LOTUS Edge™ Valve System H749LVSUS250Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 08714729960911), received between Jul 10, 2019 and May 21, 2025 — classified as 19 deaths, 61 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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-0729-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• DeathMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE AND WAS SUCCESSFULLY IMPLANTED WITH A 25MM LOTUS EDGE VALVE. TWENTY-TWO (22) DAYS POST PROCEDURE THE PATIENT DIED OF UNREPORTED CAUSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060373 ↗
• DeathJan 3, 2024Degraded; Degraded

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH MW5149228 THAT VALVE FAILURE, BLOOD IN LUNGS AND DEATH OCCURRED IN 2020, A 25MM LOTUS EDGE VALVE WAS IMPLANTED. IN THE (B)(6) OF 2022, THE PATIENT STARTED EXPERIENCING COMPLICATIONS. THE PRIMARY HEART SURGEON BELIEVED IT WAS NOT RELATED TO THE LOTUS EDGE VALVE. ON (B)(6) 2022, THE PATIENT WOKE UP FROM SLEEP UNABLE TO BREATH. THE PATIENT'S LUNGS WERE FILLING WITH BLOOD AND WAS RUSHED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR FIVE DAYS. UPON RETURNING HOME, THE PATIENT MET WITH THEIR HEART SURGEON, AND IT WAS CONCLUDED THE 25MM LOTUS EDGE VALVE WAS FAILING (COLLAPSING IN ON ITSELF) CAUSING THE BLOOD TO FLOW INTO THE LUNGS. SURGERY WAS UNABLE TO BE SCHEDULED IN TIME. THE PATIENT DIED AS A RESULT OF THE LOTUS EDGE VALVE FAILURE.

  Patient problems: Dyspnea; Pulmonary Edema

  MAUDE report 18435049 ↗
• DeathNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH A 25MM LOTUS EDGE VALVE IMPLANT PROCEDURE IN (B)(6) 2020. TWENTY FIVE DAYS POST INDEX PROCEDURE, THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 12903600 ↗
• DeathJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE PATIENT WAS TREATED WITH A 25MM LOTUS EDGE VALVE. NO PATIENT COMPLICATIONS WERE REPORTED. THE FOLLOWING DAY THE PATIENT PASSED AWAY.

  Patient problems: Death

  MAUDE report 11238451 ↗
• DeathDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRACEREBRAL HEMORRHAGE AND DEATH OCCURRED. THE PATIENT SUFFERED FROM AN INTRACEREBRAL HEMORRHAGE FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT RECEIVED HOSPICE CARE WITH INTRAVENOUS COMFORT CARE MEDICATIONS. THE PATIENT DIED IN THE HOSPITAL AND WAS NOT DISCHARGED POST TAVR.

  Patient problems: Death; Stroke/CVA

  MAUDE report 10950890 ↗
• InjuryDec 4, 2020Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC DISSECTION AND PERICARDIAL EFFUSION OCCURRED. A 25MM LOTUS EDGE VALVE WAS SELECTED FOR USE IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AN ISLEEVE INTRODUCER SHEATH WAS PLACED VIA A RIGHT TRANSFEMORAL ACCESS. THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY WITH A 20MM NON-BSC BALLOON CATHETER. THE AORTIC VALVE WAS TREATED WITH SUBSEQUENT DEPLOYMENT OF THE 25 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN EXPERIENCED DIFFICULTY LOCKING THE VALVE, BUT WAS ULTIMATELY SUCCESSFUL. DURING FINAL DEPLOYMENT, A PERICARDIAL EFFUSION WAS OBSERVED VIA TRANSTHORACIC ECHOCARDIOGRAM. THE PHYSICIAN SUSPECTED THERE WAS A SMALL DISSECTION IN THE ANNULUS THAT OCCURRED DURING THE PARTIAL RECAPTURE OR PRIOR TO THE FINAL VALVE DEPLOYMENT. THE AORTIC DISSECTION WAS SEALED BY THE FINAL DEPLOYMENT OF THE LOTUS EDGE VALVE AND THUS MITIGATED FURTHER EXTRACTION OF BLOOD IN THE PERICARDIAL SPACE. HOWEVER, THE PHYSICIAN DID NOT KNOW THE VALVE WOULD SEAL THE DISSECTION,

