EVOQUE 9850EV48USRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00690103217452), received between May 14, 2024 and Apr 9, 2026 — classified as 3 deaths, 39 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (18 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 42 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 12, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE DELIVERY SYSTEM WAS POSITIONED CENTRALLY AND COAXIALLY WITHIN THE NATIVE TRICUSPID VALVE, WITH THE CAPSULE GAP ALIGNED TO LEAFLET EXCURSION AND ANCHORS PEAKED APPROPRIATELY. MPR CONFIRMED FULL CIRCUMFERENTIAL LEAFLET CAPTURE. AT THE FIRST INFLECTION POINT, ANCHORS WERE EVENLY APPROACHING THE HINGE POINTS, ALLOWING PROGRESSION TO FULL VENTRICULAR EXPANSION. LATERAL ANCHORS WERE NOTED TO BE MORE ATRIAL THAN SEPTAL, PROMPTING COUNTER CLOCKED (IJ ACCESS) TO LOWER THE LATERAL ANCHORS AND ALIGN THE SEPTAL ANCHORS. MPR AND 2D BIPLANE IMAGING CONFIRMED SECURE SEATING AT THE HINGE POINTS PRIOR TO ATRIAL EXPANSION. THE BLUE KNOB WAS ADVANCED HALFWAY, THE NOSE CONE RETRACTED, AND ANCHOR HEIGHTS VERIFIED. AFTER COMPLETING BLUE KNOB AND UPON RELEASE, THE ANTERIOR/SEPTAL SEGMENT OF THE VALVE IMMEDIATELY DROPPED. ANCHOR TO ANNULUS MEASUREMENTS SHOWED A 12-13 MM DISTANCE ON THE ANTERIOR/SEPTAL SIDE AND 0-5 MM ON THE POSTERIOR AND LATERAL SIDES, WITH MODERATE PVL IN THE ANTERIOR-SEPTAL REGION. FEMORAL ACCESS WAS OBTAINED, AND TWO SNARES WERE USED TO ELEVATE THE ANTERIOR/SEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327784 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. FOLLOWING VALVE RELEASE AT THE ANNULUS, COMPLETE HEART BLOCK WAS OBSERVED IMMEDIATELY. NO PROCEDURAL MANEUVERS WERE IDENTIFIED AS CONTRIBUTING TO THE RHYTHM CHANGE. DUE TO THE SUSTAINED COMPLETE HEART BLOCK, A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 24012167 ↗
• InjuryJan 7, 2026Malposition of Device; Migration

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PROCEDURE MAINTAINED A CENTRAL AND COAXIAL POSITION WITHOUT LEAFLET CAPTURE ISSUES. AFTER FULL VENTRICULAR EXPANSION, ANCHORS WERE OBSERVED BELOW THE HINGE POINTS WITH NO OPTION TO REPOSITION HIGHER. DEPLOYMENT PROCEEDED, AND THE VALVE DROPPED BUT REMAINED STABLE. SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED IN THE ANTEROSEPTAL AND POSTEROSEPTAL REGIONS. THE TRANSCATHETER HEART VALVE (THV) TEAM WAS ON STANDBY AND ASSISTED IN LOADING A VALVE FOR VALVE-IN-VALVE (VIV) PLACEMENT. POST-VIV PLACEMENT, TWO JETS REMAINED, RESULTING IN MILD TO MODERATE PVL. PRIOR TO FULL VENTRICULAR EXPANSION, MEASUREMENTS FROM HINGE POINTS TO ANCHORS RANGED FROM 7-9 MM IN THE ANTERIOR, POSTERIOR, AND LATERAL POSITIONS, WHILE SEPTAL ANCHORS WERE SNUG AGAINST HINGE POINTS. ANCHORS WERE ABLE TO BE RAISED SLIGHTLY AFTERWARD, BUT NO FINAL MEASUREMENTS WERE RECORDED PRIOR TO RELEASE. FULL ATRIALIZATION WAS NOT ACHIEVABLE DUE TO CARCINOID DISEASE, AS THE VALVE AND DELIVERY SYSTEM WERE PULLED VENTRICULAR DURING EXPANSION.

