EDWARDS ESHEATH INTRODUCER SET 914ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00690103193985), received between Oct 21, 2020 and Jul 24, 2024 — classified as 6 deaths, 25 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (63 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 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BY THE ALLIANCE CLINICAL TRIAL, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, UPON REMOVAL OF THE PIGTAIL AT THE END OF THE CASE, WITHOUT WIRE, THE PIGTAIL GOT STUCK IN THE ESHEATH RESULTING IN THE ESHEATH COMING OUT OF THE PATIENT PAST THE PARTIAL EXPANDABLE PART. LFA (LEFT FEMORAL ARTERY) SHEATH SLID BACK, EXPOSING THE SPLIT PORTION AND LEADING TO BLOOD LOSS. PERIPHERAL ANGIOGRAPHY WAS PERFORMED WITHOUT AN OVERT SOURCE AND NO BLEEDING WAS IDENTIFIED. THERE WAS SOME MISCOMMUNICATION ON WHO WAS TO HOLD THE GROIN AND WHO WAS TO HOLD THE SHEATH. ADDITIONAL INFORMATION WAS FOUND THAT IN PREPARATION FOR THE ESHEATH REMOVAL, THE IMPLANTER WENT TO PULL THE PIGTAIL OUT OVER THE WIRE. THE ESHEATH CAME BACK AS WELL, PAST THE PARTIAL EXPANDABLE PART, AND THE PATIENT STARTED TO BLEED. IT WAS THEN DECIDED TO PULL THE REMAINING ESHEATH OUT AND HOLD PRESSURE. THE PATIENT'S PRESSURE BEGAN TO DROP, AND THE TEAM GAVE FLUIDS AND STARTED PRESSORS. THE ECHO WAS CHECKED FOR EFFUSION AND NO EFFUSION WAS SEEN. AN UP-AND-OVER ANGIOGRAM WAS TAKEN, AND NO BLEEDING WAS SEEN IN THE AO, ILIACS, OR FEMORALS. THE TEAM DID NOT GIVE BLOOD AS THE BLOOD LOSS WAS INSUFFICIENT TO AMOUNT

  Patient problems: Insufficient Information

  MAUDE report 19822481 ↗
• MalfunctionJul 17, 2024Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  FROM A CLINICAL STUDY, DURING THE PROCEDURE OF A 26 MM SAPIEN X4 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, RESISTANCE WAS NOTED WHEN THE DELIVERY SYSTEM WAS EXITING THE SHEATH. THE VALVE WAS SUCCESSFULLY IMPLANTED AND THERE WAS NO VASCULAR INJURY NOTED. AFTER ESHEATH REMOVAL, THE ESHEATH WAS EVALUATED THE ON THE BACK TABLE AND FOUND THE DISTAL TIP OF THE ESHEATH WAS FRACTURED/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768088 ↗
• InjuryJul 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED FROM A CLINICAL STUDY, DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN X4 VALVE, AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, THE 14FR ESHEATH WAS REMOVED WITHOUT DIFFICULTY AND TWO PERCLOSE CLOSURE DEVICES (NON-EDWARDS DEVICES) WERE SUCCESSFULLY DEPLOYED, BUT IT WAS NOTED THAT THE ACCESS SITE STILL REQUIRED MANUAL PRESSURE. AN ADDITIONAL TWO PERCLOSE CLOSURE DEVICES WERE DEPLOYED, BUT HEMOSTASIS WAS STILL UNSUCCESSFUL. A CUTDOWN WAS THEN PERFORMED ON THE RIGHT FEMORAL ARTERY (RFA) SITE. THE RFA WAS SUCCESSFULLY REPAIRED WITHOUT COMPLICATIONS. THE 14FR ESHEATH AND X4 DELIVERY SYSTEM WERE FURTHER ASSESSED AND THE 14FR ESHEATH WAS OBSERVED WITH A "FRACTURED" TIP. THE X4 DELIVERY SYSTEM AND BALLOON WERE OBSERVED TO STILL BE INTACT. IT WAS NOTED THAT THE ACCESS SITE APPEARED TO BE LARGER THAN A 14FR ESHEATH WHICH MAY HAVE BEEN CAUSED BY THE ESHEATH CATCHING ONTO THE RFA CALCIUM UPON REMOVAL. ADDITIONAL INFORMATION WAS RECEIVED INDICATING AFTER REMOVAL OF THE ESHEATH, THE DISTAL TIP OF THE ESHEATH WAS "FRACTURED AND MISSING". IMAGERY OF THE ESHEATH DEVICE WAS PROVIDED FOR EVALUATION. A REVIEW OF THE PROVIDED DEVICE IMAGERY R

