Edwards EVOQUE Valve 9850EV56USRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00690103219074), received between Nov 27, 2024 and Apr 1, 2026 — classified as 1 death, 28 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (15 reports).

1 other recall cover devices cleared under the same FDA submission (P230013); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IT WAS REPORTED THAT THE DEVICE MODEL 9850EV56 AND 56MM IMPLANTED IN THE TRICUSPID POSITION, WAS EXPLANTED ON POST OPERATIVE DAY (POD) 322 AND ANOTHER VALVE WAS IMPLANTED SAME DAY. THE PATIENT IS ALIVE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD SEVERE AORTIC REGURGITATION THAT REQUIRED SURGICAL INTERVENTION. SINCE THE PATIENT HAD A MILD-MODERATE PVL POST EVOQUE TTVR, THEY CHOSE TO REPLACE THE EVOQUE VALVE SURGICALLY AT THAT TIME AS WELL. THE PATIENT IS STABLE AND DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 24761372 ↗
• InjuryMar 9, 2026Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. A FEW DAYS POST PROCEDURE, IT WAS REPORTED THAT THE 56MM VALVE EMBOLIZED INTO THE VENTRICLE. THE EVOQUE VALVE WAS EXPLANTED AT AN UNKNOWN DATE. THE TRICUSPID VALVE WAS REPLACED SURGICALLY, AND SEPTAL LACERATION FROM EMBOLIZED EVOQUE WAS REPAIRED. THE PATIENT IS IMPROVING AND EXPECTED TO GET OFF ECMO. THE PATIENT'S WEIGHT WAS DOWN 2 KILOGRAMS, AND ANNULUS WAS MEASURING SMALLER THAN CT SCREENING. LARGE COAPTATION GAP WHICH MADE IDENTIFYING COMMISSURES VERY DIFFICULT. INTRA PROCEDURAL THERE WAS SOME DIFFICULTY CAPTURING A PORTION OF THE POSTERIOR LEAFLET. EVENTUALLY IT WAS BELIEVED THAT THE POSTERIOR HAD BEEN CAPTURED AND PROCEEDED AS NORMAL. AT RELEASE THERE WAS TRACE/MILD PVL POSTERIORLY.

  Patient problems: Foreign Body Embolism

  MAUDE report 24552348 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. A CONDUCTION DISTURBANCE WAS OBSERVED LATER THE SAME DAY OF THE PROCEDURE. ON POST OPERATIVE DAY (POD 3), A PERMANENT PACEMAKER WAS IMPLANTED DUE TO HEART BLOCK. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. FINAL VALVE DEPLOYMENT POSITION WAS APPROPRIATE POSITIONING WITHIN 0-5 MM FROM TVA. THE PERCEIVED ROOT CAUSE OF THE EVENT IS THE POSSIBLE VALVE INTERACTION WITH THE CONDUCTION SYSTEM.

  Patient problems: Heart Block

  MAUDE report 24544972 ↗
• InjuryFeb 2, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PATIENT WENT INTO HEART BLOCK AFTER VALVE WAS DEPLOYED. THE HEART WAS PACED WITH ALLIGATOR CLIPS ATTACHED TO WIRE, AND AN INTERNAL TEMPORARY PACEMAKER WAS PLACED IN THE RV PRIOR TO REMOVING THE DELIVERY SYSTEM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND BEING MONITORED FOR THE NEXT COUPLE OF DAYS. NO PROCEDURAL MANEUVERS WERE REPORTED TO HAVE TRIGGERED THE RHYTHM CHANGE. THE FINAL VALVE DEPLOYMENT POSITION WAS AT THE ANNULAR LEVEL.

