Edwards eSheath+ Introducer set 914ESPRecalls & reported problems

Summary

The FDA's MAUDE database contains 532 adverse event reports that list this exact device (DI 00690103215465), received between Dec 13, 2021 and Jun 1, 2026 — classified as 22 deaths, 149 injuries, 361 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (240 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 532 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED IN A FAILED NON-EDWARDS VALVE(26MM). THE PATIENT WAS TAKEN TO THE CATH LAB AFTER SOMETIME POST PROCEDURE FOR A PERFORATION IN THE LEFT COMMON ILIAC REQUIRING PLACEMENT OF A COVERED STENT AND WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 25349882 ↗
• MalfunctionMay 22, 2026Material Puncture/Hole

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE FIRST VALVE GOT CAUGHT IN THE ESHEATH. THE ENTIRE SYSTEM WAS REMOVED AND A 2ND VALVE AND DELIVERY SYSTEM WAS PLACED WITH GOOD RESULT. DURING DELIVERY SYSTEM INTRODUCTION INTO SHEATH, THE VALVE WOULD NOT ADVANCE IN THE SHEATH. IT WAS NOTICED THAT A TINE OF THE VALVE WAS LIFTED AWAY FROM PREPPED SYSTEM AND WAS CATCHING IN THE SHEATH. UPON FOLLOW UP, THE FCS ADVISED THAT DURING A TAVR PROCEDURE, NO DIFFICULTY WAS ENCOUNTERED DURING INSERTION OF THE ESHEATH, AND THE EXPANSION TOOL (ESHEATH+) AND LOADER WERE USED APPROPRIATELY WITH FULL INSERTION ACHIEVED. THE ESHEATH WAS INTRODUCED VIA RIGHT-SIDED ACCESS AT A STEEP ANGLE. THE DELIVERY SYSTEM AND VALVE DID NOT EXIT THE SHEATH, BECOMING LODGED NEAR THE TRANSITION BETWEEN THE BLUE AND WHITE PORTIONS OF THE SHEATH. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT, AND INSPECTION IDENTIFIED A SMALL PINHOLE IN THE SHEATH. THE DEVICE HAD BEEN PREPARED AND THE VALVE CRIMPED PER IFU, WITH NO ISSUES DURING THE CRIMPING PHASE. NO VESSEL PRE-DILATION WAS PERFORMED. THE ORIGINAL SYSTEM WAS REMOVED AND REPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256658 ↗
• InjuryMay 20, 2026Patient Device Interaction Problem

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS SUCCESSFULLY DEPLOYED. UPON REMOVAL OF THE 14FR ESHEATH, A SMALL DISSECTION WAS NOTED IN THE COMMON FEMORAL ARTERY. THE IMPLANTERS STENTED THE VESSEL AN MOVED THE PATIENT TO STANDARD RECOVERY. THE PERCEIVED ROOT CAUSE WAS THOUGHT TO BE THE SHEATH CAUGHT ON TO SOME CALCIUM, WHICH CAUSED THE VESSEL TO TEAR. THERE WAS NO MENTION OF AN EDWARDS PRODUCT BEING DEFICIENT IN ANY WAY AS A RESULT OF THIS ISSUE. PATIENT IS CURRENTLY STABLE AND IN RECOVERY.