  Patient problems: Unspecified Vascular Problem

  MAUDE report 19656547 ↗
• InjuryMay 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EDWARDS RECEIVED NOTIFICATION THROUGH A CLINICAL TRIAL THAT FOLLOWING COMPLETION OF THE CASE, IT WAS NOTED THAT THE DISTAL TIP OF 914ESA ESHEATH WAS TORN. THERE WAS NO REPORT OF RESISTANCE BETWEEN THE VALVE/DELIVERY SYSTEM AND THE ESHEATH.

  Patient problems: Insufficient Information

  MAUDE report 19250189 ↗
• MalfunctionDec 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING RESEARCH AND DEVELOPMENT (R&D) TESTING, THE 14FR ESHEATH DISTAL TIP TORE WHEN WHEN THE VALVE WAS EXITING THE SHEATH. NO DAMAGE TO THE VALVE WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350544 ↗
• MalfunctionSep 14, 2023Peeled/Delaminated; Material Separation; Material Integrity Problem; Material Split, Cut or Torn; Peeled/Delaminated; Material Separation; Material Integrity Problem; Material Split, Cut or Torn

  AS REPORTED, A SIMULATED USE ENGINEERING TESTING WAS PERFORMED USING A X4 SYSTEM, WAGON WHEEL FIXTURE AND GLASS ANATOMY MODEL. EVERYTHING WENT WELL UNTIL DEVICE WITHDRAWAL. UPON THE X4 DELIVERY SYSTEM BALLOON RETRIEVAL INTO THE SHEATH, THE SHEATH LINER WAS DELAMINATED WITH THE C-MARKER BAND DETACHED FROM THE DISTAL TIP, FOLLOWED BY A LINER TEAR THROUGH THE REST OF THE SHEATH. THE STRAIN RELIEF WAS ROLLED BACK AND THE BALLOON WAS BUNCHED UP. THE DELIVERY SYSTEM WITHDRAWAL WAS PERFORMED OUTSIDE OF THE GLASS MODEL. THE DELIVERY SYSTEM WAS FULLY UNFLEXED AND THE BALLOON WAS FULLY DEFLATED PRIOR TO WITHDRAWAL. RESISTANCE WAS FELT WHEN THE DELIVERY SYSTEM WAS FULLY RETRACTED INSIDE THE SHEATH. THE ATRION WAS CHECKED AND MORE VACUUM WAS PULLED BEFORE CONTINUING WITH THE WITHDRAWAL. THE DEPLOYMENT VOLUME USED WAS 17.2CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747121 ↗
• InjuryAug 30, 2023Failure to Advance; Failure to Advance

  AS REPORTED FROM PRO CLINICAL STUDY, A 14F ESHEATH WAS PREPPED. ALONG WITH THE SHEATH, A 23MM S3 ULTRA VALVE, AND 23MM COMMANDER DELIVERY SYSTEM (DS) WERE ALL PREPPED WITHOUT INCIDENT. THE ESHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY (RCFA) WITHOUT INCIDENT. UPON ENTRY OF THE 23MM DELIVERY SYSTEM, THE OPERATOR HAD DIFFICULTY PUSHING THE DS THROUGH THE SHEATH. THE DS AND VALVE WERE STUCK APPROXIMATELY HALFWAY THROUGH THE SHEATH. THE OPERATOR TRIED A COUPLE OF TIMES TO CONTINUE ADVANCING BUT THE PUSH FORCES WERE TOO GREAT. THE OPERATOR INJECTED A SMALL AMOUNT OF PROPOFOL TO LUBRICATE THE INTERNAL DIMENSIONS OF THE SHEATH BUT THIS ALSO DIDN'T RESOLVE THE ISSUE. THE DECISION WAS MADE TO REMOVE THE SHEATH, DS AND VALVE AND PREP A NEW SYSTEM. A NEWER ESHEATH PLUS, NEW 23MM S3 ULTRA AND 23MM DS WERE AGAIN PREPPED WITHOUT INCIDENT AND THE CASE WENT SMOOTHLY. UPON REMOVAL OF THE SECOND SHEATH A SMALL FOCAL DISSECTION WAS NOTED IN THE RCFA BY ONE OF THE SUPPORTING PHYSICIANS. THE PHYSICIAN FELT IT WAS INSIGNIFICANT AND THAT THE TEAM SHOULD CHECK ON LEG BLOOD FLOW WITH ECHO LATER IN THE DAY. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT REPORTED TO HOSPITAL WITH RIGHT LE

