EVOQUE 9850TDSUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00690103217520), received between Apr 22, 2024 and May 11, 2026 — classified as 14 deaths, 34 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (28 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 52 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 24, 2026Device-Device Incompatibility

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. RV LEAD DISLODGEMENT WAS NOTED 1 HOUR POST DEPLOYMENT OF THE VALVE. THERE WAS NO PATIENT INJURY RELATED TO AN EW DEVICE DURING THE PROCEDURE. THE LEAD DISLODGED WAS NOTED BY THE FAILURE TO CAPTURE OBSERVED ON THE TELEMETRY MONITOR POST OP. A SCREW WAS PLACED IN THE LEAD AND THEN ULTIMATELY A PERMANENT PACEMAKER WAS PLACED. THE PATIENT IS DOING WELL. THE PATIENT WAS NOT RV LEAD DEPENDENT. SCREENING SHOWED MINIMAL SLACK, AND ALTHOUGH THE PATIENT'S WEIGHT DECREASED SLIGHTLY, ONLY A SMALL INCREASE IN SLACK WAS NOTED, STILL CONSISTENT WITH MINIMAL SLACK OVERALL. DURING ANCHOR RELEASE, THE LEAD WAS DISPLACED LATERALLY. WIRE CHECK CONFIRMED A LATERAL TRAJECTORY RELATIVE TO THE LEAD. WHEN THE DELIVERY SYSTEM (DS) CROSSED, IT CAME IN SEPTAL TO THE LEAD. IN THE BEGINNING, ECHO NOTED THAT THIS POSITIONING DID NOT PLACE SIGNIFICANT PRESSURE ON THE PACEMAKER LEAD. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT WOULD BE THE VALVE PUSHING THE PACER TOO LATERAL.

  Patient problems: Arrhythmia

  MAUDE report 24434958 ↗
• DeathFeb 19, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) CASE USING THE EVOQUE SYSTEM IN WHICH THE PATIENT EXPERIENCED AN APICAL RIGHT VENTRICULAR (RV) PERFORATION AT AN UNDETERMINED POINT DURING THE PROCEDURE. CHALLENGING RV ANATOMY, INCLUDING SIGNIFICANT TRABECULATION AND A SMALL CAVITY, LIMITED INITIAL GUIDEWIRE MOBILITY. THE GUIDEWIRE AND NOSECONE BECAME TRAPPED IN AN ANTERIOR TRABECULAR POCKET. THE WIRE WAS RETRACTED INTO THE DELIVERY SYSTEM (DS), AND THE SYSTEM WAS THEN RETRACTED TO FREE THE NOSECONE FROM THE TRABECULATIONS. ADVANCEMENT PAST THE ANNULUS AND PARTIAL CAPSULE RETRACTION ALLOWED THE NOSECONE TO BE FREED. THE SYSTEM WAS THEN CENTERED AT ADEQUATE HEIGHT AND NO ABNORMAL TRAJECTORY. THE PROCEDURE PROCEEDED WITHOUT HEMODYNAMIC INSTABILITY, AND THE VALVE WAS SUCCESSFULLY DEPLOYED IN THE INTENDED POSITION. DURING DS RETRIEVAL, A SUDDEN DROP IN BLOOD PRESSURE OCCURRED. ECHOCARDIOGRAPHY REVEALED A NEW EFFUSION OF LESS THAN 20 MM AROUND THE RV. PERICARDIOCENTESIS EVACUATED 300 CC, FOLLOWED BY HEPARIN REVERSAL WITH PROTAMINE AND ONE UNIT OF BLOOD; HEMODYNAMICS STABILIZED. APPROXIMATELY 40 MINUTES, DURING WHICH THE RV EFFUSION REMAINED STABLE WITHO

  Patient problems: Cardiac Perforation

  MAUDE report 24389025 ↗
• InjuryFeb 3, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PATIENT EXPERIENCED HEART BLOCK WHEN PLACING THE GUIDEWIRE. THE PATIENT WAS PACED OFF THE WIRE FOR THE DURATION OF PROCEDURE. THE VALVE WAS DEPLOYED IN A FAVORABLE POSITION. FOLLOWING DEPLOYMENT, THE WIRE REMAINED ACROSS THE VALVE, AND EP WAS CALLED. THEY SUBSEQUENTLY IMPLANTED A PERMANENT PACEMAKER SUCCESSFULLY. MULTIPLANAR RECONSTRUCTION (MPR) ECHOCARDIOGRAPHIC GUIDANCE WAS UTILIZED. PATIENT WAS STABLE AFTER PROCEDURE WITH NO OTHER ISSUES NOTED.

