LOTUS Edge™ Valve System H749LVSUS230Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 08714729960904), received between May 31, 2019 and Dec 8, 2020 — classified as 10 deaths, 47 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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-0728-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTECTED TAVR STUDY: IT WAS REPORTED THAT COMPLETE ATRIOVENTRICULAR (AV) BLOCK OCCURRED. THE PATIENT WAS ENROLLED INTO THE PROTECTED TAVR STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS ON A PRIOR REGIMEN OF ANTIPLATELET MEDICATIONS AND ASPIRIN. AFTER HEPARIN WAS GIVEN AND DURING THE START OF THE PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) WAS 274 SEC. AN ISLEEVE INTRODUCER SHEATH WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 23MM LOTUS EDGE VALVE. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AV BLOCK. AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED AS A DIAGNOSTIC AND A PERMANENT PACEMAKER WAS IMPLANTED. TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON 81 MG OF ASPIRIN. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, POST-DILATION OF THE LOTUS EDGE VALVE WAS PERFORMED. 1-DAY POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH LEFT BUNDLE BRANCH BLOCK(LBBB) FOR WHICH OUTPATIENT FOLLOW-UP WAS PERFORMED. ON THE SAME DAY, THE COMPLETE AV BLOCK WAS CONSIDERED RECOVERED. THE LBBB WAS CONSIDERED RE

  Patient problems: Arrhythmia; Complete Heart Block; Heart Block

  MAUDE report 10971418 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTECTED TAVR STUDY. IT WAS REPORTED THAT STROKE OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS NOT ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSE OF ASPIRIN. AFTER HEPARIN HAS BEEN GIVEN AND DURING START OF PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) WAS 131 SEC. AN ISLEEVE INTRODUCER SHEATH WAS PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). A 23MM LOTUS EDGE VALVE WAS ADVANCED TO TREAT THE AORTIC VALVE. DURING DEPLOYMENT, A TWISTED POST WAS OBSERVED PRIOR TO LOCKING OF THE VALVE. THE PHYSICIAN ATTEMPTED TO MITIGATE THE TWISTED POST BY CENTRALIZING THE LOTUS EDGE DELIVERY SYSTEM CATHETER WHICH WAS UNSUCCESSFUL. A PARTIAL RESHEATH AND FULL RESHEATH WERE PERFORMED IN ACCORDANCE WITH THE IFU WITH THE SAME RESULT. THE 23MM LOTUS EDGE VALVE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER 23MM LOTUS EDGE VALVE WHICH WAS ABLE TO BE SUCCESSFULLY IMPLANTED IN THE CORRECT ANATOMICAL LOCATION. ON THE SAME DAY, POST INDEX PROCEDURE, THE SUBJECT WAS EVALUATED EMERGENTLY

  Patient problems: Stroke/CVA

  MAUDE report 10949638 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB) AND LEFT BUNDLE BRANCH BLOCK (LBBB) OCCURRED. THE PATIENT ANATOMY CONSISTED OF SMALL PERIPHERAL ARTERIES. A 15F ISLEEVE INTRODUCER SHEATH WAS INSERTED INTO THE LEFT FEMORAL ARTERY WITH NO ISSUE. A 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. POST VALVE IMPLANT, THE PATIENT DEVELOPED LBBB. A TEMPORARY PACEMAKER REMAINED IN THE PATIENT FOLLOWING COMPLETION OF THE PROCEDURE. ONE DAY POST PROCEDURE, DURING A FOLLOW-UP ECHOCARDIOGRAM, THE PATIENT WAS OBSERVED TO HAVE AN EPISODE OF SYMPTOMATIC CHB. THE CHB RESOLVED ON ITS OWN AND ELECTROPHYSIOLOGY WAS CONSULTED. IN ADDITION, THE PATIENT'S LEFT FOOT WAS OBSERVED TO BE PULSELESS. THE LOSS OF A PULSE WAS SUSPECTED TO BE CAUSED BY A CLOT FOLLOWING THE IMPLANT PROCEDURE. A HEPARIN DRIP WAS INITIATED AND THE EVENT RESOLVED. AT THE TIME OF REPORTING, THE PATIENT WAS STILL HOSPITALIZED.