  Patient problems: Foreign Body Embolism; Insufficient Information

  MAUDE report 23990535 ↗
• InjuryDec 19, 2025Migration; Migration

  EDWARDS WAS NOTIFIED OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) USING THE EVOQUE SYSTEM. THE PATIENT HAD PRIOR TRICUSPID REPAIR DEVICES IN PLACE, AND LACERATION OF THOSE DEVICES WAS PERFORMED TO CREATE SPACE FOR THE EVOQUE VALVE. THE PROCEDURE WAS COMPLETED, BUT IMAGING WAS CHALLENGING DUE TO EXISTING HARDWARE. AFTER RELEASE, THE VALVE SETTLED LOW WITH MILD PARAVALVULAR LEAK AND TRACE TRICUSPID REGURGITATION. THE PATIENT REMAINED STABLE AND WAS DISCHARGED WITHOUT INJURY. INTERNAL REVIEW LATER INDICATED THE VALVE EMBOLIZED INTO THE VENTRICLE, RESULTING IN LOSS OF ANCHOR CONTACT WITH THE ANNULUS. THE PERCEIVED ROOT CAUSE WAS LIMITED SPACE FROM PRIOR DEVICES.

  Patient problems: Foreign Body Embolism

  MAUDE report 23857180 ↗
• InjuryDec 19, 2025Malposition of Device; Intravalvular regurgitation; Malposition of Device; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) USING THE EVOQUE SYSTEM. INITIAL DELIVERY SYSTEM POSITIONING WAS TOO DEEP AND REQUIRED MULTIPLE UNSUCCESSFUL MANEUVERS TO IMPROVE HEIGHT AND TRAJECTORY. IMAGING INITIALLY SUGGESTED ADEQUATE POSITION FOR ANCHOR DEPLOYMENT, BUT SUBSEQUENT IMAGING REVEALED THE SYSTEM WAS DEEPER THAN ANTICIPATED. ATTEMPTS TO GAIN ADDITIONAL HEIGHT CAUSED THE OUTER CAPSULE TO RETRACT WITHOUT KNOB ROTATION, RESULTING IN A SLIGHT ATRIAL FLIP. FURTHER RETRACTION ATTEMPTS MET RESISTANCE, AND AFTER DETACHING THE HANDLE FOR TACTILE FEEDBACK, THE CATHETER SHIFTED APPROXIMATELY 3 CM TOWARD THE VENTRICLE. ADDITIONAL ADJUSTMENTS PROVIDED MINIMAL IMPROVEMENT, AND THE VALVE WAS RELEASED IN A NON-IDEAL POSITION, DROPPING ANTERIORLY AND POSTERIORLY WITH ANCHOR TIPS JUST ABOVE THE TRICUSPID ANNULUS PLANE. POST-RELEASE, SEVERE CENTRAL TRICUSPID REGURGITATION AND MODERATE POSTERIOR PARAVALVULAR LEAK WERE NOTED. CONTRIBUTING FACTORS INCLUDED INSUFFICIENT DEVICE MANEUVERS TO REACH OPTIMAL POSITION, IMAGING LIMITATIONS, PATIENT ANATOMY (FUNCTIONALLY BICUSPID TRICUSPID VALVE AND RV LEAD), AND SUSPECTED ENTANGLEMENT WITH SUBVALVULAR STRUCTURE

  Patient problems: Insufficient Information

  MAUDE report 23854983 ↗
• InjuryDec 12, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THROUGHOUT THE CASE, THE TRAJECTORY REMAINED POSTERIOR BUT APPROACHED NEAR-COAXIAL ALIGNMENT PRIOR TO DEPLOYMENT. PATIENT'S SADDLE-SHAPED, NON-PLANAR ANNULUS AND A DEEP COMMISSURE ANATOMY PRESENTED SIGNIFICANT CONSTRAINTS. LEAFLET CAPTURE WAS CONFIRMED ON EACH ANCHOR DURING THE ANCHOR SPIN, AND LEAFLET PINNING WAS NOT OBSERVED AT ANY POINT IN THE PROCEDURE. THE ANCHORS WERE POSITIONED AT THE HINGE POINTS OF THE ANNULUS PRIOR TO FINAL VALVE RELEASE. THE VALVE EXPANDED EVENLY AND AS EXPECTED DURING BOTH VENTRICULAR AND ATRIAL EXPANSION PHASES. HOWEVER, FOLLOWING DEPLOYMENT, THE POSTERIOR-LATERAL SIDE OF THE VALVE DROPPED VENTRICULARLY. DUE TO CANTING, THE VALVE DID NOT ACHIEVE A COMPLETE SEAL, AND AS COM PARAVALVULAR LEAK (PVL) WAS OBSERVED VIA COLOR DOPPLER FLOW. VOLUME OPTIMIZATION WAS APPROPRIATELY MANAGED ON THE DAY OF THE PROCEDURE. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS ANATOMICAL. A SNARE WAS USED TO REPOSITION AND ELEVATE THE POSTERIOR-LATERAL SIDE OF THE VALVE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT, AND THE PAT