  Patient problems: Heart Block

  MAUDE report 24246365 ↗
• InjuryFeb 2, 2026Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE CASE WAS ABORTED AND THE LEFT ILIAC VEIN REQUIRED COVERED STENT PLACEMENT AFTER VESSEL PERFORATION OCCURRED WHILE ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM THROUGH A TORTUOUS VESSEL. THE REPORTED ROOT CAUSE OF THE EVENT WAS THE PATIENT'S VESSEL TORTUOSITY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 24235377 ↗
• InjuryJan 29, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. DURING DELIVERY SYSTEM ADVANCEMENT, GUIDEWIRE PRESSURE INCREASED AS THE SYSTEM ENTERED THE RA, AND THE WIRE FORMED AN ABNORMAL PEAKED CONFIGURATION NEAR THE SVC. ALTHOUGH ADVISED TO RETRACT THE WIRE, RETRACTION WAS MINIMAL AND ADVANCEMENT CONTINUED. THE PATIENT THEN EXPERIENCED AN ACUTE DROP IN BLOOD PRESSURE, AND IMAGING SHOWED WIRE CURL DISPLACEMENT WITH A RAPIDLY ENLARGING PERICARDIAL EFFUSION. A PERICARDIAL DRAIN WAS PLACED FOR IMPENDING TAMPONADE. FOLLOWING LOSS OF PULSATILITY, CT SURGERY PERFORMED A STERNOTOMY AND FOUND THE WIRE EXTRACARDIALLY WITHIN THE PERICARDIAL SPACE. THE WIRE AND FLEX SYSTEM WERE REMOVED, THE DELIVERY SYSTEM REPOSITIONED, AND A PERICARDIECTOMY ALLOWED REPAIR OF A CARDIAC LACERATION. CHAMBER FILLING NORMALIZED AFTER REPAIR, AND THE EVENT WAS ATTRIBUTED TO INSUFFICIENT RELIEF OF GUIDEWIRE PRESSURE DURING ANNULUS CROSSING. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 24215374 ↗
• InjuryJan 19, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE WIRE WAS BRIEFLY UTILIZED FOR A HEIGHT GAIN ATTEMPT AND THEN RETRACTED. IT WAS NOTED TO BE CLEAR ON WIRE CHECK AND NO WIRE DEFORMATION OR KINKING. NO SIGNIFICANT WIRE PRESSURE WAS NOTED PRIOR TO WIRE PUSH OR AFTER. DEPLOYMENT PROCEEDED WITHOUT INCIDENT UNTIL FULL VENTRICULAR EXPANSION, AT WHICH POINT HYPOTENSION WAS OBSERVED. ECHOCARDIOGRAPHY IDENTIFIED A PERICARDIAL EFFUSION. THE VALVE WAS DEPLOYED UNDER ECHOCARDIOGRAPHIC GUIDANCE. CHEST COMPRESSIONS PERFORMED DURING ATRIAL EXPANSION. VALVE RELEASED QUICKLY AS IT APPEARED TO HAVE SOME BUILT UP TENSION AND DURING RELEASE THE DELIVERY SYSTEM (DS) MAY HAVE POTENTIALLY SHIFTED VERY MINORLY AND ADDED SOME PRESSURE ONTO THE WIRE. THE SHIFT WAS NOT ENOUGH TO BE NOTICED BY ECHO AND DIFFICULT TO CONFIRM. THE VALVE WAS IMPLANTED SUCCESSFULLY AND WORKING APPROPRIATELY WITH NO LEAK OBSERVED. PERICARDIOCENTESIS WAS PERFORMED, AND MORE THAN 2 LITERS OF BLOOD WERE REMOVED WITH NO RESOLUTION TO THE EFFUSION. THE PROCEDURE WAS CONVERTED TO A MINI STERNOTOMY AND PERICARDIAL WINDOW. THE SURGEON REPAIRED A SMALL LACERATION OF

