LOTUS Edge™ Valve System H749LVSUS270Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 08714729960928), received between Jul 1, 2019 and Jun 3, 2026 — classified as 21 deaths, 69 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (23 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, 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.

Recalls naming this device

1. Nov 17, 2020Class ITerminated

   Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

   Z-0730-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• DeathJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A 27MM LOTUS EDGE VALVE WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2026 THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385134 ↗
• DeathJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A 27MM LOTUS EDGE VALVE WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379566 ↗
• DeathJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN SEPTEMBER 2020, THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 27MM LOTUS EDGE VALVE. IN DECEMBER 2020, THE PATIENT WAS FOUND DECEASED OF UNREPORTED CAUSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17053597 ↗
• DeathNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED 29 DAYS POST IMPLANT OF A 27MM LOTUS EDGE VALVE. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844986 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CATHETER KINK OCCURRED. THE PATIENT HAD A CALCIFIED AND TORTUOUS SEVERELY BILATERAL COMMON ILIAC ARTERY AND THE RIGHT CORONARY CUSP WAS MILDLY CALCIFIED. THE LOTUS EDGE VALVE SYSTEM WAS NOTED TO BE KINKED WHILE IT ADVANCED TO THE AORTIC ARCH. A SECOND LOTUS EDGE VALVE SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977422 ↗
• DeathDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH BLOCK (LBBB), VESSEL OCCLUSION, VENTRICULAR FIBRILLATION, HYPOTENSION, AND DEATH. THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF THE 27MM LOTUS EDGE VALVE. AFTER DEPLOYMENT, THE PATIENT WENT INTO LBBB. THE POSITIONING WAS OBSERVED TO BE APPROXIMATELY 7MM DEEP, SO THE PHYSICIAN DECIDED TO REPOSITION HIGHER. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S RHYTHM RETURNED TO A NORMAL SINUS RHYTHM AND THE PHYSICIAN'S WERE SATISFIED WITH THE VALVE POSITIONING. AFTER THE LOTUS EDGE VALVE WAS RELEASED, THE PATIENT'S LEFT CORONARY SYSTEM SHUT DOWN, AS SEEN VIA ANGIOGRAPHY. THE PATIENT EXPERIENCED HYPOTENSION AND CARDIAC RHYTHM CHANGES. TWO CORONARY STENTS WERE PLACED; HOWEVER, THE PATIENT HAD SEVERAL ROUNDS OF VENTRICULAR FIBRILLATION. CHEST COMPRESSIONS WERE STARTED AND WENT FOR 45 MINUTES. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE LATER, PASSED AWAY.

  Patient problems: Arrhythmia; Death; Low Blood Pressure/ Hypotension; Stenosis; Ventricular Fibrillation

  MAUDE report 10945195 ↗
• InjuryDec 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. PRO THE PATIENTS NATIVE AORTIC VALVE ANATOMY CONSISTED OF MODERATE LEAFLET CALCIFICATION, MODERATE-TO-SEVERE TORTUOSITY, AND A HORIZONTAL AORTA. A 27MM LOTUS EDGE VALVE WAS SELECTED TO TREAT AORTIC STENOSIS. DURING DEPLOYMENT, THE LOTUS EDGE VALVE EXHIBITED ASYMMETRIC UNSHEATHING. THE OBSERVATION OCCURRED TWICE; ONCE WHEN THE VALVE WAS DEPLOYED TOO HIGH AND ONCE WHEN THE VALVE WAS DEPLOYED TOO LOW. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED THREE PARTIAL AND ONE COMPLETE RE-SHEATHINGS AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED LEFT SIDED WEAKNESS, FACIAL DROOP, AND HAD DIFFICULTY SWALLOWING. AN MRI WAS PERFORMED WHICH SHOWED SIGNS OF A CVA IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PATIENT WAS IMPLANTED WITH A PEG TUBE DUE TO THE DIFFICULTY SWALLOWING AND WAS DISCHARGED TO INPATIENT REHABILITATION.