  Patient problems: Vascular Dissection

  MAUDE report 25232238 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A 26 MM EDWARDS TRANSCATHETER HEART VALVE SAPIEN 3 ULTRA RESILIA WAS IMPLANTED IN THE AORTIC POSITION. THE VALVE WAS REPORTED TO BE SUCCESSFULLY IMPLANTED, WITH NO CENTRAL LEAK OBSERVED, AND THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, A DEVICE-RELATED MALFUNCTION WAS ENCOUNTERED INVOLVING THE COMMANDER DELIVERY SYSTEM. DURING POST'DILATATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES AND 24 CC, CONSISTENT WITH REPORTED CHARACTERISTICS OF BOTH A BALLOON BURST AND BALLOON TEAR (P1 AND P2). THERE WAS NO RETAINED VOLUME IN THE BALLOON. THE PHYSICIAN NOTED THE EVENT MAY HAVE BEEN POSSIBLY RELATED TO BULKY LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM. FOLLOWING THE RUPTURE, THERE WAS DIFFICULTY WITHDRAWING THE BALLOON INTO THE 14FR ESHEATH, DESPITE COAXIAL ALIGNMENT UPON REENTRY, FULL UNFLEXING OF THE DELIVERY SYSTEM, AND THE FLEX TIP POSITIONED AT THE TRIPLE MARKER. DUE TO THE INABILITY TO WITHDRAW THE SYSTEM, THE PHYSICIAN ELECTED TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER AS A SINGLE UNIT, WHICH REQUIRED A SURGICAL CUTDOWN. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AT THE ARTERIOTOMY SITE, AND IT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210456 ↗
• MalfunctionMay 12, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. ACCESS WAS OBTAINED FROM THE LEFT SIDE. THE 14F ESHEATH PLUS WENT IN WITHOUT ISSUES. THE 26MM COMMANDER DELIVERY SYSTEM WENT IN WITHOUT ISSUES. THE 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS DEPLOYED WITHOUT ISSUES. DURING REMOVAL OF THE 14 F ESHEATH PLUS, THE SHEATH HAD SPLIT COMPLETELY THROUGH AND THE INTRODUCER WAS STICKING OUT THROUGH THE SPLIT. THE PATIENTS PERIPHERALS WERE FINE AFTER THE PROCEDURE AND NO HARM DONE TO THE PATIENT. IMAGERY WAS PROVIDED FOR REVIEW AND THE PICTURE PROVIDED SHOWED A LINER TEAR. THE DEVICE WAS RETURNED FOR EVALUATION AND THE PRE DECONTAMINATION OBSERVATIONS SHOWED A DISTAL TIP SPLIT ON THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151083 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT WENT INTO COMPLETE HEART BLOCK AFTER THE AORTIC VALVE WAS CROSSED WITH A WIRE REQUIRING A TVP PLACEMENT. DURING VALVE DEPLOYMENT, BALLOON RUPTURE WAS NOTED. PHYSICIAN WAS ABLE TO GET THE RUPTURED BALLOON BACK INTO THE SHEATH AND TAKE EVERYTHING OUT AS A UNIT. DURING ASSESSMENT IT WAS NOTED THAT THE NOSE CONE ALONG WITH THE PART OF THE RUPTURED BALLOON WERE LEFT IN THE BODY. BOTH THE NOSE CONE AND PART OF THE RUPTURED BALLOON WERE THEN RETRIEVED USING A SNARE. DUE TO VASCULAR INJURY AND UNCONTROLLED BLEEDING, CUTDOWN WAS PERFORMED FOR REPAIR AND HEMOSTASIS WAS ACHIEVED. PATIENT DEPARTED THE HYBRID LAB IN STABLE CONDITION. UPON FOLLOW UP, THE FCS ADVISED THAT DURING THE PROCEDURE, A BALLOON-RELATED COMPLICATION WAS OBSERVED INVOLVING THE DELIVERY SYSTEM. THE EVENT INITIALLY PRESENTED AS A RADIAL BALLOON BURST (P1) AND SUBSEQUENTLY PROGRESSED TO A BALLOON TEAR (P2) AS THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE BODY IN CONJUNCTION WITH THE SHEATH. AT THE TIME OF THE INITIAL BURST, THE BALLOON AND NOSE CONE REMAINED INTACT AS A SINGLE UNIT; HOWEVER, DURING DEVICE REMOVAL, THE ASSEMBLY SEPARATED INTO TWO PIECES. THE NOSE CON