  Patient problems: Aortic Dissection; Pericardial Effusion

  MAUDE report 10945528 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARRHYTHMIA OCCURRED. THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 25MM LOTUS EDGE VALVE. PRE BALLOON AORTIC VALVUOPLASTY(BAV) WAS PERFORMED AND THE LOTUS EDGE VALVE WAS IMPLANTED SUCCESSFULLY. AT AN UNKNOWN TIME THE PATIENT DEVELOPED AN ARRHYTHMIA. POST PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE ARRHYTHMIA.

  Patient problems: Arrhythmia

  MAUDE report 10924570 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A DELIVERY SYSTEM CATHETER KINK OCCURRED. THE PATIENT WITH MILD-MODERATE CALCIUM WAS SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT. DURING ADVANCEMENT OF THE LOTUS EDGE VALVE DELIVERY SYSTEM, THERE WAS DIFFICULTY MANAGING THE RADIOPAQUE MARKER. THE PHYSICIAN PULLED THE LOTUS EDGE VALVE DELIVERY SYSTEM BACK AND THEN ROTATED THE CATHETER WHILE PUSHING FORWARD, IN ORDER TO HAVE THE RADIOPAQUE MARKER ON THE OUTER CURVE OF THE ANATOMY. THE RADIOPAQUE MARKER WAS NOT ON THE OUTER CURVE OF THE ANATOMY. THE LOTUS EDGE VALVE DELIVERY SYSTEM CATHETER KINKED ON THE OUTER SHEATH OF THE CATHETER NEAR THE LOCKING MECHANISM. THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS REMOVED AND EXCHANGED FOR ANOTHER 25MM LOTUS EDGE VALVE SYSTEM. THE NEW 25MM LOTUS EDGE VALVE SYSTEM WAS ADVANCED. THE 25MM LOTUS EDGE VALVE WAS IMPLANTED WITHOUT INCIDENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906258 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB) OCCURRED. PROCEDURE SUMMARY: A 25MM LOTUS EDGE VALVE WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT HAD A SEVERELY CALCIFIED NATIVE AORTIC VALVE. A RIGHT TRANSFEMORAL ACCESS SITE WAS GAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE LOTUS EDGE VALVE WAS IMPLANTED AT A DEPTH OF 6MM TO THE ANNULUS. TRACE PARAVALVULAR LEAK (PVL) WAS NOTED POST INDEX PROCEDURE. POST PROCEDURE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE EVENT. THE CURRENT PATIENT STATUS AT THE TIME OF REPORTING WAS GOOD.

  Patient problems: Complete Heart Block

  MAUDE report 10858587 ↗
• DeathNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC DISSECTION AND PATIENT DEATH OCCURRED. THE PATIENT WAS SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT DUE TO AORTIC STENOSIS. THE PATIENT HAD A TORTUOUS DESCENDING AORTA, MILD STENOSIS, AND MODERATE CALCIUM IN LEAFLETS WITH NONE PRESENT AT THE NATIVE ANNULUS. PREDILATATION WAS NOT PERFORMED. THE 25MM LOTUS EDGE VALVE DELIVERY SYSTEM WAS ADVANCED RELATIVELY EASY. DURING DEPLOYMENT OF THE LOTUS EDGE VALVE, A DISSECTION WAS OBSERVED IN THE ASCENDING AORTA. AFTER RELEASE OF THE LOTUS EDGE VALVE, THE DISSECTION WAS NO LONGER APPARENT AND APPEARED TO BE SEALED. THE PATIENT WAS STABLE AND WAS SENT TO RECOVERY. TWO HOURS LATER THE PATIENT DECOMPENSATED AND PASSED AWAY. THE CAUSE OF THE DISSECTION AND PATIENT DEATH IS UNKNOWN.