  Patient problems: Arrhythmia; Complete Heart Block

  MAUDE report 10879486 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 23MM LOTUS EDGE VALVE. FOUR DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED AND WAS FOUND TO HAVE A NON-ST-ELEVATION MYOCARDIAL INFARCTION INVOLVING THE INFERIOR WALL. THE RIGHT CORONARY ARTERY WAS FOUND TO NOT BE FILLING AS IT SHOULD, SO THE PHYSICIAN SUSPECTED IT WAS DUE TO THE LOTUS EDGE VALVE OR NATIVE LEAFLET LOCATION POST THE VALVE IMPLANT PROCEDURE. NO ACTION WAS TAKEN TO TREAT AND THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED. ON 28 APR 2022, IT WAS REPORTED THAT THE PATIENT HAD DIED ON (B)(6) 2020.

  Patient problems: Myocardial Infarction

  MAUDE report 10824491 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DELIVERY SYSTEM KINKED. A 23MM LOTUS EDGE VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE LOTUS EDGE VALVE DELIVERY SYSTEM KINKED WHEN EXITING THE ISLEEVE INTRODUCER IN THE DESCENDING AORTA. THE DEVICE WAS REMOVED AND NEW 23MM LOTUS EDGE VALVE WAS PREPPED AND IMPLANTED WITHOUT INCIDENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10792330 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLETE HEART BLOCK (CHB). A PATIENT WAS SELECTED FOR A 23MM LOTUS EDGE VALVE IMPLANT. THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 23MM LOTUS EDGE VALVE. PRIOR TO THE BALLOON VALVULOPLASTY, THE PATIENT DEVELOPED BUNDLE BRANCH BLOCK AND THEN AFTER THE VALVE DEPLOYMENT BEGAN, THE PATIENT WENT INTO CHB. A PERMANENT PACEMAKER WAS IMPLANTED AFTER THE VALVE IMPLANT PROCEDURE IN ORDER TO TREAT THE CHB. THERE WERE NO FURTHER PATIENT CONSEQUENCES REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 10778296 ↗
• DeathNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AORTIC DISSECTION AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. NO INDICATION OF AORTIC DISSECTION WAS PRESENT DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. EARLY IN THE MORNING ON THE DAY FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WAS TAKEN TO SURGERY TO INVESTIGATE HYPOTENSIVE EVENTS THE PATIENT HAD EXPERIENCED OVERNIGHT. AN AORTIC DISSECTION WAS NOTED BELOW THE LEFT RENAL DOWN TO THE LEFT COMMON ILIAC (LCI). THE PATIENT WAS MADE "DO NOT RESUSCITATE" (DNR) STATUS BY THE FAMILY AND DIED DURING SURGERY.

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

  MAUDE report 10775158 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STROKE FOLLOWING THE PROCEDURE. A 23MM LOTUS EDGE VALVE SYSTEM WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT(TAVR) PROCEDURE. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. THE LOTUS EDGE VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. WITHIN 24 HOURS POST PROCEDURE, THE PATIENT DEVELOPED A STROKE.

  Patient problems: Stroke/CVA

  MAUDE report 10652706 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT LEFT BUNDLE BRANCH BLOCK (LBBB) AND 1ST DEGREE ATRIOVENTRICULAR(AV) BLOCK OCCURRED. PRIOR TO INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING DOSE OF ASPIRIN. AFTER HEPARIN WAS GIVEN AND PRIOR TO SENTINEL DEVICE INSERTION, THE ACTIVATED CLOTTING TIME (ACT) WAS 318 SEC. AN INTRODUCER SHEATH WAS PLACED INTO THE RIGHT RADIAL ARTERY AND THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS DEPLOYED WITH THE PROXIMAL FILTER INTO THE BRACHIOCEPHALIC ARTERY AND DISTAL FILTER INTO THE LEFT COMMON CAROTID ARTERY. AN INTRODUCER SHEATH WAS THEN PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH DIRECT DEPLOYMENT OF A 23MM LOTUS EDGE VALVE INVOLVING REPOSITIONING INTO THE PROPER ANATOMICAL LOCATION. THE SENTINEL SYSTEM WAS THEN SUCCESSFULLY RETRIEVED WITHOUT ANY COMPLICATIONS. ON THE SAME DAY OF THE INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH LBBB AND 1ST DEGREE AV BLOCK. ELECTROCARDIOGRAM AND ELECTROPHYSIOLOGY WERE PERFORMED AS DIAGNOSTICS FOR BOTH THE EVENTS. THE EVENTS WERE TREATED WITH IMPLANTATION OF A DUAL-CHAMBER RIGHT-SIDED PACEMAKER