  Patient problems: Stroke/CVA

  MAUDE report 10925362 ↗
• InjuryDec 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT MAJOR HEMORRHAGE OCCURRED. THE PATIENT, WITH CALCIUM AT THE NATIVE ANNULUS, LEAFLETS, AND LEFT VENTRICULAR OUTFLOW TRACT, WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT. AFTER THE 27MM LOTUS EDGE VALVE (BATCH 24309261) WAS DEPLOYED, ASYMMETRIC UNSHEATHING AND A TWISTED POST WAS OBSERVED. THE PHYSICIAN'S TRIED TWICE TO MITIGATE THE OBSERVATIONS BY RE-SHEATHING AND DEPLOYING INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) HOWEVER, WAS UNSUCCESSFUL. A SECOND 27MM LOTUS EDGE VALVE (BATCH 24325029) WAS PREPARED AND THE FIRST VALVE WAS REMOVED. THE SECOND VALVE WAS DEPLOYED AND AGAIN DURING DEPLOYMENT STAGE 1, EXHIBITED ASYMMETRIC UNSHEATHING. THE SECOND 27MM LOTUS EDGE VALVE WAS RE-SHEATHED AND THEN FULLY DEPLOYED INTO A DEEPER, MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) WHICH SUCCESSFULLY MITIGATED THE OBSERVATION. TWO DAYS POST INDEX PROCEDURE, MAJOR HEMORRHAGE OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10925153 ↗
• MalfunctionNov 25, 2020Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY INSERTING INTO THE INTRODUCER AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT AND NOTED TO HAVE MILD TO MODERATE LEAFLET CALCIFICATION. THE PATIENT WAS NOTED TO HAVE A GASTROINTESTINAL BLEED PRIOR TO THE PROCEDURE. A 15F ISLEEVE INTRODUCER SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY AND A 27MM LOTUS EDGE VALVE SYSTEM WAS ADVANCED. THE LOTUS EDGE VALVE DELIVERY CATHETER WAS HYDRATED WITH SALINE PRIOR TO INSERTION. THE WET DRY GAUZE TECHNIQUE WAS NOT USED DURING ADVANCEMENT. CONTINUOUS FLUSHING WAS DONE DURING INSERTION. DURING ADVANCEMENT, THERE WAS ACTIVE BACK TRACTION ON THE SAFARI2 GUIDEWIRE USED. THE 27MM LOTUS EDGE VALVE SYSTEM WAS DIFFICULT TO INTRODUCE AND THE LOTUS INTRODUCER SHEATH(LIS) GOT STUCK AT THE LEVEL OF THE COMMON ILIAC CLOSE TO THE AORTIC BIFURCATION. FORCE WAS REQUIRED TO ADVANCE THE LOTUS EDGE VALVE SYSTEM THROUGH THE 15F ISLEEVE INTRODUCER SHEATH. A KINK WAS NOTED IN THE 15 ISLEEVE INTRODUCER SHEATH. THE LOTUS EDGE VALVE WAS NOT ADVANCED PAST THE TIP OF THE 15F ISLEEVE INTRODUCER SHEATH BEFORE THE KINK WAS NOTED. THE KINK WAS NEAR THE PROXIMAL TO MID PORTION OF THE 15F ISLEEVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906747 ↗
• MalfunctionNov 24, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT A DELIVERY SYSTEM KINK OCCURRED. A 27MM LOTUS EDGE VALVE WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AN ISLEEVE INTRODUCER SHEATH WAS PLACED. A 27MM LOTUS EDGE VALVE WAS ADVANCED AND DIFFICULTY WAS ENCOUNTERED. A KINK IN THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS OBSERVED WHEN ADVANCING UP THE AORTA BEFORE THE ARCH. THE LOTUS EDGE VALVE WAS REMOVED AND REPLACED WITH ANOTHER VALVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT. THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10897431 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB) OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY AND THE INDEX PROCEDURE WAS PERFORMED THAT DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN. A LOADING DOSE OF ASPIRIN WAS GIVEN. AFTER HEPARIN WAS GIVEN, AND PRIOR TO THE SENTINEL CEREBRAL PROTECTION SYSTEM BEING INSERTED, THE ACTIVATED CLOTTING TIME AS 285 SEC. AN INTRODUCER WAS PLACED INTO THE RIGHT RADIAL ARTERY AND THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS INSERTED AND SUCCESSFULLY DEPLOYED. A LOTUS INTRODUCER SHEATH WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE INTO THE PROPER ANATOMICAL LOCATION. ON THE SAME DAY, POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH RECURRENT CHB. HOSPITALIZATION WAS PROLONGED AS VENTRICULAR FIBRILLATION AND RESPIRATORY FAILURE WERE ALSO OBSERVED AND TREATED WITH MEDICALLY AND WITH A CARDIOVERSION, BUT WERE NOT RELATED TO THE LOTUS EDGE VALVE. A DUAL CHAMBER ICD WAS IMPLANTED AND ELECTRO CARDIOVERSION WAS PERFORMED IN RESPONSE TO THE VENTRICULAR FIBRILLATION AND RESPIRATORY FAILURE. THREE DAYS POST INDEX PR

