Edwards eSheath+ Introducer set 916ESPRecalls & reported problems

Summary

The FDA's MAUDE database contains 298 adverse event reports that list this exact device (DI 00690103215472), received between Dec 20, 2021 and Aug 19, 2026 — classified as 18 deaths, 68 injuries, 212 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (146 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. 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 298 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329088 ↗
• MalfunctionJun 25, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A RIGHT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE WHEN PASSING THE 29MM COMMANDER DELIVERY SYSTEM (DS) WITH THE VALVE THROUGH THE 16F ESHEATH+ AND ARTERIOTOMY SITE, IT WAS FELT THE VALVE WAS STUCK ON THE SIDE WALL OF THE SHEATH RIGHT AFTER THE STRAIN RELIEF PORTION. THE SURGEON USED A HEMOSTAT AROUND THE SHEATH TO DILATE THE TRACK AT WHICH POINT THE SYSTEM WAS ADVANCED AND THEN THE DS AND VALVE CONTINUED TO ADVANCE WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFUL, AND THERE WAS NO PATIENT HARM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PERCEIVED ROOT CAUSE WAS THE SKIN TRACT WAS NOT DILATED ENOUGH. PER ENGINEERING EVALUATION, THE DISTAL TIP IS TORN RADIALLY AND AXIALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618957 ↗
• MalfunctionJun 12, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, RESISTANCE WAS FELT DURING INSERTION OF THE VALVE WITH DELIVERY SYSTEM THROUGH THE 16FR ESHEATH+, AND THE VALVE GOT CAUGHT WITHIN THE PARTIALLY EXPANDABLE. A BENT TINE WAS NOTICED ON FLURO. THE DEVICES WERE REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFUL. PER REPORT, THERE MAY HAVE BEEN INTERACTION WITH THE ESHEATH+ WHEN REMOVING THE 25MM TRU BALLOON CAUSING ISSUES GETTING INTO AND BACK THROUGH THE SHEATH. PER DEVICE IMAGE RECEIVED, THE ESHEATH+ HAS A SHEATH PUNCTURE WITH THE BENT VALVE TINES EXPOSED THROUGH THE PUNCTURE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488660 ↗
• MalfunctionMay 27, 2026Deformation Due to Compressive Stress; Material Split, Cut or Torn; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A SUBCLAVIAN TRANSCATHETER MITRAL VALVE REPLACEMENT PROCEDURE TO IMPLANT A 29 MM SAPIEN 3 ULTRA RESILIA VALVE INTO A PRE EXISTING SURGICAL ANNULOPLASTY RING, THE DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE 16 F ESHEATH+ AND THE VALVE HAD A BENT STRUT. DURING THE PROCEDURE, THERE WAS NO DIFFICULTY INSERTING THE ESHEATH AND THE ESHEATH WAS NOT INSERTED AT A STEEP ANGLE. HOWEVER, DUE TO USING RIGHT SUBCLAVIAN VEIN ACCESS, MORE SHEATH WAS OUTSIDE OF THE BODY THAN CUSTOMARY. THE DELIVERY SYSTEM WITH VALVE BECAME STUCK IN THE MIDDLE OF THE FULLY EXPANDABLE PORTION OF THE ESHEATH. RESISTANCE SEEMED TO BE MORE THAN USUAL PRIOR TO THE SYSTEM COMING TO A COMPLETE STOP. IT WAS THEN NOTED UNDER FLUOROSCOPY THAT A STRUT WAS BENT UP AT A ROUGHLY 90 DEGREE ANGLE TO THE NORMAL PLANE. THE SYSTEM WAS REMOVED AS A SINGLE UNIT. A NEW SYSTEM WAS PREPARED AND SUCCESSFULLY DEPLOYED. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE CAUSE OF THE EVENT WAS UNCLEAR. THE ESHEATH WAS RETURNED FOR EVALUATION AND UPON VISUAL INSPECTION A LINER TEAR AND LINER STRAND WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304474 ↗
• MalfunctionMay 21, 2026Material Integrity Problem

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSCAROTID AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, AFTER THE VALVE WAS DEPLOYED SUCCESSFULLY, THE ESHEATH+ WAS REMOVED AND NOTED THAT THE TIP WAS TORN. ALL PIECES APPEARED INTACT AND ATTACHED, BUT THERE WAS A TORN PORTION OF THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INDICATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244047 ↗
• MalfunctionMay 20, 2026Peeled/Delaminated; Detachment of Device or Device Component

