EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 00690103193961), received between May 17, 2017 and Apr 22, 2026 — classified as 17 deaths, 98 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (88 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 22, 2019Terminated

   This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

   Z-0835-2019 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Rupture

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING IMPLANTATION OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, 29MM COMMANDER DELIVERY SYSTEM BALLOON BURST. VALVE WAS FULLY EXPANDED PRIOR TO THE BALLOON RUPTURE. A NON-EDWARDS BALLOON WAS INSERTED TO PRE-DILATE BEFORE VALVE IMPLANTATION. NO PATIENT INJURY. BALLOON WAS CHECKED AND ALL PIECES REMAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954064 ↗
• MalfunctionMar 25, 2026Inflation Problem

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION. AS THE 29 MM SAPIEN 3 VALVE AND 29 MM COMMANDER DELIVERY SYSTEM WAS EXITING THE 16F ESHEATH PLUS THERE WAS ADDITIONAL RESISTANCE. THE VALVE AND DELIVERY SYSTEM WERE GETTING STUCK AT THE TIP OF THE SHEATH BUT WAS ABLE TO BE ADVANCED. THE SHEATH APPEARED VISIBLY NORMAL ON FLUORO. PROCEDURE WAS CONTINUED. DURING DEPLOYMENT THE 29 MM COMMANDER DELIVERY SYSTEM BALLOON APPEARED TO INFLATE MORE ON PROXIMAL END THAN DISTAL END WHICH APPEARED UNUSUAL. VALVE PLACEMENT WAS AS INTENDED AND NO ISSUES WITH VALVE UPON IMPLANT. ONCE SHEATH WAS REMOVED THE DISTAL END OF THE SHEATH APPEARED TO BE MISSING. TIP NOT FOUND. NO INJURY AT THIS TIME. PATIENT IS STABLE AND WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688015 ↗
• InjuryFeb 27, 2026Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29 MM SAPIEN 3 VALVE, THE 29 MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED AT THE END OF INFLATION. BLOOD WAS SEEN IN THE SYRINGE. THE VALVE WAS NOTED TO HAVE DEPLOYED APPROPRIATELY AND WAS EXPANDED. A POST-DILATION WAS NOT NEEDED. THERE WAS DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM THROUGH THE 16FR ESHEATH+, AND A VASCULAR CUTDOWN WAS PERFORMED TO REMOVE THE SYSTEM. THE PERCEIVED ROOT CAUSE OF THE BALLOON RUPTURE WAS REPORTED TO BE ANNULAR CALCIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470922 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY LEFT TRANSFEMORAL APPROACH, THE VALVE COULD NOT BE FULLY DEPLOYED BECAUSE THE BALLOON FAILED TO RECEIVE NOMINAL INFLATION VOLUME. VALVE AND DELIVERY SYSTEM WERE PREPPED NORMALLY (NOMINAL VOLUME). DURING INITIAL VALVE DEPLOYMENT, VALVE EXPANDED APPROXIMATELY 60-70% WHEN THE IMPLANTER NOTED HE WAS AT FULL VOLUME ON THE ATRION. THE BALLOON WAS DEFLATED. VALVE WAS ANCHORED SECURELY IN ANNULUS BY EXISTING CALCIFICATION. ATRION WAS RELOADED WITH NOMINAL VOLUME FOR A 29MM VALVE (33ML) AND A SECOND INFLATION/POST-DILATION WAS ATTEMPTED. AT THIS TIME, IT WAS NOTED THAT CONTRAST WAS EXITING THE DELIVERY SYSTEM NEAR THE CONNECTION BETWEEN THE FINE ADJUSTMENT WHEEL AND THE BALLOON CATHETER. THIS DELIVERY SYSTEM WAS REMOVED. A SECOND DELIVERY SYSTEM WAS PREPPED WITH THE SAME ATRION TO NOMINAL VOLUME (33ML) AND SUCCESSFUL INFLATION/EXPANSION OF THE VALVE WAS ACHIEVED. THERE WERE NO ABNORMALITIES NOTED DURING PREP, NO RESISTANCE DURING DELIVERY SYSTEM INSERTION THROUGH THE SHEATH, SLOW INFLATION/DEFLATION TIME, ASYMMETRICAL INFLATION, WITHDRAWAL DIFFICULTIES WITH THE DELIVERY SYSTEM AND/OR S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457850 ↗