  Patient problems: Complete Heart Block

  MAUDE report 10886730 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT BUNDLE BRANCH BLOCK (LBBB) OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT. AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, NEW ONSET OF LBBB OCCURRED. A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT IS DOING WELL.

  Patient problems: Arrhythmia

  MAUDE report 10885996 ↗
• InjuryNov 20, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT HYPOTENSION AND HEART BLOCK OCCURRED. PROCEDURE SUMMARY: THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT DUE TO AORTIC STENOSIS. A RIGHT TRANSFEMORAL ACCESS SITE WAS GAINED. THE NATIVE AORTIC ANNULUS AND LEFT VENTRICLE OUTFLOW TRACT (LVOT) WERE HIGHLY CALCIFIED. THE NATIVE AORTIC VALVE WAS SUSPECTED TO BE A BICUSPID VALVE WITH AN EXTREMELY HORIZONTAL AORTIC ARCH. DURING DEPLOYMENT OF THE LOTUS EDGE VALVE, ASYMMETRIC UNSHEATHING OF THE VALVE OCCURRED MULTIPLE TIMES. THE PATIENT EXPERIENCED HYPOTENSION. THE LOTUS EDGE VALVE WAS THEN REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S VALVE. ELECTROCARDIOGRAM (EKG) CHANGES WERE NOTED AND HEART BLOCK DEVELOPED DURING THE LOTUS EDGE VALVE DEPLOYMENT ATTEMPTS. THE HEART BLOCK DID NOT RESOLVE AND THE PATIENT RECEIVED A PERMANENT PACEMAKER. THE PATIENT WAS STILL RECOVERING AT THE TIME OF REPORTING.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 10878495 ↗
• DeathNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYPOTENSION, PERICARDIAL PERFUSION, A PERFORATION AND DEATH OCCURRED. PROCEDURE SUMMARY: A 27MM LOTUS EDGE VALVE SYSTEM (LOT: 0025743067) WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DURING INSERTION, THE LOTUS EDGE VALVE DELIVERY SYSTEM KINKED AS IT WAS ADVANCED OVER THE TRANSVERSE AORTIC ARCH. THE LOTUS EDGE VALVE SYSTEM WAS REMOVED FROM THE PATIENT AND A SECOND 27MM LOTUS EDGE VALVE SYSTEM (LOT:0025743062) WAS INSERTED THROUGH THE SAME INTRODUCER SHEATH OVER A SAFARI2 GUIDEWIRE. AFTER CROSSING THE NATIVE AORTIC ANNULUS, STAGE ONE OF VALVE DEPLOYMENT WAS POSITIONED TOO HIGH SO A PARTIAL RECAPTURE WAS PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE SECOND POSITIONING ATTEMPT RESULTED IN THE VALVE BEING SLIGHTLY DISTAL, SO THE LOTUS EDGE VALVE WAS RECAPTURED, REPOSITIONED AND THEN RELEASED. DURING REMOVAL OF THE LOTUS EDGE VALVE DELIVERY SYSTEM AS THE DEVICE WAS COMING AROUND THE AORTIC ARCH THERE WAS A SIGNIFICANT DROP IN BLOOD PRESSURE. A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE CHEST CAVITY WAS OPENED. IT WAS OBSERVED THE NOSECONE OF THE LOTUS EDGE DELIVERY SYSTEM HAD PERFORATE