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE USING A 29MM SAPIEN 3 ULTRA RESILIA VALVE, PRECLOSING THE ARTERY WAS CHALLENGING DUE TO THE PATIENT'S LARGE BODY HABITUS, AND INSERTION OF THE ESHEATH WAS DIFFICULT WHILE TUNNELING THROUGH A LONG, RESISTANT TISSUE TRACT AND INTO THE ARTERY. ONCE THE ESHEATH WAS FULLY INSERTED, THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE PROCEEDED AS PLANNED, AND A 29 MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY DEPLOYED. INSERTION OF THE DELIVERY SYSTEM WAS MET WITH MODERATE RESISTANCE. UPON REMOVING THE DELIVERY SYSTEM, THERE WAS SIGNIFICANT RESISTANCE COMING BACK THROUGH THE ESHEATH. UNDER FLUOROSCOPY, IT APPEARED THAT THE RADIOPAQUE CUFF OF THE ESHEATH WAS NO LONGER AT THE DISTAL TIP OF THE ESHEATH, BUT RATHER MID SHEATH WITH THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER. A 20MM DRYSEAL WAS THEN INTRODUCED AT THE SITE AND THE VASCULAR SURGERY TEAM WAS CALLED. UPON REMOVAL OF THE ESHEATH AND DELIVERY SYSTEM, IT WAS IDENTIFIED THAT THE INNER LINING OF THE ESHEATH SEPARATED FROM THE OUTER LINING AND BUCKLED ON ITSELF. VASCULA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233242 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING PROCEDURE, THERE WAS NO RESISTANCE DURING INSERTION OF THE ESHEATH. IT WAS NOTED THAT THE DELIVERY SYSTEM AND VALVE JUMPED FORWARD SLIGHTLY UPON CROSSING THE DISTAL TIP OF THE SHEATH. THERE WAS NO WITHDRAWAL DIFFICULTIES. AFTER THE ESHEATH WAS REMOVED, IT WAS NOTED THAT THE DISTAL TIP OF THE ESHEATH WAS TORN. THERE WAS NO PATIENT INJURY. THE PROVIDED POST-PROCEDURAL DEVICE IMAGE WAS REVIEWED AND SHEATH DISTAL TIP TORN RADIALLY WITH STRETCHING VISIBLE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203228 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143068 ↗
• MalfunctionMay 8, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS) DURING A TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, DURING SAPIEN 3 ULTRA RESILIA INSERTION, SOME RESISTANCE WAS SEEN AT THE DISTAL PORTION OF THE 16F ESHEATH+. DURING ESHEATH+ REMOVAL, A TORN DISTAL TIP WAS NOTED. NO ILL HARM TO PATIENT. PER ADDITIONAL INFORMATION PROVIDED BY THE FCS, THERE WAS NO DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. THE EXPANSION TOOL WAS USED AND THE LOADER WAS ABLE TO BE FULLY INSERTED IN THE SHEATH/SHEATH HOUSING. THE SHEATH WAS NOT INSERTED AT A STEEP ANGLE AND WAS NOT TORQUED DURING THE PROCEDURE. THERE WERE NO WITHDRAWAL ISSUES. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS DUE TO VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125453 ↗
• MalfunctionMay 7, 2026Peeled/Delaminated

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA (S3UR) VALVE IN THE AORTIC POSITION, THERE WERE MULTIPLE ISSUES DURING THE PROCEDURE. THE FIRST 29 MM S3UR WAS DEPLOYED AT 90/10 (70/30 AFTER DEPLOYMENT) AND EMBOLIZED INTO THE ASCENDING AORTA DUE TO A LOSS OF CAPTURE. THE VALVE THEN CAUGHT ON THE COMMANDER DELIVERY SYSTEM BALLOON AND PULLED BACK INTO THE ARCH AND LEFT THERE AS IT WAS UNABLE TO BE TRACKED INTO THE DESCENDING AORTA. THE BALLOON WAS INFLATED MULTIPLE TIMES WHILE TRYING TO RETRIEVE THE EMBOLIZED VALVE. THE COMMANDER DELIVERY SYSTEM BALLOON THEN WOULD NOT GO BACK INTO THE 16F ESHEATH+ AS IT WAS BUNCHED UP (NOT TORN OR BURST) SO IT WAS REMOVED AS ONE UNIT. A NEW 29 MM S3UR VALVE AND SYSTEM WERE PREPPED AND DELIVERED SUCCESSFULLY. AT THE END OF THE PROCEDURE THE NON-EDWARDS CLOSURE DEVICES WERE LOST, SO CRYSTAL WAS PLACED FOR HEMOSTASIS AND VASCULAR SURGERY WAS CALLED. A SURGICAL CUTDOWN AND REPAIR OF THE FEMORAL ARTERY WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION IN ICU FOLLOWING THE PROCEDURE. AFTER REMOVAL OF THE DEVICES, THE COMMANDER DELIVERY SYSTEM BALLOON WAS FOUND TO BE BUNCHED UP AND THERE WAS DAMAGE TO THE