  Patient problems: Heart Block

  MAUDE report 24234751 ↗
• InjuryDec 10, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DURING THE PROCEDURE, A PIGTAIL WAS USED TO PLACE THE WIRE. AT ONE POINT, THE MANEUVERS ON THE DELIVERY SYSTEM WERE NOT TRANSLATING PROPERLY AND WE WERE STUCK POSTERIORLY, BUT WE WERE ABLE TO GET CENTERED AND COAXIAL PRIOR TO DEPLOYMENT. ONCE THE VALVE WAS DEPLOYED, THE VALVE CANTED SLIGHTLY ANTERIOR SEPTAL, BUT THE VALVE WAS STABLE WITH TRACE PARAVALVULAR LEAK (PVL)/DIASTOLIC COMPETITIVE FLOW FOUND ON THE SEPTAL SIDE. THE PATIENT HAD A FOLLOW-UP TRANSTHORACIC ECHO (TTE) A FEW HOURS AFTER THE PROCEDURE, AND THE VALVE CANTED EVEN MORE ON THE ANTERIOR SIDE, CAUSING A SEVERE PVL SHOWN BY COLOR DOPPLER ON TTE AND TEE. A 29 MM SAPIEN VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE 56 MM EVOQUE VALVE TO RESTABILIZE THE VALVE, AND MOST OF THE PVL WAS SEALED. THERE WAS APPROPRIATE VOLUME OPTIMIZATION THE DAY OF THE PROCEDURE. THERE WAS NOTHING TO NOTE WITH RESPECT TO PATIENT ANATOMY THAT IMPACTED THE SEALING. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE REPORTED POTENTIAL ROOT CAUSE OF THE EVENT WAS THAT THE SYST

  Patient problems: Insufficient Information

  MAUDE report 23769834 ↗
• InjuryNov 6, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE VALVE IMPLANTED INITIALLY WITH NO ISSUES. IT WAS NOTICED AFTER THE CASE THAT THE WIRE WAS A BIT TOUGH TO REMOVE, LIKELY ENTANGLED IN SUBVALVULAR STRUCTURES. WIRE CAN BE SEEN ENTANGLED VIA FLOURO. IT TOOK A BIT OF EFFORT TO FLEX DOWN TO THE ANNULUS. VALVE DROPPED ON SEPTAL ASPECT AND RAISED ON POSTERIOR ASPECT. PROCEDURAL IMAGING WAS PROVIDED, BUT NOTHING STOOD OUT. SPINAL CURVATURE WAS NOTED TO HAVE NO IMPACT ON PROCEDURAL MANEUVERS, ONLY MINOR RESISTANCE ON INSERTION/REMOVAL. POST PROCEDURE DIURETICS UNKNOWN. AFTER FOLLOW UP TEE, IT WAS DETERMINED THAT THE VALVE WAS MOBILE IN THE ANNULUS. THE PATIENT REMAINED IN STABLE CONDITION. HOWEVER, THE PATIENT WAS TAKEN FOR OPEN SURGERY WHERE THE SURGEON FOUND THAT THE VALVE WAS IN THE RIGHT ATRIUM (RA). IN SURGERY, IT WAS FOUND THAT ANCHOR PERFORATED ON SEPTAL LEAFLET AND THAT THE POSTERIOR LEAFLET HAD WEAR AND TEAR. SURGEON WAS ABLE TO STABILIZE BY STITCHING THE VALVE INTO PLACE ON THE POSTERIOR SIDE. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THAT THE VALVE WAS UNSTABLE AND "ROCKING" IN ANNULUS. THE PATIENT DID NO

  Patient problems: Foreign Body Embolism

  MAUDE report 23492964 ↗
• InjuryNov 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. ASIDE FROM ECTOPY FROM THE WIRE, NOTHING HAPPENED UNTIL THE VALVE WAS DEPLOYED. THEN A MINUTE AFTER DEPLOYMENT, THE THIRD-DEGREE HEART BLOCK WAS NOTED. THE TEAM PROCEEDED TO PUT IN TEMP PACING WIRE. THE VALVE POSITION WAS PERFECT. ALL ANCHORS WERE UP TO THE HINGE POINTS. THE PATIENT DID RECEIVE A PERMANENT PACEMAKER. THE PATIENT WAS REPORTED TO BE STABLE AND ALIVE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Heart Block