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

  MAUDE report 23789809 ↗
• InjuryNov 17, 2025Malposition of Device; Migration; Intravalvular regurgitation; Malposition of Device; Migration; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. UPON FINAL VALVE RELEASE, THE DEVICE DROPPED MORE THAN 1 CM ANTERIORLY/LATERALLY. THE VALVE REMAINED STABLE, BUT MODERATE PARAVALVULAR LEAK (PVL) AND SEVERE CENTRAL TRICUSPID REGURGITATION (TR) WERE OBSERVED; IMAGING LOCALIZED PVL TO THE ANTERIOR POSITION. PATIENT BLOOD PRESSURE WAS LOW (60-70 MMHG) UNDER FULL SUPPORT. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED: THE EVOQUE VALVE WAS SECURED WITH A SNARE, AND A 29 MM S3UR VALVE WAS IMPLANTED WITH +2 CC INFLATION. POST-INTERVENTION, PVL REDUCED TO MILD, TR RESOLVED, VALVE STABILITY CONFIRMED, AND BLOOD PRESSURE IMPROVED TO 90-110 MMHG. NO PATIENT INJURY OCCURRED; PATIENT REMAINED STABLE. HISTORY INCLUDED CARCINOID DISEASE MANAGED WITH OCTREOTIDE; IMAGING WAS CHALLENGING, REQUIRING ICE. VALVE EXPANSION APPEARED APPROPRIATE PRIOR TO RELEASE; POSTERIOR CAPTURE WAS BRIEFLY LOST DURING VENTRICULAR EXPANSION BUT RECAPTURED. ROOT CAUSE LIKELY RELATED TO CARCINOID DISEASE.

  Patient problems: Foreign Body Embolism; Low Blood Pressure/ Hypotension

  MAUDE report 23573144 ↗
• InjuryNov 10, 2025Malposition of Device; Intravalvular regurgitation; Malposition of Device; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE LEFT FEMORAL WAS VERY TORTUOUS, AND THE ANATOMY KINKED THE WIRE BEFORE THE IVC BIFURCATION. RE-DILATION OF ACCESS SITE WAS NECESSARY. PHYSICIAN WAS ABLE TO GET DELIVERY SYSTEM (DS) UP TO THE TRICUSPID VALVE WITH SIGNIFICANT EFFORT. ONCE DS WAS ACROSS THE VALVE, THE DS WAS VERY DEEP MEASURING AROUND 40MM FROM CAPSULE EDGE TO THE ANNULUS. THE WIRE WAS PUSHED TO GAIN HEIGHT AND MADE THE CAPSULE GAP, AND MEASURED ABOUT 20MM FROM ANNULUS. DS WAS RELATIVELY CENTRAL TO COAPTATION. THERE WAS DIFFICULTY WITH ECHO VISUALIZATION THROUGHOUT THE CASE. AFTER THE FIRST INFLECTION POINT, IT WAS HARD TO SEE THE SEPTAL LEAFLET. SWITCHED TO ICE AT THIS POINT IN THE PROCEDURE, AND IT WAS NOTED THAT THE PHYSICIAN HAD A SEPTAL TRAJECTORY AND DEEP IN THE ANATOMY. SEPTAL ANCHOR WAS SNUG UP TO ANNULUS, HOWEVER THE LATERAL ANCHOR WAS VERY DEEP. AT FULL VENTRICULAR EXPANSION, NO MANEUVERS WERE TRANSLATING AND WENT THROUGH ABOUT 30 MINUTES OF TROUBLESHOOTING. SECONDARY WAS ADDED INCREMENTALLY, AND THE HANDLE WAS COUNTER CLOCK TO GAIN HEIGHT, HOWEVER THIS DID NOT TRANSLATE. IT IS SUSPE