• MalfunctionFeb 13, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29 MM SAPIEN 3 VALVE, THE 29 MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED "VERTICALLY" TOWARDS THE END OF VALVE DEPLOYMENT DUE TO SINOTUBULAR JUNCTION (STJ) CALCIUM. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. A SECOND 29 MM COMMANDER DELIVERY SYSTEM WAS PREPPED AND USED TO POST-DILATE THE VALVE WITH THE SAME AMOUNT OF VOLUME WITH AN ADDITIONAL 2 CC TO ENSURE THE VALVE WAS FULLY DEPLOYED. IT WAS NOTED THAT THE BALLOON WAS LINED UP LOWER IN THE VALVE FOR THE POST-DILATION. THE PATIENT WAS STABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333927 ↗
• InjuryDec 12, 2025Fluid/Blood Leak; Difficult to Remove; Fluid/Blood Leak; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING DEPLOYMENT OF A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON BURST DURING DEPLOYMENT AND THE VALVE EMBOLIZED. DURING INFLATION, THE BALLOON RUPTURED, AND BLOOD WAS OBSERVED IN THE SYRINGE. THE VALVE WAS NOT ABLE TO BE FULLY DEPLOYED AND REMAINED APPROXIMATELY 20-30% EXPANDED. THE DELIVERY SYSTEM COULD NOT BE WITHDRAWN THROUGH THE PARTIALLY DEPLOYED VALVE DESPITE MULTIPLE ATTEMPTS. WHILE ATTEMPTING TO MAINTAIN WIRE AND VALVE POSITION DURING REMOVAL, THE VALVE EMBOLIZED TO THE DESCENDING AORTA. CONTRALATERAL ACCESS WAS OBTAINED, AND A WIRE WAS ADVANCED THROUGH THE EMBOLIZED VALVE. A 28 MM TRUE BALLOON WAS THEN ADVANCED OVER THE WIRE AND USED TO FULLY DEPLOY THE 29 MM VALVE IN THE DESCENDING AORTA. FOLLOWING THIS MANEUVER, THE DELIVERY SYSTEM WAS REMOVED AND A NEW 29 MM SAPIEN 3 VALVE WAS IMPLANTED. THE PATIENT REMAINED IN STABLE CONDITION AT THE END OF THE PROCEDURE. NO PATIENT INJURY OR MAJOR VASCULAR COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23795258 ↗
• InjuryNov 25, 2025Material Fragmentation; Difficult to Remove; Material Split, Cut or Torn; Material Fragmentation; Difficult to Remove; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT UNDERWENT A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION. ONCE THE VALVE WAS POSITIONED FOR FINAL DEPLOYMENT AND FAST PACING BEGUN, IT WAS NOTED THERE WAS NO FLUID MAKING IT INTO THE BALLOON DUE TO A BALLOON TEAR. THE VALVE STAYED CRIMPED ONTO THE DELIVERY SYSTEM AND WAS ATTEMPTED TO BE WITHDRAWN AS A SINGLE UNIT, BUT THE VALVE WOULD NOT ENTER THE ESHEATH+. IN RESPONSE, THE SYSTEM WAS MOVED DOWN INTO THE FEMORAL ARTERY FOR CUT-DOWN. DURING REMOVAL, THE DELIVERY SYSTEM SEPARATED FROM THE VALVE AND BALLOON, THE INTERNAL INFLATION LUMEN BECAME LODGED IN THE PATIENT'S ILIAC, AND THE VALVE HAD BECOME STUCK. ULTIMATELY, ALL THE DEVICES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649750 ↗
• InjurySep 18, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING DEVICE WITHDRAWAL AFTER VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON WAS STUCK AT THE ACCESS SITE, AS IT WAS NOT FULLY RETRACTED INTO THE SHEATH. A FEMORAL CUTDOWN WAS PERFORMED, AND THE VESSEL WAS REPAIRED WITH A PATCH. SUBSEQUENTLY, THE PATIENT DEVELOPED A COLD LEG, AND AN EMBOLECTOMY WAS PERFORMED.

