SAPIEN 3 Ultra RESILIA 9755RSL20Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00690103215793), received between Apr 17, 2023 and Jun 22, 2026 — classified as 4 deaths, 37 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Intravalvular regurgitation” (10 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 2 WEEKS POST TAVR WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE PATIENT WAS TREATED VIA THV IN THV WITH ANOTHER 20MM SAPIEN ULTRA RESILIA VALVE DUE TO MODERATE PVL.

  Patient problems: Insufficient Information

  MAUDE report 25586547 ↗
• InjuryMay 27, 2026Calcified; Patient-Device Incompatibility

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED AND A SURGICAL VALVE WAS IMPLANTED. THE CAUSE OF THE EXPLANT IS DUE TO CALCIFICATION AND AORTIC VALVE PANNUS. ACCORDING TO THE MEDICAL RECORDS, A PRE-PROCEDURE TEE WAS PROVIDED THAT SHOWED AORTIC VALVE WITH TAVR IN PREVIOUSLY PLACED SURGICAL AORTIC VALVE REPLACEMENT (SAVR) WHICH APPEARED WELL-SEATED, MEAN GRADIENT OF 41MMHG, CALCIFICATION SEEN ON THE PROSTHETIC LEAFLET OF WHERE THE NATIVE RIGHT CORONARY CUSP (RCC) WOULD BE, NO PARAVALVULAR LEAK (PVL) OR AORTIC INSUFFICIENCY. THE PATIENT WENT FOR A TAVR EXPLANT OF THEIR SAPIEN 3 ULTRA RESILIA ON WHICH WAS REPLACED WITH A 23 MM NON-EW MECHANICAL VALVE. OTHER PROCEDURES PERFORMED AT THIS TIME INCLUDE REDO STERNOTOMY, AORTIC/LVOT PATCH ROOT ENLARGEMENT, PULMONIC ROOT RE-REPLACEMENT: 25 MM TISSUE CONDUIT, AND A LEFT CORONARY 6MM DACRON GRAFT. POST-OP TEE SHOWED THE AV WAS REPLACED BY A 23MM NON-EW MECHANICAL VALVE AND FINDINGS WERE CONSISTENT WITH A NORMAL FUNCTIONING PROSTHETIC VALVE. THE EXPLANTED TAVR VALVE WAS FOUND TO HAVE AORTIC VALVE PANNUS. THE TAVR EXPLANT

  Patient problems: Insufficient Information

  MAUDE report 25295979 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY THAT A 20MM SAPIEN 3 ULTRA RESILIA VALVE, IMPLANTED IN THE AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 18 DAYS. IT WAS REPLACED WITH AN EW SURGICAL VALVE. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25237074 ↗
• InjuryApr 16, 2026Insufficient Device Problem Information

  AS REPORTED BY OUR IMPLANT PATIENT REGISTRY APPROXIMATELY (B)(6) POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS EXPLANTED FOR UNKNOWN REASON, AND A SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24903337 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  AS REPORTED BY A IMPLANT PATIENT REGISTRY, APPROXIMATELY 8 MONTHS POST TAVR WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 24821731 ↗
• InjuryMar 9, 2026Fluid/Blood Leak