  Patient problems: Vascular Dissection

  MAUDE report 17649504 ↗
• MalfunctionApr 6, 2023Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY AN EDWARDS QUALITY ENGINEERING MANAGER, THE ENGINEERING TEAM WAS CONDUCTING TESTING USING THE DV SYSTEM ADVANCEMENT TEST METHOD ZWICK IN THE DV LAB. NONE OF THE DEVICES INVOLVED ATYPICAL CONDITIONING OR MANEUVERS. THE SHEATHS AND DELIVERY SYSTEMS WERE FULLY COMMERCIAL PRODUCT. THE VALVES WERE SCRAP UNITS FROM COMMERCIAL LOTS, BUT SCRAP CODES NOT EXPECTED TO AFFECT BENCHTOP TESTING. THERE IS NO PATIENT INVOLVEMENT. THE THIRD 14FR ESHEATH WAS TESTED USING A 23MM S3U VALVE WITH 23MM COMMANDER AND EXPERIENCED A TIP TEAR. THE TIP DID NOT TEAR OFF, BUT IT DID NOT OPEN CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16697513 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH SOCIAL MEDIA, A DISSECTION OF THE FEMORAL ARTERY OCCURRED DURING THE TAVR PROCEDURE. TWO DAYS POST DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO A BLOOD CLOT IN THE FEMORAL ARTERY THAT REQUIRED SURGICAL INTERVENTION. AS REPORTED BY A TAVR PATIENT THROUGH SOCIAL MEDIA, DURING A TRANSFEMORAL TAVR PROCEDURE, DURING THE ATTEMPT TO PLACE THE SHEATH, THE RIGHT FEMORAL ARTERY WAS DISSECTED. NO ACTIONS WERE TAKEN AS THE DOCTOR BELIEVED THE DISSECTION WOULD HEAL ON ITS OWN. A 26MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY DEPLOYED IN THE AORTIC POSITION. TWO DAYS POST DISCHARGE, 'TIGHTNESS' IN THE RIGHT CALF OCCURRED AND THE PATIENT RETURNED TO THE HOSPITAL. SURGERY WAS PERFORMED TO REMOVE A BLOOD CLOT AT THE ACCESS SITE. THE PATIENT WAS DISCHARGED 4 DAYS POST-SURGERY. THE PATIENT REPORTED A QUICK RECOVERY AND FEELING WELL. THE VALVE REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 14950428 ↗
• MalfunctionMay 4, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING THE PROCEDURE WITH A 26MM ULTRA SAPIEN IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE BALLOON RUPTURED DURING DEPLOYMENT, AND THEY WERE UNABLE TO GET BALLOON COMPLETELY BACK INTO SHEATH, THEY HAD TO REMOVE SHEATH, DELIVERY SYSTEM AS ONE UNIT AND HAD TO CUT DOWN TO REPAIR FEMORAL ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BALLOON RUPTURED WHEN IT WAS FULLY INFLATED A BAV (TF)/ BAVC (TA) WAS NOT USED, NO EXTRA VOLUME WAS ADDED TO THE BALLOON PRIOR TO THE INFLATION. THE INFLATION TECHNIQUE WAS SLOW TO MEDIUM AND THEY USED 23CC VOLUME. THE VALVE WAS IMPLANTED WITH GOOD RESULTS PRE-DECONTAMINATION RESULTS INDICATE THAT THE SHEATH TIP WAS DAMAGED; SHEATH FULLY CIRCUMFERENTIALLY DELAMINATED 1.75 INCHES FROM DISTAL TIP AND C-MARKER BAND IS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274652 ↗
• MalfunctionMar 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, THERE WAS DIFFICULTY PULLING THE BALLOON/DELIVERY SYSTEM BACK INTO THE SHEATH DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE USER DECIDED TO REMOVE THE DELIVERY SYSTEM AND SHEATH AS ONE UNIT. UPON WITHDRAWAL OF THE ESHEATH FROM THE DELIVERY SYSTEM, THE SEAM WAS SPLIT ON THE EXPANDABLE PART OF THE SHEATH WHICH SHOWED A LINER TEAR AND DISTAL TIP SPLIT ON THE SHEATH. THERE WAS NO REPORT OF ANY INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908300 ↗