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 23511210 ↗
• InjurySep 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE UPON DEPLOYMENT, PATIENT WENT INTO COMPLETE HEART BLOCK. THE PATIENT WAS PACED OFF WIRE AND A TEMP PACER WAS PLACED THROUGH THE VALVE. EP WAS CONSULTED AND THEY PLACED A TEMP PACER LEAD FROM THE IJ. THE PATIENT IS CURRENTLY PACER DEPENDENT AND IN STABLE CONDITION. THE CONDUCTION DISTURBANCE WAS NOTICED RIGHT AT DEPLOYMENT. THE FINAL VALVE DEPLOYMENT POSITION WAS GOOD. PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS THE VALVE INTERACTING WITH THE CONDUCTION SYSTEM.

  Patient problems: Heart Block

  MAUDE report 23069127 ↗
• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE PHYSICIAN STATED THAT EVENING AFTER IMPLANT THE PATIENT WAS SEVERELY BRADYCARDIC FOR UNCLEAR REASONS. THE PHYSICIAN ENDED UP PUTTING A TEMP WIRE IN, BUT THE NEXT DAY THE PPM (PATIENT HAD PPM AT TIME OF IMPLANT) WAS WORKING NORMALLY WHEN INTERROGATED. THE PATIENT IS NOW IN STABLE CONDITION. THE FINAL VALVE DEPLOYMENT POSITION WAS GOOD.

  Patient problems: Bradycardia

  MAUDE report 22890552 ↗
• InjuryAug 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE ON FOLLOW UP, IT WAS NOTED THE PATIENT HAD A MODERATE CENTRAL LEAK AND A GRADIENT OF 4. THE LEAK WAS NOT OBSERVED INTRAPROCEDURAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SYMPTOMATIC AND ADMITTED WITH HEART FAILURE LIKE SYMPTOMS. THE PATIENT IS STABLE BUT WAS IN THE HOSPITAL. LEAK WAS NOT TREATED. PATIENT RECEIVED DIURESIS. IT WAS BELIEVED THE LEAK IN TOTAL, CONTRIBUTED TO HEART FAILURE HOSPITALIZATION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22820437 ↗
• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DURING WIRE PLACEMENT, THE PATIENT WENT INTO COMPLETE HEART BLOCK FOR A FEW SECONDS BUT RECOVERED. HOWEVER, AT RELEASE, PATIENT AGAIN WENT INTO COMPLETE HEART BLOCK. THE WIRE WAS USED TO TEMPORARILY PACE AND CPR WAS GIVEN. PHYSICIAN WAS CALLED AND LEADLESS PACEMAKER WAS PLACED. FINAL DEPLOYMENT WAS AT ANNULAR LEVEL. THE VALVE WAS NOT DEPLOYED TOO VENTRICULAR.

  Patient problems: Heart Block

  MAUDE report 22610912 ↗
• 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. UPON DEPLOYMENT/FULL RELEASE OF THE EVOQUE VALVE, PATIENT WENT INTO COMPLETE HEART BLOCK WITH AN UNDERLYING JUNCTIONAL RHYTHM ABOUT 40BPM WHICH CONVERTED TO 2:1 2ND DEGREE AV BLOCK AFTER ABOUT A MINUTE. THE FINAL VALVE DEPLOYMENT POSITION WAS STABLE AT ANNULAR LEVEL. DUE TO THE STABLE RHYTHM, IT WAS DECIDED TO REMOVE THE EVOQUE DELIVERY SYSTEM AND WIRE AND PLACE A TEMPORARY PACING WIRE THROUGH THE FEMORAL VEIN ACCESS SITE. EP WAS CONSULTED. ONCE EP ARRIVED, PATIENT HAD CONVERTED TO A SINUS TACHYCARDIA ABOUT 115BPM. IT WAS DECIDED TO PLACE A TEMP-PERM PACEMAKER VIA RIGHT INTERNAL JUGULAR ACCESS IN CASE HIGH GRADE AV BLOCK RETURNS. THE PATIENT DID END UP NEEDING THE PERMANENT PACEMAKER (PPM). THE TEMP-PERM WAS REMOVED, AND A LEADLESS PPM WAS SUCCESSFULLY PLACED. THE PATIENT IS DOING WELL.