  MAUDE report 23472092 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) USING THE EVOQUE SYSTEM. FORTY-EIGHT DAYS POST-PROCEDURE, THE PATIENT WAS HOSPITALIZED WITH COMPLETE LEAFLET THROMBOSIS, TORRENTIAL TRICUSPID REGURGITATION, RIGHT VENTRICULAR FAILURE, HYPOXIA, AND SIGNIFICANT RIGHT-TO-LEFT SHUNTING. A VALVE-IN-VALVE PROCEDURE WAS CONSIDERED FOR (B)(6) 2025 BUT WAS NOT PERFORMED. THE PATIENT WAS ON THE MAXIMUM DOSE OF ELIQUIS; HOWEVER, MEDICAL OPINION INDICATED THE PATIENT WAS UNDER-ANTICOAGULATED. PHYSICIANS INITIATED COUMADIN THERAPY FOR 30 DAYS TO ADDRESS THE THROMBUS BEFORE REASSESSING OPTIONS. SHUNTING REVERSED FROM LEFT-TO-RIGHT POST-IMPLANT TO STRONG RIGHT-TO-LEFT. THE PATIENT HAD A PREEXISTING ATRIAL SEPTAL DEFECT (ASD), WHICH WAS CLOSED 48 DAYS AFTER THE INITIAL PROCEDURE. THE PATIENT IS NOW STABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23337630 ↗
• InjuryAug 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE 9 DAYS POST IMPLANT THE PATIENT WAS IN HEART BLOCK AND NEEDED SUPPORT SO A PERMANENT PACEMAKER WAS IMPLANTED. THE VALVE DEPLOYMENT WAS NORMAL. THE PATIENT DID NOT HAVE ANY CONDUCTION DISTURBANCE BEFORE THE PROCEDURE. THE CONDUCTION DISTURBANCE WAS NOTICED 9 DAYS POST IMPLANT.

  Patient problems: Heart Block

  MAUDE report 22816081 ↗
• InjuryJul 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM, DURING WHICH IT WAS CONFIRMED THAT INTERACTION BETWEEN THE VALVE AND THE RIGHT VENTRICULAR (RV) LEAD RESULTED IN RV LEAD DISLODGEMENT. APPROXIMATELY 4.5 HOURS POST-PROCEDURE, THE PATIENT'S EXISTING PACEMAKER WAS NO LONGER CAPTURING, AND THEIR HEART RATE DROPPED INTO THE 30S. A TEMPORARY PACEMAKER WAS PLACED AT THAT TIME. ON POSTOPERATIVE DAY (POD) 2, A NEW PERMANENT PACEMAKER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS NOTED THAT THE RV LEAD HAD BEEN ADHERED TO THE SUPERIOR VENA CAVA (SVC), LEAVING MINIMAL IF ANY SLACK WHEN CROSSING NEAR THE CENTER OF THE SEPTAL LEAFLET. RV DYSFUNCTION, WHICH WAS MILD PRIOR TO THE IMPLANT, PROGRESSED TO MODERATE POST PROCEDURE. THE PROCEDURE AND VALVE DEPLOYMENT WERE OTHERWISE ROUTINE. THERE WERE NO CONCERNS WITH THE VALVE PRIOR TO DEPLOYMENT, AND IT WAS REPORTED TO HAVE BEEN DEPLOYED SUCCESSFULLY WITH NO ISSUES. THE PATIENT'S RHYTHM AND HEMODYNAMICS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Bradycardia