  Patient problems: Cardiac Perforation; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10841627 ↗
• MalfunctionNov 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A LOTUS EDGE VALVE DELIVERY SYSTEM KINK OCCURRED. PROCEDURE SUMMARY: A 27MM LOTUS EDGE VALVE SYSTEM (LOT: 0025743067) WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DURING INSERTION, THE LOTUS EDGE VALVE DELIVERY SYSTEM KINKED AS IT WAS ADVANCED OVER THE TRANSVERSE AORTIC ARCH. THE LOTUS EDGE VALVE SYSTEM WAS REMOVED FROM THE PATIENT AND A SECOND 27MM LOTUS EDGE VALVE SYSTEM (LOT:0025743062) WAS INSERTED THROUGH THE SAME INTRODUCER SHEATH OVER A SAFARI2 GUIDEWIRE. AFTER CROSSING THE NATIVE AORTIC ANNULUS, STAGE ONE OF VALVE DEPLOYMENT WAS POSITIONED TOO HIGH SO A PARTIAL RECAPTURE WAS PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE SECOND POSITIONING ATTEMPT RESULTED IN THE VALVE BEING SLIGHTLY DISTAL, SO THE LOTUS EDGE VALVE WAS RECAPTURED, REPOSITIONED AND THEN RELEASED. DURING REMOVAL OF THE LOTUS EDGE VALVE DELIVERY SYSTEM AS THE DEVICE WAS COMING AROUND THE AORTIC ARCH THERE WAS A SIGNIFICANT DROP IN BLOOD PRESSURE. A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE CHEST CAVITY WAS OPENED. IT WAS OBSERVED THE NOSECONE OF THE LOTUS EDGE DELIVERY SYSTEM HAD PERFORATED THE APEX OF THE LE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841626 ↗
• MalfunctionNov 13, 2020Difficult to Insert; Difficult to Remove; Material Deformation; Difficult to Insert; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE DELIVERY SYSTEM KINKED. A 27MM LOTUS EDGE VALVE WAS SELECTED FOR IMPLANT. UPON INSERTION THROUGH THE ISLEEVE INTRODUCER SHEATH, THE LOTUS EDGE VALVE DELIVERY SYSTEM EXHIBITED RESISTANCE AND THEN KINKED IN TWO LOCATIONS ALONG THE CATHETER. THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS REMOVED WITH RESISTANCE. A NEW LOTUS EDGE VALVE WAS INSERTED AND SUCCESSFULLY IMPLANTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10835662 ↗
• DeathNov 5, 2020Difficult to Insert; Difficult to Remove; Material Deformation; Difficult to Insert; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE LOTUS EDGE VALVE DELIVERY SYSTEM KINKED, HYPOTENSION, AORTIC DISSECTION, HEMORRHAGE AND DEATH OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT DUE TO AORTIC STENOSIS. SEVERE TORTUOSITY AND CALCIUM WAS NOTED IN THE ABDOMINAL AORTA. A RIGHT TRANSFEMORAL ACCESS SITE WAS GAINED. A LOTUS INTRODUCER SHEATH(LIS) WAS PLACED. PREDILATATION WAS PERFORMED WITH 20MM NON-BSC BALLOON CATHETER. A 27MM LOTUS EDGE VALVE DELIVERY SYSTEM WAS ADVANCED INTO THE LIS INTRODUCER AND RESISTANCE WAS FELT AS THE DELIVERY SYSTEM EXITED THE INTRODUCER. A KINK IN THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS OBSERVED AT 1CM PROXIMAL TO THE END OF THE DELIVERY SYSTEM CATHETER. CALCIUM IN THE GREATER ASPECT OF THE AORTIC CURVE WAS NOTED. THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED THROUGH THE LIS. THE LIS ACCORDIONED DURING REMOVAL, SO BOTH THE LIS AND LOTUS EDGE VALVE DELIVERY SYSTEM WERE REMOVED AS ONE UNIT. THE PATIENT BECAME HYPOTENSIVE AND AN AORTIC DISSECTION JUST ABOVE THE AORTIC BIFURCATION WAS OBSERVED. A NEW LIS WAS PREPARED AND INTRODUCED INTO THE PATIENT. AN OCCLUSION BALLOON WAS ADVANCED INTO THE PATIENT AND INFLATED. TWO NON-BSC ABDOMINA