  Patient problems: Aortic Dissection; Death

  MAUDE report 10817358 ↗
• MalfunctionNov 3, 2020Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DELIVERY SYSTEM FAILED TO RE-SHEATH. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. BALLOON AORTIC VALVULOPLASTY(BAV) WAS PERFORMED WITH A 20MM NON-BOSTON SCIENTIFIC(BSC) BALLOON. A 25MM LOTUS EDGE VALVE SYSTEM WAS IMPLANTED. AFTER THE LOTUS EDGE VALVE WAS DEPLOYED SUCCESSFULLY, THE PHYSICIAN ATTEMPTED TO TURN THE CONTROL KNOB TO RE-SHEATH THE LOTUS EDGE VALVE DELIVERY SYSTEM SHEATHING AIDS, BUT THE HANDLE WOULD NOT ROTATE. THE LOTUS EDGE VALVE DELIVERY SYSTEM WAS THEN REMOVED WITH THE SHEATHING AIDS EXPOSED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780676 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB) OCCURRED. THE PATIENT WAS SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT. AT AN UNKNOWN TIME, THE PATIENT DEVELOPED CHB AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Complete Heart Block

  MAUDE report 10780254 ↗
• MalfunctionNov 2, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE LOTUS EDGE VALVE DELIVERY SYSTEM FROZE ON THE GUIDEWIRE. THE PATIENT WAS SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT. A RIGHT TRANSFEMORAL APPROACH WAS GAINED. A SAFARI2 GUIDE WIRE WAS INSERTED. A 25MM LOTUS EDGE VALVE WAS ADVANCED OVER THE SAFARI2 GUIDEWIRE. THE 25MM LOTUS EDGE VALVE WAS POSITIONED AND UNSHEATHED. THE PHYSICIAN ASSESSED THE POSITION OF THE 25MM LOTUS EDGE VALVE AND DETERMINED A POSITION CHANGE WAS WARRANTED. THE 25MM LOTUS EDGE VALVE WAS RESHEATHED. THE X-RAY IMAGING EQUIPMENT WENT DOWN RESULTING IN THE LOSS OF FLUOROSCOPY. THE X-RAY IMAGING EQUIPMENT STILL HAD VIDEO CAPABILITIES. THE PHYSICIAN ELECTED TO REMOVE THE 25MM LOTUS EDGE VALVE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE 25MM LOTUS EDGE VALVE, THE LOTUS EDGE VALVE DELIVERY SYSTEM LOCKED UP ON THE SAFARI2 GUIDE WIRE IN THE DESCENDING AORTA. THE LOTUS EDGE VALVE DELIVERY SYSTEM AND SAFARI2 GUIDE WIRE WERE REMOVED FROM THE PATIENT TOGETHER AS ONE UNIT. THE DEVICES WERE NOT ABLE TO BE SEPARATED OUTSIDE OF THE PATIENT. THE PHYSICIANS ATTEMPTED TO PROCEED WITH THE PROCEDURE BY USING A PORTABLE C-ARM IMAGING EQUIPMENT TO COMPLETE THE PROCEDURE; HOWEVER, THE IMAGING WAS SUBSTANDARD. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10774727 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLETE HEART BLOCK (CHB) OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A TRANSFEMORAL APPROACH. A LOTUS INTRODUCER WAS PLACED. A SMALL SAFARI2 GUIDE WIRE WAS POSITIONED. THE MILD TO MODERATELY CALCIFIED NATIVE AORTIC VALVE WAS TREATED WITH THE SUCCESSFUL IMPLANT OF A 25MM LOTUS EDGE VALVE. NO PARAVALVULAR LEAK (PVL) WAS NOTED. AT AN UNKNOWN TIME, THE PATIENT DEVELOPED CHB. A PERMANENT PACEMAKER WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 10669695 ↗
• DeathOct 1, 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 SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT. A RIGHT TRANSFEMORAL ACCESS WAS GAINED. AFTER THE SUCCESSFUL LOTUS EDGE VALVE IMPLANT, THE PATIENT WAS OBSERVED TO HAVE COMPLETE HEART BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED TWO DAYS POST INDEX PROCEDURE AND DIED LATER THAT NIGHT AT HOME. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Complete Heart Block; Death