• MalfunctionMar 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  RECEIVED A CALL THROUGH THE THV HOTLINE. AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING THE PROCEDURE OF A 23 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, AFTER THE VALVE WAS DEPLOYED AND THE ESHEATH WAS REMOVED, IT WAS OBSERVED THAT THE DISTAL END OF THE ESHEATH WAS TORN, HOWEVER NOTHING WAS DETACHED. THERE WAS NO INJURY TO PATIENT. THE PATIENT WAS IN STABLE CONDITION AND WENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695051 ↗
• MalfunctionFeb 23, 2022Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  AS REPORTED, DURING THE RIGHT TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, HIGH INSERTION FORCES WERE ENCOUNTERED DURING INSERTION OF THE COMMANDER DELIVERY SYSTEM INTO THE ESHEATH. WHEN THE DELIVERY SYSTEM EXITED THE ESHEATH TIP, THE WHOLE SYSTEM APPEARED TO JUMP FORWARD AND THE OPERATOR STATED HE FELT A "POP". THE VALVE WAS EVALUATED UNDER FLUOROSCOPY AND APPEARED WITHIN NORMAL CONDITION PER THE OPERATOR. THE VALVE WAS SUCCESSFULLY DEPLOYED. POST-DEPLOYMENT, THE DEVICE WAS REMOVED WITH NO ISSUES. UPON REMOVAL OF THE 14F ESHEATH, IT WAS NOTED THE TIP WAS TORN, WHICH WAS SUSPECTED TO HAVE POSSIBLY OCCURRED WHEN THE DELIVERY SYSTEM EXITED THE ESHEATH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585226 ↗
• MalfunctionFeb 10, 2022Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  AS REPORTED, DURING THE PROCEDURE OF A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE BALLOON RUPTURE AT PEAK INFLATION. WHEN ATTEMPTING TO PULL INSIDE, THE 14F ESHEATH WANTED TO COLLAPSE AND THE TEAM WAS UNABLE TO GET THE DELIVERY SYSTEM FULLY INTO THE SHEATH. THE PRELIMINARY ENGINEERING EVALUATION OF THE RETURNED ESHEATH REVEALED A DISTAL TIP SPLIT AND DELAMINATION ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510056 ↗
• MalfunctionFeb 2, 2022Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A LEFT SIDE TRANSFEMORAL TAVR, THERE WAS RESISTANCE BETWEEN A 23MM SAPIEN 3 ULTRA VALVE/DELIVERY SYSTEM AND THE 14FR ESHEATH. THE DISTAL TIP OF THE SHEATH HAD A SLIGHT TEAR (DISTAL TIP SPLIT). AS REPORTED, THE VESSEL WAS PRE-DILATED WITH A 6 MM BALLOON AND SHOCKWAVE. DURING THE FIRST VALVE INSERTION, THERE WAS SOME RESISTANCE, AND IT WAS BELIEVED THAT THE LOADER WAS NOT FULLY INSERTED INTO THE SHEATH POTENTIALLY CAUSING DAMAGE AS IT CROSSED THE VALVES OF THE SHEATH. THE FIRST VALVE AND DELIVERY SYSTEM HAD A VALVE FRAME STRUT PROTRUDING THRU THE SKIRT AFTER ADVANCING THRU THE ESHEATH AND PERFORMING VALVE ALIGNMENT. THE ENTIRE 1ST SYSTEM AND ESHEATH WERE REMOVED. THE DISTAL TIP OF THE 1ST SHEATH HAD A SLIGHT TEAR UPON REVIEW AFTER ITS REMOVAL. A NEW 2ND SYSTEM AND ESHEATH WAS INTRODUCED AND VALVE WAS SUCCESSFULLY DEPLOYED. AFTER THE 2ND SYSTEM WAS REMOVED AND ACCESS SITE WAS CLOSED, THE PATIENT'S PRESSURE DROPPED AND ALL AVAILABLE RECOVERY EFFORTS WERE ENACTED. THE PATIENT DID NOT RECOVER AND EXPIRED. PER SALESFORCE, THERE WAS A MAJOR VASCULAR COMPLICATION AND MAJOR BLEEDING. PER THE FIELD CLINICAL SPECIALIST,