  Patient problems: Insufficient Information

  MAUDE report 25116128 ↗
• InjuryApr 30, 2026Material Puncture/Hole; Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TMVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN AN EXISTING NON-EDWARDS SURGICAL VALVE, DURING THE PROCEDURE THE TEAM WAS ADVANCING THE 1ST DELIVERY SYSTEM THROUGH THE 16F ESHEATH PLUS. THE TEAM NOTICED THE SHEATH WAS STARTING TO KINK. THE TEAM NOTICED SOME RESISTANCE. THE TEAM PULLED BACK AND TRIED TO ADVANCE WITH SAME RESULT. THE TEAM TRIED AGAIN AND THE SYSTEM CAME THROUGH THE SHEATH. WE REPLACED THE ENTIRE SYSTEM AND SUCCESSFULLY PLACED THE VALVE. THERE WAS A SMALL VEIN DISSECTION. THE TEAM THREW THE ENTIRE SYSTEM AWAY. PER FCS EVALUATION OF PHOTOS, IT WAS INDICATED THE DAMAGE TO THE SHEATH OBSERVED MOST SIMILARLY RESEMBLED BOTH LINER PUNCTURE THROUGH THE DYNAMIC EXPANSION AND LINER STRAND. THE SYSTEM WAS PUSHED ON AND DURING THIS TIME THE SHEATH MAY HAVE BEEN MANIPULATED AND THE DEVICE, ON THE IMAGE, CAME THROUGH THE SIDE. WHEN VISUALIZING, IT TORE THROUGH THE DYNAMIC EXPANSION. THE 1ST SHEATH WAS NO INSERTED AT A STEEP ANGLE AND THERE WERE NO INSERTION DIFFICULTIES.

  Patient problems: Vascular Dissection

  MAUDE report 25045841 ↗
• MalfunctionApr 17, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A DISTAL TIP SPLIT WAS OBSERVED ON A 16FR ESHEATH+. A 29MM COMMANDER DELIVERY SYSTEM WAS USED TO DEPLOY A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC ANNULUS. IT WAS NOTED THAT THE DELIVERY SYSTEM HAD BEEN TORQUED DURING THE PROCEDURE DUE TO A HORIZONTAL HEART AND A LEFT SUBCLAVIAN APPROACH. DURING VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON WOULD NOT COMPLETELY INFLATE. APPROXIMATE INFLATION TIME WAS 10 SECONDS, AND THE DEFLATION TIME WAS AN ADDITIONAL 10 SECONDS. ASYMMETRICAL INFLATION WAS NOT OBSERVED. THE VALVE WAS DEPLOYED IN THE INTENDED LOCATION BUT WAS LEFT UNDER EXPANDED. THERE WAS NO ISSUE WITHDRAWING THE DELIVERY SYSTEM THROUGH THE 16FR ESHEATH+. A SECOND DELIVERY SYSTEM WAS OPENED AND INSERTED THROUGH THE SAME ESHEATH+. THE SECOND DELIVERY SYSTEM WAS USED TO FULLY EXPAND THE VALVE, WHICH WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT THE 16FR ESHEATH TIP WAS DAMAGED, WHICH WAS THOUGHT TO HAVE OCCURRED WHEN THE DELIVERY SYSTEM WAS TORQUED, AND WAS A RESULT OF DELIVERY SYSTEM MANIPULATION. THE PERCEIVED ROOT CAUSE OF THE DEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913043 ↗
• InjuryApr 15, 2026Difficult to Insert