  Patient problems: Embolism/Embolus

  MAUDE report 23084783 ↗
• DeathSep 12, 2025Difficult or Delayed Positioning; Difficult to Remove; Device Slipped; Difficult or Delayed Positioning; Difficult to Remove; Device Slipped

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, VALVE ALIGNMENT WAS OFF DUE TO TORTUOUS ANATOMY. VALVE ALIGNMENT DIFFICULTY OCCURRED THROUGHOUT EVERY LOCATION IN THE ABDOMINAL AORTA. IT WAS VERY DIFFICULT TO FIND A STRAIGHT PORTION FOR ALIGNMENT. ISSUES OCCURRED DURING FINE ADJUSTMENT. VALVE WAS BETWEEN THE VALVE MARKERS BEFORE WE CROSSED THE ANNULUS. AFTER CROSSING ANNULUS, WE ATTEMPTED TO PARTIALLY INFLATE THEN GO DOWN ON BALLOON, REPOSITION AND FINISH INFLATION. THE VALVE BECAME UNDER ALIGNED. IT WAS DETERMINED TO DEPLOY WITH THE UNDERSTANDING IT WOULD BE A LONG PACING RUN TO GIVE TIME TO ADJUST THE BALLOON AFTER PARTIAL INFLATION. THE VALVE WAS NOT DEPLOYED IN THE INTENDED LOCATION. VALVE SLIGHTLY EMBOLIZED AORTIC (100/0) BALLOON WOULD NOT ADJUST. INFLATION WAS STOPPED TO KEEP VALVE FROM MIGRATING HIGHER IN AORTA. LONG PACING RUN SENT PATIENT INTO VT (VENTRICULAR TACHYCARDIA). COULD NOT STABILIZE THE PATIENT AFTER 30 MINUTES OF CODING. THE PATIENT EXPIRED. THE VALVE WAS STUCK ON THE BALLOON AND TRAVELED BACK INTO THE FEMORAL ARTERY AFTER THE PATIENT EXPIRED. THE SYSTEM WAS CUT TO GET DELIVERY SYSTEM OUT OF THE BODY. PER CLARIFICAT