  Patient problems: Insufficient Information

  MAUDE report 25143362 ↗
• MalfunctionMay 5, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA RIGHT TRANSFEMORAL ARTERY, THE 14F ESHEATH+ WAS FOUND TO HAVE A DISTAL TIP TEAR UPON REMOVAL OF IT. THERE WAS NO RESISTANCE DURING INSERTION OR REMOVAL OF THE DEVICES. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25079691 ↗
• MalfunctionMay 4, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. AFTER THE VALVE WAS SUCCESSFULLY DEPLOYED, UPON REMOVAL OF THE ESHEATH, A PORTION OF THE DISTAL SHEATH AT THE RADIOPAQUE BAND WAS NOTED TO BE PARTIALLY DETACHED. WHEN FOLDED FLAT, THE PARTIAL FLAP APPEARED TO REPRESENT THE COMPLETE SHEATH. POST-PROCEDURE IMAGING OF THE ACCESS SITE CONFIRMED THAT NO SHEATH MATERIAL WAS PRESENT WITHIN THE PATIENT'S VASCULATURE. CT IMAGING IDENTIFIED A CALCIFIED SHELF APPROXIMATELY 3 TO 4 CM ABOVE THE ILIAC BIFURCATION IN THE AORTA. THE PHYSICIAN BELIEVED THIS CALCIFIED SHELF CONTRIBUTED TO THE SHEATH COMPROMISE. NO ALLEGATIONS OF PATIENT INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076212 ↗
• MalfunctionApr 30, 2026Peeled/Delaminated

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 2 YEARS, 1 MONTH, AND 17 DAYS POST-IMPLANT OF A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE 26 MM SAPIEN 3 ULTRA RESILIA VALVE WAS NOTED TO HAVE MODERATE PARAVALVULAR LEAK (PVL). THE OPERATOR DECIDED TO POST DILATE THE ALREADY EXISTING VALVE, WHICH THE ACCOUNT NOTED "HAS RECOILED". DURING INFLATION OF THE COMMANDER DELIVERY SYSTEM WITH +1CC OF EXTRA VOLUME, THE BALLOON RUPTURED RADIALLY AND UMBRELLAED OVER THE NOSE CONE WHILE PULLING BACK INTO THE ESHEATH+. THE DELIVERY SYSTEM WAS IMMEDIATELY BROUGHT BACK INTO THE ESHEATH+ AND REMOVED AS A UNIT. THE ESHEATH+ TIP COULD NOT BE REMOVED THROUGH THE ARTERIOTOMY, SO A VASCULAR CUTDOWN WAS NEEDED. THE POST DILATION WAS UNSUCCESSFUL AND ABORTED AFTER THE BALLOON BURST. THE PATIENT RECEIVED A 6X6MM DUCT OCCLUDER TO PLUG THE PVL. THE PATIENT LEFT THE ROOM IN STABLE CONDITION. PER IMAGERY REVIEW BY EDWARDS ENGINEER, A POSSIBLE LINER DELAMINATION WAS NOTED ON THE 14F ESHEATH+.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043034 ↗
• MalfunctionApr 28, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THE 14FR ESHEATH+ BECAME CAUGHT ON THE SKIN AS IT WAS BEING INTRODUCED INTO THE PATIENT, AND THE TIP OF THE ESHEATH+ BECAME ''DISRUPTED''. A SECOND 14FR ESHEATH+ WAS PREPPED/USED AND THE S3UR VALVE WAS SUCCESSFULLY IMPLANTED. PER REPORT, THERE WAS NO HARM TO THE PATIENT WHO WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT. THE DEVICE IS NOT AVAILABLE FOR RETURN/EVALUATION. ACCORDING TO THE PROVIDED DEVICE IMAGERY, THE DISTAL TIP OF THE ESHEATH+ APPEARED TO BE SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018673 ↗