  MAUDE report 22681346 ↗
• InjuryJul 17, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. VALVE DROPPED POSTERIOR/SEPTAL UPON DEPLOYMENT. THERE IS TRACE CENTRAL REGURGITATION, BUT NO PARAVALVULAR LEAK (PVL) WAS NOTED DURING POST PROCEDURAL ASSESSMENT. THE VALVE WAS STABLE, AND PATIENT WAS IN STABLE CONDITION. HOWEVER, ON POSTOPERATIVE DAY (POD) 1 THE PATIENT'S VALVE EMBOLIZED INTO THE RIGHT VENTRICLE (RV) AND WAS TAKEN TO SURGERY. THE PATIENT IS DOING WELL. THE PHYSICIAN WAS CENTRAL AND COAXIAL LEADING UP TO DEPLOYMENT. THE SYSTEM RETRACTED TO LEVEL OUT ANCHORS, BUT TOO POSTERIOR IN POSITION UPON DEPLOYMENT AND THAT'S WHY THE ANCHOR DROPPED. THE LEAFLET CAPTURE WAS CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN. NO LEAFLET PINNING OBSERVED. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO THE FINAL VALVE RELEASE. THE VALVE EXPANDED EVENLY AND AS EXPECTED DURING VENTRICULAR AND ATRIAL EXPANSION STAGES. THE VALVE WAS AT THE HINGE POINTS FOR ANTERIOR, SEPTAL, LATERAL AND POSTERIOR AS THE FINAL POSITION POST DEPLOYMENT. POSTERIOR SEPTAL IS THE ONLY ONE THAT DROPPED. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT IS NO BASAL R

  Patient problems: Insufficient Information

  MAUDE report 22538205 ↗
• InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. FOLLOWING VALVE IMPLANTATION, THE PATIENT DEVELOPED A NEW RIGHT BUNDLE BRANCH BLOCK (RBBB). BY POSTOPERATIVE DAY (POD) 1, THE QRS DURATION HAD RETURNED TO BASELINE (119 MS), AND NO HIGH-GRADE ATRIOVENTRICULAR (AV) BLOCK WAS OBSERVED ON TELEMETRY. THE PATIENT REMAINED IN ATRIAL FIBRILLATION, CONSISTENT WITH THEIR BASELINE RHYTHM. ON POD 3, A LEADLESS PACEMAKER WAS IMPLANTED DUE TO INTERMITTENT BRADYCARDIA WITH A SUSPECTED LEFT BUNDLE ESCAPE RHYTHM, DESPITE QRS NARROWING. THE PATIENT RECOVERED WITH SEQUELAE.

  Patient problems: Bradycardia; Heart Block

  MAUDE report 22389135 ↗
• InjuryJun 24, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THE ANTERIOR LEAFLET WAS TETHERED AT 19MM AND THAT IS THOUGHT TO BE THE CAUSE OF THE INITIAL DROP AFTER DEPLOYMENT. THE VALVE DROPPED EVEN MORE AFTER WIRE MANIPULATION WHEN THE CURL APPEARED TO GET WRAPPED IN THE DROP LOOP. THE PHYSICIAN PLACED PIGTAIL AND YANKED ON THE WIRE, VALVE DROPPED SIGNIFICANTLY. BECAUSE THE VALVE CANTED, A SNARE HAD TO BE USED AND IT WAS NECESSARY TO DO A VALVE IN VALVE. DURING THE ANCHOR SPIN, LEAFLET CAPTURE WAS CONFIRMED ON ALL ANCHORS, NO MAJOR ISSUES GETTING UNDER THE ANTERIOR TETHERED LEAFLET. MINIMAL PVL OBSERVED. MOST OF THE ANCHORS LOST CONTACT WITH THE ANNULUS, IT WAS THOUGHT THAT THE VALVE WAS HELD IN PLACE BY THE ANTERIOR PAPILLARY MUSCLE. THE DECISION WAS THEN MADE TO DO VALVE IN VALVE. SAPIEN DEPLOYED AT CORRECT HEIGHT WITHIN EVOQUE VALVE AND THERE WAS NO LEAK BETWEEN VALVES. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322404 ↗
• InjuryJun 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE A TEMPORARY PACEMAKER WAS PLACED POST PROCEDURE DUE TO NEW ONSET HEART BLOCK.

