EVOQUERecalls & reported problems across all models

We found 4 models of EVOQUE by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2024 and May 11, 2026 — classified as 21 deaths, 131 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (58 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EVOQUE problems

EVOQUE models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EVOQUE 9850TDSUS

  Prosthesis, Tricuspid Valve, Percutaneously Delivered
  14 deaths52 reports
• EVOQUE 9850EV48US

  Prosthesis, Tricuspid Valve, Percutaneously Delivered
  3 deaths42 reports
• EVOQUE 9850EV52US

  Prosthesis, Tricuspid Valve, Percutaneously Delivered
  2 deaths40 reports
• EVOQUE 9850EV44US

  Prosthesis, Tricuspid Valve, Percutaneously Delivered
  2 deaths22 reports

Recent EVOQUE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathMay 11, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE A RIGHT VENTRICULAR (RV) PERFORATION OCCURRED. PERICARDIOCENTESIS WAS PERFORMED FIRST, BUT ACCESSING THE PERICARDIUM PROVED CHALLENGING AND TOOK LONGER THAN USUAL. THE PATIENT WAS SUBSEQUENTLY CONVERTED TO SURGERY AND UNDERWENT OPEN HEART SURGERY FOR REPAIR OF THE LACERATION WITH SUTURE AND WAS IN STABLE CONDITION. HOWEVER, ONE OR TWO DAYS POST PROCEDURE THE PATIENT EXPIRED. PERFORATION LIKELY OCCURRED DURING VALVE CROSSING AND DID NOT PROGRESS BEYOND THAT POINT. THE TEAM DECIDED TO REPOSITION THE PROBE AND EQUIPMENT TO THE OPPOSITE SIDE, MOVING UNDERNEATH THE CATHETER. DURING THIS PROCESS, SOMETHING (POSSIBLY THE LEAD SHIELD) UNINTENTIONALLY BUMPED THE DELIVERY SYSTEM, LIKELY PUSHING THE WIRE INTO THE VENTRICLE. SUBSEQUENTLY, A DROP IN PRESSURE WAS OBSERVED EITHER DURING CROSSING OR SHORTLY THEREAFTER, AND EFFUSION WAS IDENTIFIED ONCE THE MACHINES WERE RESTARTED. INITIAL GUIDEWIRE PLACEMENT WAS WITHIN THE POSTERIOR POCKET. THE WIRE CURL WAS ALONG THE POSTERIOR WALL IN RELATION TO THE ANATOMY. AT THE TIME THE PERFORATION OCCURRED, THE SYSTEM HAD BEEN ADVAN

  Patient problems: Cardiac Perforation

  MAUDE report 25144308 ↗
• InjuryMay 7, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. ON POST OPERATIVE DAY (POD) 50, THE PATIENT PRESENTED IN CLINIC POST-TTVR WITH BIOPROSTHETIC VALVE STENOSIS AND ACUTE HEART FAILURE. ON FOLLOW-UP EVALUATION, THE REPORTED MECHANISM OF VALVE FAILURE WAS THROMBOSIS, PER PHYSICIAN. IT WAS CONFIRMED THAT THE PATIENT HAD BEEN ANTICOAGULATED. THE PATIENT WAS TREATED WITH IV HEPARIN AND WAS DISCHARGED AFTER FAILING TO SHOW SIGNIFICANT CLINICAL IMPROVEMENT DESPITE TREATMENT WITH IV HEPARIN. THE PHYSICIAN DECIDED TO FURTHER TREAT THE PATIENT BY IMPLANTING ANOTHER VALVE WITHIN THE EXISTING EVOQUE VALVE. SUBSEQUENTLY, THE VALVE IN VALVE WAS PERFORMED ON POD 57 AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25111468 ↗
• DeathApr 30, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT AFTER IMPLANTATION OF EVOQUE DEVICE MODEL 9850EV44US 44MM WAS IMPLANTED IN THE TRICUSPID POSITION, THAT THE PATIENT IS DECEASED. ALTHOUGH IT WAS INDICATED THAT THE PATIENT DID NOT HAVE A CONDUCTION DISTURBANCE PRIOR TO EVOQUE IMPLANT, ADDITIONAL INFORMATION INDICATED THAT, THE PATIENT REQUIRED EP MONITORING POST EVOQUE IMPLANT. AS A RESULT, THERE WAS SOME SORT OF CONDUCTION/ ARRYTHMIA REQUIRING MONITORING PRIOR TO THE DEATH. PATIENT DIED FROM SINUS ARREST ON POST OPERATIVE DAY (POD) 9. PHYSICIAN INDICATED DEATH WAS NOT RELATED TO DEVICE MALFUNCTION.