  Patient problems: Arrhythmia; Foreign Body In Patient

  MAUDE report 23039073 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  AS REPORTED BY THE FCS, A 79-YEAR-OLD MALE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE VIA TRANSFEMORAL ACCESS THROUGH THE RIGHT FEMORAL ARTERY. THE PATIENT HAD A HISTORY OF SEVERE AORTIC STENOSIS (SAS) AND ENDOVASCULAR ANEURYSM REPAIR (ELG FOR AAA). THE PROCEDURE INVOLVED IMPLANTING A 29 MM SAPIEN 3 VALVE IN THE NATIVE TRI-LEAFLET AORTIC POSITION. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE, AND THE VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT EVIDENCE OF CENTRAL LEAK. DURING THE PROCEDURE, A DEVICE-RELATED ISSUE OCCURRED INVOLVING THE DELIVERY SYSTEM. WHILE ADVANCING THE SYSTEM THROUGH THE AORTIC ARCH, A KINK WAS OBSERVED IN THE DELIVERY SYSTEM. UPON CROSSING THE VALVE AND ATTEMPTING TO RETRACT THE PUSHER TO THE SECOND MARKER AS PER THE INSTRUCTIONS FOR USE (IFU), THE PUSHER COULD NOT BE PULLED PAST THE FIRST MARKER. NEGATIVE PRESSURE WAS APPLIED TO THE ATRION DEVICE, AND BLOOD WAS OBSERVED ENTERING THE SYSTEM. BASED ON THESE FINDINGS, THE PHYSICIAN ELECTED TO ABORT THE DEPLOYMENT AND REMOVED THE VALVE, DELIVERY SYSTEM, AND ESHEATH FROM THE PATIENT'S BODY. THE DELIVERY SYSTEM IS BEING RETURNED FOR EVALUATION, AND A BIOKIT HAS BEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018880 ↗
• MalfunctionSep 9, 2025Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED ON A PATIENT USING A 29 MM EDWARDS SAPIEN 3 VALVE IN THE AORTIC POSITION. THE PROCEDURE WAS CONDUCTED VIA TRANSFEMORAL ACCESS, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED IN STABLE CONDITION AND WAS DISCHARGED FOLLOWING THE PROCEDURE. NO CENTRAL LEAK WAS OBSERVED, AND NO PATIENT INJURY OCCURRED. DURING VALVE DEPLOYMENT, THE BALLOON "RUPTURED" AT THE POINT OF MAXIMUM INFLATION. DESPITE THE "RUPTURE", THE FULL NOMINAL VOLUME WAS DELIVERED, RESULTING IN A MODERATE LEAK AND A MEAN GRADIENT OF 5 MMHG. A SECOND DELIVERY SYSTEM WAS PREPARED, AND THE BALLOON WAS INFLATED TO FULL VOLUME, WHICH RESULTED IN A MILD TO TRACE LEAK WITH THE SAME GRADIENT. THE DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY THROUGH A 16 FRENCH SHEATH, AND ALL COMPONENTS WERE ACCOUNTED FOR. THE BALLOON REMAINED INTACT UPON REMOVAL. THE PHYSICIAN INDICATED THAT THE RUPTURE WAS MOST LIKELY CAUSED BY CALCIUM AT THE SINOTUBULAR JUNCTION (STJ) CATCHING THE SHOULDERS OF THE BALLOON. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER, AND NO LEAK WAS OBSERVED IN THE DELIVERY SYSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000241 ↗
• MalfunctionAug 20, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE DELIVERY SYSTEM BALLOON RUPTURED DURING INFLATION, AND THERE WAS DIFFICULTY REMOVING THE DELIVERY SYSTEM. THE PATIENT HAD A PREVIOUSLY IMPLANTED 23MM HOMOGRAFT AND WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB FOR TREATMENT OF A DYSFUNCTIONAL RIGHT VENTRICLE/PULMONARY ARTERY CONDUIT WITH REGURGITATION. SERIAL ANGIOPLASTY WAS PERFORMED USING A 24MM ATLAS GOLD BALLOON, FOLLOWED BY A 26MM