EVOQUE 9850EV52USRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00690103217469), received between Apr 30, 2024 and Apr 6, 2026 — classified as 2 deaths, 38 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 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 40 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryFeb 2, 2026Malposition of Device; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED A FEW DAYS POST PROCEDURE. THE EVOQUE VALVE WAS NOTED TO BE CANTED ON ONE SIDE (ATRIAL). ACCORDING TO THE CLINICAL TEAM, THE VALVE LEAFLETS WERE FROZEN, RESULTING IN TORRENTIAL TRICUSPID REGURGITATION. ON POSTOPERATIVE DAY (POD) 7, THE 52 MM EVOQUE VALVE WAS REPOSITIONED MORE VENTRICULARLY WITH THE ASSISTANCE OF SNARING AND A 29MM DELIVERY SYSTEM (BALLOON ONLY). A 29 MM VALVE WAS THEN SUCCESSFULLY IMPLANTED. PLUGS WERE ALSO PLACED IN THE SAME SETTING AS THE VALVE IN VALVE, RESULTING IN ONLY TRACE TRICUSPID REGURGITATION. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. DURING EVOQUE IMPLANTATION THE DEVICE WAS OBSERVED TO BE POSITIONED HIGH UPON FULL FLIP. IT WAS ABOVE THE ANNULUS AND PINNING THE LEAFLETS FROM APPROXIMATELY THE 5 TO 10 O'CLOCK POSITIONS. AFTER THE HIGH ANCHORS WERE RECOGNIZED, ALL POSSIBLE ATTEMPTS WERE MADE TO ACHIEVE ADDITIONAL DEPTH. HOWEVER, THE ANCHORS BENEATH THE POSTERIOR HINGE POINTS REMAINED IMMOBILE. THEY WERE STUCK AND NO MANEUVERS WOULD TRANSLATE. CAPTURE COULD NOT BE ACHIEVED FROM 5 TO 1

  Patient problems: Hemolysis; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24235364 ↗
• InjuryJan 22, 2026Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THERE WAS NO INDICATION OF ACTIVE INFECTION OR ENDOCARDITIS BEFORE THE PROCEDURE. HOWEVER, THE PATIENT HAD ENDOCARDITIS YEARS AGO AND IT WAS KNOWN. AS A RESULT, THE CLIN DEV WAS CONTACTED TO MAKE SURE THERE WAS ENOUGH ANTERIOR LEAFLET TO GRAB. IT WAS CONFIRMED THAT THERE WAS FULL LEAFLET CAPTURE. POST IMPLANT THE VALVE APPEARED TO BE SEATED APPROPRIATELY WITH NO LEAK. HOWEVER, THE VALVE WAS LOWER 24 HOURS POST DEPLOYMENT. UPON REVIEW, IT APPEARS SEPTAL AND POSTERIOR ANCHORS WERE LOW UPON DEPLOYMENT ~17-20 FROM HINGE POINTS) WHICH LED TO THE VALVE CANTED POST PROCEDURE AS THERE WAS ONLY ANNULAR OS FOR THIS PATIENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS UP 30 KG, HOWEVER, THE MEASUREMENTS WERE STILL WITHIN LIMITS FOR THE 52 MM VALVE. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT. THE PATIENT WENT TO SURGERY TO REPLACE THE VALVE AT AN UNKNOWN DATE POST PROCEDURE. THE PATIENT PASSED AFTER MULTIPLE ORGAN FAILURE POST OP.

