EDWARDS ESHEATH INTRODUCER SET 916ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00690103193992), received between Mar 11, 2021 and Jun 18, 2023 — classified as 3 deaths, 13 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (18 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2023Activation, Positioning or Separation Problem; Material Split, Cut or Torn; Activation, Positioning or Separation Problem; Material Split, Cut or Torn

  AS REPORTED, FROM CLINICAL STUDY, THE EXPANSION JOINT AT THE TIP OF THE ESHEATH WAS TORN AND PER IMAGERY PROVIDED, MATERIAL SEPARATION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17149480 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Material Twisted/Bent; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Twisted/Bent; Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS ENGINEER, DURING A SIMULATED PARTICLE TEST, A 16FR ESHEATH+ USED WITH 29MM COMMANDER DELIVERY SYSTEM AND A SAPIEN 3 VALVE EXPERIENCED INSERTION DIFFICULTY THROUGH THE TIP OF THE ESHEATH+. IT WAS OBSERVED THAT A PART OF THE DISTAL TIP WAS TORN, DISLODGED FROM THE SHEATH, AND WAS STUCK ON THE DISTAL STRUTS OF THE CRIMPED VALVE. THE TORN SHEATH MATERIAL WAS OBSERVED TO REMAIN ON THE VALVE UNTIL VALVE DEPLOYMENT, AFTER WHICH IT BECAME DISLODGED AND WAS COLLECTED AS A LOOSE PARTICLE BY IN THE SIMULATED USE MODEL. THE SAMPLE WAS SUBMITTED TO GLOBAL PRODUCT SURVEILLANCE TEAM (NO DECONTAMINATION NECESSARY SINCE SAMPLE WAS NOT PATIENT CONTACT AND FROM SIMULATED USE TEST USING DI WATER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014970 ↗
• InjuryFeb 12, 2023Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  AS REPORTED, DURING THE PROCEDURE THE 1ST ESHEATH WAS OPENED AND PREPARED WITHOUT DIFFICULTY. THE OPERATOR EXPERIENCED CHALLENGING ACCESS WITH DIFFICULTY ADVANCING THE ESHEATH. THE TIP OF THE ESHEATH WAS REPORTED TO BE BENT AND THE OPERATOR WAS UNABLE TO SAFELY ADVANCE THE SHEATH. THE PERCEIVED CAUSE OF DIFFICULTY ADVANCING THE SHEATH WAS SEVERE TORTUOSITY. THE VESSEL WAS REPORTED TO BE PERFORATED WITH EXTRAVASATION NOTED ON ANGIOGRAM. VASCULAR SURGERY WAS CONSULTED. THE PATIENT HAD AN EPISODE OF HYPOTENSION (A DROP IN SYSTOLIC BP <70) DUE TO BLOOD LOSS AND RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND 1-UNIT OF PLATELETS DURING THE VASCULAR REPAIR. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE CARDIOVASCULAR INTENSIVE CARE UNIT IN STABLE CONDITION. AT THE TIME OF THIS REPORT, THE PATIENT WAS IN GOOD CONDITION AND AWAITING DISCHARGE TO A REHAB FACILITY.