ATLAS GOLD BALLOON WHICH RUPTURED AT 14 ATMOSPHERES, AND THEN A 28MM TRUE BALLOON. A 29MM TRANSCATHETER HEART VALVE WAS CRIMPED ONTO A DELIVERY SYSTEM BALLOON, AND A PALMAZ P5010 STENT WAS MOUNTED DIRECTLY ON THE VALVE (''PIGGYBACKED''). DURING INFLATION, THE DELIVERY SYSTEM BALLOON RUPTURED; HOWEVER, THE VALVE REMAINED STABLE, THOUGH UNDER-DEPLOYED IN THE ANATOMY. THE RUPTURED DELIVERY SYSTEM WAS REMOVED WITH SOME DIFFICULTY. A NEW 28MM TRUE BALLOON WAS THEN USED TO POST-DILATE THE VALVE AT 6 ATMOSPHERES. FINAL ANGIOGRAPHY SHOWED NO HEMODYNAMIC GRADIENT AND NO PULMONARY REGURGITATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, SHEATHS WERE REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853680 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE COMMANDER DELIVERY SYSTEM FLEX TIP SEPARATED FROM THE FLEX SHAFT DURING WITHDRAWAL OF THE DELIVERY SYSTEM. THE PATIENT HAD A HISTORY OF ABDOMINAL AORTIC ANEURYSM (AAA) GRAFTS. THE 16FR ESHEATH+ WAS NOT INSERTED AT A STEEP ANGLE. HOWEVER, THERE WAS DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. DURING ADVANCEMENT OF THE VALVE THROUGH THE EXPANDABLE PORTION OF THE SHEATH, SOME PUSH FORCE WAS REQUIRED, BUT THE PROCEDURE PROCEEDED NORMALLY. THE VALVE WAS SUCCESSFULLY IMPLANTED IN THE INTENDED POSITION. DURING WITHDRAWAL OF THE COMMANDER DELIVERY SYSTEM INTO THE SHEATH, SLIGHT RESISTANCE WAS ENCOUNTERED. THERE WAS A SMALL AMOUNT OF RETAINED VOLUME IN THE BALLOON. THE INTERVENTIONAL CARDIOLOGIST (IC) PAUSED AND WITHDREW ADDITIONAL VOLUME FROM THE INDEFLATOR, WHICH FACILITATED COMPLETE REMOVAL OF THE SYSTEM FROM THE SHEATH. WHILE WALKING BACK TO THE TABLE WITH THE DELIVERY SYSTEM, THE FIELD CLINICAL SPECIALIST OBSERVED THAT THE FLEX TIP HAD SEPARATED FROM THE FLEX SHAFT. THE IC AND TEAM WERE INFORMED. NO DAMAGE TO THE SHEATH WAS REPORTED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806737 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  AS REPORTED THROUGH A REVIEW OF MEDICAL RECORDS RECEIVED THROUGH OUR SURGICAL VALVE TEAM, DURING DEPLOYMENT OF A 29MM SAPIEN 3 VALVE IN AN EDWARDS SURGICAL VALVE IN THE PULMONIC POSITION, THE DISTAL PORTION OF THE BALLOON INFLATED SIGNIFICANTLY BEFORE THE PROXIMAL PORTION OF THE BALLOON INFLATED. THE VALVE WAS NICELY IMPLANTED ACROSS THE BIOPROSTHETIC VALVE AS INTENDED. AFTER A REVIEW OF MEDICAL RECORDS PROVIDED, THE PATIENT UNDERWENT A THV IN SURGICAL VALVE IN THE PULMONIC POSITION. A LONG DRYSEAL SHEATH WAS USED VIA RFV. PRE-DILATION WITH A NON-EW BALLOON RESULTED WITH SURGICAL VALVE RING FRACTURE. A 29MM S3UR VALVE WITH 2+SS WAS DEPLOYED WITHIN THE PRE-EXISTING SURGICAL VALVE. PER RECORDS, 'INTERESTINGLY, THE DISTAL PORTION OF THE BALLOON INFLATED SIGNIFICANTLY BEFORE THE PROXIMAL POSITION OF THE BALLOON INFLATED. HOWEVER, WE ENDED UP WITH A NICE IMPLANT.' MEAN GRADIENT BETWEEN 3 AND 4 MMHG. THE PROCEDURE ENDED WITH NO REPORTED COMPLICATIONS, MALFUNCTIONS OF AN EW OR SERIOUS INJURY. NO REPORT OF WHAT CAUSED THE BALLOON TO INFLATE UNEVENLY NOR IF THE PATIENT HAD ANY SEQUELA DUE TO THE BALLOON INFLATION.