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

  MAUDE report 24148153 ↗
• InjuryJan 7, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. PRIOR TO DEPLOYMENT, THE ANCHORS IN THE SEPTAL-LATERAL (SL) POSITION WERE SNUG, WHILE THE ANTERIOR AND POSTERIOR ANCHORS HAD APPROXIMATELY 3-4 MM OF SPACE BETWEEN THE ANCHORS AND THE ANNULUS. DURING MPR SPIN, THE ANTERIOR LEAFLET WAS DIFFICULT TO ASSESS. THE SECONDARY OPERATOR WAS UNSURE IF LEAFLET WAS ADEQUATELY CAPTURED, POTENTIALLY CAUGHT ON CHORD OUTSIDE OF ANCHOR. DURING RELEASE, THE ANTERIOR ANCHOR CAME FREE FROM LOCKING RING FIRST. THE DELIVERY SYSTEM (DS) MIGRATED SLIGHTLY POSTERIOR AFTER ANTERIOR CAME OFF. THE REST OF ANCHORS CAME OFF WITHIN SECONDS OF THE ANTERIOR. UPON DEPLOYMENT, THE VALVE APPEARED STABLE AND WELL-POSITIONED. APPROXIMATELY FIVE SECONDS LATER, WHILE MANEUVERING THE DS OUT OF THE VALVE AND AWAY FROM THE POSTERIOR LOCKING TABS, THE VALVE DROPPED ON THE ANTERIOR SIDE. MILD ANTERIOR PVL WAS NOTED FOLLOWING THIS CANTING. AFTER THE VALVE SHIFTED ANTERIORLY, THE INTERVENTIONAL CARDIOLOGIST SNARED THE ANTERIOR LOCKING TAB, PULLED UPWARD, AND DEPLOYED ANOTHER VALVE. TO FURTHER STABILIZE THE VALVE, AN ADDITIONAL VALVE WAS IMPLANTED AS WELL. TH

  Patient problems: Insufficient Information

  MAUDE report 23990367 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE FINAL VALVE DEPLOYMENT POSITION WAS CENTRAL AND COAXIAL AT THE TRICUSPID VALVE ANNULUS (TVA). HOWEVER, IT WAS REPORTED THAT A PERMANENT PACEMAKER WAS IMPLANTED AT AN UNSPECIFIED TIME POST PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Arrhythmia

  MAUDE report 23866065 ↗
• InjuryDec 22, 2025Perivalvular Leak; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THREE NON-EDWARDS TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) DEVICES WERE PRESENT AND THE MOST CENTRAL DEVICE WAS LACERATED TO CREATE A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). AN EVOQUE VALVE WAS SUCCESSFULLY IMPLANTED. HOWEVER, SEALING THE PARAVALVULAR LEAK (PVL) IN THE ANTEROSEPTAL (AS) COMMISSURE WHERE THE TWO REMAINING INTACT TEER DEVICES WERE LOCATED, WAS UNSUCCESSFUL. TWO VASCULAR PLUGS WERE PLACED IN AN ATTEMPT TO ADDRESS THE LEAK, BUT MODERATE TO SEVERE PVL PERSISTED. PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE WAS THE INABILITY TO ACHIEVE A SEAL AROUND THE TWO TEER DEVICES IN THE ANTEROSEPTAL COMMISSURE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT, AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865278 ↗
• InjuryOct 30, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. IMPLANTING PHYSICIAN REPORTED THAT THE EVOQUE VALVE EMBOLIZED AND IS IN THE RIGHT VENTRICLE (RV). THE PATIENT IS IN HEART FAILURE (HF). THE INDEX PROCEDURE WAS NOTED TO BE A STRAIGHTFORWARD 52MM IMPLANT (59 MIN) WITH A FINAL RESULT OF TRACE PVL (POSTERIORLY LOCATED), AND THE DEVICE WAS STABLE. IT WAS NOTED THAT THE PATIENT WAS MEDICALLY VOLUME OPTIMIZED PRE-PROCEDURE. THE POST OPERATIVE 30 DAY ECHO WAS DONE AND THE VALVE WAS FOUND TO BE IN THE RV.

  Patient problems: Foreign Body Embolism

  MAUDE report 23426833 ↗
• InjuryOct 29, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE VALVE WAS DEPLOYED AND WAS STABLE. IT DID NOT MIGRATE OR EMBOLIZE ON DEPLOYMENT. IT WAS NOT UNTIL COLOR WAS PUT ON THE ECHO IMAGES THAT IT WAS NOTED THERE WAS SEVERE PVL ON THE POSTERIOR SIDE WITH THE VALVE BEING VERY FAR FROM THE ANNULUS AND A FUNCTIONING NATIVE POSTERIOR LEAFLET. A CENTRAL LEAK OF THE VALVE WAS ALSO NOTED AND RESOLVED BY THE TIME THE PATIENT WAS TAKEN OFF OF THE TABLE. OUTER FRAME OF THE VALVE WAS COMPRESSED INTO AN OVAL SHAPE BUT CENTRAL FRAME OF THE VALVE REMAINED CIRCULAR. THE PATIENT WAS TAKEN OFF THE TABLE IN STABLE CONDITION. IMAGING ISSUES WERE A CONSTRAINT DURING THE PROCEDURE. LEAFLET CAPTURE WAS CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN. THERE WAS 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. THE VALVE DID NOT EXPAND EVENLY AND AS EXPECTED DURING VENTRICULAR AND ATRIAL EXPANSION STAGES. THE FINAL POSITION OF THE VALVE POST DEPLOYMENT IS THE POSTERIOR SIDE OF THE VALVE WAS ABOUT 1- 1.5CM BELOW THE ANNULUS OF THE VALVE. S-L AN