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A 20M SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED INTO A NON-EDWARDS 26MM THV NO PROCEDURAL COMPLICATIONS. A UNICORN PROCEDURE INVOLVING THE LEFT LEAFLET WAS PERFORMED, AND MILD CENTRAL AORTIC INSUFFICIENCY (AI) WAS NOTED. THE PATIENT WAS ALIVE AT PROCEDURE COMPLETION. GIVEN THE HIGH IMPLANT HEIGHT OF THE PRIOR VALVE AND ELEVATED RISKS FOR SINUS SEQUESTRATION, CORONARY OBSTRUCTION, AND SURGICAL COMPLICATIONS RELATED TO KIDNEY DISEASE, THE CASE WAS DEEMED HIGH RISK. ECMO WAS INITIATED PREEMPTIVELY AND LATER SUCCESSFULLY DISCONTINUED. THE PATIENT IS CURRENTLY CLINICALLY STABLE, WITH IMPROVED AI DESPITE PERSISTENT LEAFLET INTERACTION. APPROXIMATELY NINE DAYS LATER, THE PATIENT RETURNED TO THE CATH LAB, WHERE CATHETER-BASED REMOVAL OF A FLAIL LEAFLET FROM THE PRIOR NON-EDWARDS VALVE WAS PERFORMED, RESOLVING THE CENTRAL AI. THE PATIENT HAD AN EDWARDS SURGICAL VALVE IMPLANTED APPROXIMATELY 7 YEARS PRIOR, FOLLOWED BY A NON-EDWARDS THV APPROXIMATELY 5 YEARS LATER. THE NON-EDWARDS VALVE DEVELOPED A FLAIL LEAFLET CAUSING SEVERE AI, WHICH SUBSEQUENTLY INTERFERED WITH ONE LEAFLET OF THE NEWLY IMPLANTED SAPIEN 3 ULTRA RESILIA VAL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24552518 ↗
• InjuryFeb 27, 2026Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A PATIENT WITH A PREVIOUSLY IMPLANTED 21MM EDWARDS SURGICAL VALVE, UNDERWENT A VALVE IN VALVE PROCEDURE. AS REPORTED, A 20MM SAPIEN 3 ULTRA RESILIA VALVE WAS PREPPED PER IFU AND IMPLANTED. THE TEAM DECIDED TO BVF WITH A 22MM TRUE. THE FIRST ATTEMPT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS PERFORMED AND VALVE FRACTURE WAS ACHIEVED. THE PATIENT WAS NOT RECOVERING WELL, SO A TEE WAS BROUGHT IN AND IT WAS DETERMINED THAT THE PATIENT HAD MODERATE TO SEVERE AORTIC INSUFFICIENCY (AI). THE VALVE WAS POSITIONED AT THE TOP OF SURGICAL FRAME TO TOP OF THV FRAME AS INTENDED. THERE WAS BELIEVED TO BE AN ISSUE WITH THE MOVEMENT OF THE LEAFLET DUE TO OVEREXPANSION OF THE NEW THV. A SECOND COMMANDER/20MM S3UR WERE PREPPED PER IFU AND THE SAPIEN VALVE WAS IMPLANTED. THE PATIENT RECOVERED WELL AND LEFT THE ROOM STABLE. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY EDWARDS DEVICES WERE DEFICIENT. THE PERCEIVED ROOT CAUSE WAS POST-DILATING THE 20MM S3UR WITH 22MM TRUE BALLOON TO FRACTURE THE SURGICAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24475403 ↗
• InjuryFeb 10, 2026Insufficient Device Problem Information