  Patient problems: Heart Block

  MAUDE report 22137009 ↗
• InjuryMay 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED A REPORT OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THE PATIENT EXPERIENCED A RHYTHM DISTURBANCE UPON PLACING THE WIRE. THE PHYSICIAN CALLED IT HEART BLOCK AND GAVE THE PATIENT DOPAMINE. THE PATIENT WAS STABLE SO THEY CONTINUED THE PROCEDURE AND SAFELY DEPLOYED THE VALVE WITHOUT FURTHER ISSUES. AFTER REMOVING THE SYSTEM, A TEMPORARY PACEMAKER WAS PLACED ACROSS THE VALVE WITHOUT ISSUE.

  Patient problems: Heart Block

  MAUDE report 22117604 ↗
• InjuryMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE WHILE LOOKING AT ANCHOR HEIGHTS THE PATIENT WENT INTO HEART BLOCK. THE PATIENT WAS PACED OFF THE SAFARI WIRE THEN THE LV UNTIL THE END OF PROCEDURE. AT THE END OF THE PROCEDURE A MICRA WAS PLACED WITHOUT ANY ISSUES. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 22107595 ↗
• InjuryMay 21, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE UPON RELEASE, THE ANTERIOR SIDE DROPPED WITH SOME ROCKING MOTION. THE PHYSICIAN SNARED THE LOCKING TAB FROM LEFT IJ, PULLED TENSION AND HELD FOR A ABOUT 10 MINUTES. RELEASED SNARE AND VALVE WAS POSITIONED CORRECTLY. NO ROCKING, NO PVL, NO TR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066710 ↗
• InjuryMay 16, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THE VALVE POSITION LOOKED GOOD UPON INITIAL RELEASE THEN CANTED VENTRICULAR ON THE POSTERIOR SIDE. EVEN THOUGH THE VALVE SEEMED STABLE, THE TEAM OPTED FOR SURGICAL EXPLANTATION. ANTERIOR LEAFLET NOTED TO STILL BE CAPTURED WHEN THEY EXPLANTED THE VALVE (NO COMMENT ON POSTERIOR LEAFLET). PATIENT IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22038206 ↗
• InjuryMay 15, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THE VALVE DROPPED ON THE ANTERIOR SIDE AFTER DEPLOYMENT. THE ECHO OBSERVED COMPETITIVE FLOW ON THE ANTERIOR SIDE OF THE VALVE. AN EN-SNARE WAS USED TO GRAB AN ANTERIOR LOCKING TAB TO PULL THE VALVE MORE ATRIAL ON THE ANTERIOR SIDE AND A 29MM SAPIEN WAS DEPLOYED INSIDE THE EVOQUE VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22024828 ↗
• InjuryMay 14, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE UPON RELEASE OF THE EVOQUE VALVE, THE VALVE IMMEDIATELY CANTED TOWARDS VENTRICULARLY ANTERIOR AND SEPTAL, WITH ROCKING MOTION. SAFARI WIRE ACROSS VALVE PLANE, AND DS LEFT IN PLACE TO AID IN VALVE STABILITY. THE CT SURGEON WAS CONSULTED, AND A MID-STERNOTOMY INCISION WAS MADE, ON PUMP PROCEDURE, THE EVOQUE WAS REMOVED, AND DS/WIRE WAS GUIDED OUT. THE SURGICAL VALVE WAS PLACED. WHEN THE SURGEON WAS OPENING THE CHEST, AN ADHESED LIMA GRAFT WAS ACCIDENTLY SEVERED. THE CHEST WAS CLOSED, AND ATTEMPTS TO WEAN OFF THE PUMP WERE MADE, WITHOUT SUCCESS. ECMO WAS PLACED, AND THE PATIENT WAS TRANSFERRED TO CVICU, AND SUBSEQUENTLY DIED SHORTLY AFTER.