  Patient problems: Foreign Body Embolism

  MAUDE report 23415485 ↗
• InjuryOct 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. PER PHYSICIAN THE PATIENT HAS HEART BLOCK. THE CONDUCTION DISTURBANCE WAS NOTICED POST OPERATIVELY AFTER THE PATIENT WAS DISCHARGED HOME. EXACT DATES ARE NOT KNOWN. THE PATIENT WAS RE-ADMITTED ON POST OPERATIVE DAY 8 FOR EVALUATION AND IMPLANT OF PERMANENT PACEMAKER. EXACT BASELINE RHYTHM IS NOT KNOWN BUT NO BUNDLE BRANCH BLOCK WAS NOTED. AT FINAL VALVE DEPLOYMENT ALL 0-5 FROM ANNULUS, AND NO ISSUES NOTED.

  Patient problems: Heart Block

  MAUDE report 23398506 ↗
• InjurySep 9, 2025Migration; Intravalvular regurgitation; Migration; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE PRIOR TO DEPLOYMENT THE EVOQUE ANCHORS WERE AT HINGE POINTS OF ANNULUS, AND ON RELEASE THE VALVE SHIFTED DOWN ON THE ANTERIOR SIDE UNDERNEATH THE 2 INTACT TEER DEVICES (PASCAL ~4 YEARS OLD). POST EVOQUE VALVE DEPLOYMENT THERE WAS SEVERE WITH MILD PVL AT THE CLIPS AND THE INNER FRAME OF THE EVOQUE VALVE BECAME SLIGHTLY OVAL INSTEAD OF CIRCULAR. THE LEAK WAS ASSESSED WITH ICE AND DETERMINED THAT THE PVL JET AND THE CENTRAL TR JETS WERE SEPARATE JETS. IT WAS DECIDED TO PROCEED WITH VALVE IN VALVE (VIV) BECAUSE OF THE SEVERE TR CENTRAL LEAK. THE ORIENTATION OF THE CLIPS WAS BIASED AT A DIAGONAL ANGLE, THEN THESE CLIPS PUSHED INTO THE FRAME, CONTRIBUTING TO THE FRAME COMPRESSION. THE PATIENT LEFT THE ROOM WITH A MILD PVL AND A STABLE VALVE. AT FULL ANCHOR FLIP, SEPTAL HAD RESTRICTED LEAFLET MOTION, LOOKED PINNED. ADDED ABOUT 1 CM OF DEPTH TO UNPIN SEPTAL LEAFLET. ONCE THE SEPTAL REGAINED LEAFLET MOTION, TOOK DEPTH OFF. PROCEEDED WITH EXPANSION AS NORMAL. THE VALVE DROPPED 1-2CM BELOW ANNULUS UPON RELEASE ON ANTERIOR SIDE. DID NOT OBSERVE OVAL COMPRESSION OF VAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011814 ↗
• InjuryJul 17, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. AFTER RELEASE, SEPTAL ANT/SEPTAL SIDE RAISED WHILE POST/LATERAL DROPPED. AT LEAST 2 SEPTAL ANCHORS WERE ABOVE THE ANNULUS. DUE TO ANCHORS BEING ABOVE THE ANNULUS ON THE SEPTAL SIDE SURGICAL INTERVENTION WAS THE BEST OPTION. THE VALVE WAS REMOVED AND A SURGICAL VALVE WAS IMPLANTED. THERE WAS MODERATE PVL REGURGITATION ON SEPTAL SIDE. DURING THE PROCEDURE AND LEADING UP TO THE VALVE DEPLOYMENT, LEAFLETS WERE CAPTURED AND AT APPROPRIATE HEIGHT. LEAFLET CAPTURE WAS CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN. THE ANCHORS WERE AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE. THE VALVE DID EXPAND EVENLY AND AS EXPECTED DURING VENTRICULAR AND ATRIAL EXPANSION STAGES. THERE WAS APPROPRIATE VOLUME OPTIMIZATION THE DAY OF THE PROCEDURE. THE PRESSURE WAS NOTED TO START DROPPING WHICH SPED UP REST OF DEPLOYMENT. IT WAS OBSERVED THAT POST VALVE TILTING, THE NOSECONE MAY HAVE GOTTEN CAUGHT IN BETWEEN 2 LOCKING TABS. KEPT COUNTER CLOCKING UNTIL THE NOSECONE CAME OFF AND THEN THE NOSECONE WAS ABLE TO BE REMOVED. AN INTERNAL IMAGING REVIEW SHOWED THAT THE 52

  Patient problems: Insufficient Information

  MAUDE report 22537784 ↗
• InjuryJul 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PATIENT HAD COMPLETE AV BLOCK AND ASYSTOLE AT INITIAL WIRE PLACEMENT. THE PATIENT WAS PACED THROUGH SAFARI AND A TEMP PACER WAS PLACED IN THE RV. EPI WAS GIVEN FOR ASYSTOLE. THE TEMP PACER AT ANCHORS WAS REMOVED AT 90 AND THE PATIENT WAS PACED THROUGH THE SAFARI UNTIL DEPLOYMENT. THE PHYSICIAN PLACED A TEMP CS LEAD POST DEPLOYMENT. THE FINAL VALVE DEPLOYMENT POSITION WAS AT THE ANNULAR LEVEL. THE PATIENT WAS IN STABLE CONDITION. THE PATIENT RECEIVED A PERMANENT PACEMAKER POST PROCEDURE.

  Patient problems: Asystole; Heart Block

  MAUDE report 22471760 ↗
• InjuryJun 24, 2025Malposition of Device; Intravalvular regurgitation; Malposition of Device; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THERE WAS CENTRAL TR NOTED POST-DEPLOYMENT, GRADED MODERATE. THE NEXT DAY TTE DEMONSTRATED SEVERE TR. ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INTERVENTIONS WERE TAKEN AND NONE WERE PLANNED. THE PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322279 ↗
• InjuryJun 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE AT THE TIME OF THE PROCEDURE, THERE WERE NO ARRYTHMIAS OR CONDUCTION DISTURBANCES. THERE WAS A PRE-EXISTING EFFUSION THAT WAS STABLE THROUGHOUT THE PROCEDURE. THE RV FUNCTION WAS MEASURED POST DEPLOYMENT AND WAS NORMAL. AFTER THE PATIENT WAS TAKEN OUT OF THE ROOM, SHE EXPERIENCED PROLONGED EPISODES OF VT AND VENTRICULAR ECTOPY. THIS SETTLED DOWN AND THE PATIENT APPEARED TO BE RECOVERING WELL. LATER THAT AFTERNOON, THE TROPONINS WERE ELEVATED TO NEARLY 10,000 AND THE PATIENT HAD SIGNIFICANT CHEST PAIN SO THE PHYSICIAN TOOK HER BACK TO THE LAB. THE CORONARIES WERE REPORTED TO BE COMPLETELY CLEAN, BUT THEY BELIEVED THAT THE VALVE OR POSSIBLY THE ANCHOR WAS PRESSING INTO THE SEPTUM CAUSING SOME SORT OF SEPTAL INFARCT. THE PATIENT DID DEVELOP RIGHT BUNDLE BRANCH BLOCK (RBBB) AND HER PAIN WAS MANAGED WITH IV MORPHINE. THE PHYSICIAN ADVISED HE STILL SUSPECTS MYOPERICARDITIS SECONDARY TO A SEPTAL INFARCT CAUSED BY OVERSIZING AND THE SEPTAL ANCHOR. TROPONINS ARE DOWNWARD TRENDING. THE PATIENT'S PAIN HAS RESOLVED AND THE MORPHINE HAS BEEN DISCONTINUED. ECHO THE FOLLOWING MORNING LOOKED NORMAL AND THE EKG CONTINU