  Patient problems: Aortic Dissection; Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 10791279 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMBOLIC DEBRIS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT TRANSFEMORAL APPROACH. A LOTUS INTRODUCER SHEATH WAS INSERTED. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS INSERTED INTO POSITION. A 27MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED TO TREAT THE AORTIC VALVE. DURING THE PROCEDURE, EMBOLIC DEBRIS ENTERED THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE EMBOLIC DEBRIS WAS ASPIRATED AND THE LAD STENTED. NO PATIENT INJURY OCCURRED. THE PATIENT CONDITION IS STABLE.

  Patient problems: Thromboembolism

  MAUDE report 10791132 ↗
• MalfunctionNov 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DELIVERY SYSTEM KINK OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT DUE TO AORTIC STENOSIS. THE PATIENT ANATOMY WAS NOTED TO BE LARGE WITH MILD TORTUOSITY. DURING INSERTION OF THE 27MM LOTUS EDGE VALVE DELIVERY SYSTEM THROUGH A 15F ISLEEVE INTRODUCER SHEATH, BOTH THE 15FISLEEVE INTRODUCER SHEATH AND 27MM LOTUS EDGE VALVE DELIVERY SYSTEM KINKED. THE 15F ISLEEVE INTRODUCER SHEATH AND 27MM LOTUS EDGE VALVE DELIVERY SYSTEM WERE REMOVED. A LOTUS INTRODUCER WAS PLACED AND A NEW VALVE WAS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT IS SAFE AND WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779050 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT BUNDLE BRANCH BLOCK(LBBB) OCCURRED. A 27MM LOTUS EDGE VALVE SYSTEM WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. AN AN UNKNOWN TIME, THE PATIENT DEVELOPED LBBB. NO ADDITIONAL INFORMATION WAS RECEIVED AT THE TIME OF REPORTING.

  Patient problems: Arrhythmia

  MAUDE report 10667146 ↗
• MalfunctionOct 12, 2020Activation, Positioning or Separation Problem; Difficult to Advance; Human-Device Interface Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Human-Device Interface Problem

  IT WAS REPORTED THAT DIFFICULTY ADVANCING THE DELIVERY SYSTEM AND STROKE OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20MM NON-BSC BALLOON CATHETER. A 27MM LOTUS EDGE VALVE SYSTEM WAS ADVANCED. THE PHYSICIAN ENCOUNTERED CHALLENGES CROSSING THE NATIVE AORTIC VALVE WITH THE 27MM LOTUS EDGE VALVE SYSTEM. THE GUIDE WIRE AND THE NOSECONE OF THE 27MM LOTUS EDGE VALVE SYSTEM WERE REPOSITIONED. THE 27MM LOTUS EDGE VALVE SYSTEM WAS THEN ABLE TO CROSS THE NATIVE AORTIC ANNULUS SUCCESSFULLY. THE 27MM LOTUS EDGE VALVE WAS IMPLANTED. SUCCESSFUL REPOSITIONING OF THE 27MM LOTUS EDGE VALVE INVOLVED RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE, HIGHER POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN ENCOUNTERED DIFFICULTY LOCKING THE 27MM LOTUS EDGE VALVE, BUT WAS SUCCESSFULLY LOCKED AFTER TROUBLESHOOTING WITH THE PUSH-PULL TECHNIQUE. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS IN RECOVERY AND SIGNS OF A MINOR STROKE WERE OBSERVED. THE PATIENT'S PROGNOSIS IS GOOD. IT WAS FURTHER REPORTED THAT THERE WAS NO DIFFICULTY OR CHALLENGES CROSSING THE NATIVE VALVE

  Patient problems: No Known Impact Or Consequence To Patient; Transient Ischemic Attack