  AS REPORTED TO THE IMPLANT PATIENT REGISTRY (IPR), 3 MONTHS AND 16 DAYS 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 DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 24305713 ↗
• InjuryJan 12, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 4 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM 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 24042176 ↗
• MalfunctionDec 24, 2025Material Deformation; Material Deformation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A TRANSFEMORAL TAVR PROCEDURE WAS PERFORMED TO IMPLANT A 20 MM SAPIEN 3 ULTRA RESILIA VALVE. DURING VALVE ALIGNMENT, IT WAS NOTED THAT THE OUTFLOW VALVE STRUTS APPEARED TO BE OVERLAP/BENT. AFTER FURTHER ASSESSMENT OF THE VALVE, IT WAS DECIDED TO REMOVE EVERYTHING. A NEW 20 MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889477 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEARS AND 6 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THE S3UR VALVE WAS FOUND TO BE STENOTIC WITH A MEAN GRADIENT OF 80MMHG AND A MEAN VELOCITY OF 4M/S. ADDITIONAL INFORMATION PROVIDED PER FCS INDICATING THE PATIENT PRESENTED WITH PROGRESSIVE SHORTNESS OF BREATH (SOB) AND DYSPNEA ON EXERTION WITH ACTIVITY. WHILE THE MEAN GRADIENT CONTINUED TO DECLINE POST TAVR, IT INCREASED TO 65MMHG IN (B)(6) 2025. IN ADDITION, THE AORTIC VALVE AREA MEASURED 0.9CM^2 IN (B)(6) 2025, THEN WAS AT 0.6CM^2 IN EARLY (B)(6) 2025. IN (B)(6) 2025, THE TAVR VALVE WAS EXPLANTED AND AN AORTIC VALVE REPLACEMENT WAS PERFORMED WITH A MECHANICAL VALVE. ALSO, AN AORTIC ROOT REPLACEMENT WAS PERFORMED USING A VALVED CONDUIT GRAFT WITH AN ANNULAR ENLARGEMENT AND STERNAL PLATING. ACCORDING TO THE PROVIDED MEDICAL RECORDS, THE PATIENT HAD SIGNIFICANTLY ELEVATED BIOPROSTHETIC GRADIENTS PER CONSULTATION IN (B)(6) 2025. A SUBSEQUENT TOMOGRAPHY REVEALED EVIDENCE OF THROMBOSIS OF THE TAVR VALVE. IT WAS NOTED IN THE RECORDS THAT THE PATIENT

  Patient problems: Dyspnea

  MAUDE report 23752331 ↗
• InjuryOct 27, 2025Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 1 YEAR AND 2 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. UPON FOLLOW UP, THE VCC ADVISED THAT THE PATIENT HAD RESIDUAL PARAVALVULAR LEAK AND SUBSEQUENT HEMOLYTIC ANEMIA WHICH CAUSED THEM TO HAVE SEVERAL HOSPITALIZATIONS FOR DECOMPENSATED HF AND ANEMIA REQUIRING TRANSFUSIONS. THE PATIENT WAS ADMITTED TO CBMC ON (B)(6) 2025 FOR COMPLAINTS OF SOB. (PRIOR TO THIS, THEY HAD 4 HOSPITALIZATIONS FOR THE SAME THING AT MOUNTAINSIDE MEDICAL CENTER) THEY ATTEMPTED A BALLOON VALVULOPLASTY ON (B)(6) 2025 BUT THE LEAK WAS PERSISTENTLY MODERATE - SEVERE. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2025 WHERE THE DECISION WAS MADE TO EXPLANT THE TAVR VALVE. THEY EXPLANTED THE SAPIEN 20 MM AND IMPLANTED AN INSPIRIS 21 MM ON (B)(6) 2025. THE PATIENT ALSO HAD AN ASCENDING AORTA ENLARGEMENT AORTOPLASTY AND A LEFT ATRIAL APPENDAGE OCCLUSION CLIP IN THE SAME SURGERY. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 79-YEAR-OLD FEMALE, WITH A PAST MEDICAL HISTORY OF SEVERE AORTIC STENOSIS, HEART FAILURE WITH PRESERVED EJECTION

  Patient problems: Hemolytic Anemia; Insufficient Information

  MAUDE report 23398011 ↗
• InjurySep 12, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THE TEMPORARY PACEMAKER WAS TURNED OFF BEFORE THE COMMANDER BALLOON WAS DEFLATED CAUSING THE 20MM SAPIEN 3 ULTRA RESILIA VALVE TO POP OUT OF THE ANNULUS. THE TEAM WAS ABLE TO DEPLOY THE VALVE IN THE DESCENDING AORTA. A NEW VALVE WAS OPENED AND SUCCESSFULLY DEPLOYED IN THE ANNULUS. THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. THE VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CENTRAL LEAK. THERE WAS NO ALLEGATION OF EDWARDS DEVICE DEFICIENCY, AS THE TEAM AGREED THAT THE VALVE EMBOLIZED DUE TO PACING STOPPING PREMATURELY. IT WAS TURNED OFF TOO EARLY BECAUSE THE OPERATOR TOLD THEM TO STOP PACING BEFORE THE BALLOON WAS DOWN. THE DELIVERY SYSTEM BALLOON WAS MOSTLY INFLATED WHEN THE PACER WAS TURNED OFF.