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. PATIENT HAD A VERY CALCIFIED EXTERNAL AND COMMON ILIAC. PRETREATED THE ENTIRE ILIAC SYSTEM WITH SHOCKWAVE IVL AND DILATED UP TO 18F WITH THE ESHEATH PLUS DILATOR. UPON INSERTION WITH THE FIRST 16F ESHEATH PLUS, THE SPLIT END OF THE SHEATH CAUGHT AND GOT STUCK ON A PIECE OF CALCIUM RIGHT BEFORE THE INTERNAL ILIAC ARTERY. A SECOND 26F ESHEATH PLUS WAS PREPPED AND INSERTED, BUT THE PATIENT BECAME UNSTABLE HYPOTENSIVE AND BRADYCARDIC. THE ILIAC WAS IMAGED AND A LARGE EXTRAVASATION IN THE EXTERNAL ILIAC ARTERY WAS NOTED. TWO COVERED STENTS WERE PLACED AND THE BLEED WAS CONTROLLED. INJURY THOUGHT TO OCCUR WITH FIRST SHEATH DURING INSERTION. DECISION WAS MADE NOT TO MOVE FORWARD WITH VALVE DEPLOYMENT, LET THE PATIENT STABILIZE, AND BRING THEM BACK FOR CAROTID FIRST APPROACH.

  Patient problems: Perforation of Vessels

  MAUDE report 24886403 ↗
• MalfunctionApr 14, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS ENGINEER, DURING EXECUTION OF DESIGN VERIFICATION PROTOCOL FOR HYDRODYNAMIC TESTING OF A 29MM SAPIEN X4 VALVE, WHILE THE ENGINEER WAS ADVANCING THE SYSTEM THROUGH THE 16F ESHEATH+, WHEN A LOT OF RESISTANCE WAS EXPERIENCED. THEY STOPPED ADVANCING AND THE UNIT WAS INSPECTED. IT APPEARED THAT THE 16F ESHEATH+ WAS NOT SCORED, THEREFORE THE VALVE WAS NOT ABLE TO ADVANCE THROUGH THE TIP. THE UNIT WAS REMOVED FROM THE WATER BATH, AND THE TIP OF THE SHEATH WAS SCORED MANUALLY, SO THEY WERE ABLE ADVANCE AND DEPLOY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876228 ↗
• MalfunctionApr 9, 2026Material Split, Cut or Torn; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THIS WAS A COMPLEX AORTIC REPAIR WITH 3 FENESTRATIONS. LUMENS APPEARED OPEN ON CT SO RIGHT TF WAS ATTEMPTED. A 16F ESHEATH+ WAS ADVANCED WITH NO ISSUES; HOWEVER, IT WAS NOT LONG ENOUGH TO GO ABOVE GRAFT. THE COMMANDER DELIVERY SYSTEM AND 29MM S3 VALVE WERE ADVANCED, AND THE VALVE HAD ISSUES EXITING THE TIP OF THE ESHEATH. CHANGING ANGLE ON THE TIP OF THE SHEATH/ PIN AND PULL TECHNIQUE WERE USED. EVENTUALLY THE 29MM S3 VALVE WAS ADVANCED PAST ESHEATH+ AND VALVE ALIGNMENT WAS SUCCESSFUL. UPON THE VALVE GOING OVER THE ARCH, THE INTERVENTIONAL CARDIOLOGIST SAW SOMETHING THAT LOOKED LIKE RADIOPAQUE MATERIAL EXTERIOR TO THE VALVE ITSELF SEEMINGLY ATTACHED TO THE VALVE. THE DELIVERY SYSTEM AND 29MM S3 VALVE WERE RETRACTED SUCCESSFULLY INTO ESHEATH+ AND REMOVED FROM THE BODY. THE ESHEATH+ WAS RIPPED AT THE TIP; HOWEVER, ALL APPEARED INTACT. THERE WAS NO DAMAGE OR BENT STRUTS VISIBLE TO THE VALVE. THE ESHEATH WAS CUT TO LOOK FOR SUSPECTED PIECE OF GRAFT MATERIAL BUT NOTHING WAS FOUND. A SECOND 16FR ESHEATH+ WAS ADVANCED WITH NO ISSUES. A SECOND COMMANDER AND 29MM S3 VALVE WERE ADVANCED WITH NO ISSUES. VALVE ALIGNMENT WAS PERFORMED ABOVE THE GRAF