  Patient problems: Arrhythmia

  MAUDE report 25050174 ↗
• DeathApr 9, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IT WAS REPORTED THAT A PERFORATION OF THE SPECULATE POSTERIOR AREA OF RV APEX OCCURRED. COMPRESSIONS AND A PERICARDIAL WINDOW WERE PERFORMED, HOWEVER, THE PATIENT PASSED. THE CAUSE OF DEATH IS REPORTED TO BE RV PERFORATION/ CARDIAC ARREST. THE PERCEIVED ROOT CAUSE OF THE EVENT IS POOR WIRE MANAGEMENT. ISSUES SUCH AS POOR WIRE MANAGEMENT LED TO EXCESSIVE FORCE AT CROSSING WHICH LED TO THE PERFORATION. THE GUIDEWIRE WAS SITTING POSTERIOR AND SEPTAL WHEN THE PERFORATION OCCURRED. THE PERFORATION/PERICARDIAL EFFUSION WAS CAUSED BY THE WIRE. THERE WAS EXCESSIVE WIRE FORCE DURING CROSSING, CAUSING STIFF PORTION OF WIRE TO PERFORATE THE RV. THE DELIVERY SYSTEM WAS CROSSING WHEN THE PERFORATION OCCURRED. THERE WAS NO INTENTIONAL PUSH ON THE GUIDEWIRE TO OBTAIN HEIGHT AND/OR NAVIGATIONAL MANEUVERS WITH EXCESS FORCE ALREADY ON THE GUIDEWIRE. WIRE PLACEMENT WAS INITIALLY SHALLOW WITH A LATERAL POSITIONING AND WAS NOTED TO BE INTERACTING WITH THE LEAFLETS. THE WIRE WAS WITHDRAWN AND REINSERTED INTO A DEEP POSTERIOR POCKET. SIGNIFICANT WIRE PRESSURE WAS OBSERVED DURING ADVA

  Patient problems: Cardiac Perforation

  MAUDE report 24834833 ↗
• InjuryApr 9, 2026Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PATIENT EXPERIENCED PULSELESS ELECTRICAL ACTIVITY WHICH REQUIRED CPR AND DEFIBRILLATION SHOCKS. THE PEA OCCURRED BETWEEN 30 MINUTES AND 2 HOURS AFTER THE PATIENT LEFT THE PROCEDURE. THE PATIENT COUGHED UP BLOOD PRIOR TO EXPERIENCING RESPIRATORY ARREST AND PEA. THE PATIENT HAD BROKEN RIBS DUE TO CPR. AFTER THIS EVENT THE PATIENT HAD A CT, AND THE VALVE WAS IDENTIFIED AS CANTED. THE VALVE WAS IMPLANTED WELL AND WAS DISLODGED DURING CPR POST PROCEDURE. NO ACTIONS HAVE BEEN TAKEN TO TREAT THE CANTING. THE VALVE WAS NOTED TO BE CANTED TOWARD THE ATRIUM, WHICH LIMITED AVAILABLE OPTIONS FOR ADDITIONAL ACTION. ALTHOUGH OTHER POTENTIAL ACTIONS SUCH AS MOVING TO SURGERY WERE BEING CONSIDERED FOR THE PATIENT, ACCORDING TO THE LATEST UPDATE THE PATIENT IS DNR AND IS BEING TRANSFERRED TO HOSPICE. THE REPORTED PERCEIVED ROOT CAUSE FOR PEA WAS DUE TO RESPIRATORY ARREST. DURING THE INDEX PROCEDURE, ALL OF THE SECONDARY FLEX WAS NEEDED TO GET RELATIVELY CENTRAL, AND ALL OF THE DEPTH KNOB WAS NEEDED TO BE DEEP ENOUGH TO CAPTURE LEAFLETS. HOWEVER, THERE WERE SUFFICIENT DEVICE

  Patient problems: Insufficient Information

  MAUDE report 24834798 ↗
• MalfunctionApr 6, 2026Difficult or Delayed Activation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. AFTER CROSSING THE TRICUSPID VALVE, THE CAPSULE COULD NOT BE RETRACTED. A NEW SYSTEM WAS PREPARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY DURING THE PROCEDURE, AND THE PATIENT IS DOING WELL. THERE WERE NO CHALLENGES DURING PREP, NO PATIENT TORTUOSITY EVEN THOUGH THIS WAS LEFT SIDED GROIN ACCESS, AND NO DIFFICULTIES WITH INSERTION. ATTEMPTS TO RETRACT THE INNER CAPSULE WERE NOT MADE AS THE SYSTEM WAS UNUSABLE WITH THE OUTER CAPSULE IMMOBILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791861 ↗
• InjuryApr 6, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IMMEDIATELY FOLLOWING DEPLOYMENT, THE PATIENT WENT INTO COMPLETE HEART BLOCK (CHB). THE UNDERLYING RHYTHM WAS ATRIAL FIBRILLATION AND RIGHT BUNDLE BRANCH BLOCK (RBBB). TEMPORARY PACING WAS INITIATED USING THE WIRE IN THE RV, AND ADDITIONAL ACCESS WAS OBTAINED FOR LV PACING WHILE AWAITING EP. EP SUBSEQUENTLY PLACED A LEADLESS PACEMAKER ACROSS THE VALVE. NO PATIENT INJURY OCCURRED DURING THE PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 24789501 ↗
• MalfunctionApr 2, 2026Difficult or Delayed Activation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DUE TO TORTUOUS ANATOMY, THE TRICUSPID VALVE ANNULUS COULD NOT BE CROSSED FROM RIGHT SIDED ACCESS. THE APPROACH WAS SWITCHED TO LEFT ACCESS; HOWEVER, THE CAPSULE WAS UNABLE TO BE RETRACTED. AFTER UNSUCCESSFUL ATTEMPTS FROM BOTH RIGHT AND LEFT ACCESS USING THE SAME SYSTEM, A NEW SYSTEM WAS SELECTED FOR INTERNAL JUGULAR (IJ) ACCESS. MINOR KINKS WERE NOTED ON THE INTEGRATED SHEATH. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766151 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DURING THE PROCEDURE, THE PATIENT WENT INTO COMPLETE HEART BLOCK AFTER DEPLOYMENT OF THE VALVE. TEMPORARY PACING INTERVENTION WAS PERFORMED FOLLOWED BY AN IMPLANTATION OF A LEADLESS PERMANENT PACEMAKER IMMEDIATELY AFTER THE EVOQUE PROCEDURE. THE PATIENT IS IN STABLE CONDITION. THE PATIENT DID NOT HAVE ANY CONDUCTION DISTURBANCE PRIOR TO THE PROCEDURE. NO MANEUVERS TRIGGER RHYTHM CHANGE. THE FINAL VALVE DEPLOYMENT POSITION WAS ANNULAR. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT IS COMPLETE HEART BLOCK AFTER DEPLOYMENT OF THE EVOQUE VALVE.

  Patient problems: Heart Block

  MAUDE report 24735115 ↗
• InjuryMar 25, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. APPROXIMATELY 12 TO18 HOURS POST PROCEDURE, THE PATIENT WAS NOTED TO HAVE EXPERIENCED A CONDUCTION DISTURBANCE. POST PROCEDURE THAT PATIENT'S HEART RATE WAS REPORTED TO GENERALLY BE IN THE 40S. THE PATIENT WAS STRUGGLING AND AFTER EP EVALUATION A FAILURE TO THRIVE WAS NOTED. ON POSTOPERATIVE DAY (POD) 2, THE PATIENT REQUIRED PLACEMENT OF A PERMANENT PACEMAKER DUE TO HEART BLOCK. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE IMPLANT WAS DEPLOYED AS INTENDED IN THE TVA. THE PATIENT'S HEART RATE WAS NOTED TO BE IN THE 90S PRE-PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 24690298 ↗
• InjuryMar 19, 2026Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. ONCE DEPLOYED, THE ANTERIOR ANCHOR SLID INTO RVOT AS THERE WAS NOTHING FOR THE ANCHOR TO SEAT IN, CAUSING THE VALVE TO CANT. THERE WAS NO PATIENT INJURY REPORTED DUE TO THIS EVENT AND NO ADDITIONAL ACTIONS WERE TAKEN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT ANATOMY WAS A CONSTRAINT DURING THE PROCEDURE AS THERE WAS A DEEP SA COMMISSURE. LEAFLET CAPTURE WAS CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN. NO LEAFLET PINNING WAS OBSERVED AT ANY POINT IN THE PROCEDURE. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE. THE VALVE EXPANDED EVENLY AND AS EXPECTED DURING VENTRICULAR AND ATRIAL EXPANSION STAGES. VALVE TILTED DOWN ANTERIORLY AND SEPTALLY POST DEPLOYMENT. THIS CAUSED MILD PVL OBSERVED IN AS COMM AREA ALONG WITH MILD CENTRAL TR. COLOR FLOW DOPPLER WAS UTILIZED ON TEE TO QUANTIFY PVL. APPROPRIATE VOLUME OPTIMIZATION WAS DONE THE DAY OF THE PROCEDURE. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THAT THE ANTERIOR ANCHOR SLID INTO RVOT, CAUSING VALVE TO CANT AND THERE WAS NOTHING FOR

  Patient problems: Foreign Body Embolism; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24644545 ↗
• DeathMar 10, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. AN EFFUSION WAS NOTED AS SOON AS THE DELIVERY SYSTEM (DS) CROSSED THE VALVE. THERE WAS A 1CM LACERATION NOTED AT THE RV APEX. THE PATIENT WAS CONVERTED TO AN UNPLANNED THORACIC OR CARDIAC SURGERY. THE PATIENT WAS STABLE AFTER THE RIGHT VENTRICLE WAS REPAIRED. HOWEVER, THE PATIENT DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC) OVERNIGHT, THE FAMILY CHOSE TO WITHDRAW SUPPORT AND THE PATIENT EXPIRED. DIC WAS CONFIRMED TO BE THE CAUSE OF DEATH. DURING INDEX PROCEDURE, THE CATH LAB STAFF WERE MANAGING THE WIRE WITH IC DIRECTION. NO PIGTAIL WAS USED. THE WIRE CURL WITH LOCATED POST APEX, IN THE POCKET BETWEEN PAPS. THE WIRE WAS CLEAR OF ANATOMY DURING WIRE CHECK. WIRE PUSH WAS NOT USED FOR HEIGHT. NO EVIDENCE OF WIRE MISMANAGEMENT, WIRE CURLED AROUND ANATOMY, EXCESSIVE PRESSURE ON WIRE CURL, OR WIRE DEFORMATION OR KINKING.

  Patient problems: Cardiac Perforation

  MAUDE report 24558620 ↗
• InjuryMar 9, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE CASE WAS UNREMARKABLE UNTIL VENTRICULAR EXPANSION. ONCE VENTRICULAR EXPANSION WAS COMPLETED, THE BLOOD PRESSURE DROPPED AND A LARGE EFFUSION WAS VISUALIZED. THE VALVE WAS DEPLOYED AND PERICARDIOCENTESIS STARTED BUT FAILED. CPR WAS INITIATED PRIOR TO PERICARDIOCENTESIS, FOLLOWED BY CONVERSION TO OPEN-HEART SURGERY TO REPAIR THE LACERATION. AN APPROXIMATELY 3/4 INCH RV APICAL PERFORATION WAS FOUND DURING SURGERY WITH AN ESTIMATED 4L BLOOD LOSS. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION AND CLOSED FROM OPEN HEART SURGERY. THE VALVE REMAINED WELL SEATED POST CPR AND SURGERY. THE INITIAL GUIDEWIRE PLACEMENT WAS THE POSTERIOR TO ANTERIOR PAP MUSCLE, SITTING ON THE MODERATOR BAND BELOW LEAFLET LEVEL, AND NOT QUITE APICAL. THE GUIDEWIRE WAS SITTING SLIGHTLY SHALLOWER AND IT WAS PULLED BACK CONSISTENTLY WHEN THE PERFORATION OCCURRED. THE PLACEMENT OF THE DELIVERY SYSTEM WAS UNCHANGED AND UNREMARKABLE RELATIVE TO THE GUIDEWIRE WHEN THE PERFORATION OCCURRED. THERE WAS NO WIRE PUSH OR ENTANGLEMENT THROUGHOUT CASE. NO INTENTIONAL PUSH ON THE GUIDEWIRE TO OBTAIN

  Patient problems: Cardiac Perforation

  MAUDE report 24552366 ↗
• MalfunctionMar 3, 2026Difficult or Delayed Activation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. SIGNIFICANT DIFFICULTY WAS ENCOUNTERED WHEN RETRACTING THE OUTER CAPSULE. UNINTENTIONAL ANCHORING OCCURRED AT 45 DEGREES FOLLOWING BACK DRIVING. RETRACTION OF THE OUTER CAPSULE REMAINED CHALLENGING THROUGHOUT THE PROCEDURE. THE CAPSULE WAS EVENTUALLY RETRACTED BY ADDING 2.75 OF DEPTH; HOWEVER, DEPTH COULD NOT BE REMOVED ONCE THE CAPSULE RETRACTED PAST THE LOCKING RING. ANY ATTEMPT TO REDUCE DEPTH RESULTED IN FURTHER ADVANCEMENT OF THE OUTER CAPSULE BEYOND THE LOCKING RING. AFTER ADJUSTING DEPTH FROM 2.75 TO 2, AN AUDIBLE CLICK WAS NOTED, AFTER WHICH BOTH THE DEPTH AND WHITE KNOBS BECAME NONRESPONSIVE. DUE TO TOO VENTRICULAR POSITIONING WITH THE 56 MM VALVE, SECONDARY WAS USED TO ATRIALIZE THE VALVE. SECONDARY WAS BROUGHT TO MAXIMUM, COUNTER CLOCKED, THEN FOLLOWED BY MAXIMIZING PRIMARY AND APPLYING A WIRE PUSH. THE BLUE KNOB WORKED PROPERLY. LEAFLET CAPTURE WAS CONFIRMED. NO LEAFLET PINNING OBSERVED AT ANY POINT IN THE PROCEDURE. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE. VALVE EXPANDED EVENLY AND AS EXPECTED DURING VENTRIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503007 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IT WAS REPORTED THAT AV BLOCK WAS NOTED EARLY DURING PLACEMENT OF THE SAFARI WIRE BUT SUBSEQUENTLY SUBSIDED. AT RELEASE, THE PATIENT AGAIN WENT INTO AV BLOCK AND TEMPORARY PACING MEASURES WERE PUT IN PLACE. PACING WAS PERFORMED OFF THE WIRE UNTIL EP CAME AND PLACED A PERMANENT PACEMAKER. FINAL VALVE DEPLOYMENT POSITION WAS NOTED TO BE AT THE CORRECT ANNULAR HINGE POINT. SL DIMENSION WAS MUCH SMALLER THAN AP DIMENSION. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 24472390 ↗

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