  Patient problems: Insufficient Information

  MAUDE report 22020412 ↗
• InjuryMay 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE ON FOLLOW UP WITH THE IMPLANTING PHYSICIANS, IT WAS REVEALED THAT OVERNIGHT (NIGHT AFTER THE IMPLANT), THE PATIENT WENT INTO SECOND DEGREE HEART BLOCK WITH ESCAPE RHYTHM IN 48-60BPM RANGE. THE PATIENT RECEIVED A PERMANENT PACEMAKER WITH CS LEAD; HOWEVER, CS WAS ONLY INTERMITTENTLY CAPTURING AND THEN THE SITE ELECTED TO IMPLANT A MICRA LEADLESS. THE PATIENT HAS BEEN DISCHARGED AND IS IN STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 21954335 ↗
• InjuryApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED A REPORT OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE AN ECHO WAS DONE WHILE THE PATIENT WAS STILL IN THE HOSPITAL AT SOME UNSPECIFIED POINT POST PROCEDURE, AND HALT WAS SEEN ON THE EVOQUE VALVE, AND THE PATIENT WAS PUT ON IV HEPARIN. THE MEAN GRADIENT THROUGH THE VALVE WAS 5MMHG. THE PATIENT WAS DISCHARGED ON WARFARIN AND LAST REPORTED INR WAS 1.3 PRIOR TO DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940013 ↗
• DeathApr 23, 2025Malposition of Device; Migration; Malposition of Device; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, IMMEDIATELY UPON DEPLOYMENT, IMPLANT WAS NOTED TO BE HIGH ON THE LATERAL SIDE OF ANNULUS. MODERATE PVL (PARAVALVULAR LEAK) WAS NOTED IN THE LATERAL PORTION. OVERALL, THE VALVE POSITION WAS STABLE. ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST STATED THAT THE PATIENT NEVER LEFT THE HOSPITAL AND HAD A CARDIOGENIC SHOCK. THE PATIENT THEN PASSED AWAY. THE CARDIOGENIC SHOCK WAS ALLEGED TO BE RELATED TO THE EVOQUE VALVE.

  Patient problems: Cardiogenic Shock

  MAUDE report 21895733 ↗
• InjuryApr 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO INTRAPROCEDURAL RHYTHM CHANGES. ON POST-OPERATIVE DAY (POD) 1, PATIENT DEVELOPED COMPLETE HEART BLOCK AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Heart Block

  MAUDE report 21752192 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, ON POST-OPERATIVE DAY (POD) 2, THE PATIENT WAS NOTED TO HAVE AN ATRIOVENTRICULAR BLOCK (AVB) WITH A JUNCTIONAL ESCAPE. ON POD 3, A LEADLESS PACEMAKER WAS IMPLANTED. DURING THE PROCEDURE, THE PATIENT DID NOT HAVE CONDUCTION DISTURBANCES AND PACING WAS NOT NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND FINAL VALVE DEPLOYMENT WAS IN A VERY GOOD POSITION AND WITH NO MALPOSITION. ON POD 2, THE PATIENT BECAME PRE-SYNCOPAL AND WAS NOTED TO BE BRADYCARDIC TO THE 20S (FLUTTER) ON TELEMETRY AND AN ATRIOVENTRICULAR BLOCK (AVB) WITH A JUNCTIONAL ESCAPE. DOPAMINE WAS INITIATED WITH SLOW RESPONSE, BUT ULTIMATELY STABILIZED THE HEART RATE (HR) IN THE 60S. ALSO, GLUCAGON IN THE SETTING OF BETA BLOCKER WAS ADMINISTERED. PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR CARE, WITH PLANS FOR LEADLESS PACEMAKER IMPLANTATION ON POD 3.

  Patient problems: Heart Block

  MAUDE report 21684606 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P230013. One submission often covers many models, so check the product and lot details in each record.

• Z-2172-2026 · Mar 27, 2026 · Open, Classified
  Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO