EDWARDS COMMANDER DELIVERY SYSTEMRecalls & reported problems across all models

We found 4 models of EDWARDS COMMANDER DELIVERY SYSTEM by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 261 adverse event reports in the FDA's MAUDE database, received between May 17, 2017 and Apr 22, 2026 — classified as 19 deaths, 116 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (103 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EDWARDS COMMANDER DELIVERY SYSTEM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 22, 2019Class IITerminated

   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 · names 4 of these models · Recall details · FDA record ↗

Most reported EDWARDS COMMANDER DELIVERY SYSTEM problems

EDWARDS COMMANDER DELIVERY SYSTEM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall17 deaths225 reports
• EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall1 death25 reports
• EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall1 death6 reports
• EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 recall5 reports

Recent EDWARDS COMMANDER DELIVERY SYSTEM adverse event reports

The 15 most recent reports across all models, 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 30, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR (TRANSCATHETER PULMONIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 (S3) VALVE IN A PRE-EXISTING SURGICAL VALVE, THE BALLOON TO THE 26MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED WHILE THE S3 VALVE WAS BEING INFLATED AT +2ML NOMINAL VOLUME. THE DS WAS RETRIEVED THROUGH THE NON-EDWARDS SHEATH AND NO REMNANTS OF THE FRACTURED BALLOON WERE LEFT BEHIND IN THE PATIENT. NO DAMAGE TO THE S3 VALVE WAS NOTED. THE DS IS NOT AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714794 ↗
• 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 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST THAT DURING A TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT TPVR WITH A 26MM SAPIEN 3 VALVE, THE PULMONARY ARTERY CONDUIT WAS PRE-STENTED WITH A NON-EDWARDS CAORCTATION (CP) COVERED STENT THEN A NON-EDWARDS PERIPHERAL STENT WAS IMPLANTED INSIDE THAT. THEN OUR 26MM SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED IN THAT, BUT POST- DEPLOYMENT ASSESSMENT REVEALED A HIGHER-THAN-EXPECTED GRADIENT THAT WAS SUB VALVULAR. AN ANGIOGRAM REVEALED THERE WAS A CONTAINED RUPTURE OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AT THE LEADING EDGE OF THE STENTS. THE PHYSICIAN THEN IMPLANTED A LONG 6CM CP COVERED STENT THROUGHOUT THE PULMONARY ARTERY, COVERING THE NEWLY PLACED VALVE, LEAVING ABOUT 1CM OUT OF THE PROXIMAL END OF THE FIRST STENTS. THIS WAS AN ATTEMPT TO COVER THE TEAR/RUPTURE. THE PHYSICIAN THEN PLACED THIS 6CM STENT AND POST DILATED WITH A 30MM NON-EDWARDS CATHETER FOR APPOSITION. POST ANGIOGRAM SHOWED THAT THE RUPTURE WAS COVERED AND THERE WAS NO EXTRAVASATION. THE PHYSICIAN THEN NEEDED TO PLACE A SECOND VALVE INSIDE THE OTHER IMPLANTS AND DID THIS USING A 29MM SAPIEN 3 VALVE. THIS IS THE FUNCTIONING VALVE IN THE PATIENT. THE PATIENT

  Patient problems: Cardiac Perforation

  MAUDE report 23863102 ↗
• 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 ↗
• MalfunctionNov 21, 2025Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT DURING A TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT TPVR WITH A 26MM SAPIEN 3 VALVE, DURING VALVE DEPLOYMENT THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON BURST WHILE IMPLANTING THE VALVE. THE VALVE WAS IMPLANTED WITH ADDITIONAL VOLUME ADDED TO THE DELIVERY SYSTEM RECOMMENDED NOMINAL VOLUME +2CC WAS ADDED IN ORDER TO ACHIEVE A "SNUG FIT". FIRST THE IMPLANTER WENT WITH NOMINAL VOLUME, THEN KEPT ADDING VOLUME BETWEEN +1CC AND +2CC, WHICH IS WHEN THE BALLOON BURST. THERE WAS SOME DIFFICULTY WITHDRAWING THE BALLOON INTO THE GORE DRYSEAL SHEATH AS IT WAS GETTING STUCK AT THE TIP, SO THE SYSTEM WAS REMOVED FROM THE PATIENT AS ONE UNIT, AS INSTRUCTED IN THE DEVICE TRAINING MANUALS. DURING MANIPULATION OF THE DEVICES ON THE BACK TABLE, THE DELIVERY SYSTEM WAS PULLED FROM THE SHEATH, AND A PIECE OF THE BALLOON HAD SEPARATED. IT WAS THEN FOUND THAT THE BALLOON HAD SEPARATED. THE ROOT CAUSE OF THE BALLON BURST IS PERCEIVED TO BE THE EXTRA INFLATION ADDED TO THE BALLOON. THERE WAS NO PATIENT INJURY, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616431 ↗
• MalfunctionOct 21, 2025Crack; Crack

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 20MM SAPIEN 3 VALVE IN THE MITRAL POSITION. WHEN THE 20MM SAPIEN 3 VALVE AND 20MM COMMANDER DELIVERY SYSTEM WERE INSERTED INTO THE GORE DRYSEAL, THE IMPLANTING PHYSICIAN SAID HE FELT A CRACK IN THE COMMANDER DELIVERY SYSTEM CATHETER. UPON REMOVAL OF THE FIRST DELIVERY SYSTEM AND VALVE, IT WAS NOTICED THAT ALL THE FLEX WAS NOT TAKEN BACK OUT OF THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY. A SECOND 20MM SAPIEN 3 VALVE AND 20MM COMMANDER DELIVERY SYSTEM WERE USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347669 ↗
• 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 ↗

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