  Patient problems: Foreign Body Embolism

  MAUDE report 23043302 ↗
• InjurySep 5, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE TEAM WANTED TO POST DILATE THE VALVE. THE TEAM INFLATED THE 20MM ATLAS TO 12-14ATM TWICE, AND POST ANGIOGRAM SHOWED CENTRAL PULMONARY REGURGITATION POSSIBLY DUE TO A STUCK LEAFLET. THE TEAM WAS ABLE TO CONFIRM THAT 2 OF THE LEAFLETS WERE FUNCTIONING APPROPRIATELY. THE OPERATOR ATTEMPTED TO USE A PIGTAIL TO DISLODGE THE STUCK LEAFLET BUT WAS UNSUCCESSFUL. IT WAS THEN DETERMINED TO PLACE A SECOND 20MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT UNDERWENT A VALVE IN VALVE PROCEDURE. THERE WAS NO PULMONARY REGURGITATION WAS SEEN.

  Patient problems: Insufficient Information

  MAUDE report 22982464 ↗
• InjurySep 3, 2025Difficult to Open or Close; Intravalvular regurgitation; Difficult to Open or Close; Intravalvular regurgitation

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST THAT DURING A PULMONIC TRANSCATHETER VALVE REPLACEMENT WITH A 20 MM SAPIEN 3 ULTRA RESILIA VALVE THE PHYSICIAN WANTED TO POST DILATE THE VALVE AND USED A 20MM ATLAS GOLD TO DO THE INFLATION. THE PHYSICIAN INFLATED THE ATLAS TO 12 14 ATM TWICE AND THE POST ANGIOGRAM SHOWED CENTRAL PULMONARY REGURGITATION. THE PHYSICIAN DECIDED TO ALSO LOOK WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND MILD REGURGITATION WAS NOTED AS WELL AS THE POTENTIAL FOR A STUCK LEAFLET. THEY WERE ABLE TO CONFIRM TWO OF THE LEAFLETS WERE FUNCTIONING APPROPRIATELY. THE PHYSICIAN ATTEMPTED TO USE A PIGTAIL TO DISLODGE THE STUCK LEAFLET BUT WAS UNSUCCESSFUL. THERE IS A POSSIBILITY THAT DURING POST DILATION OF THE VALVE WITH THE 22MM ATLAS, THE VALVE WAS OVER-DILATED, FORCING ONE OF THE LEAFLETS TO GET STUCK AND NOT FUNCTION PROPERLY. THE VALVE POSITION WAS 100/0 WITHIN A PALMAZ STENT, AND THIS SETUP WAS PLACED WITHIN A CONDUIT. THE PHYSICIAN THEN DETERMINED TO DO A VALVE IN VALVE PLACING A SECOND 20MM SAPIEN 3 ULTRA RESILIA VALVE TO FIX THE ISSUE. THE NEW VALVE WAS IMPLANTED SUCCESSFULLY AND THERE WAS NO PULMONARY REGURGITATION SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956757 ↗
• InjuryAug 15, 2025Gradient Increase; Migration or Expulsion of Device; Perivalvular Leak; Gradient Increase; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT APPROXIMATELY 2 YEARS AND 2 MONTHS POST TRANSFEMORAL TAVR WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE THE VALVE HAD MIGRATED IN THE PATIENT TOWARD THE VENTRICLE. THE PATIENT PRESENTED WITH ANEMIA DUE TO HEMOLYSIS. THE MEAN GRADIENT WAS 28.6MM HG. A VALVE IN VALVE WAS DONE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. AT THE START OF THE PROCEDURE ECHOCARDIOGRAM SHOWED SEVERE PARAVALVULAR LEAK (PVL). AFTER DEPLOYMENT OF SECOND VALVE THERE WAS STILL MORE THAN MODERATE PVL, SO THE TEAM DILATED WITH A 20MM TRUE BALLOON WITH MINIMAL IMPROVEMENT, THEY THEN DECIDED TO POST DILATE WITH A 21MM TRUE BALLOON RESULTING IN MILD PVL. THE PVL WAS POSSIBLY CAUSED BY THE VALVE MIGRATION TOWARD THE VENTRICLE, SO THE EXTERNAL SKIRT OF THE TAVR VALVE WAS NOT COVERING THE ANNULUS, AND THE MIGRATION WAS POSSIBLY CAUSED DUE TO BEING UNDERSIZED. THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED.