  Patient problems: Arrhythmia; Myocardial Infarction; Stroke/CVA

  MAUDE report 10612846 ↗
• InjurySep 18, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT BUNDLE BRANCH BLOCK (LBBB) AND EMBOLIZATION OCCURRED. THE NATIVE AORTIC ANNULUS WAS 22.5MM IN DIAMETER WITH MILD TO MODERATE LEAFLET CALCIFICATION. A 23 MM LOTUS EDGE VALVE WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT OF THE LOTUS EDGE VALVE THERE WAS A MILD WAIST ON THE NONCORONARY CUSP SIDE AND THE IMPLANT DEPTH WAS APPROXIMATELY -3 TO -4 MM. A NEW ONSET LBBB OCCURRED. THE LOTUS EDGE VALVE WAS RELEASED. AFTER RELEASE, THE SHEATHING AID NEAR THE LEFT CORONARY CUSP GOT STUCK. THE SHEATHING AID APPEARED PERPENDICULAR TO THE VALVE FRAME. AFTER APPROXIMATELY 90 TO 120 SECONDS OF GENTLE PULLING AND WIRE ADVANCEMENT, THE SHEATHING AIDS FREED. UPON RELEASE OF THE SHEATHING AIDS, THE LOTUS EDGE VALVE MOVED 15-20MM SUPERIOR INTO THE SINOTUBULAR JUNCTION. THE PHYSICIANS OPTED FOR SURGERY WHERE THE LOTUS EDGE VALVE WAS EXPLANTED AND A 21MM SURGICAL VALVE WAS IMPLANTED. THE SURGERY WENT WITHOUT ANY COMPLICATIONS. THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: Arrhythmia

  MAUDE report 10553535 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK OCCURRED. THE PATIENT WAS NOTED TO HAVE SEVERE ANNULAR AND LEFT VENTRICULAR OUTFLOW TRACT(LVOT) CALCIFICATION AND WAS SELECTED FOR A 23 MM LOTUS EDGE VALVE IMPLANTATION. THE PHYSICIAN PERFORMED PRE-DILATION WITH A 20 MM BALLOON, ACCORDING TO THE INSTRUCTIONS FOR USE(IFU). THEN THE NATIVE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 23 MM LOTUS EDGE VALVE INVOLVING SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE WITH RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE VALVE WAS RELEASED IN A DEEP IMPLANT POSITION ((NON-CORONARY CUSP(NCC) SIDE WAS ABOUT 3MM AND LEFT CORONARY CUSP(LCC) SIDE WAS ABOUT 6-7MM)). A FEW HOURS POST INDEX PROCEDURE, THE PATIENT WENT INTO COMPLETE HEART BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE EVENT.. THE PATIENT HAD NO ADDITIONAL CONSEQUENCES.

