERY EARLY DETERIORATION OF THE CURRENT PROSTHESIS, THIS IS MOST CONSISTENT WITH EARLY STRUCTURAL VALVE DEGENERATION RATHER THAN HALT. A CTA REVIEW SHOWED A S3 29 MM IN THE AORTIC POSITION WITH SUBOPTIMAL COMMISSURAL ALIGNMENT. THE THV APPEARS UNDEREXPANDED AT THE MID-FRAME. CALCIFICATION PRESENT ON THE PROSTHETIC LEAFLETS. NO CLEAR RADIOLOGIC EVIDENCE OF HALT. RCA OSTIUM IS ABOVE THE NEO-SKIRT RISK PLANE. LCA OSTIUM IS PARTIALLY BELOW THE NEO-SKIRT RISK PLANE.

  Patient problems: Dyspnea

  MAUDE report 24698236 ↗

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