  Patient problems: Coronary obstruction/occlusion; Heart Block; Pericarditis

  MAUDE report 22178302 ↗
• InjuryJun 4, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN THE TRICUSPID POSITION WHERE, FOLLOWING VALVE RELEASE, THE ANTERIOR SIDE APPEARED TO MIGRATE ATRIALLY. TEE CONFIRMED ATRIALIZATION OF THE ANTERIOR VALVE SEGMENT, WITH NATIVE LEAFLETS VISUALIZED BENEATH THE DEVICE. THE PATIENT HAD A HISTORY OF SIGNIFICANT WEIGHT LOSS (FROM 95.45 KG TO 58.3 KG), PRIOR MECHANICAL MITRAL VALVE REPLACEMENT CAUSING ACOUSTIC SHADOWING, AND CHALLENGING RV WIRE PLACEMENT DUE TO INTERFERENCE FROM A PACEMAKER LEAD AND PAPILLARY MUSCLE. THESE PROCEDURAL FACTORS WERE PRESENT IN A CASE WHERE LIMITED VISUALIZATION, POSTERIOR WIRE BIAS, AND DIFFICULTY ACHIEVING DEPTH WERE OBSERVED, AND VALVE MALPOSITION OCCURRED. NO POST-DEPLOYMENT INTERROGATION WAS PERFORMED, AS THE PATIENT WAS TRANSITIONED TO CT SURGERY FOR VALVE REMOVAL. ON POD 2, THE PATIENT RETURNED TO SURGERY FOR WASHOUT AND CLOSURE AFTER BEING LEFT OPEN FOR 48 HOURS, REPORTEDLY DUE TO ANTICOAGULATION-RELATED BLEEDING CONCERNS.

  Patient problems: Insufficient Information

  MAUDE report 22142832 ↗
• InjuryMay 28, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE THE PATIENT WAS SCREENED FOR A 52 MM EVOQUE WITH ANNULAR OVERSIZING OF 14.8%/20.9% AND BASAL OVERSIZING OF -15.5%/-2%; SCREENING NOTED A SEPTAL FLAIL. UNREMARKABLE PROCEDURE THROUGH DEPLOYMENT, ALL ANCHORS CONFIRMED TO CAPTURE LEAFLETS MINUS THE AREA OF THE SEPTAL LEAFLET THAT WAS FLAIL AND THE COMMISSURES. ANTERIOR SEPTAL SIDE OF THE DEVICE DROPPED POST DEPLOYMENT. SNARES WERE APPLIED FROM BOTH INTERNAL JUGULAR AND FEMORAL APPROACH TO STABILIZE THE VALVE POSITION. A 29MM SAPIEN (S3) WAS IMPLANTED IN THE EVOQUE VALVE; SNARES WERE REMOVED POST SAPIEN DEPLOYMENT, VALVE STAYED IN PLACE AND IS STABLE WITH A REMAINDER TRACE PVL IN THE POSTERIOR SEPTAL LOCATION OF WHERE THE FLAIL WAS LOCATED. PER INTERNAL IMAGING EVALUATION, IT WAS CONFIRMED THAT THE 52MM EVOQUE VALVE EMBOLIZED INTO THE RIGHT VENTRICLE REQUIRING ONE SAPIEN VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098307 ↗
• InjuryApr 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE FOLLOWING INDUCTION BY ANESTHESIA, THE PATIENT HEART RATE WAS GENERALLY IN THE 60-50S, BUT REGULARLY DIPPED INTO THE HIGH 40S. PATIENT HEART RATE PRIOR TO ANESTHESIA WAS NOT DISCLOSED TO THE EDWARDS TEAM. FOLLOWING SUCCESSFUL DEPLOYMENT OF VALVE, THE PATIENT HEART RATE WAS REGULARLY IN THE HIGH 30S, HOWEVER NEVER LOST HEMODYNAMIC STABILITY. FINAL VALVE DEPLOYMENT POSITION WAS- ANTERIOR WAS SLIGHTLY LOWER THAN POSTERIOR/SEPTAL/LATERAL (AROUND 4-6MM). IMPLANTING TEAM BELIEVED THIS CHANGE IN RATE TO BE HEART BLOCK AND ELECTED TO CROSS NEW EVOQUE VALVE WITH TEMPORARY PACING WIRE AND OBSERVE. PER THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS ANCHOR CONTACTING THE SEPTUM. PER LATEST INFORMATION, THE PATIENT WENT FOR A PERMANENT PACEMAKER WITH CS LEAD. CURRENTLY IN-PATIENT AND ON DOBUTAMINE DRIP.

  Patient problems: Heart Block

  MAUDE report 21922980 ↗
• DeathApr 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE THE PROCEDURE WAS COMPLETED. ON POST-OPERATIVE DAY (POD) 10, PATIENT EXPERIENCED COMPLETE HEART BLOCK AND EXPIRED.

  Patient problems: Heart Block

  MAUDE report 21752274 ↗
• InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH TRACE CENTRAL TRICUSPID REGURGITATION (TR) AND NO PARAVALVULAR LEAK (PVL). ON POST-OPERATIVE DAY (POD) 2, THE PATIENT WAS NOTED TO BE IN COMPLETE HEART BLOCK AND SUBSEQUENTLY RECEIVED A PERMANENT PACEMAKER.

  Patient problems: Heart Block

  MAUDE report 21732450 ↗
• InjuryMar 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE EVERYTHING WENT WELL BUT IMMEDIATELY POST-PROCEDURE, THE PATIENT WENT INTO HEART BLOCK. PHYSICIANS IMPLANTS A PERMANENT PACEMAKER (PPM) AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Heart Block

  MAUDE report 21691834 ↗
• InjuryMar 25, 2025Malposition of Device; Migration; Malposition of Device; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, UPON DEPLOYMENT, THE VALVE SHIFTED AND REQUIRED THE PLACEMENT OF TWO SAPIEN VALVE-IN-VALVE DEPLOYMENTS. UPON DEPLOYMENT, THE EVOQUE VALVE SHIFTED MORE VENTRICULAR. MINUTES AFTER THE RELEASE, THE VALVE APPEARED TO BE ROCKING OR UNSTABLE, WITH INCREASED PVL ON THE SEPTAL SIDE. THE DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE PROCEDURE WITH A 29MM SAPIEN. AFTER THE SAPIEN DEPLOYMENT, THERE WAS A LEAK BETWEEN THE EVOQUE AND SAPIEN SEALING SKIRTS. A SECOND 29MM SAPIEN VALVE WAS DEPLOYED.

  Patient problems: Failure of Implant

  MAUDE report 21691778 ↗
• InjuryMar 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE PRE-PROCEDURE, PATIENT HAD A-FIB WITH A BUNDLE BRANCH BLOCK (BBB) AND A SMALL SHALLOW RV. DURING WIRE PLACEMENT, THE PATIENT EXPERIENCED ARRHYTHMIAS. POST IMPLANTATION, PATIENT DEVELOPED BRADYCARDIA AND A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Bradycardia

  MAUDE report 21654927 ↗
• InjuryMar 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE, DURING THE PROCEDURE, THE PATIENT WENT INTO HEART BLOCK WHEN THE DELIVERY SYSTEM (DS) CROSSED THE ANNULUS. THE TEAM PACED OFF THE SAFARI WIRE TO COMPLETE THE PROCEDURE AND THEN A PERMANENT PACEMAKER (PPM) WAS IMPLANTED IMMEDIATELY POST-PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 21599994 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE PATIENT WAS BRADYCARDIC ON PRE-PROCEDURAL TEE IMAGING WITH HEART RATE (HR) AT 50BPM AND STAYED IN 50'S THROUGHOUT THE PROCEDURE. POST DEPLOYMENT, THE VALVE WAS WELL SEATED AT ALL HINGE-POINTS OF THE ANNULUS (NO MALPOSITION), BUT THE HEART RATE WAS AROUND 38BPM AND 40 BPM AND THE SITE PLANNED TO PLACE A TEMPORARY PACEMAKER. IT WAS REPORTED ON POST-OPERATIVE DAY (POD) 1, A PERMANENT PACEMAKER (PPM) WAS IMPLANTED. THE PATIENT IS DOING WELL AND NO FURTHER TREATMENT OR INTERVENTIONS HAVE BEEN REPORTED.

  Patient problems: Bradycardia

  MAUDE report 21508030 ↗
• InjuryFeb 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE VALVE IN TRICUSPID POSITION WHERE AFTER VALVE DEPLOYMENT, PATIENT DEVELOPED A NEW LEFT BUNDLE BRACH BLOCK (LBBB). SITE IMPLANTED TEMPORARY PACER, FROM RIGHT INTERNAL JUGULAR ACCESS, ACROSS EVOQUE VALVE. ON POST-OPERATIVE DAY (POD) 2, A PERMANENT PACEMAKER WAS IMPLANTED. PATIENT IS CURRENTLY DOING WELL AND NO ADDITIONAL TREATMENTS OR INTERVENTIONS REPORTED.

  Patient problems: Heart Block

  MAUDE report 21315311 ↗

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