  Patient problems: Hemolysis; Insufficient Information

  MAUDE report 22819761 ↗
• InjuryAug 8, 2025Perivalvular Leak; Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WAS PERFORMED USING A 20 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE. FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE MODERATE PULMONARY INSUFFICIENCY (PARAVALVULAR LEAK). BASED ON THIS FINDING, THE CLINICAL TEAM ELECTED TO IMPLANT A 20 MM NON-EDWARDS VALVE WITHIN THE PREVIOUSLY DEPLOYED S3UR VALVE. FOLLOW-UP COMMUNICATION WITH THE FCS CONFIRMED THAT THE IMPLANTING PHYSICIAN DID NOT ALLEGE ANY DEFICIENCY WITH THE EDWARDS LIFESCIENCES DEVICES USED. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS UTILIZED TO ASSESS THE S3UR VALVE, BUT IMAGING WAS LIMITED, AND NOT ALL THREE LEAFLETS COULD BE VISUALIZED. THE ROOT CAUSE OF THE PARAVALVULAR LEAK REMAINS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22750931 ↗
• InjuryJul 25, 2025Malposition of Device; Malposition of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THE PATIENT WAS AN URGENT ADD ON TAVR IN SAVR CASE WITH A NON-EDWARDS VALVE IN THE AORTIC POSITION. PER THE CT MEASUREMENTS, THE PATIENT HAD MINIMAL VALVE TO CORONARY (VTC) DISTANCE AND VALVE TO AORTA (VTA) DISTANCE. THE PATIENT WAS NOT A SURGICAL CANDIDATE, SO THE TEAM DECIDED TO PERFORM A UNICORN PROCEDURE ON THE RIGHT CUSP AND SNORKEL STENT ON THE LEFT CORONARY ARTERY. THE TEAM WAS SUCCESSFULLY ABLE TO BURN THROUGH THE RIGHT CUSP BUT WHEN A 4MM PTA BALLOON WAS INSERTED TO DILATE THE CUSP OPENING, PATIENT DECOMPENSATED. A 20 MM S3UR VALVE WAS PREPPED PER IFU, AND TEAM ATTEMPTED TO DELIVER THE VALVE VIA UNICORN APPROACH BUT THEY WERE UNABLE TO ADVANCE THE VALVE THROUGH THE SURGICAL VALVE CUSP- AT THIS POINT IMPLANTER DECIDED TO DEPLOY THE VALVE. THE VALVE PARTIALLY CROSSED THE CUPS VIA UNICORN AND WOULD NOT FULLY PASS THROUGH AND AT THE POINT THEY DEPLOYED THE VALVE, AND IT LANDED HIGH INSIDE THE SURGICAL VALVE. THE CUSP PERF WAS THEN DILATED WITH A BIGGER BALLOON AND A NEW 20MM S3UR WAS THEN DEPLOYED AT THE INTENDED PLACEMENT INSIDE THE SAVR. PATIENT WAS UNSTABLE, CPR WAS BEING PERFORMED DURING THIS TIME. THE PATIENT WAS NEVER ABLE TO