• MalfunctionApr 27, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE ESHEATH INTRODUCER WAS NOTED TO HAVE A CIRCUMFERENTIAL TEAR AT THE DISTAL TIP WHICH WAS NOTICED AT THE COMPLETION OF THE CASE UPON REMOVAL. THE CASE WAS SUCCESSFULLY COMPLETED. AS PER FOLLOW-UP WITH THE FCS, THERE WAS NO RESISTANCE DURING INSERTION OF THE ESHEATH; HOWEVER, THERE WAS RESISTANCE NOTED WHILE PUSHING THE VALVE OUT OF THE DISTAL TIP. THERE WERE NO DIFFICULTIES WITH ESHEATH REMOVAL OR DELIVERY SYSTEM WITHDRAWAL, AND THE ESHEATH WAS NOT TORQUED DURING THE PROCEDURE. THE PATIENT SUSTAINED NO INJURY AND LEFT THE ROOM IN STABLE CONDITION. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THAT THE DISTAL END OF THE SHEATH DID NOT BREAK AWAY PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999797 ↗
• MalfunctionApr 27, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, THERE WAS SOME DIFFICULTY ENCOUNTERED WHEN TRYING TO ADVANCE THE 26MM COMMANDER DELIVERY SYSTEM (DS) INTO THE 14FR ESHEATH+, AT WHICH POINT THE NOSECONE OF THE DS EXITED THROUGH THE SEAM OF THE ESHEATH+. IN RESPONSE, THE ESHEATH+ WAS BROUGHT TO A STRAIGHTER SEGMENT OF THE PATIENT'S ANATOMY AND THE DS WAS ROTATED WHILE ENTERING THE ESHEATH+, WHICH ALLOWED THE DS TO SUCCESSFULLY ADVANCE. AN ADDITIONAL 2ML WAS ADDED TO THE BALLOON OF THE DS PRIOR TO INFLATION. DURING VALVE DEPLOYMENT, THE BALLOON TO THE DS BURST DUE TO THE CALCIUM BURDEN. THE S3UR VALVE WAS SUCCESSFULLY IMPLANTED AND THE ACCESS SITE WAS CLOSED WITHOUT COMPLICATION. THE DS AND ESHEATH+ WERE REMOVED AS A SINGLE UNIT AND ARE NOT AVAILABLE FOR RETURN/EVALUATION. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998535 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A LEFT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE NATIVE AORTIC POSITION, SIGNIFICANT RESISTANCE WAS FELT UPON ADVANCING THE S3UR VALVE AND 23MM COMMANDER DELIVERY SYSTEM THROUGH THE 14FR ESHEATH+ AT ITS SHEATH SHAFT (FULLY EXPANDABLE PORTION). THE OPERATING TEAM ATTEMPTED TO RE-ADVANCE THE SYSTEM, WHICH RESULTED IN THE ESHEATH+ SEPARATING FROM THE HEMOSTATIC VALVE/HUB. THE FIRST SYSTEM WAS WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT WHILE MAINTAINING WIRE ACCESS, THEN THE DEVICES WERE DISCARDED BY THE HOSPITAL STAFF. A NEW SYSTEM WAS PREPPED AND THE SECOND S3UR VALVE WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO INJURY TO THE PATIENT AS EVIDENCED BY CONTRAST INJECTION. NO BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984365 ↗
• MalfunctionApr 24, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TAVR PROCEDURE THE TEAM WAS UNABLE TO PASS THE 14F ESHEATH PLUS THROUGH CALCIFIED ILIAC STENT, DESPITE VESSEL DILATION AND SHOCKWAVE. IT WAS NOTED THE SHEATH WAS SPLITTING A THE TIP (INDICATED TO BE A DISTAL TIP SPLIT).A NEW SHEATH WAS PREPPED AS PER IFU. UNABLE TO PASS NEW SHEATH THROUGH ILIAC STENT AFTER SHOCKWAVE. IC AND CTS DECIDED IT WAS BEST TO STOP AT THAT TIME. ALTERNATIVE ACCESS NEEDED. THERE WAS NO VALVE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983500 ↗