  MAUDE report 10662517 ↗
• DeathOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. MILD CALCIUM WAS NOTED ON THE NATIVE AORTIC LEAFLETS. MILD BILATERAL COMMON ILIAC ARTERY (CIA) AND FEMORAL CALCIFICATION AND MODERATE BILATERAL TORTUOSITY WAS NOTED. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT TRANSFEMORAL APPROACH. A 15F ISLEEVE INTRODUCER SHEATH WAS PLACED. AN EXTRA SMALL (XS) SAFARI2 GUIDE WIRE WAS POSITIONED. A 27MM LOTUS EDGE VALVE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE HAD A SUCCESSFUL OUTCOME. ELEVEN (11) DAYS LATER, THE PATIENT DIED. AN AUTOPSY WAS NOT PERFORMED.

  Patient problems: Death

  MAUDE report 10662117 ↗
• MalfunctionOct 6, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT A LOTUS EDGE VALVE DELIVERY SYSTEM KINK OCCURRED. A 27MM LOTUS EDGE VALVE SYSTEM WAS PREPPED WITH THE NOSECONE PROPERLY SEATED. A RIGHT FEMORAL ARTERY ACCESS SITE WAS GAINED. HOWEVER, UPON INSERTION INTO THE ISLEEVE, RESISTANCE WAS FELT. AS THE IMPLANT TEAM WATCHED THE INSERTION ON THE SCREEN, THE PHYSICIAN NOTICED THEY HAD A KINK IN THE LOTUS EDGE VALVE SYSTEM. THE LOTUS EDGE VALVE SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A 29MM NON-BSC VALVE. THE PATIENT HAD NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638177 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ARRHYTHMIA OCCURRED. THE PATIENT WAS SELECTED FOR A 27MM LOTUS EDGE VALVE IMPLANT TO TREAT SEVERE AORTIC STENOSIS. DURING DEPLOYMENT, A WIDENING OF THE QRS COMPLEX WAS OBSERVED. AFTER THE 27MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED, THE PHYSICIANS ELECTED TO LEAVE THE TEMPORARY PACEMAKER IN. THE PATIENT APPEARED TO BE INTERMITTENTLY DEPENDENT ON THE TEMPORARY PACEMAKER, SO THREE DAYS POST INDEX PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE NEW LEFT BUNDLE BRANCH BLOCK. THERE WERE NO FURTHER CONSEQUENCES. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, THE PATIENT HAD A NEW REQUIREMENT FOR DIALYSIS.

  Patient problems: Arrhythmia; Renal Failure

  MAUDE report 10615237 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB), LEFT BUNDLE BRANCH BLOCK(LBBB), AND MYOCARDIAL INFARCTION OCCURRED. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSES OF 325 MG ASPIRIN AND 600 MG OF CLOPIDOGREL. AN ISLEEVE INTRODUCER SHEATH WAS PLACED THEN A 25 MM LOTUS EDGE VALVE (LOT: 25319445) WAS INSERTED BUT NOT IMPLANTED AND WAS RETRIEVED DUE TO SMALL SIZING. A SECOND 27 MM LOTUS EDGE VALVE (LOT: 25785357) WAS IMPLANTED SUCCESSFULLY IN THE CORRECT ANATOMICAL LOCATION. DURING THE INDEX PROCEDURE, POST VALVE DEPLOYMENT THE SUBJECT DEVELOPED CHB. POST PROCEDURE EVENT SUMMARY: ON THE SAME DAY AS THE INDEX PROCEDURE, EVENT ELECTROCARDIOGRAM (ECG) REVEALED PROLONGED PR INTERVAL, LEFT BUNDLE BRANCH BLOCK, AND PROBABLE ACUTE INFARCT(MYOCARDIAL INFARCTION). THE EVENT LED TO PROLONGATION OF HOSPITALIZATION. ON THE SAME DAY POST INDEX PROCEDURE, A NEW MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE NON-BSC DUAL CHAMBER PERMANENT PACEMAKER WAS IMPLANTED SUCCESSFULLY. TWO DAYS POST INDEX PROCEDURE, THE EVENT WAS CONSIDERED

  Patient problems: Arrhythmia; Complete Heart Block; Myocardial Infarction

  MAUDE report 10609576 ↗