  Patient problems: Insufficient Information

  MAUDE report 22634988 ↗
• InjuryJul 7, 2025Difficult to Remove; Device Slipped; Difficult to Remove; Device Slipped

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE (S3), THE PATIENT WAS BROUGHT DOWN TO THE CATH LAB FOR A TPVR. INITIALLY THE PLAN WAS TO GO RIJ AND BALLOON SIZE THE ANNULUS. AFTER BALLOONING, THE DECISION FOR A 29 S3 WAS MADE. AFTER MULTIPLE TRIES UTILIZING THE NON-EDWARDS SHEATH THAT WAS IN THE RIJ, THE DECISION TO ABORT AND GO RFA DUE TO TORTUOSITY. WHILE TRYING TO REMOVE THE 29 S3 AND COMMANDER SYSTEM, THE COMMISSURES ON THE VALVE FRAME, WE BELIEVE, DID NOT ALLOW FOR THE VALVE TO BE PULLED BACK INTO THE NON-EDWARDS SHEATH AND UNDER FLUOROSCOPY, THE TEAM VISUALIZED THE VALVE BEING PUSHED OFF THE BALLOON OF THE COMMANDER SYSTEM. AFTER STOPPING WE WERE ABLE TO SNARE THE VALVE FOR PROTECTION THROUGH THE RFA AND WERE ABLE TO PULL THE COMMANDER SYSTEM, THE 29 S3, AND THE SHEATH OUT OF THE RIJ. VALVE NEVER EMBOLIZED IN THE PT. BODY. ACCESS SITE WAS DRY AND HEMATOMA FREE. ONCE SWITCHING TO THE GROIN, A NEW 29MM S3 WAS PREPPED AND DEPLOYED WITH NO ISSUES. PER THE FCS THE DEVICE WAS NOT DAMAGED TO THE EYE, BUT NOTICED THE VALVE WAS SLIPPING OFF THE BALLOON DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413514 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE OFF-LABEL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 29 MM SAPIEN 3 VALVE IN THE MITRAL ANNULAR CALCIFICATION (MAC), THERE WAS DIFFICULTY CROSSING THE SEPTUM WITH THE 29 MM COMMANDER DELIVERY SYSTEM AND VALVE. IT WAS NOTED THAT ACCESS HAD BEEN OBTAINED WITHOUT ANY ISSUES. PRIOR TO ATTEMPTING TO CROSS THE SEPTUM, THE SEPTUM WAS CROSSED AND DILATED WITH A 12 MM NON-EDWARDS BALLOON. THE COMMANDER DELIVERY SYSTEM AND VALVE WERE ABLE TO BE INSERTED WITHOUT ANY ISSUES. THE VALVE WAS ALSO ABLE TO BE ALIGNED ON THE BALLOON WITHOUT ANY ISSUES. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO CROSS THE SEPTUM, A DECISION WAS MADE TO LEAVE THE VALVE ON THE COMMANDER DELIVERY SYSTEM IN THE RIGHT ATRIUM (RA) AND USE ANOTHER ACCESS SITE TO CROSS THE SEPTUM AND IT WAS THEN DILATED WITH A 16 MM NON-EDWARDS BALLOON. THE COMMANDER DELIVERY SYSTEM AND VALVE WERE ABLE TO CROSS THE SEPTUM WITHOUT ANY ISSUES. SUBSEQUENTLY, WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON IN THE MITRAL ANNULUS, IT WAS DISCOVERED THAT THE BALLOON HAD "RUPTURED". THE SYSTEM WAS WITHDRAWN, AND A NEW 29 MM SAPIEN 3 VALVE WAS PREPPED ALONG WITH A NEW 29