  Patient problems: Heart Block

  MAUDE report 22472378 ↗
• InjuryJul 2, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM, DURING WHICH HEAVY ANNULAR CALCIUM INTERFERED WITH ANCHOR POSITIONING. UPON FINAL RELEASE, THE VALVE SHIFTED VENTRICULAR. THE EVOQUE VALVE WAS STABILIZED USING A SNARE INSERTED VIA THE FEMORAL APPROACH. DUE TO MODERATE PARAVALVULAR LEAK (PVL), A 29MM SAPIEN VALVE WAS IMPLANTED WITHIN THE EVOQUE VALVE, ALIGNING ITS SEALING SKIRT WITH THE EVOQUE LOCKING TABS TO MINIMIZE PVL. FINAL RESULT WAS TRACE TRICUSPID REGURGITATION. THE PATIENT HAD SEVERE TRICUSPID STENOSIS WITH LEAFLET CALCIFICATION, AND PRE-DILATION WITH A 28MM BALLOON WAS PERFORMED TO IMPROVE ORIFICE SIZE. DESPITE INITIAL CHALLENGES WITH CALCIUM INTERACTION, THE PROCEDURE CONCLUDED WITH SATISFACTORY HEMODYNAMIC OUTCOME. IT IS SUSPECTED THAT HEAVY ANNULAR CALCIUM CONTRIBUTED TO SUBOPTIMAL ANCHOR ENGAGEMENT AND VALVE SHIFT DURING DEPLOYMENT.

  Patient problems: Insufficient Information

  MAUDE report 22388902 ↗
• InjuryJun 26, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE UPON FINAL RELEASE, VALVE APPEARED UNSTABLE THEN MIGRATED VENTRICULAR. TO STABILIZE, 2 SNARES WERE PLACED (ONE FROM GROIN, ONE FROM IJ) TO HOLD THE EVOQUE IN PLACE, WHILE SAPIEN 29 MM WAS PREPPED. SAPIEN WAS DEPLOYED AND EVOQUE VALVE WAS STABILIZED. THERE WAS MILD-MOD LEAK AFTER THAT WAS CONFIRMED WITH TEE BUT THE PHYSICIAN DID NOT FEEL LIKE POST DILATING WOULD BE BENEFICIAL AT THIS TIME SO THE PHYSICIAN WANTS TO LET IT ENDOTHELIALIZE AND THEN RE-EVALUATE. THERE WAS MILD PVL BETWEEN EVOQUE AND SAPIEN. PATIENT WAS STABLE IMMEDIATELY POST PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE PREVIOUS ANNULOPLASTY BAND HAD MINOR DEHISCENCE WHICH MAY HAVE IMPACTED SHADOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340726 ↗
• InjuryJun 9, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE UPON RELEASE THE VALVE IMMEDIATELY DROPPED INTO THE RV ON ALL SIDES >10MM WITH ANTERIOR THE DEEPEST. VALVE WAS STABLE WITH SEVERE PVL CUMULATIVELY ON ALL SIDES. POST DEPLOYMENT A DECISION WAS MADE TO PROCEED WITH VALVE IN VALVE WITH A 29MM S3UR DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22169754 ↗
• InjuryJun 6, 2025Migration; Migration

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE UPON RELEASE THE VALVED CANTED, HOWEVER PER DEVICE PROCTOR AND ECHO PROCTOR THERE WAS NO MALPOSITION. THE ECHO ON POD 1 SHOWS DEVICE IN THE SAME POSITION WITH NO MIGRATION AND MILD PVL. THE VALVE APPEARED STABLE STILL ON POD 2. THERE WAS NO MIGRATION NOTED PER PHYSICIANS, BUT STILL MILD TR. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH MILD CENTRAL AND PVL, AND TR. AN INTERNAL IMAGING REVIEW CONFIRMED THAT THE EVOQUE VALVE EMBOLIZED INTO THE RIGHT VENTRICLE, ACUTELY AFTER DEVICE DEPLOYMENT. THE ANTERIOR, SEPTAL, AND LATERAL SIDES OF THE EVOQUE VALVE ARE IN THE RIGHT VENTRICLE, RESULTING IN MOST OF THE ANCHORS LOSING CONTACT WITH THE ANNULUS. THE EVOQUE VALVE APPEARS MINORLY UNSTABLE. THE FINAL TRANSVALVULAR TR IS MILD AND THE FINAL PVL IS QUALITATIVELY MILD TO MODERATE.