• MalfunctionApr 22, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING A RIGHT-TRANSFEMORAL TAVR PROCEDURE, RESISTANCE WAS FELT WHEN ADVANCING THE COMMANDER DELIVERY SYSTEM AND SAPIEN 3 ULTRA RESILIA VALVE THROUGH THE 14FR ESHEATH+. A SHEATH DISTAL TIP TEAR OCCURRED. THE ACCESS VESSEL WAS NOT PREDILATED. NO RESISTANCE WAS EXPERIENCED WHEN INSERTING THE SHEATH INTO THE PATIENT. ONCE THE VALVE AND DELIVERY SYSTEM WERE ADVANCED THROUGH THE SHEATH, THE SHEATH TIP BEGAN TO TEAR, AND RESISTANCE WAS FELT. THE PHYSICIAN DECIDED TO NOT ADVANCE ANY FURTHER AND REMOVED THE DEVICES AS A SINGLE UNIT. THERE WAS NO DIFFICULTY DURING DEVICE WITHDRAWAL. A 22FR NON-EW SHEATH WAS INSERTED. A NEW 23MM SAPIEN 3 ULTRA RESILIA VALVE AND COMMANDER DELIVERY SYSTEM WERE PREPARED. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES. THE PATIENT HAD NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960873 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 26 MM SAPIEN 3 ULTRA (S3U) VALVE IN THE AORTIC POSITION, THERE WAS NOTED TO BE SOME RESISTANCE WHEN THE DELIVERY SYSTEM AND S3U ENTERED 14F ESHEATH+. THERE WAS SOME DIFFICULTY, BUT WHEN THE VALVE EXITED THE TIP THERE WAS A LITTLE POP AND OPERATOR HAD TO PUSH. ON THE WAY OUT WE NOTICED THE SHEATH HAD DAMAGE TO THE TIP (DISTAL TIP TEAR). THE VALVE WAS IMPLANTED SUCCESSFULLY WITHOUT ANY HARM TO THE PATIENT. THEY WERE STABLE FOLLOWING THE PROCEDURE. THERE WERE NO WITHDRAWAL DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895320 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THERE WAS +1CC ADDED TO THE ATRION, UPON INFLATION OF THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON, DURING VALVE DEPLOYMENT, THE BALLOON RUPTURED. THE DECISION WAS MADE TO BRING THE 14F ESHEATH+ AND DS OUT AS A UNIT, SO A SECOND SHEATH AND DS WERE PREPPED AND THE ATRION WAS FILLED WITH NOMINAL VOLUME. WHEN THE SHEATH WAS REMOVED IT WAS NOTICED THERE WAS DAMAGE OBSERVED AT THE DISTAL END OF THE SHEATH, THE DISTAL TIP WAS SPLIT. THE INITIAL SHEATH AND DS WERE REMOVED FROM THE PATIENT AND THE SECOND SHEATH AND WAS INSERTED FOLLOWED BY THE SECOND DS. THE VALVE WAS THEN POST DILATED. THE CAROTID ARTERY NEEDED SURGICAL REPAIR, WHICH WAS SUCCESSFULLY COMPLETED BY THE SURGEON. THE PERCEIVED ROOT CAUSE OF THE BALLOON RUPTURE WAS STJ CALCIUM. THE SECOND SHEATH AND DS WERE THEN REMOVED. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894552 ↗
• MalfunctionApr 7, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, UPON ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM WITH VALVE THROUGH THE DISTAL TIP OF THE ESHEATH+,, THE IMPLANTER REPORTED RESISTANCE BUT WAS ABLE TO PUSH THE VALVE/ SYSTEM THROUGH. AT THE END OF THE CASE, WHEN THE DEVICES WERE REMOVED IT'S NOTED THERE WAS A TEAR AT THE DISTAL TIP OF THE ESHEATH+. THERE WERE NO OTHER COMPLICATIONS, NOR ANY PATIENT INJURIES. THE PATIENT WAS STABLE. CLARIFICATION NOTED THAT THE DELIVERY SYSTEM WAS STUCK AT THE DISTAL TIP OF THE ESHEATH+

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798935 ↗