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294224 ↗
• MalfunctionMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM SAPIEN 3 VALVE WAS TO BE IMPLANTED IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. THE VALVE AND 29MM COMMANDER DELIVERY SYSTEM WERE ADVANCED WITHOUT ISSUE. THE VALVE WAS ALIGNED IN A STRAIGHT SEGMENT OF THE DESCENDING AORTA PER IFU WITHOUT DIFFICULTY. THE VALVE AND DELIVERY SYSTEM WERE POSITIONED IN THE ANNULUS AND PACING WAS STARTED. WHEN THE OPERATOR TRIED TO DEPLOY THE VALVE, THE BALLOON DID NOT INFLATE. WHEN THEY PULLED NEGATIVE, BLOOD WAS OBSERVED IN THE INFLATION DEVICE. THE VALVE, DELIVERY SYSTEM, AND SHEATH WERE REMOVED WITHOUT DIFFICULTY AND WITH NO PATIENT COMPLICATION. A NEW 29MM SAPIEN 3 VALVE AND NEW COMMANDER DELIVERY SYSTEM WERE PREPARED AND DEPLOYED SUCCESSFULLY. THE PATIENT IS STABLE.UPON REMOVAL OF THE DELIVERY SYSTEM, A BALLOON TEAR WITH IC BOND BREAK WAS OBSERVED. LEAKING WAS SEEN OUT OF THE PROXIMAL PORTION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107657 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 4 YEARS AND 14 DAYS POST IMPLANTATION OF A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE DEVICE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. UPON REVIEWING THE MEDICAL RECORDS, IT WAS NOTED THAT DURING THE EXPLANT, THE VALVE STRUT HAD DAMAGED THE INTIMA NEAR THE SINOTUBULAR JUNCTION (STJ) ALONG THE LEFT CORONARY CUSP OF THE AORTA. THIS DAMAGE WAS REPAIRED WITH TWO PLEDGETED SUTURES. HOWEVER, IT IS UNCLEAR FROM THE MEDICAL RECORDS WHETHER THE DAMAGE OCCURRED DURING THE INDEX PROCEDURE OR AS A RESULT OF THE EXPLANT PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 21683794 ↗
• MalfunctionMar 13, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT UNDERWENT A TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION. DURING THE PROCEDURE, THE BALLOON TO THE 29MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED AT FULL VOLUME DUE TO THE PRESENCE OF MODERATE SINOTUBULAR JUNCTION (STJ) CALCIUM. THE DS WAS REMOVED THROUGH THE ESHEATH+ WITHOUT ISSUE. PER REPORT, THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602066 ↗
• MalfunctionMar 6, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, 29MM COMMANDER DELIVERY SYSTEM BALLOON HAD A VERTICAL RUPTURE AT THE END OF DEPLOYMENT DURING A TRANSFEMORAL TAVR WITH A 29MM SAPIEN 3 VALVE. APPROXIMATELY +1CC ABOVE NOMINAL WAS ADDED TO THE DELIVERY SYSTEM BALLOON PRIOR TO INFLATION. THE VALVE WAS ABLE TO BE FULLY DEPLOYED. THE DELIVERY SYSTEM WAS ABLE TO BE WITHDRAWN THROUGH THE 16FR ESHEATH+ WITHOUT DAMAGE, COMPLICATIONS, OR VASCULAR BLEEDING TO THE PATIENT. PATIENT WAS IN STABLE CONDITION AT THE END OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542865 ↗
• DeathFeb 21, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED BY AN EDWARDS FIELD CLINICAL SPECIALIST, DURING THE TAVR PROCEDURE, THERE WERE COMPLICATIONS, INCLUDING MAJOR BLEEDING AND DIFFICULTY USING THE DEVICE. ADDITIONALLY, THERE WAS A MAJOR VASCULAR COMPLICATION AT THE ACCESS SITE. THIS VASCULAR COMPLICATION LED TO THE PATIENT'S DEATH AND NECESSITATED UNPLANNED SURGERY. PER A VOLUNTARY MEDWATCH, THE COMMANDER DELIVERY SYSTEM COULD NOT BE WITHDRAWN THROUGH THE ESHEATH, AND THE SHEATH LAYERS WERE SEPARATED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21437494 ↗
• InjuryJan 31, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING TRICUSPID VALVE IN RING PROCEDURE VIA JUGULAR APPROACH WITH A 29MM SAPIEN 3 VALVE, PLASTIC OF BALLOON FROM FIRST 29MM COMMANDER DELIVERY SYSTEM HAD DIFFICULTY WITH REMOVAL FOLLOWING VALVE IMPLANT. THE PHYSICIAN PULLED NEGATIVE WITH 20 CC SYRINGE WITH BALLOON COLLAPSE AND WAS ABLE TO MOVE THE FIRST DELIVERY SYSTEM. AFTER IMPLANTATION OF THE FIRST VALVE THERE WAS TRIVIAL CENTRAL LEAK, MILD PARAVALVULAR LEAK AND SEPTAL OUTPOUCHING WITH LEAK COMMUNICATING BETWEEN OPEN CELLS AND RVOT REQUIRING A SECOND 29MM SAPIEN 3 VALVE. THE SECOND VALVE WAS PREPPED PER STANDARD FASHION, NO DIFFICULTY SLIDING INTRODUCER CAP ON, AND THE VALVE WAS DEPLOYED WITHOUT ISSUE. WE COULD SEE DISPLACEMENT OF THE SHEATH MARKER WITH RETRACTING THE SECOND DELIVERY SYSTEM THROUGH THE SHEATH BUT THE SHEATH COULD BE SEEN ON ECHO TO BE IN PLACE IN THE SVC. THE SHEATH AND DELIVERY SYSTEM WERE REMOVED AS ONE UNIT WITH EXPANSION OF THE SKIN KNICK. A SECOND SHEATH WAS PLACED FOR HEMOSTASIS. ON VISUAL INSPECTION THE CLEAR EXPANSION MEMBRANE OF THE FIRST SHEATH HAD TORN ABOUT 4 CM WITH THE BALLOON OF THE SECOND DELIVERY SYSTEM CAUGHT ON THE END. THE METAL MARKER WAS CO