  Patient problems: Foreign Body Embolism

  MAUDE report 22160329 ↗
• InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE ON POD 10 THE PATIENT EXPERIENCED INTERMITTENT 3RD DEGREE AV BLOCK AND PRESENTED TO THE ER FOR THE IMPLANTING OF LEADLESS PACEMAKER AND WAS STILL ADMITTED ON POD 15 WHEN IT WAS REPORTED.

  Patient problems: Heart Block

  MAUDE report 22066704 ↗
• InjuryMay 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE PROCEDURE IN TRICUSPID POSITION WHERE AFTER SUCCESSFUL DEVICE DEPLOYMENT THE PATIENT WAS PACING AT A RATE OF 48BPM AND DURING THE CASE WAS IN ATRIAL FIBRILLATION. THE RA LEAD DID APPEAR FLUOROSCOPICALLY TO BE IN CONTACT WITH SOME OF THE LOCKING TABS IN THE RA. THE LEAD SEEMED TO TOUCH THE EVOQUE PERIODICALLY DURING CARDIAC CYCLE. THE PHYSICIAN WAS PLANNING TO INTERROGATE THE RA LEAD AND CHECK THE THRESHOLDS AND EVALUATE THE NEED FOR A RV TEMPORARY BALLOON TIPPED PACING LEAD OR POTENTIALLY A CS LEAD IF NEEDED. THE DECISION WAS LATER MADE THAT A MICRA WOULD BE IMPLANTED IN A FEW WEEKS DUE TO THE INTERACTION OF THE EVOQUE WITH THE RA LEAD.

  Patient problems: Bradycardia

  MAUDE report 22037955 ↗
• InjuryApr 3, 2025Particulates; Patient Device Interaction Problem; Particulates; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION A FEW DAYS AFTER THE PROCEDURE, THE ECHO NOTED THERE WAS WHAT INITIALLY WAS THOUGHT TO BE THROMBUS IN OR AT THE VALVE ON THE RA-SIDE WHICH WAS NOT PRESENT PRIOR. THE VALVE STILL APPEARED TO BE WORKING FLAWLESSLY, AND THE PATIENT WAS STABLE. THE PHYSICIAN LATER DECIDED TO PERFORM AN ANGIOVAC TO REMOVE THE SUSPECTED THROMBUS. HE STATED THAT MULTIPLE PASSES WERE MADE WITH THE ANGIOVAC EVEN AT THE HIGHEST SUCTION (40ML) AND THE SUSPECTED THROMBUS WOULD NOT DISPLACE FROM WHAT HE BELIEVES IS THE VALVE BODY. SINCE THE THROMBUS HAD VIGOROUSLY BEEN EVACUATED AT THE ANGIOVAC TIP BUT REMAINED UNCHANGED, IT WAS DECIDED THIS WAS NOT A THROMBUS. THE NEXT DAY, THE PHYSICIAN CAPTURED THE ATTACHED VIDEO WITH AN ICE PROBE IN THE RA. FROM THIS IMAGING, THE PHYSICIAN CONCLUDED THE ISSUE TO BE A POSSIBLE THREAD FROM THE EVOQUE VALVE. USING ICE IMAGING IN THE SAME SETTING, HE ATTEMPTED TO BURN THIS OBJECT LOOSE FROM THE VALVE FRAME. HE WAS ABLE TO POSITION THE PROBE AT OR ON THE SUSPECT OBJECT, YET WAS UNSUCCESSFUL IN ABLATING THE OBJECT'S ATTACHMENT. HE SAYS THE PATIENT IS AND HAS REMAINED STABLE THROUGHOUT, WHILE THE VALVE BY TEE & TTE L

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 21762448 ↗
• InjuryApr 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT PASSED AWAY.

  Patient problems: Arrhythmia

  MAUDE report 21752736 ↗

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