  Patient problems: Insufficient Information

  MAUDE report 13431278 ↗
• MalfunctionJan 28, 2022Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  AS REPORTED, DURING THE PROCEDURE OF A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THERE WAS DIFFICULTY INSERTING THE ESHEATH INTO THE PATIENT. A PERIPHERAL ANGIOPLASTY OF THE CALCIUM WAS PERFORMED AND THE ANGIOPLASTY BALLOON WAS LEFT INFLATED INSIDE THE TIP OF THE ESHEATH. THIS ACTION DAMAGED THE TIP OF THE ESHEATH CAUSING PRE-EXPANSION THE TIP WHICH WAS NOTED TO BE SPLIT AND FRAYED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385218 ↗
• MalfunctionJan 26, 2022Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  DURING THE IMPLANTATION OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION THERE WAS DIFFICULTY ADVANCING THE CRIMPED VALVE ON THE COMMANDER PAST THE TIP OF THE ESHEATH. WITH EXCESSIVE FORCE THE VALVE WAS EVENTUALLY ADVANCED THROUGH THE ESHEATH AND INTO THE ABDOMINAL AORTA. THERE WAS NOTICEABLE DAMAGE TO THE TIP OF THE ESHEATH ON FLURO. THE IMPLANTER WAS NOT COMFORTABLE DEPLOYING THE VALVE IN FEAR THAT IT WAS COMPROMISED GETTING IT PAST THE TIP OF THE SHEATH. ATTEMPTS WERE MADE TO RETRIEVE THE VALVE INTO THE ESHEATH IN ORDER TO REMOVE ALL AS ONE UNIT BUT WAS UNABLE TO GET THE VALVE INSIDE THE ESHEATH. THERE WAS AN ATTEMPT TO REMOVE EVERYTHING TOGETHER WITH THE VALVE BUTTED UP TO THE ESHEATH BUT THE VALVE GOT STUCK IN THE FEMORAL ARTERY. VASCULAR SURGERY PERFORMED A CUTDOWN ON THE ARTERY TO GET THE VALVE OUT. A SECOND 14FR ESHEATH WAS PLACED THROUGH A PURSE STRING IN THE ARTERY PLACED BY THE SURGEON. A 26MM SAPIEN 3 VALVE SUCCESSFULLY DEPLOYED WITHOUT ISSUE. IT WAS HYPOTHESIZED THAT PERHAPS THE REMOVAL OF THE 22 VIDA BAV DAMAGED THE TIP. AS REPORTED BY THE FCS, WE JUST FOUND OUT THAT THIS PATIENT WAS BROUGHT TO CT AND WAS FOUND TO HAVE A HEMORRHAGIC STROKE AND HAS DECEASED. UPON

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

  MAUDE report 13358664 ↗
• InjuryJan 26, 2022Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  AS REPORTED BY THE FCS, AFTER IMPLANTATION OF A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION IT WAS NOTICED UPON REMOVAL OF THE ESHEATH THAT A SMALL SECTION >1MM TO BE TORN / PEELED BACK AT THE DISTAL END. THE PHYSICIANS BELIEVE THE ESHEATH MAY HAVE PEELED BACK DURING THE INSERTION OF THE SHEATH CAUSING DAMAGE TO THE ARTERY. THE CONSEQUENCES TO THE PATIENT WAS THAT THE PATIENT HAD TO HAVE ADDITIONAL ACCESS CLOSURE PROCEDURES DONE INTERVENTIONALLY. VALVE SUCCESSFULLY IMPLANTED.