  Patient problems: Complete Heart Block

  MAUDE report 10546797 ↗
• InjurySep 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT HYPOTENSION, AND CARDIAC ARREST OCCURRED. THE PROCEDURE WAS INDICATED IN ORDER FOR THE PATIENT TO BE ELIGIBLE FOR PULMONARY VASODILATOR THERAPY FOR PULMONARY HYPERTENSION. VASCULAR ACCESS WAS OBTAINED VIA A LEFT TRANSFEMORAL APPROACH. THE ANATOMY CONTAINED MILD TO MODERATE CALCIUM WITH A HEAVY CALCIUM IN THE SINOTUBULAR JUNCTION (STJ). A 23MM LOTUS EDGE VALVE WAS ADVANCED TO TREAT THE NATIVE AORTIC VALVE. UPON LOCKING OF THE 23 MM LOTUS EDGE VALVE, THE PATIENT'S BLOOD PRESSURE DROPPED. MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. THE DEGREE OF PVL WAS NOT CONSISTENT WITH THE PATIENT'S DEGREE OF HYPOTENSION. THE 23MM LOTUS EDGE VALVE HAD A NOTICEABLE WAIST AT THE ANNULAR LEVEL AND WAS WELL ANCHORED. THE PATIENT'S PULSE WAS LOST AND REQUIRED ONE MINUTE OF CARDIOPULMONARY RESUSCITATION (CPR). SEVERAL VASOPRESSOR MEDICATIONS WERE GIVEN, THEN BYPASS CANNULAE WERE PLACED IN BOTH GROINS AND A PUMP WAS PLACED. JUST PRIOR TO GOING ON THE PUMP, THE PATIENT'S SYSTOLIC BLOOD PRESSURE WAS 160, CARDIAC FUNCTION RETURNED TO NEAR BASELINE AND RESTORATION OF THE PATIENT'S PULSE. THE PATIENT WAS INTUBATED. THE PROCEDURE CONTINUED WITH THE REMOVAL OF THE 23MM LOTUS EDGE VALVE.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 10502183 ↗
• InjuryAug 31, 2020Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTNESS OF BREATH AND VALVE THROMBOSIS OCCURRED. A 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. ASPIRIN AND PLAVIX WERE GIVEN POST PROCEDURE. TWENTY EIGHT (28) DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. ECHOCARDIOGRAPHY INDICATED AN INCREASE IN GRADIENT FROM 7MM HG TO 46MMHG AND CONFIRMED VALVE THROMBOSIS. PLAVIX WAS DISCONTINUED AND ELOQUIS 2.5 TAKEN TWICE A DAY (BID) WAS PRESCRIBED. PATIENT WILL RETURN FOR FOLLOWUP ECHOCARDIOGRAM IN TWO WEEKS.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Dyspnea; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10474519 ↗
• MalfunctionAug 19, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT FAILURE TO ADVANCE OCCURRED. A 23MM LOTUS EDGE VALVE SYSTEM, XS SAFARI2 GUIDEWIRE, AND AN ISLEEVE WERE SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT(TAVR) PROCEDURE. ACCESS WAS GAINED THROUGH A LEFT TRANSFEMORAL APPROACH. PRE-DILATION WAS COMPLETED WITH A 16MM NON-BSC BALLOON, ACCORDING TO THE INSTRUCTIONS FOR USE(IFU). THE 23MM LOTUS EDGE VALVE SYSTEM WAS ADVANCED BUT FAILED TO CROSS THE NATIVE VALVE. THE PHYSICIAN ATTEMPTED TO CROSS THE NATIVE VALVE WITH THE 23MM LOTUS EDGE VALVE SYSTEM MULTIPLE TIMES WITHOUT SUCCESS. THE 23MM LOTUS EDGE VALVE SYSTEM WAS REMOVED. A NON-BSC VALVE SYSTEM WAS INSERTED AND ALSO FAILED TO CROSS THE NATIVE VALVE. WIRE POSITION WAS LOST. THE PHYSICIAN RECROSSED THE NATIVE VALVE WITH A .035 GUIDEWIRE AND POSITIONED THE WIRE INTO THE VENTRICLE. THE NON-BSC VALVE WAS THEN ABLE TO CROSS THE NATIVE VALVE AND WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10427070 ↗
• MalfunctionAug 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LOTUS EDGE VALVE DELIVERY SYSTEM KINKED WHEN INSERTED INTO THE ISLEEVE INTRODUCER. A 23MM LOTUS EDGE VALVE SYSTEM WAS CHOSEN FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. DURING INSERTION OF THE DELIVERY SYSTEM INTO THE ISLEEVE INTRODUCER, A KINK NEARLY THE CURVATURE ON THE DELIVERY SYSTEM CATHETER OCCURRED. THE PROCEDURE OUTCOME WAS NOTED TO BE SUCCESSFUL. THE PATIENT IS ALIVE AND WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10416815 ↗
• DeathJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AORTIC DISSECTION AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE WAS SELECTED FOR USE. WHILE ADVANCING THE LOTUS EDGE VALVE DELIVERY SYSTEM THROUGH THE ASCENDING AORTA, AN AORTIC DISSECTION OCCURRED. THE PATIENT'S PRESSURE DROPPED AND THE DISSECTION WAS SEEN BY ANGIOGRAPHY. THE PATIENT DIED DURING THE PROCEDURE. THE CAUSE OF DEATH WAS AORTIC DISSECTION.

  Patient problems: Aortic Dissection; Death

  MAUDE report 10323084 ↗
• InjuryJul 22, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AORTIC VALVE THROMBOSIS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT TRANSFEMORAL APPROACH. A 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED HOWEVER, UPON IMPLANT, A GRADIENT OF 28MM WAS NOTED. UPON REMOVAL OF THE 23MM LOTUS EDGE VALVE SYSTEM, THROMBUS WAS NOTED THROUGHOUT THE IMPLANT. THE CLOT WAS ON THE BRAID FRAME AND THE SHEATHING AIDS. THERE WAS NO INDICATION THROMBUS WAS PRESENT ON THE 23MM LOTUS EDGE VALVE PRIOR TO REMOVAL. NO FURTHER TREATMENT WAS ADMINISTERED FOR THE THROMBUS AS THE PATIENT HAD BEEN HEPARINIZED AND THE PATIENTS ACT WAS ABOVE 300. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL IMPLANT OF A 25MM LOTUS EDGE VALVE. THE PATIENT HAS HAD NO FURTHER ISSUES.