  Patient problems: Perforation of Vessels

  MAUDE report 16359798 ↗
• MalfunctionFeb 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BY RESEARCH & DEVELOPMENT (R&D), DURING TESTING, A 16FR ESHEATH TORE AT THE DISTAL TIP AS THE 29MM X4 DELIVERY SYSTEM WITH CRIMPED 29MM SAPIEN X4 VALVE PASSED THROUGH THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326619 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  AS REPORTED BY RESEARCH & DEVELOPMENT (R&D), DURING TESTING, A 16FR ESHEATH TORE AT THE DISTAL TIP AS THE 29MM X4 DELIVERY SYSTEM WITH CRIMPED 29MM SAPIEN X4 VALVE PASSED THROUGH THE TIP. THE ESHEATH ALSO EXHIBITED SEPARATION OF THE TIP WHICH WAS FOUND TO BE ATTACHED TO THE CRIMPED VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326552 ↗
• InjuryDec 2, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED FROM A CLINICAL TRIAL, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE OF A 23MM SAPIEN X4 VALVE, THE 23MM X4 DELIVERY SYSTEM WITH 23MM SAPIEN X4 VALVE WAS UNABLE TO ADVANCE THROUGH THE 14FR ESHEATH. THE ENTIRE SYSTEM WAS WITHDRAWN AS ONE UNIT AND A SECOND 23MM X4 DELIVERY SYSTEM AND 23MM SAPIEN X4 VALVE WAS PREPPED ALONG WITH A 16FR ESHEATH. THE SECOND SYSTEM WAS UNABLE TO ADVANCE THROUGH THE 16FR ESHEATH. THE ENTIRE SYSTEM WAS WITHDRAWN AS ONE UNIT. TO COMPLETE THE PROCEDURE, A DECISION WAS MADE TO USE A 23MM COMMANDER DELIVERY SYSTEM ALONG WITH A 23MM SAPIEN 3 ULTRA VALVE AND 16FR ESHEATH+. THE SAPIEN 3 ULTRA VALVE WAS IMPLANTED SUCCESSFULLY. AN ABDOMINAL RUNOFF WAS PERFORMED WHICH REVEALED A DISSECTION AT THE RIGHT FEMORAL ARTERY (RFA) ACCESS SITE. A DECISION WAS MADE TO BALLOON USING A NON-EDWARDS DEVICE. IT WAS INFLATED AT 5ATM AND THE DISSECTION WAS RESOLVED. NEURO CHECKS WERE ALSO PERFORMED AND THE PATIENT LEFT THE CATH LAB IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 15905490 ↗
• InjuryApr 4, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT TF TAVR PROCEDURE OF A 23 MM SAPIEN 3 ULTRA VALVE IN THE NON-EDWARDS VALVE, SEVERE DIFFICULTY WAS NOTED WHEN PASSING THE FIRST VALVE THROUGH THE ESHEATH. THE VALVE WOULD NOT ADVANCE PAST THE FEMORAL HEAD. IT WAS DECIDED TO REMOVE THE DELIVERY SYSTEM AND VALVE FROM THE PATIENT. A NEW SYSTEM AND VALVE WERE OPENED AND THE VALVE PASSED THROUGH THE 16F ESHEATH WITHOUT ISSUE. UPON REMOVAL, THERE WAS A EXTRAVASATION AROUND ACCESS SITE OBSERVED AND VASCULAR SURGERY WAS CONSULTED. THERE WAS NO DAMAGE OF THE DEVICES NOTED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 14000613 ↗
• InjuryFeb 24, 2022Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  AFTER SUCCESSFUL DEPLOYMENT OF A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE ESHEATH WAS REMOVED USING 1 PERCLOSE AND AN 8FR ANGIOSEAL TO OBTAIN HEMOSTASIS. A POST ANGIOGRAM WAS PERFORMED TO CONFIRM PROPER HEMOSTASIS OF THE RIGHT FEMORAL ARTERY. THE ANGIOGRAM SHOWED THERE WAS A FILLING DEFECT AND SLOW FLOW THROUGH THE VESSEL DISTAL TO THE POINT OF ACCESS. VASCULAR SURGERY WAS CALLED AND A SURGICAL CUTDOWN OF THE VESSEL WAS PERFORMED. UPON FURTHER REVIEW THE VASCULAR SURGEON DETERMINED THE DISSECTION OF THE RIGHT FEMORAL ARTERY WAS DUE TO INSERTION OF THE ESHEATH. WHEN THE SHEATH WAS REMOVED IT CAUSED THE DISSECTION FLAP TO OCCLUDE FLOW WITHIN THE VESSEL.

  Patient problems: Vascular Dissection

  MAUDE report 13595917 ↗
• MalfunctionFeb 22, 2022Difficult to Advance; Material Split, Cut or Torn; Physical Resistance/Sticking; Difficult to Advance; Material Split, Cut or Torn; Physical Resistance/Sticking

  AS REPORTED, DURING LAB TESTING, THERE WERE TWO CASES OF A SAPIEN 3 VALVE CATCHING INSIDE THE ESHEATH TIP BEFORE IT EXITED THE SHEATH. AFTER PUSHING OUT, A SMALL BLUE TIP SECTION RIPPED OFF. THE TEST INVOLVED MEASURING PUSH OUT FORCES OF A CRIMPED VALVE ON COMMANDER BALLOON SHAFT THROUGH ESHEATH AND OUT OF ITS TIP. TWO UNITS SAW HIGH FORCES OF 35.34N AND 27.26N BEFORE THE VALVE EXITED THE ESHEATH. THE TWO UNITS SEEMED TO HAVE A SMALLER OR CONSTRICTED INTERNAL DIAMETER OR SOME ANOMALY AT THE TIP THAT MAY HAVE CAUSED THE VALVE TO CATCH ONTO THE ESHEATH TIP BEFORE IT WAS PUSHED OUT. A TOTAL OF FIVE UNITS FROM THIS SAME LOT WERE TESTED. PER ADDITIONAL INFORMATION RECEIVED, THE VALVE WAS CRIMPED THEN ALIGNED ON THE INFLATION BALLOON. ALL DEVICES WERE PREPPED AND TESTED PER PROTOCOL. NO ABNORMALITIES WERE NOTED DURING VALVE CRIMPING. THE VALVE WAS COAXIAL ON THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581419 ↗
• MalfunctionFeb 16, 2022Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  DURING THE IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION PATIENT TORTUOSITY CAUSED FOR AN INCREASED PUSH FORCE FOR THE CRIMPED VALVE TO GO THROUGH THE ESHEATH. THE VALVE DELIVERED NORMALLY, BUT ON TRYING TO REMOVE THE DELIVERY SYSTEM, THE SHEATH WAS SPLIT AND THE DS AND SHEATH HAD TO BE REMOVED AS A UNIT. COMPLETION ANGIO SHOWS NO DISRUPTION TO RIGHT ILIAC, FEMORAL, OR ACCESS SITE. PATIENT SEEMED TO BE UNAFFECTED BY THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546419 ↗
• MalfunctionJan 21, 2022Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  AS REPORTED, AFTER SUCCESSFUL DEPLOYMENT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE RUPTURED BALLOON GOT CAUGHT ON THE EDGE OF THE ESHEATH AND WOULD NOT RE-TRACK INTO THE SHEATH. THE ESHEATH WAS NOTED TO HAVE A SPLIT AND STRETCHED AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315374 ↗
• MalfunctionJan 19, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A TF TAVR CASE THE TEAM HAD TROUBLE WITH BALLOON ALIGNMENT WITH FIRST SYSTEM. THEY ATTEMPTED BALLOON ALIGNMENT, PERFORMED IN THE STRAIGHT PORTION OF THE AORTA. THE RESET THE ALIGNMENT KNOB. PULLED NEGATIVE ON THE BALLOON WITH THE ATRION. THE TEAM COULD NOT GET THE VALVE TO GO BACK IN THE SHEATH TO REMOVE FROM THE BODY. EVENTUALLY IT APPEARED TO HAVE SUCCESSFULLY RETRACTED THE VALVE FRAME INTO THE ESHEATH. PULLED UNIT OUT AS ONE BUT VALVE STRIPPED OFF THE DELIVERY SYSTEM INTO THE SOFT TISSUE OF THE ACCESS TRACK FROM THE SKIN SURFACE TO THE ARTERY. THE VESSEL HAD BEEN DAMAGED SEVERELY FROM THE LACERATION FROM THE VALVE BECOMING STUCK IN THE TISSUE TRACK THAT THE 16 FR E-SHEATH WAS JUST TOO SMALL TO SEAL THE HOLE IN THE VESSEL. REPLACEMENT WITH 16F ESHEATH DID NOT ACHIEVE HEMOSTASIS. USED A 24F DRY SEAL WITH GOOD HEMOSTASIS. SECOND SYSTEM WAS PREPPED AND VALVE ALIGNMENT WITHOUT COMPLICATION AND IMPLANTED WITHOUT COMPLICATION. SURGICAL CUT DOWN TO REPAIR THE RIGHT FEMORAL ARTERY AFTER THE INJURY FROM THE EMBOLIZED 29 MM VALVE. SYSTEM IS AVAILABLE TO RETURN. VASCULAR REPAIR PERFORMED BY VASCULAR SURGEON AT THE END OF THE CASE WITH SUCCESSFUL REPAIR OF THE CFA. PATIEN

  Patient problems: Insufficient Information

  MAUDE report 13297350 ↗
• MalfunctionJan 11, 2022Peeled/Delaminated; Peeled/Delaminated

  PER THE FIELD CLINICAL SPECIALIST (FCS), DURING A JUGULAR TTVR PROCEDURE FOR A 29MM SAPIEN 3 VALVE, DURING VALVE ALIGNMENT, THE BALLOON COULD NOT BE FULLY ALIGNED WITH THE VALVE. MULTIPLE ATTEMPTS TO MADE TO TROUBLESHOOT, BUT SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE BALLOON WOULD NOT ALIGN INSIDE THE VALVE. AFTER MANY ATTEMPTS AT BALLOON ALIGNMENT, THE TEAM DECIDED TO REMOVE THE SYSTEM AS A UNIT AND PREPARE A NEW SYSTEM. AS THE VALVE WAS INITIALLY BEING INSERTED INTO THE ESHEATH, THERE WERE NO DIFFICULTY. HOWEVER, THE OPERATOR QUICKLY BEGAN TO NOTE RESISTANCE WHICH INCREASED WHEN CONTINUED BACKWARD PRESSURE WAS APPLIED. THE RADIOPAQUE MARKER OF THE ESHEATH INDICATED THE VALVE WAS PARTIALLY INSIDE THE ESHEATH, HOWEVER, THE POSITION OF THE VALVE AND DELIVERY SYSTEM IN THE PATIENT'S ANATOMY INDICATED THE VALVE HAD TRAVELED FURTHER INSIDE THE ESHEATH THAN THE MARKER WAS INDICATING. DUE TO THE INCREASED RESISTANCE, THE VALVE, DELIVERY SYSTEM AND SHEATH COULD NOT BE FURTHER REMOVED FROM THE BODY WITHOUT RISK OF SERIOUS INJURY, SO SURGERY WAS CALLED TO PERFORM A CUTDOWN TO REMOVE THE SYSTEM. THE CUTDOWN WAS PERFORMED SUCCESSFULLY AND THE DECISION WAS MADE TO PROCEED WITH A 26FR DRYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233058 ↗
• MalfunctionDec 3, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A TF TAVR CASE, THE DELIVERY SYSTEM BALLOON RUPTURED DURING VALVE DEPLOYMENT WITH -1CC FLUID. THE PHYSICIAN WAS ADVISED TO PULL THE DELIVERY SYSTEM AND SHEATH OUT AS ONE UNIT WHILE WATCHING UNDER FLUORO IMAGING. THE SHEATH APPEARED START TO BE BEND OVER ON ITSELF BECAUSE OF THE DELIVERY SYSTEM'S BURST BALLOON LARGER PROFILE. THE PHYSICIAN PUSHED THE DELIVERY SYSTEM FORWARD TO FREE UP THE BALLOON BUT THE DELIVERY SYSTEM BALLED UP AND WOULDN'T PASS THROUGH THE ILIAC. THE DELIVERY SYSTEM AND SHEATH WERE REMOVED BY SURGICAL CUTDOWN. THE PATIENT HAD VERY TORTUOUS ANATOMY. DURING PRE-DECONTAMINATION OF THE RETURNED DEVICE, CIRCUMFERENTIAL LINER DELAMINATION WAS OBSERVED OF THE RETURNED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930050 ↗
• InjuryNov 24, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A TF TAVR CASE THE PATIENT'S ABDOMINAL AORTA WAS TORTUOUS AND DURING THE REMOVAL OF COMMANDER BALLOON THROUGH THE ESHEATH IN THIS TORTUOUSITY CAUSED THE SEAM OF THE ESHEATH TO INVAGINATE AND KINK. THE DILATOR WAS USED TO STRAIGHTEN THE ESHEATH FOR REMOVAL OF THE ESHEATH. WHEN THE ESHEATH WAS REMOVED THERE WAS A LINEAR VASCULAR TEAR AT THE ARTERIOTOMY. THE VESSEL TISSUE AT THE ARTERIOTOMY AS STATED BY THE VASCULAR SURGEON WAS ANUERYSMAL AND FRAGILE. A VASCULAR SURGEON REPAIRED THE ARTERIOTOMY VIA SURGICAL CUTDOWN. IMAGERY PROVIDED SHOWS CIRCUMFERENTIAL LINER DELAMINATION. THERE WAS NO DAMAGE NOTED TO THE DELIVERY SYSTEM. PER THE SPECIALIST, THE BLUE PORTION OF THE ESHEATH HAD NO DAMAGE, THE CLEAR PORTION OF THE ESHEATH DELAMINATED AND WAS PULLED INTO THE ESHEATH.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 12872688 ↗
• MalfunctionNov 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING THE IMPLANTATION OF A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA THE TRANSFEMORAL APPROACH WITH 29MM COMMANDER DELIVERY SYSTEM SET, THE PHYSICIAN THOUGHT THE SHEATH MAY HAVE SPLIT AT THE DISTAL TIP DURING INSERTION SO A SECOND SHEATH WAS REQUESTED. THERE WAS DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852698 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS RETURNED FOR EVALUATION. OUR ENGINEERING FINDINGS WERE NO DISTAL TIP SPLIT OR DAMAGE WAS OBSERVED ON THE ESHEATH. IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE FIRST VALVE AND DELIVERY SYSTEM WERE PULLED BACK INTO THE SHEATH AND REMOVED FROM THE BODY. A DISSECTION OF THE EXTERNAL ILIAC WAS OBSERVED. VASCULAR SURGERY WAS PERFORMED WITH A STENT GRAFT TO REPAIR THE LEFT EXTERNAL ILIAC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 12808027 ↗
• InjuryNov 12, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED, DURING A TF TAVR CASE, THE TEAM WAS UNABLE TO DELIVER THE FIRST 29MM SAPIEN 3 VALVE THROUGH THE FIRST 16F ESHEATH. THE TEAM ENDED UP IMPLANTING THAT VALVE IN THE DESCENDING AORTA RATHER THAN ATTEMPTING TO REMOVE IT THROUGH A BADLY DAMAGED SHEATH. THE TEAM SWITCHED ACCESS SITE TO THE LEFT FEMORAL ARTERY AND WERE SUCCESSFUL IN IMPLANTING A SECOND 29MM SAPIEN 3 VALVE IN THE CORRECT AORTIC POSITION THROUGH A SECOND 16F ESHEATH. THE RIGHT SIDE REQUIRED A CUT-DOWN REPAIR OF THE FEMORAL ARTERY, BUT OTHERWISE THE PATIENT IS STABLE AND RECOVERING. OF NOTE, THE PHYSICIAN EXPERIENCED MORE THAN USUAL RESISTANCE WHILE ATTEMPTING TO PUSH THE COMMANDER WITH VALVE THROUGH THE ESHEATH. IT WAS REVEALED ON FLUOROSCOPY THAT THE CRIMPED VALVE HAD STARTED TO AVULSE THE ESHEATH. AFTER AN AORTIC OCCLUSION BALLOON WAS PLACED FROM THE CONTRALATERAL GROIN, AND ANOTHER PHYSICIAN PERFORMED A CUT-DOWN ON THE RIGHT FEMORAL ARTERY, UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE VALVE BACK INTO THE ESHEATH. THE DECISION WAS MADE TO TRY AND ADVANCE THE VALVE FORWARD INTO THE ESHEATH WITH THE OCCLUSION BALLOON ON STANDBY, BUT THIS WAS NOT SUCCESSFUL INITIALLY; HOWEVER, AFTER THE AMPLATZ EXTRA-STIFF WIR

  Patient problems: Perforation of Vessels

  MAUDE report 12807507 ↗
• InjuryOct 11, 2021Peeled/Delaminated; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Peeled/Delaminated; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A THV TERRITORY MANAGER THAT DURING A RIGHT TRANSFEMORAL TAVR, THERE WAS RESISTANCE DURING INSERTION OF THE 29MM SAPIEN 3 VALVE INTO THE 16FR ESHEATH. FLUORO IMAGES SHOWED THAT THE ESHEATH WAS PERFORATED AND THE DEVICES WERE SURGICALLY REMOVED. AS REPORTED, THE PATIENT HAD SEVERE TORTUOSITY IN EXTERNAL ILIAC ARTERY. MULTIPLE SHEATHS WERE REQUIRED TO ULTIMATELY GET UP WITH THE ESHEATH. ONCE THE ESHEATH WAS PLACED, A 29MM COMMANDER DELIVERY SYSTEM WAS PREPPED AND INSERTED INTO THE ESHEATH. DIFFICULTY PUSHING THE VALVE THROUGH THE ESHEATH WAS EXPERIENCED AND ULTIMATELY THE ESHEATH AND DELIVERY SYSTEM WERE OBSERVED TO BE KINKING. THE DELIVERY SYSTEM WAS NOT MOVING FORWARD THOUGH THE ESHEATH AT THE LEVEL OF THE EXTERNAL ILIAC ARTERY. THE DIFFICULTY WAS EXPERIENCED APPROXIMATELY HALFWAY INTO THE ESHEATH. FLUORO PICTURES SEEMED TO SHOW THAT THE SHEATH WAS PERFORATED. THE UNDEPLOYED THV APPEARED TO BE HERNIATED THROUGH THE SIDE OF THE ESHEATH. THE SYSTEM WAS UNABLE TO BE ADVANCED OR REMOVED. THE PROCEDURE WAS STOPPED AND VASCULAR SURGERY WAS CALLED. THE PATIENT REMAINED STABLE AND WAS TAKEN TO VASCULAR OR FOR SURGICAL REMOVAL OF THE DEVICES. THE ESHEATH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611814 ↗
• InjurySep 28, 2021Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE FOR A 29MM SAPIEN 3 VALVE, RESISTANCE WAS FELT WHEN ADVANCING THE ESHEATH INTO THE ARTERY. POST DEPLOYMENT, WHILE VIEWING THE ESHEATH UNDER FLUOROSCOPY, THE TEAM NOTICED THE ESHEATH WAS SPLIT AND THE WIRE WAS EXITING THE SIDE OF THE ESHEATH JUST BEFORE THE DISTAL TIP. THE ESHEATH WAS REMOVED SLOWLY WITHOUT DIFFICULTY. HEMOSTASIS WAS UNSUCCESSFUL WHILE TRYING TO CINCH THE PERCLOSE SUTURES AND MANUAL COMPRESSION WAS APPLIED TO CONTROL THE BLEEDING. AN ANGIOGRAM REVEALED A VASCULAR INJURY AT THE PUNCTURE SITE. THE ACCESS WAS GAINED AT THE SUPERFICIAL FEMORAL ARTERY AND A BALLOON WAS ADVANCED AND INFLATED. THE DECISION WAS MADE TO CALL THE SURGICAL VASCULAR TEAM AND A SUCCESSFUL CUT DOWN AND REPAIR OF THE FEMORAL ARTERY WAS PERFORMED. NO CONCLUSION WAS MADE ON WHAT CAUSE THE VASCULAR INJURY. THE TEAM WAS NOT SURE IF WAS THE FORCE IT TOOK TO ADVANCE THE ESHEATH INTO THE ARTERY BECAUSE OF THE PATIENTS PERIPHERAL VASCULAR DISEASE OR THE SPLIT ESHEATH DURING REMOVAL.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 12538525 ↗
• InjurySep 24, 2021Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  A 29MM S3 WAS PARTIALLY DEPLOYED IN THE EXTERNAL SUBCLAVIAN AREA. AFTER ATTEMPTING TO OBTAIN ACCESS VIA TRANSFEMORAL APPROACH, DUE TO PATIENT FACTORS, THEY TRANSITIONED TO SUBCLAVIAN ACCESS. AFTER GAINING ACCESS, THE PHYSICIANS INSERTED THE 16F SHEATH INTO THE SUBCLAVIAN ARTERY AND THEY NOTICED THAT THE SHEATH SEEMED TO SPLIT. THE PHYSICIANS DECIDED TO TAKE IT OUT AND INSERT A NEW ONE. A NEW 16F SHEATH WAS INSERTED AND THE PHYSICIANS PROCEEDED WITH INSERTING THE VALVE ON THE DELIVERY SYSTEM. THE SURGEON WAS ADVANCING THE VALVE WHEN SHE FELT AS IF IT WAS TAKING SOME FORCE TO INSERT. THEY PROCEEDED BUT THEN NOTICED THAT THE VALVE WAS OUTSIDE OF THE SHEATH. THEY USED FLUOROSCOPY TO CONFIRM THAT THE VALVE WAS IN FACT OUTSIDE OF THE SHEATH. THEY TRIED TO GET THE VALVE BACK INSIDE OF THE SHEATH BY PULLING THE SHEATH BACK, ADVANCING THE SHEATH AND THEN PUTTING UP A BALLOON THROUGH THE GROIN ACCESS TO HELP GUIDE THE VALVE AND SHEATH BUT, NOTHING WORKED. THEY DECIDED THAT THEY WERE NOT GOING TO BE ABLE TO DEPLOY THE VALVE. AS THEY WERE NOT ABLE REMOVE THE SHEATH AND DELIVERY SYSTEM, THE VALVE WAS MOUNTED ONTO THE BALLOON AND PARTIALLY DEPLOYED INTO THE SUBCUTANEOUS TISSUE OUTSIDE OF THE SUB

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12530653 ↗
• InjurySep 15, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A RIGHT TRANSFEMORAL TAVR PROCEDURE FOR A 23MM SAPIEN 3 ULTRA VALVE, THERE WAS RESISTANCE WHILE ADVANCING THE VALVE THROUGH THE 14FR ESHEATH. THE DEVICES WERE REMOVED AS A UNIT, AND A 16FR ESHEATH WAS USED. THERE WAS STILL RESISTANCE AT THE SAME LOCATION WHILE ADVANCING THE VALVE, BUT THE TEAM WAS ABLE TO PUSH THE VALVE THROUGH THE 16F ESHEATH. THERE WAS DIFFICULTY WHILE CROSSING THE ANNULUS DUE TO THE ROOT ANGLE AND BICUSPID ANATOMY (THIS WAS A SEPARATE CHALLENGE FROM THE SHEATH/ADVANCING VALVE ISSUE). THE TEAM LOST WIRE POSITION FROM THE LV, AND THE VALVE WAS REMOVED WITH THE ESHEATH. THE ESHEATH WAS EXCHANGED FOR A 3RD TIME, AND A NEW 23 SAPIEN 3 ULTRA VALVE WAS OPENED AND INSERTED THROUGH THE 16FR ESHEATH WITH NO ISSUE. THE VALVE DEPLOYED WITH GOOD RESULT AND THE DELIVERY SYSTEM WAS REMOVED. UPON REMOVAL OF THE THIRD 16FR ESHEATH, A VASCULAR DISSECTION/PERFORATION AND EXTRAVASATION WAS REVEALED. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. AN OCCLUSION BALLOON WAS INSERTED TO THE AORTA AND INFLATED TO CONTROL THE BLEEDING AND RESTORE BLOOD PRESSURE. A VASCULAR SURGEON WAS CALLED TO REPAIR VIA AN ENDOVASCULAR STEN

  Patient problems: Perforation of Vessels

  MAUDE report 12472331 ↗
• MalfunctionSep 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A TRANSCATHETER MITRAL VALVE IN VALVE (VIV) PROCEDURE, DIFFICULTIES WERE ENCOUNTERED DURING THE ATTEMPT TO ALIGN THE SAPIEN 3 VALVE. AFTER SEVERAL ATTEMPTS, THE INITIAL ESHEATH, COMMANDER DELIVERY SYSTEM AND VALVE WERE REMOVED. FOLLOWING THE DEVICE WITHDRAWAL, THE SHEATH WAS NOTED TO BE 'SIGNIFICANTLY' SPLIT. DURING A TMVR VIV PROCEDURE, DEPLOYMENT OF A 29MM SAPIEN 3 VALVE WAS ORIGINALLY PLANNED. FOLLOWING THE INSERTION OF THE INITIAL 16FR ESHEATH, THE SCARRING AT THE ACCESS SITE MADE INSERTION OF THE SAPIEN 3 VALVE AND DELIVERY SYSTEM CHALLENGING, BUT EVENTUALLY THE VALVE WAS INSERTED. EXTREME DIFFICULTY WAS THEN ENCOUNTERED DURING THE ATTEMPT TO MOUNT AND ALIGN THE VALVE ON THE DELIVERY SYSTEM BALLOON IN THE VENA CAVA (VC). THE BALLOON APPEARED TO BE GETTING CAUGHT ON THE STRUT OF THE STENT AND WOULD NOT MOUNT. SOME ANGULATION AND TORTUOSITY AS WELL AS THE PATIENT'S SHORT ANATOMY ALSO MADE THE WORKING SPACE IN THE VC VERY LIMITED. AFTER SEVERAL ATTEMPTS AND ADJUSTMENTS, IT WAS DETERMINED THAT THE SAFEST CALL WAS TO REMOVE THE SYSTEM. IN THE PROCESS, THE SHEATH WAS SPLIT SIGNIFICANTLY. NO INJURY TO THE PATIENT WAS REPORTED. A SECOND SHEATH WAS PREPARED, BUT WAS DAMAGED DURI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422307 ↗
• MalfunctionAug 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A TF TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, IN THE AORTIC POSITION VIA THE TRANSFEMORAL APPROACH, THE DELIVERY SYSTEM BALLOON RUPTURED. DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW SYSTEM. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE FIELD CLINICAL SPECIALIST, THE COMMANDER BALLOON WAS TORN PRIOR TO INFLATION. THE DELIVERY SYSTEM WAS PREPPED WITH NOMINAL VOLUME. THERE WERE NO DIFFICULTIES REMOVING THE DELIVERY SYSTEM. PER THE PRELIMINARY ENGINEERING EVALUATION: THE ESHEATH DISTAL TIP APPEARS SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368037 ↗
• MalfunctionAug 13, 2021Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  WHILE PERFORMING AN EDWARDS LIFESCIENCES INTERNAL ENGINEERING TESTING, IT WAS OBSERVED THAT THE 16FR ESHEATH TIP HAD TORN DURING INSERTION OF A 29MM TRANSCATHETER HEART VALVE (THV) AND 29MM COMMANDER DELIVERY SYSTEM THROUGH THE ESHEATH. THE THV HAD BEEN PURPOSEFULLY ALTERED TO HAVE ALL APICES EXPOSED THROUGH THE SKIRT, AS PER ENGINEERING REQUEST FOR THIS TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317192 ↗