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832668 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A LEFT TRANSFEMORAL TRANSCATHETER AORTIC VALVE PROCEDURE WAS PERFORMED TO IMPLANT A 26 MM SAPIEN 3 ULTRA RESILIA VALVE. THE 16F ESHEATH+ WAS NOT INSERTED AT A STEEP ANGLE AND THERE WAS NO RESISTANCE WITH INSERTION. HOWEVER, RESISTANCE WAS ENCOUNTERED ADVANCING THE COMMANDER DELIVERY SYSTEM WITH VALVE THROUGH THE TIP OF THE ESHEATH+. THE PHYSICIAN NOTED IT FELT VERY TIGHT WHEN PUSHING THE VALVE OUT OF THE END OF THE ESHEATH, BUT IT FINALLY GAVE. THE VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED UPON REMOVAL THAT THE DISTAL TIP OF THE ESHEATH HAD TORN, IT WAS BELIEVED TO HAVE TORN UPON THE DELIVERY SYSTEM REACHING THE TIP OF THE ESHEATH. THERE WAS NO PATIENT INJURY. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE EXPANSION TOOL WAS USED. THE LOADER WAS FULLY INSERTED INTO THE ESHEATH HOUSING. THE VESSEL WAS NOT PREDILATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715440 ↗
• MalfunctionMar 25, 2026Material Separation; Material Split, Cut or Torn; Physical Resistance/Sticking

  AS REPORTED BY AN EDWARDS LIFESCIECES FIELD CLINICAL SPECIALIST, REGARDING A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION. AS THE 29MM SAPIEN 3 VALVE AND 29MM 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 29MM 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 24688009 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THERE WAS UNUSUAL RESISTANCE WHEN INSERTING THE 29MM COMMANDER DELIVERY SYSTEM (DS) THROUGH THE 16FR ESHEATH+. PER FLUOROSCOPY, THERE DID NOT APPEAR TO BE ANY ESHEATH+ KINKING OR OTHERWISE OBVIOUS REASONS WHY THE VALVE WAS NOT ABLE TO EXIT THE END OF THE ESHEATH+. IN RESPONSE, THE OPERATING TEAM EXERTED A LITTLE EXTRA FORCE, AT WHICH POINT THE VALVE DID EXIT THE ESHEATH+. THERE WERE NO ADDITIONAL COMPLICATIONS AND THE VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. UPON REMOVAL FROM THE PATIENT, THE DISTAL END OF THE ESHEATH+ WAS NOTED TO BE TORN. IT WAS REPORTED THAT THE DS WAS REMOVED FROM THE PATIENT FIRST, THEN THE ESHEATH+. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION WITH NO SIGNS OF A VASCULAR INJURY. ACCORDING TO THE PROVIDED DEVICE IMAGERY, THE DISTAL TIP WAS TORN RADIALLY, BUT OPENED ALONG THE AXIAL SCORE LINE. ALSO, STRETCHING WAS VISIBLE ALONG THE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645882 ↗
• MalfunctionMar 19, 2026Material Puncture/Hole

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE BECAME STUCK IN THE DOUBLE-WRAPPED PORTION OF THE ESHEATH. AFTER THE VALVE WAS UNABLE TO ADVANCE, THE VALVE AND SHEATH WERE REMOVED TOGETHER AS A SYSTEM. ONCE REMOVED, A PUNCTURE WAS NOTED IN THE SHEATH, AND A TINE OF THE VALVE WAS BENT. THE OPERATOR THEN USED A LUNDERQUIST WIRE TO DELIVER A SECOND VALVE. THE SECOND VALVE WAS DELIVERED WITHOUT ISSUE. THE PATIENT DID NOT EXPERIENCE ANY INJURY RELATED TO THIS EVENT AND WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS REPORTED AS VESSEL TORTUOSITY. ADDITIONAL ACTIONS TAKEN INCLUDED KEEPING THE SHEATH STRAIGHT, USING A STIFF WIRE, AND FLUSHING WITH PROPOFOL FOR LUBRICATION. IN ADDITION, THE PHYSICIAN STATED THAT AN ACUTE BEND IN THE VESSEL CAUSED THE VALVE TO BECOME STUCK. IMAGERY REVIEW FOUND THAT THE SHEATH PUNCTURED AT THE STRAIN RELIEF AND LINER EXPANDED AS DESIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641329 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE, THERE WAS SLIGHT DIFFICULTY ENCOUNTERED DURING THE FINE ADJUST PORTION OF VALVE ALIGNMENT. VALVE ALIGNMENT WAS ATTEMPTED IN A STRAIGHT SECTION OF THE ANATOMY. IT WAS ABLE TO BE RESOLVED BY UNLOCKING AND THEN RE-LOCKING. SUBSEQUENTLY, DURING VALVE DEPLOYMENT, THERE WAS NON-UNIFORM EXPANSION OF THE VALVE. IT WAS NOTED THAT WHILE DEPLOYING THE VALVE, THE DISTAL PORTION POINTING TOWARDS THE LEFT VENTRICLE (LV) OPENED SIGNIFICANTLY LATER THAN THE PROXIMAL PORTION OF THE VALVE DIRECTED TOWARDS THE AORTA. THE VALVE WAS REPORTED TO BE BETWEEN THE MARKERS BEFORE DEPLOYMENT. ULTIMATELY, THE VALVE DEPLOYED SATISFACTORY. POST-DEPLOYMENT ECHOCARDIOGRAPHY SHOWED THE VALVE WAS FULLY EXPANDED. THE PATIENT WAS TRANSFERRED FOR RECOVERY IN STABLE CONDITION. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION RECEIVED FROM THE FCS, THERE WAS NO DAMAGE OBSERVED ON THE DELIVERY SYSTEM AND NO DAMAGE OBSERVED ON THE ESHEATH+. THERE WAS NORMAL RESISTANCE DURING INSERTION OF THE DELIVERY SYSTEM WITH VALVE THROUGH THE SHEATH. THE INF

  Patient problems: Insufficient Information

  MAUDE report 24592081 ↗
• MalfunctionMar 11, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT-SIDE TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE NATIVE AORTIC POSITION, THERE WAS DIFFICULTY ADVANCING THE 29MM COMMANDER DELIVERY SYSTEM (DS) WITH THE VALVE THROUGH THE 16FR ESHEATH+. THE DS WAS PULLED BACK AND ADVANCED AGAIN, WITH RESISTANCE STILL NOTED. ONCE THE VALVE REACHED THE DISTAL TIP OF THE ESHEATH+, THE DISTAL TIP OF THE ESHEATH+ BECAME TORN. THE VALVE WAS SUCCESSFULLY IMPLANTED. UPON REMOVING THE ESHEATH+, ALL ITS PIECES WERE ACCOUNTED FOR AND STILL TOGETHER (NO DETACHMENT). PER REPORT, THERE WAS NO INJURY TO THE PATIENT WHO WAS IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569949 ↗
• MalfunctionMar 9, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION. THE FIRST ESHEATH WAS FOUND TO HAVE DAMAGE TO THE INTRODUCER DILATOR TIP AFTER IT WAS REMOVED FROM THE PATIENT, PRIOR TO INTRODUCTION OF THE DELIVERY SYSTEM AND VALVE DEPLOYMENT. THE PATIENT WAS NOTED TO HAVE TORTUOUS AND CALCIFIED ACCESS. SOME RESISTANCE WAS ENCOUNTERED DURING SHEATH INSERTION, AT WHICH POINT THE IMPLANTER STOPPED AND WITHDREW THE DEVICE. THE SKIN INCISION WAS ADEQUATE, AND THE INSERTION ANGLE WAS NOT STEEP. A SECOND ESHEATH WAS OPENED, PREPARED, AND USED SUCCESSFULLY, ALLOWING THE VALVE TO BE DELIVERED WITHOUT ISSUE. INSPECTION OF THE SECOND ESHEATH TIP REVEALED NO DAMAGE. A NON-EDWARDS WIRE WAS USED TO FACILITATE SHEATH INSERTION DUE TO THE TORTUOUS NATURE OF THE RIGHT FEMORAL ARTERY. THERE WAS NO PATIENT INJURY. THE PERCEIVED ROOT CAUSE OF THE DAMAGE WAS DUE TO PATIENT ANATOMY. THE PROVIDED DEVICE-RELATED PHOTO WAS REVIEWED, AND NOTED THAT THE INTRODUCER TIP APPEARS SPLIT ALONG ONE SIDE, AND THERE IS VISIBLE CURVATURE PRESENT ON THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550072 ↗
• MalfunctionMar 6, 2026Material Puncture/Hole; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A THV TERRITORY MANAGER THAT A PATIENT UNDERWENT RIGHT SIDE TRANSFEMORAL TAVR WITH A 29MM SAPIEN 3UR VALVE. AS REPORTED, THE HEART TEAM INSERTED THE ORIGINAL 16FR ESHEATH+ WITHOUT ISSUE. WHEN ADVANCING THE VALVE, THE DELIVERY SYSTEM AND VALVE EXERTED SIGNIFICANTLY HIGHER PUSH-FORCE THAN EXPECTED. AT THIS TIME, THE TEAM TOOK A FLOURO IMAGE OF THE VALVE, SWINGING THE GANTRY FROM SIDE TO SIDE, TO CHECK THE STRUTS OF THE S3UR. AN INFLOW STRUT WAS PROTRUDING LATERALLY AND THE TEAM DECIDED IT WOULD BE BEST TO REMOVE THE SHEATH, DELIVERY SYSTEM AND VALVE AS A UNIT. A NEW 29MM S3UR VALVE WAS PREPPED, A NEW 16FR ESHEATH+ WAS INSERTED AND THE CASE WAS COMPLETED WITHOUT ISSUE. THE PATIENT HAD NO VASCULAR COMPLICATION, NO PVL, NO PACEMAKER AND NO ADDITIONAL ISSUES WERE OBSERVED THROUGHOUT THE CASE. THE PATIENT WAS STABLE AND DISCHARGED WITH NO PROCEDURAL COMPLICATIONS. THE DEVICE WAS DISCARDED. PER THE IMAGES PROVIDED, THE VALVE STRUT WAS OBSERVED TO BE PUNCTURED THROUGH THE SHEATH STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537373 ↗
• InjuryMar 6, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, VASCULAR CLOSURE WAS ATTEMPTED BUT FAILED TO ACHIEVE HEMOSTASIS AFTER THE VALVE WAS SUCCESSFULLY DEPLOYED. CONTINUED BLEEDING WAS NOTED, AND MANUAL PRESSURE APPLIED. PER REPORT, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THE 16FR ESHEATH+ MAY HAVE CAUSED AN ARTERIAL INJURY UPON REMOVAL DUE TO THE DISTAL TIP OF THE ESHEATH+ BEING SPLIT. THE SURGEON PERFORMED SURGICAL CUTDOWN, AND THE TISSUE TRACT WAS CLOSED USING THE PERCLOSE DEVICE. HOWEVER, THERE WAS A FALSE SENSE OF HEMOSTASIS PRIOR TO CUTDOWN. HEMOSTASIS WAS ACHIEVED SURGICALLY. THE PATIENT WAS STABLE AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE 16FR ESHEATH+ WAS PREPPED ACCORDING TO IFU. PER RESPONSE FROM THE TERRITORY MANAGER, THERE WAS A DISTAL TIP TEAR OBSERVED ON THE DEVICE UPON REMOVAL.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 24535936 ↗
• MalfunctionMar 5, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE MITRAL VALVE IN VALVE POSITION, THE TEAM WAS UNABLE TO CROSS THE SEPTUM DURING THE PROCEDURE AS IT WAS THICKENED DUE TO A PREVIOUS SEPTUM REPAIR. THE TEAM ATTEMPTED TO CROSS THE FIRST VALVE ON THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS DAMAGED DURING THE CASE AS IT WAS TORQUED BY THE OPERATOR WHEN TRYING TO ADVANCE IT WITH THV VALVE THROUGH THE SURGICAL VALVE. AFTER MULTIPLE ATTEMPTS, THE TEAM DECIDED TO REMOVE AND REPLACE THE SYSTEM. DURING THE REMOVAL, THE VALVE WAS PULLED OFF THE BALLOON WHEN ATTEMPTING TO PULL THE DELIVERY SYSTEM AND VALVE BACK INTO THE SHEATH, AND OUT OF THE PATIENT. AFTER THE VALVE DISLODGED FROM THE DELIVERY SYSTEM, THE TEAM REMOVED THE DELIVERY SYSTEM AND SHEATH, BUT MAINTAINED CONTROL OF THE VALVE BY LEAVING THE WIRE IN. THE TEAM THEN ELECTED TO UPGRADE TO A LARGE GORE SHEATH AND USED A BAV BALLOON BY INFLATING PARTIALLY, PULLING THE VALVE INTO THE GORE SHEATH SAFELY. THE DEVICES WERE REMOVED WITH NO HARM TO THE PATIENT. NO SURGERY OR CUT DOWN WAS NEEDED. IT WAS NOTED AFTER REMOVAL; THERE WAS A SHEATH LINER TEAR. ADDITIONALLY, POST REMOVAL FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524149 ↗