  Patient problems: Hematoma

  MAUDE report 21284705 ↗
• MalfunctionJan 30, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING IMPLANT OF A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 29MM COMMANDER DELIVERY SYSTEM BALLOON BURST UPON COMPLETE OR NEAR-COMPLETE DEPLOYMENT. NO ADDITIONAL VOLUME WAS ADDED TO THE DELIVERY SYSTEM BALLOON PRIOR TO INFLATION. SIGNIFICANT SINOTUBULAR JUNCTION CALCIUM AND ANNULAR CALCIUM WAS NOTED ON THE CT REPORT. THERE WAS DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM BALLOON INTO THE TIP OF THE 16FR ESHEATH+. THE BALLOON WAS CAREFULLY PULLED INTO THE SHEATH, AND THE ENTIRE SYSTEM WAS REMOVED. IT WAS OBSERVED THAT THE SHEATH HAD BEEN DAMAGED DURING THE WITHDRAWAL OF THE DELIVERY SYSTEM. IMAGES PROVIDED OF THE DEVICE SHOW SHEATH LINER DELAMINATION. ANGIOGRAM OF ILIAC SYSTEM TAKEN REVEALED INTACT VESSEL. THE ACCESS SITE WAS PERCLOSED IN NORMAL FASHION AND PATIENT LEFT OR IN STABLE CONDITION. THE PHYSICIANS ARE CONFIDENT THE FAILURE WAS DUE TO PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280011 ↗
• MalfunctionDec 6, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST DURING A TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA VALVE, THE 29MM COMMANDER DELIVERY SYSTEM BALLOON TORE DURING DEPLOYMENT. THE DEVICE WAS REMOVED WITHOUT INCIDENT. THERE WAS NO EXTRA VOLUME ADDED. PER PHOTOS PROVIDED, THE BALLOON WAS BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866105 ↗
• InjuryDec 5, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM SAPIEN 3 VALVE WAS TO BE IMPLANTED IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. THE 16FR ESHEATH+ WAS INSERTED WITHOUT ISSUE. A BAV WAS PERFORMED WITHOUT ISSUE. THERE WAS RESISTANCE WHEN INSERTING THE COMMANDER DELIVERY SYSTEM THROUGH THE EXPANDABLE PORTION OF THE SHEATH. IT WAS NOTICED THAT THE DELIVERY SYSTEM WAS STUCK WITHIN THE SHEATH AT THE AREA OF THE AORTA-ILIAC BIFURCATION. AN INJECTION SHOWED EXTRAVASATION AND WHAT SEEMED LIKE THE VALVE BEING OUTSIDE OF THE LINER OF THE SHEATH. ATTEMPTS AT BUDDY BALLOON, SNARING, PUSHING AND PULLING THE SHEATH, AND TURNING THE DELIVERY SYSTEM TO FREE THE VALVE WERE PERFORMED. AT THIS POINT THE PUSHER AND THE VALVE WERE NO LONGER TOUCHING, HOWEVER, THE VALVE REMAINED CRIMPED ON THE BALLOON. THE PATIENT'S BLOOD PRESSURE BEGAN TO SOFTEN, SO VASCULAR SURGERY WAS CALLED. THE PATIENT WAS RECEIVING BLOOD PRODUCTS AND INCREASING SUPPORT. AS THE DELIVERY SYSTEM COULD ONLY MOVE FORWARD, THE DEVICES COULD NOT BE WITHDRAWN. VASCULAR SURGERY WAS ABLE TO PULL THE SHEATH BACK A FAIR AMOUNT, WHICH ALLOWED THE DELIVERY SYSTEM AND VALVE TO BE PUSHED THROUGH THE TIP OF THE SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 20859565 ↗