• MalfunctionApr 6, 2026Material Separation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE INITIAL VALVE AND COMMANDER GOT STUCK IN THE ESHEATH NEAR THE RIGHT COMMON/EXTERNAL ILIAC BIFURCATION. THE PHYSICIAN WAS UNABLE TO ADVANCE THE VALVE ANY FURTHER AFTER CHANGING ANGLES AND REATTEMPTING TO ADVANCE. THE VALVE DID NOT EXIT THE TIP OF THE ESHEATH AND THERE WAS NO DAMAGE ON THE SHEATH. THE SYSTEM WAS REMOVED AS ONE UNIT AND A NEW ESHEATH, DELIVERY SYSTEM, AND VALVE WERE PREPPED. THE SECOND VALVE ALSO GOT STUCK AT THE SAME SPOT, AND THE PHYSICIAN NOTICED THAT THE PARTIALLY EXPANDABLE PART OF THE SHEATH HAD "POPPED OFF" OR HAD BECOME DISCONNECTED INTERNALLY FROM THE SHEATH HUB BUT THE OUTER LAYER WAS STILL CONNECTED TO THE HUB. AFTER MULTIPLE ATTEMPTS, A DIFFERENT PHYSICIAN WAS CALLED INTO THE ROOM AND THEY WERE ABLE TO ADVANCE THE VALVE THROUGH THE ESHEATH TO DEPLOY SUCCESSFULLY. THE TEAM DID ADD PROPOFOL THROUGH THE SIDE PORT ON THE LAST ATTEMPT THAT WAS SUCCESSFUL. ONCE THE DEVICE WAS REMOVED, THE STRAIN RELIEF DISCONNECTED ENTIRELY. THE PERCEIVED ROOT CAUSE OF THE EVENT IS NOT KNOWN. ALL DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791832 ↗
• MalfunctionApr 6, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING PREP FOR A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO IMPLANT A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, UPON REMOVING THE 14F ESHEATH+ FROM THE STERILE PACKAGE, IT WAS IDENTIFIED THAT IT HAD A TORN DISTAL TIP. THE ESHEATH+ WAS NOT USED. A NEW 14F ESHEATH+ WAS USED AND THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790089 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION. UPON REMOVAL OF THE 14F ESHEATH PLUS, THE PHYSICIAN NOTED THAT THE TIP OF THE SHEATH WAS TORN. A SMALL DETACHED PIECE OF THE SHEATH WAS REMOVED WITH THE SHEATH. IT WAS JUST THE ONE PIECE AND THEY CONFIRMED THERE WERE NOT ANY OTHER PIECES LEFT IN THE BODY. THE PHYSICIAN STATED THAT HE DID FEEL A SORT OF POP WHEN ADVANCING THE VALVE THROUGH THE SHEATH. THERE WAS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758547 ↗
• MalfunctionApr 1, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY RIGHT TRANSFEMORAL APPROACH, AS THE 26MM COMMANDER DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, IT WAS NOTED THAT THE SHEATH LINER WAS NO LONGER INTACT AND THE DELIVERY SYSTEM WAS PROTRUDING THROUGH THE SIDE OF THE SHEATH. PATIENT WAS COMPLAINING OF PAIN IN GROIN SO THE DELIVERY SYSTEM AND SHEATH WERE REMOVED TOGETHER. THERE WAS NO DAMAGE TO ANY OTHER EW DEVICES USED IN THE CASE. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DISCHARGED. THE ANGLE OF INSERTION WAS NOT STEEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757716 ↗
• InjuryMar 31, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA LEFT TRANSFEMORAL APPROACH, DURING INFLATION OF THE COMMANDER DELIVERY SYSTEM WHILE DEPLOYING THE VALVE, THERE WAS ASYMMETRICAL INFLATION AND DELAY OF INFLATION OCCURRED AT THE DISTAL PORTION OF THE BALLOON. THE VALVE WAS SUCCESSFULLY DEPLOYED WITH NO PATIENT INJURIES DUE TO THE INFLATION PROBLEMS. THE PATIENT WAS STABLE AND AWAITING VASCULAR REPAIR FOR A NON-EDWARDS CLOSURE DEVICE INJURY. PER IMAGING REVIEW, ESHEATH+ DISTAL TIP TEAR AND SYSTEM COMPONENTS SEPARATE WERE FOUND.