  Patient problems: Vascular Dissection

  MAUDE report 13358635 ↗
• InjuryJan 21, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE FOR A 23MM SAPIEN 3 ULTRA VALVE, THE VALVE BECAME STUCK IN THE ESHEATH IN THE COMMON FEMORAL ARTERY DURING INSERTION. AFTER MULTIPLE ATTEMPTS TO ADVANCE THE VALVE, THE DECISION WAS MADE TO REMOVE ESHEATH, VALVE, AND DELIVERY SYSTEM AND INSERT NEW SYSTEM. AS THE DEVICES WERE BEING REMOVED, THE VALVE WAS PUSHED OUT OF THE ESHEATH WHILE STILL BEING ON THE DELIVERY SYSTEM. THE VASCULAR SURGEON PERFORMED A CUT DOWN IN THE FEMORAL ARTERY TO EXTRACT THE VALVE. A NEW SYSTEM WAS PREPPED AND ADVANCED WITH NO ADDITIONAL ISSUES. THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13316097 ↗
• MalfunctionJan 14, 2022Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Output Problem; Material Split, Cut or Torn; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A TRANSFEMORAL TAVR, THERE WAS RESISTANCE BETWEEN A 23MM S3U VALVE/DS AND THE 14FR ESHEATH. AS REPORTED, AFTER 14FR ESHEATH WAS INSERTED INTO THE PATIENT WITHOUT ISSUE, THE 23MM ULTRA VALVE WAS INSERTED INTO THE ESHEATH. IT WAS NOTED BY THE CARDIOLOGIST THAT THERE WAS SOME RESISTANCE/INCREASED FORCE WHEN VALVE WAS EXITING THE DISTAL END OF THE SHEATH. THE VALVE APPEARED NORMAL AND WAS ALIGNED ON THE BALLOON WITHOUT ISSUE. THE VALVE WAS THEN ADVANCED OVER THE WIRE TO OPTIONAL POSITION FOR DEPLOYMENT AND WAS THEN DEPLOYED SUCCESSFULLY WITHOUT ISSUE. THE PHYSICIAN DID STATE THAT REMOVAL OF DELIVERY SYSTEM ALSO HAD INCREASED FORCE WHEN BRING THE BALLOON PORTION OF THE DELIVERY SYSTEM BACK INTO THE SHEATH. THE INFLATION DEVICE WAS PULLED ALL THE WAY BACK, SO THERE WAS NEGATIVE PRESSURE ON THE BALLOON/ FULLY DEFLATED. AFTER THE ESHEATH WAS REMOVED IT WAS NOTED THAT THERE WAS A SMALL TEAR RIGHT AT THE DISTAL END OF THE SHEATH WHERE IT APPEARS THE VALVE SOMEHOW GOT CAUGHT ON THIS PART WHEN IT WAS BEING ADVANCE THROUGH THE SHEATH AND OUT THE DISTAL END. PATIENT APPEARED FINE WITH NO RESULTING VASCULAR ISSUES / COMPLI

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

  MAUDE report 13261971 ↗
• MalfunctionJan 14, 2022Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Difficult to Remove; Material Separation; Material Integrity Problem