  MAUDE report 10616519 ↗
• DeathSep 30, 2020Entrapment of Device; Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Twisted/Bent; Entrapment of Device; Use of Device Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DIFFICULTY TO LOCK, A TWISTED POST, JAMMED POST AND FAILURE TO RE-SHEATH OCCURRED A PATIENT WITH A BICUSPID AORTIC VALVE WAS SELECTED FOR A 25MM LOTUS EDGE VALVE IMPLANT. FEMORAL ACCESS WAS ACHIEVED AND AN EXTRA SMALL SAFARI2 GUIDEWIRE WAS INSERTED INTO THE LEFT VENTRICLE (LV). A 20MM NON-BSC BALLOON WAS INSERTED AND USED TO PREDILATE THE NATIVE AORTIC VALVE ANNULUS. THE 25MM LOTUS EDGE VALVE SYSTEM WAS INSERTED AND MET RESISTANCE AT THE NATIVE AORTIC ANNULUS. THE LOTUS EDGE VALVE SYSTEM WAS REMOVED AND A 22MM NON-BSC BALLOON WAS INSERTED AND USED TO PREDILATE THE NATIVE ANNULUS. THE SAFARI2 GUIDEWIRE WAS REMOVED AND A 260CM NON-BSC GUIDEWIRE WAS EXCHANGED INTO THE LV VIA A PIGTAIL CATHETER. THE LOTUS EDGE VALVE SYSTEM WAS ADVANCED OVER THE NON-BSC GUIDEWIRE AND IT WAS DISCOVERED THAT THE WIRE WAS TOO SHORT. UPON REMOVAL OF THE LOTUS EDGE VALVE SYSTEM THE WIRE POSITION IN THE LV WAS LOST. MULTIPLE ATTEMPTS WERE MADE TO RECROSS THE ANNULUS WITH MULTIPLE WIRES AND CATHETERS. A TRANSSEPTAL APPROACH WAS THEN ATTEMPTED AND ACCESSED. A .021 GUIDEWIRE AND A CATHETER WERE INSERTED THROUGH THE TRANSSEPTAL SHEATH AND ADVANCED TO THE DESCENDING AORTA. A SNARE WAS USED TO

  Patient problems: Atrial Fibrillation; No Consequences Or Impact To Patient; Vascular Dissection