  Patient problems: Insufficient Information

  MAUDE report 22613234 ↗
• DeathJul 16, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 20MM S3UR AORTIC VALVE IMPLANTED FOR 1 YEAR AND 9 MONTHS EXPIRED DURING A SURGICAL PROCEDURE TO DO A HEMI ARCH AND POSSIBLE EXPLANT OF THE 20MM S3UR VALVE. PER MEDICAL RECORDS, THE PATIENT SOUGHT TREATMENT AT THE ED FOR CHEST PAIN AND WAS ADMITTED FOR ANEURYSM AORTIC WITHOUT RUPTURE, NUMEROUS PSEUDOANEURYSM, AND PROSTHETIC AORTIC VALVE STENOSIS. A CARDIAC CT DURING THIS ADMISSION REVEALED MULTILOBULATED ANEURYSM INVOLVING THE AORTIC ARCH AND DESCENDING AORTA. COMPARED TO A PRIOR CT, THERE WAS NO SIGNIFICANT CHANGE IN SIZE OR APPEARANCE OF THE PSEUDOANEURYSM AT THE AORTIC ROOT OR CHANGE IN THE SIZE OR APPEARANCE OF MULTIPLE ADDITIONAL PSEUDOANEURYSMS OF THE DISTAL ASCENDING AORTA AND AORTIC ARCH. THERE WAS A FOCAL OUTPOUCHING (14 X 16 X 9 MM), LOCATED BELOW THE RIGHT SINUS OF VALSALVA COMMUNICATING WITH THE LVOT (MYCOTIC PSEUDOANEURYSM VERSUS POSTSURGICAL). THERE WAS SURGICAL MATERIAL IN THE ADJACENT MEMBRANOUS INTERVENTRICULAR SEPTUM WITH MILDLY THICKENED LEAFLETS. THE PATIENT UNDERWENT A PROCEDURE FOR BENTALL ROOT REPLACEMENT, AORTIC ANNULUS ENLARGEMENT, RECONSTRUCTION OF THE LVOT, INTERPOSITION SVG TO LM AND RCA, CABG

  Patient problems: Chest Pain; Pseudoaneurysm

  MAUDE report 22523254 ↗
• InjuryJul 9, 2025Intravalvular regurgitation; Intravalvular regurgitation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAV IN SAV PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE (S3UR), THE IC USED A 20 ATLAS GOLD TO FRACTURE THE NON-EDWARDS SURGICAL VALVE AND IT EITHER RIPPED OR OVEREXPANDED THE INITIAL 20MM S3UR, WE IMPLANTED ANOTHER 20MM S3UR DUE TO WIDE OPEN AI. PATIENT IS STABLE AND EXTUBATED, DOING WELL. UPON FOLLOW UP, THE FCS ADVISED THAT THE TERM "RIPPED OR OVEREXPANDED THE INITIAL 20MM S3UR," WAS SUGGESTING THAT THE BAV BALLOON (20MM ATLAS GOLD) USED POST-TAVR DEPLOYMENT MAY HAVE TORN THE LEAFLET OF THE 20MM S3UR TAVR, LEADING TO SIGNIFICANT AORTIC INSUFFICIENCY (AI). IT IS UNCLEAR IF THERE WAS DAMAGE TO THE INITIAL S3UR, BUT REGURGITATION WAS OBSERVED ON TTE, CLASSIFIED AS MODERATE TO SEVERE. NO OTHER EW DEVICES WERE DAMAGED DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 22462807 ↗
• InjuryJun 19, 2025Perivalvular Leak; Device Stenosis; Perivalvular Leak; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST AND VALVE CLINIC COORDINATOR, APPROXIMATELY 1 YEAR AND 8 MONTHS AFTER A TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 ULTRA RESILIA VALVE, THE PATIENT WAS HOSPITALIZED AND THE VALVE EXHIBITED A MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) AND STENOSIS WITH A VALVE AREA OF 1 CM2 AND INCREASED GRADIENT OF 20 MMHG. THE PERCEIVED ROOT CAUSE OF THE PVL WAS CALCIUM. THE PATIENT PRESENTED WITH NEAR SYNCOPE, ORTHOSTATIC HYPOTENSION, AND DIZZINESS WHICH HAD PRECEDED THE VALVE DYSFUNCTION. THE PATIENT IS BEING EVALUATED FOR A POSSIBLE VALVE IN VALVE PROCEDURE.