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A TRANSFEMORAL TAVR, THERE WAS DIFFICULTY WITHDRAWING THE COMMANDER DELIVERY SYSTEM BACK INTO THE ESHEATH FOR WITHDRAWAL. AS REPORTED, POST VALVE DEPLOYMENT, THE PHYSICIAN EXPERIENCED DIFFICULTY RETRIEVING DS INTO SHEATH TIP. THE BALLOON DID NOT RUPTURE DURING DEPLOYMENT. THE PHYSICIAN CONTINUED TO PULL THE DELIVERY OUT OF THE SHEATH AND THE BALLOON SEPARATED FROM DS SHAFT ON THE PROXIMAL END. THE TIP OF DS WAS STUCK IN ESHEATH HUB PER FLUORO IMAGE. THE TIP OF ESHEATH WAS DAMAGED, IT LOOKED LIKE IT 'ACCORDIONED' BACK ON ITSELF. PER PRE-DECO EVALUATION, CIRCUMFERENTIAL DELAMINATION 2" IN LENGTH WAS FOUND AND THE C-MARKER BAND WAS PRESENT. NO ADVERSE EVENTS WERE SUFFERED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261968 ↗
• MalfunctionJan 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PER THE FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE FOR A 20MM SAPIEN 3 ULTRA IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, MORE PUSH FORCE WAS REQUIRED TO ADVANCE VALVE AND DELIVERY SYSTEM (DS) OUT THE DISTAL END OF ESHEATH. THE OPERATOR FELT RESISTANCE THEN A ''POP'' AS THE TIP OF THE ESHEATH RELEASED THE VALVE & DS. PER FOLLOW-UP THE FCS NOTED THE LOADER WAS FULLY INSERTED INTO ESHEATH AND THE INSERTION ANGEL AT ~45 DEGREES. DAMAGE ON THE ESHEATH WAS OBSERVED WHEN REMOVED. PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206479 ↗
• MalfunctionDec 27, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A TF TAVR CASE IN A PATIENT WITH A HISTORY OF AN EVAR WITH A DESCENDING AORTIC STENT INTO BILATERAL ILIAC STENTS, THE TEAM PLACED A LUNDERQUIST WIRE IN ORDER TO STRAIGHTEN THE PATIENT'S LEFT ILIAC ARTERY TORTUOSITY AND USED A 14F ESHEATH DILATOR TO DILATE THE VESSEL. ONCE THE VESSEL WAS DILATED THE ESHEATH WAS INSERTED OVER THE WIRE. THE TEAM THEN REPLACED THE WIRE WITH A SAFARI EXTRA STIFF WIRE INTO THE ESHEATH. NEXT, THE TEAM PERFORMED A BALLOON VALVULOPLASTY AND THE BAV BALLOON WAS EXCHANGED FOR THE DELIVERY SYSTEM. AS THE DELIVERY SYSTEM WITH VALVE TRAVERSED THE LEFT ILIAC THE TEAM WAS NOT ABLE TO ADVANCE IT PAST THE EXTERNAL ILIAC DUE TO TORTUOSITY. THE TEAM ATTEMPTED TO RETRACT THE DELIVERY SYSTEM A LITTLE TO THEN READVANCE AT A DIFFERENT ANGLE. THIS BACK AND FORTH WAS PERFORMED SEVERAL TIMES BUT THE DELIVERY SYSTEM WOULD NOT ADVANCE. THE TEAM TRIED ONE MORE TIME TO ADVANCE AND DURING THIS ATTEMPT, A STRUT OF THE 26MM SAPIEN 3 ULTRA VALVE ON THE INFLOW SIDE BENT BACKWARDS AT A 90 DEGREE ANGLE. THE TEAM DISCUSSED THE FACT THAT THEY WOULD NEED TO BRING THE SHEATH AND DELIVERY SYSTEM OUT TOGETHER AND POSSIBLY DO A GROIN CUTDOWN. A SECOND ESHEATH WAS OPENED AN

  Patient problems: Insufficient Information

  MAUDE report 13091091 ↗
• MalfunctionDec 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE, THERE WAS RESISTANCE WHILE ADVANCING THE DELIVERY SYSTEM AND VALVE THROUGH THE SHEATH. THE DEVICES WERE REMOVED WITH NO PATIENT INJURY. INSPECTION OF THE SHEATH AFTER REMOVAL SHOWED THE TIP OF THE SHEATH WAS TORN. NEW DEVICES WERE USED SUCCESSFULLY. THE PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13066586 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AFTER A SUCCESSFUL TAVR BY (B)(6) APPROACH THE PATIENT HAD A STROKE. ACCORDING TO THE INFORMATION RECEIVED FROM THE PHYSICIANS THE PATIENT WAS RESPONSIVE WITH NO STROKE SYMPTOMS IMMEDIATELY POST TAVR HOWEVER THEY FORMED A HEMATOMA AROUND THE SURGICAL SITE AND EVENTUALLY HAD LEFT SIDED WEAKNESS AND WERE TAKEN TO SURGERY TO ADDRESS THE ISSUE. SUSPECTED FAILURE IN CLOSING THE SITE.

  Patient problems: Hematoma; Stroke/CVA

  MAUDE report 12849546 ↗