  MAUDE report 10608282 ↗
• MalfunctionSep 18, 2020Mechanical Problem; Difficult to Remove; Use of Device Problem; Mechanical Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED THAT FAILURE TO RE-SHEATH THE DELIVERY SYSTEM OCCURRED. A PATIENT WAS SELECTED FOR A 25 MM LOTUS EDGE VALVE IMPLANT. DURING THE PROCEDURE, THE NOSECONE WOULD NOT FULLY RE-SHEATH BACK INTO THE DELIVERY SYSTEM AFTER THE VALVE WAS RELEASED. IN ADDITION, THE HANDLE WOULD NOT ROTATE ANY FURTHER. THERE WERE NO PATIENT CONSEQUENCES, THE PATIENT IS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553465 ↗
• 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. VASCULAR ACCESS WAS OBTAINED VIA A RIGHT TRANSFEMORAL APPROACH. A LOTUS INTRODUCER SHEATH WAS PLACED. BALLOON VALVULOPLASTY (BAV) WAS PERFORMED WITH A NON-BSC BALLOON CATHETER. THE PATIENT SHOWED SIGNS OF COMPLETE HEART BLOCK AT THE TIME OF BAV DUE TO THE PATIENT'S THICKENED LEFT VENTRICULAR OUTFLOW TRACT (LVOT) SEPTUM. A 25MM LOTUS EDGE VALVE WAS IMPLANTED TO TREAT THE NATIVE AORTIC VALVE. THE PATIENT'S HEART BLOCK RESOLVED SOME BUT WORSENED WITH THE IMPLANT OF THE 25MM LOTUS EDGE VALVE. THE FOLLOWING DAY A PERMANENT PACEMAKER WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 10546955 ↗
• MalfunctionSep 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DELIVERY SYSTEM KINKED. THE PATIENT HAD SEVERE ABDOMINAL AORTIC CALCIFICATION. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. A 25MM LOTUS EDGE VALVE (LOT 25699511) WAS ADVANCED THROUGH AND PAST THE TIP OF THE ISLEEVE INTRODUCER APPROXIMATELY 10MM. AN AORTIC DISSECTION NEAR THE DISTAL END OF THE ISLEEVE INTRODUCER WAS OBSERVED. CALCIFICATION WAS PRESENT IN THE AREA OF THE DISSECTION; THE DISSECTION WAS BELIEVED TO BE AS A RESULT OF THE ISLEEVE SHEATH NEAR THE CALCIFICATION. THE LOTUS EDGE VALVE DELIVERY SYSTEM AND ISLEEVE INTRODUCER WERE REMOVED WITHOUT DIFFICULTY. THE LOTUS EDGE VALVE (LOT 25699511) HAD KINKS APPROXIMATELY 1 INCH FROM THE TIP AND 3-4 INCHES FROM THE TIP. THE ISLEEVE INTRODUCER WAS APPROPRIATELY EXPANDED AND ALSO HAD A KINK. AN ANGIOGRAM WAS TAKEN AND CONFIRMED THE DISSECTION. THE ABDOMINAL AORTA WAS REPAIRED WITH A GRAFT. AFTER THE REPAIR, A NEW ISLEEVE INTRODUCER WAS ADVANCED THROUGH THE GRAFT SUCCESSFULLY. A NEW 25MM LOTUS EDGE VALVE WAS IMPLANTED SUCCESSFULLY. LATER THAT DAY, THE PATIENT DIED. THE CAUSE OF DEATH IS BELIEVED TO BE A RESULT OF THE ABDOMINAL AORTA DISSECTION CAUSED BY THE INTRODUCER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546691 ↗
• DeathSep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AORTIC DISSECTION AND DEATH OCCURRED. THE PATIENT WAS A FRAIL HIGH RISK PATIENT WITH DILATED HORIZONTAL AORTA AND EXTREMELY TORTUOUS ANATOMY. A 25MM LOTUS EDGE VALVE WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE FIRST POSITIONING OF THE LOTUS EDGE VALVE WAS HIGH AND RESULTED IN THE VALVE POPPING OUT OF THE NON-CORONARY CUSP (NCC). THE IMPLANTING TEAM REPOSITIONED AND THE LOTUS EDGE VALVE WAS IMPLANTED WITH WHAT LOOKED LIKE A GREAT RESULT. THERE WAS NO OBVIOUS SIGN OF AORTIC DISSECTION ON ECHOCARDIOGRAM (ECHO) OR ANGIOGRAPHY. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION. THE FOLLOWING MORNING, AORTIC DISSECTION WAS CONFIRMED VIA ECHO. NO TREATMENT WAS ABLE TO BE PROVIDED AND THE PATIENT DIED THE SAME MORNING. THE CAUSE OF DEATH WAS AORTIC DISSECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO EXPERIENCED AN ARRHYTHMIA POST PROCEDURE.

  Patient problems: Aortic Dissection; Arrhythmia; Death; Vascular Dissection

  MAUDE report 10536462 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT BUNDLE BRANCH BLOCK(RBBB) AND COMPLETE HEART BLOCK (CHB) OCCURRED. A 25MM LOTUS EDGE VALVE SYSTEM WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCESS WAS GAINED FROM A RIGHT TRANSFEMORAL APPROACH. DURING THE PROCEDURE THE PATIENT DEVELOPED RBBB. POST PROCEDURE THE PATIENT DEVELOPED CHB AND WAS IMPLANTED WITH A PERMANENT PACEMAKER TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED HOME AND IS DOING FINE.