  Patient problems: Aortic Insufficiency; Thrombosis

  MAUDE report 10310927 ↗
• InjuryJun 24, 2020Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED 01 JUNE 2020. IT WAS REPORTED THAT DIFFICULTY ADVANCING THE LOTUS EDGE DELIVERY SYSTEM THROUGH THE INTRODUCER OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA TRANSFEMORAL APPROACH. AN ISLEEVE INTRODUCER SHEATH WAS PLACED. A 23MM LOTUS EDGE VALVE SYSTEM WAS PREPARED FOR USE. WHEN THE PHYSICIAN ADVANCED THE 23MM LOTUS EDGE VALVE DELIVERY SYSTEM, THE PHYSICIAN ENCOUNTERED EXTREME RESISTANCE. EVENTUALLY, THE PHYSICIAN WAS ABLE TO ADVANCE THE 23MM LOTUS EDGE VALVE DELIVERY SYSTEM THROUGH THE ISLEEVE INTRODUCER SHEATH. THE 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS A SMALL PERICARDIAL EFFUSION NOTED; HOWEVER, IT WAS 'VERY, VERY, VERY SMALL' IN SIZE. THE PATIENT WAS OBSERVED FOR 30 MINUTES. THE EFFUSION DID NOT GROW, SO THE PHYSICIANS WERE NOT CONCERNED WITH IT. IT WAS FURTHER REPORTED THAT A NEW PATHOLOGICAL Q-WAVE OR LEFT BUNDLE BRANCH BLOCK (LBBB) OCCURRED REQUIRING A PACE MAKER OCCURRED POST PROCEDURE.

  Patient problems: Arrhythmia; Pericardial Effusion

  MAUDE report 10192116 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1ST DEGREE HEART BLOCK OCCURRED. ACCESS WAS GAINED THROUGH THE LEFT TRANSFEMORAL. A 23MM LOTUS EDGE VALVE WAS IMPLANTED AND APPROXIMATELY TWO (2) MINUTES POST IMPLANT THE PATIENT DEVELOPED 1ST DEGREE HEART BLOCK. THE PATIENT RECEIVED A PERMANENT PACEMAKER AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Arrhythmia

  MAUDE report 10185059 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. THE PATIENT'S PERIPHERAL VESSELS WERE HIGHLY CALCIFIED AND SMALL. INTRAVASCULAR LITHOTRIPSY WAS PERFORMED WITH A NON-BSC DEVICE. THEN RIGHT FEMORAL PERCUTANEOUS ACCESS WAS OBTAINED. A 23MM LOTUS EDGE DELIVERY SYSTEM WAS ADVANCED AND DISSECTED THE FEMORAL ARTERY. THE DISSECTION WAS STENTED SUCCESSFULLY. A VALVE WAS NOT IMPLANTED.

  Patient problems: Vascular Dissection

  MAUDE report 10175528 ↗
• DeathApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MASSIVE STROKE AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE WAS IMPLANTED IN A PATIENT. THE PATIENT EXPERIENCED A MASSIVE STOKE. THREE DAYS POST IMPLANT PROCEDURE, THE PATIENT DIED.

  Patient problems: Death; Stroke/CVA

  MAUDE report 10016021 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK AND STROKE OCCURRED. PRIOR TO VALVE IMPLANT, HEPARIN WAS ADMINISTERED AND AN ACT OF GREATER THAN 250 WAS ACHIEVED. AFTER THE SUCCESSFUL DEPLOYMENT OF THE LOTUS EDGE VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. THE PATIENT RECEIVED A PERMANENT PACEMAKER(PPM) AFTER THE CONCLUSION OF THE VALVE IMPLANT AND WAS RECOVERING IN THE ICU. THREE DAYS POST IMPLANT, THE PATIENT HAD A STROKE OF THE POSTERIOR BASAL WHILE STILL IN THE HOSPITAL. THE PATIENT WAS STARTED ON COUMADIN FOLLOWING THE STROKE. THE PATIENTS SYMPTOMS OF DIZZY AND CONFUSED RESOLVED AND HAS SINCE BEEN DISCHARGED HOME AND IS UNDERGOING REHAB THERAPY.