  Patient problems: Foreign Body Embolism

  MAUDE report 24746546 ↗
• MalfunctionMar 31, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE DURING VALVE INFLATION THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON RUPTURED THE BURST APPEARED TO BE RADIAL. THERE WAS DIFFICULTY BRINGING THE DS BACK INTO THE SHEATH AND A SNARE WAS USED TO BRING THE DS BACK INTO THE SHEATH. THE DS AND SHEATH WERE THEN BEING BROUGHT OUT AS ONE UNIT, BUT THE NOSE CONE APPEARED TO BE STUCK AT THE ACCESS SITE. A WIRE CUTTER WAS USED TO SNIP THE DS THAT WAS OUTSIDE THE PATIENT AND VASCULAR SURGERY WAS CALLED TO HELP WITH REMOVAL AND POSSIBLE CUTDOWN. A NON-EDWARDS SHEATH WAS PLACED OVER THE PORTION OF THE BALLOON THAT WAS STILL IN THE PATIENT'S GROIN. THEN THE REST OF THE BALLOON CAME OUT OF THE GROIN. THE GROIN WAS THEN CLOSED USING A NON-EDWARDS DEVICE. THE VALVE WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT IS IN STABLE CONDITION. THE RATIO OF CONTRAST TO SALINE WAS 15ML OF CONTRAST TO 15:85. THERE WAS NO SHEATH DAMAGE AND VALVE ALIGNMENT WAS DONE IN A STRAIGHT SECTION. ENGINEER EVALUATION FOUND THE DISTAL TIP WAS SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743047 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component; Activation Failure; Material Split, Cut or Torn; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT RIGHT SIDE TRANSFEMORAL TAVR. AS REPORTED, A 23 MM DELIVERY SYSTEM AND 23 MM S3UR VALVE WERE INSERTED VIA A 14FR ESHEATH+. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO ADVANCE THROUGH THE BLUE PORTION (SHEATH SHAFT/FULLY EXPANDABLE) OF THE ESHEATH. THE DECISION WAS MADE TO REMOVE THE SYSTEM AS A UNIT AND ADVANCE A NEW VALVE, SYSTEM AND ESHEATH. FURTHER REVIEW ON THE BACK TABLE SHOWED DAMAGE TO THE SYSTEM AND ESHEATH. THE SECOND 23 MM S3UR DELIVERY SYSTEM AND 23 MM S3UR VALVE WERE INSERTED VIA 14 FR ESHEATH SUCCESSFULLY INTO THE PROPER POSITION AND DEPLOYED. THE PATIENT WAS NOT HARMED AND SAFELY REMOVED FROM THE TABLE ONCE CASE WAS COMPLETED. THE DEVICE WILL BE RETURNED FOR EVALUATION. THROUGH FOLLOW UP WITH THE FIELD CLINICAL SPECIALIST, THERE WAS NO DIFFICULTY FACED WHEN INSERTING ESHEATH INTO PATIENT. THE EXPANSION TOOL WAS USED. THE LOADER WAS ABLE TO BE FULLY INSERTED INTO THE ESHEATH/ESHEATH HOUSING. THE ESHEATH WAS NOT INSERTED AT A STEEP ANGLE. THE DELIVERY SYSTEM AND VALVE DID NOT EXIT THE TIP OF THE SHEATH. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THAT THE SEAM DID NOT SEPARATE. PER PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706335 ↗