  Patient problems: Arrhythmia; Complete Heart Block

  MAUDE report 10530666 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A 25MM LOTUS EDGE VALVE WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCESS WAS GAINED THROUGH A RIGHT TRANSFEMORAL APPROACH. ONE MONTH AFTER THE SUCCESSFUL 25MM LOTUS EDGE VALVE IMPLANT, THE PATIENT WAS BROUGHT IN FOR A FOLLOW-UP APPOINTMENT. A COMPUTED TOMOGRAPHY(CT) SCAN WAS PERFORMED AND THE RADIOLOGIST DESCRIBED THE HYPO-ATTENUATING LEAFLET THICKENING AND NOTED VALVE THROMBOSIS WAS PRESENT. GRADIENT HAD INCREASED FROM 11MM ONE DAY POST IMPLANT TO 29MM. THE PATIENT WAS PUT ON COUMADIN AND WILL BE SEEN IN 30 DAYS.

  Patient problems: Thrombosis

  MAUDE report 10527818 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 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. ONE MONTH AFTER THE 25MM LOTUS EDGE VALVE IMPLANT, THE PATIENT WAS BROUGHT IN FOR A FOLLOW-UP APPOINTMENT. A COMPUTED TOMOGRAPHY(CT) SCAN WAS PERFORMED AND THE RADIOLOGIST DESCRIBED THE HYPO-ATTENUATING LEAFLET THICKENING AND NOTED VALVE THROMBOSIS WAS PRESENT. GRADIENT HAD INCREASED FROM 5MM ONE DAY POST IMPLANT TO 19MM. THE PATIENT WAS PUT ON COUMADIN AND WILL BE SEEN IN 30 DAYS. IT WAS FURTHER REPORTED THAT THE 23MM LOTUS EDGE VALVE WAS INCORRECTLY ATTRIBUTED TO THIS PATIENT. THE EVENT OF BRAID FRAME CLOT / THROMBUSDURING T

  Patient problems: Thrombosis

  MAUDE report 10513648 ↗
• InjurySep 3, 2020Activation, Positioning or Separation Problem; No Apparent Adverse Event; Activation, Positioning or Separation Problem; No Apparent Adverse Event

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED 13 AUGUST, 2020. IT WAS REPORTED THAT DURING THE PROCEDURE, THE 25MM LOTUS EDGE VALVE WAS DIFFICULT TO LOCK AND REQUIRED MULTIPLE REPOSITIONINGS IN ORDER TO LOCK. THE 25MM LOTUS EDGE VALVE WAS ABLE TO BE LOCKED AND DEPLOYED WITH A GOOD FINAL RESULT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION RECEIVED REPORTS ON THE DATE OF THE INDEX PROCEDURE, MINOR VASCULAR COMPLICATION OCCURRED. FOUR (4) DAYS POST INDEX PROCEDURE A CONDUCTION DISTURBANCE REQUIRING PACEMAKER OCCURRED.

  Patient problems: Arrhythmia; Blood Loss

  MAUDE report 10491475 ↗
• DeathAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTECTED TAVR STUDY: IT WAS REPORTED THAT INCOMPLETE LEFT BUNDLE BRANCH BLOCK (LBBB) 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. THE PATIENT WAS NOT ON PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. A LOADING DOSE OF ASPIRIN WAS GIVEN PRIOR TO THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 25MM LOTUS EDGE VALVE. ON THE SAME DAY OF THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH INCOMPLETE LBBB. IN RESPONSE TO THE EVENT, ELECTROPHYSIOLOGY STUDY WAS PERFORMED AS DIAGNOSTIC. ONE (1) DAY POST INDEX PROCEDURE, A PERMANENT PACEMAKER WAS IMPLANTED. THREE (3) DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON 81 MG OF ASPIRIN. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, THE PATIENT PASSED AWAY. CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Arrhythmia; Death

  MAUDE report 10471464 ↗