  Patient problems: Aortic Valve Stenosis; Complete Heart Block; Stroke/CVA

  MAUDE report 9993099 ↗
• MalfunctionApr 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DELIVERY SYSTEM KINKED. PROCEDURE SUMMARY: THE 23 MM LOTUS EDGE VALVE SYSTEM (LOT# 23962060) WAS LOADED ONTO A XS SAFARI GUIDEWIRE. THE LOTUS EDGE VALVE KINKED AT THE MID PORTION OF THE CONSTRAINED VALVE IN THE DELIVERY SYSTEM, WHILE ENTERING THE ISLEEVE SHEATH, AS THE SHEATH WAS NOT FULLY INSERTED AS DIRECTED. THE ISLEEVE WAS THEN ADJUSTED TO PROPER INSERTION DEPTH. NO ADVERSE EVENT, A NEW 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY DEPLOYED. THE PATIENT WAS DISCHARGED THE NEXT DAY AND IS DOING GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933552 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYPOTENSION OCCURRED. A LOTUS INTRODUCER SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY AND A 23MM LOTUS EDGE VALVE WAS ADVANCED FOR IMPLANTATION. UPON INITIAL DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE AND WAS GIVEN VASOPRESSORS. PARTIAL RE-SHEATHING WAS PERFORMED TO REPOSITION, IN ACCORDANCE WITH THE DIRECTIONS FOR USE. ONCE THE LOTUS EDGE VALVE WAS PLACED AND FUNCTIONING, THE HYPOTENSION RESOLVED. THE IMPLANT WAS SUCCESSFUL AND THE LOTUS EDGE DELIVERY SYSTEM WAS REMOVED. UPON REMOVAL OF THE LOTUS INTRODUCER SHEATH, THE PATIENT HAD A VASOSPASM. MEDICATION WAS GIVEN TO RELAX ARTERY. THE LOTUS INTRODUCER SHEATH WAS SLOWLY REMOVED FROM THE VESSEL. AN ASSESSMENT SHOT WAS TAKEN AND IT WAS SEEN THAT THE EXTERNAL TO COMMON ILIAC WAS SEVERELY DAMAGED. COVERED STENTS WERE PLACED. BLOOD WAS GIVEN TO THE PATIENT. A VASCULAR SURGEON WAS CALLED IN AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM. THE PATIENT DIED IN THE OPERATING ROOM. THE DEATH WAS NOT RELATED TO THE LOTUS EDGE VALVE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9883501 ↗
• InjuryMar 25, 2020Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT HARMS AND DEATH, HOWEVER, THERE WAS MILD TO MODERATE PROSTHETIC AORTIC VALVE REGURGITATION AFTER IMPLANTATION OF THE 23MM LOTUS EDGE VALVE. IT WAS REPORTED THAT HYPOTENSION, VENTRICULAR FIBRILLATION, CARDIAC ARREST AND DEATH OCCURRED. THE NATIVE AORTIC ANNULUS WAS 24.2MM IN DIAMETER. THE PERIPHERAL VESSELS WERE EXTREMELY CALCIFIED. A LOTUS INTRODUCER SHEATH WAS SELECTED FOR USE AND WOULD NOT ADVANCE DUE TO THE CALCIFICATION. THE PROCEDURE WAS CONTINUED WITHOUT AN ACCESS SHEATH. A 25MM LOTUS EDGE VALVE WAS ADVANCED AND HAD DIFFICULTY CROSSING THE NATIVE AORTIC ANNULUS. THE 25MM LOTUS EDGE VALVE WAS REMOVED AND BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. THE 25MM LOTUS EDGE VALVE WAS REINSERTED FOR IMPLANTATION. UPON UNSHEATHING, ASYMMETRIC APPEARANCE WAS NOTED. WHEN THE LOTUS EDGE VALVE WAS DEPLOYED AND BROUGHT TO LOCK, ONE OF THE POSTS WOULD NOT LOCK. ADDITIONAL MANEUVERS WERE TRIED TO LOCK THE POST. DURING THIS TIME, THE PATIENT'S BLOOD PRESSURE DROPPED. THE 25MM LOTUS EDGE VALVE WAS REMOVED. THE PATIENT HAD COMPLICATIONS OF VENTRICULAR FIBRILLATION AND CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION

  Patient problems: Aortic Insufficiency; Cardiac Arrest; Death; Low Blood Pressure/ Hypotension; No Consequences Or Impact To Patient; Ventricular Fibrillation

  MAUDE report 9878978 ↗