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

  MAUDE report 22294351 ↗
• InjuryJun 3, 2025Perivalvular Leak; Device Stenosis; Perivalvular Leak; Device Stenosis

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 1 YEAR, 6 MONTHS, 12 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. PER MEDICAL RECORDS RECEIVED, THE PATIENT UNDERWENT A STERNOTOMY WITH EXPLANT OF THE 20MM SAPIEN 3 ULTRA RESILIA VALVE, DUE TO STENOSIS WITH A GRADIENT OF 20MMHG, AND NO RESOLUTION OF THE SYMPTOMS EXPERIENCED PRIOR TO IMPLANT. TEE REPORT ALSO SHOWED PARAVALVULAR LEAK. THE VALVE WAS REPLACED WITH A 23MM INSPIRIS VALVE AFTER AORTIC ROOT REPLACEMENT, AND A 27MM MITRAL VALVE WAS ALSO PLACED AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 22137587 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT UNDERWENT A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION. DURING THE TAVR, THERE WAS DIFFICULTY FACED WHEN INSERTING THE ESHEATH+ INTO THE PATIENT AND THE S3UR VALVE BECAME STUCK IN THE ESHEATH+ AT THE COMMON FEMORAL ARTERY DUE TO THE PATIENT'S VASCULAR DISEASE (CALCIUM AND TORTUOSITY). THE DEVICES WERE REMOVED AS A SINGLE UNIT AND A NEW SYSTEM WAS USED. A SECOND S3UR VALVE WAS IMPLANTED SUCCESSFULLY. PER REPORT, THERE WAS NO INJURY TO THE PATIENT. ACCORDING TO PRE-DECONTAMINATION FINDINGS OF THE RETURNED DEVICES, THE S3UR VALVE HAD A BENT STRUT THAT PUNCTURED THROUGH THE STRAIN RELIEF OF THE ESHEATH+ APPROXIMATELY 1.25 INCHES FROM THE DISTAL STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981838 ↗
• InjuryMay 5, 2025Difficult to Open or Close; Difficult to Open or Close

  AS REPORTED FROM PATIENT SUPPORT (PSC), PSC RECEIVED A CALL FROM A CARE ADVOCATE IN VERMONT. APPROXIMATELY 1 MONTH POST TAVR WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE, THE PATIENT PASSED AWAY. ACCORDING TO CARE ADVOCATE, IT WAS FOUND THAT PATIENT HAD ''BLOOD CLOTS IN HER INTESTINES'' AND WAS TRANSFERRED VIA AMBULANCE BACK TO DARTMOUTH HITCHCOCK MEDICAL CENTER FOR HIGHER LEVEL OF CARE. PATIENT REMAINED AT THE HOSPITAL FOR 18 DAYS AND COULD ''NEVER FULLY RECOVER''. PER PATIENT'S CERTIFICATE, CAUSE OF DEATH STATES ''SEPTIC SHOCK, ANASTOMOTIC LEAK FROM SMALL INTESTINE, AND SEVERE AORTIC STENOSIS S/P TRANSCATHETER AORTIC VALVE REPLACEMENT''. PER MEDICAL RECORD REVIEW, A TTE APPROXIMATELY 1 MONTH POST TAVR SHOWED, A GRADIENT OF 45.1MMHG AND AVA OF 0.37CM2..

  Patient problems: Insufficient Information

  MAUDE report 21961876 ↗
• InjuryApr 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED TO THE IMPLANT PATIENT REGISTRY (IPR), 1 YEAR, 4 MONTHS, AND 7 DAYS POST-IMPLANT OF A 20 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 20 MM SAPIEN 3 ULTRA RESILIA VALVE WAS EXPLANTED, AND AN EDWARDS SURGICAL VALVE WAS IMPLANTED. THE REASON FOR EXPLANT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21760910 ↗

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