  Patient problems: Cardiac Perforation

  MAUDE report 24109178 ↗
• InjuryJan 12, 2026Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE PROCEDURE WAS INITIATED VIA THE RIGHT FEMORAL APPROACH, AS THE LEFT FEMORAL ACCESS WAS UNAVAILABLE DUE TO PRIOR VASCULAR COMPLICATIONS. A DEEP CAPSULE GAP WAS NOTED, PROMPTING SETUP FOR A FLIP MANEUVER. WIRE PRESSURE AND POSITION WAS SUFFICIENT AND UNCHANGED THROUGHOUT THE PROCEDURE. AS THE ANCHORS BEGAN TO EMERGE, THE FLIP WAS GRADUALLY CORRECTED BY ADVANCING AND ADDING THE PRIMARY BACK. AT THE FLIP, ADJUSTMENTS WERE MADE TO ENSURE THE DELIVERY SYSTEM (DS) WAS CENTRAL AND COAXIAL, WITH THE WIRE REMAINING UNTOUCHED TO MAINTAIN APPROPRIATE HEIGHT. IMAGING PROVED CHALLENGING, AND LEFT MPR TO RESET. UPON RETURNING TO 2D IMAGING, AN EFFUSION WAS IDENTIFIED. THE TEAM PROCEEDED WITH OPEN-HEART SURGERY TO ADDRESS A SUSPECTED RIGHT VENTRICULAR (RV) PERFORATION AND SURGICALLY REPAIR THE TRICUSPID VALVE. BOTH INTERVENTIONS WERE COMPLETED SUCCESSFULLY. A SURGICAL VALVE WAS PLACED AND THE SURGEON NOTED THE PERFORATION AT THE RV APEX. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 24046213 ↗
• InjuryDec 23, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE DELIVERY SYSTEM WAS OVER THE SAFARI WIRE WHEN A TORN PAPILLARY MUSCLE/ FLAIL LEAFLET WAS NOTED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, WITH NO PATIENT INJURY NOTED AND NO ADDITIONAL ACTIONS TAKEN.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 23879805 ↗
• DeathDec 22, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. INITIAL GUIDEWIRE PLACEMENT WAS AT THE RIGHT VENTRICULAR (RV) APEX. THE FLEX SECTIONS OF THE SYSTEM WERE POSITIONED IN THE MID-RIGHT ATRIUM (RA), WITH THE DELIVERY SYSTEM (DS) ADVANCED ACROSS THE TRICUSPID VALVE. ONE UNIT OF DEPTH WAS ADDED FROM THE CAPSULE GAP TO THE ATRIAL FLIP. AT THE TIME OF INJURY, THE VALVE WAS FULLY EXPANDED ON THE VENTRICULAR SIDE, AND THE DS WAS BEING TILTED ANTERIORLY BY ADVANCING IT FORWARD. THERE WAS NO INTENTIONAL FORWARD PRESSURE APPLIED TO THE GUIDEWIRE TO GAIN HEIGHT, NOR WERE THERE NAVIGATIONAL MANEUVERS INVOLVING EXCESSIVE GUIDEWIRE FORCE. VENTRICULAR EXPANSION OF THE VALVE PROCEEDED WITHOUT ANY ISSUES OR CONCERNS. IT WAS NOTED THAT THE POSTERIOR ANCHOR SAT LOWER THAN THE ANTERIOR ANCHOR, PROMPTING THE INTERVENTIONAL CARDIOLOGIST (IC) TO ADVANCE THE DS BY TWO CLICKS ON THE STABILIZER. IMMEDIATELY FOLLOWING THIS ADJUSTMENT, THE ANESTHESIOLOGIST REPORTED A DROP IN BLOOD PRESSURE. AN EFFUSION SWEEP WAS PERFORMED, REVEALING A RIGHT ATRIAL/RIGHT VENTRICULAR (RA/RV) PERICARDIAL EFFUSION WITH COMPLETE CAVITY COLLAPSE CONSISTENT WITH

  Patient problems: Cardiac Perforation

  MAUDE report 23866165 ↗
• MalfunctionDec 16, 2025Activation, Positioning or Separation Problem

  OPERATOR PULLED NOSE CONE INTO DELIVERY SYSTEM/ NO PT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815608 ↗
• InjuryNov 19, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. THE ILIAC VEIN WAS PERFORATED UPON DELIVERY SYSTEM (DS) INSERTION. A STENT WAS PLACED IN THE VEIN. THE PROCEDURE WAS ABORTED DUE TO ACCESS DIFFICULTIES. HOWEVER, THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 23596399 ↗
• InjuryOct 30, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM. UPON SWITCHING TO IJ ACCESS, A SHEATH WAS USED WITHOUT ECHO IMAGING GUIDANCE TO PLACE THE WIRE. ONCE IMAGING BECAME AVAILABLE, IT WAS OBSERVED THAT THE WIRE WAS WRAPPED AROUND THE ICD LEAD. AN ATTEMPT WAS MADE TO CORRECT THE ISSUE USING THE DELIVERY SYSTEM (DS). THE DS WAS MOVED MORE ATRIAL AND RELAXED PRIMARY AND WIRE WAS PULLED BACK AND IMMEDIATELY PUSHED BACK OUT. AS THE DS WAS ADVANCED DEEPER INTO THE RA, THE ICD LEAD MOVED ALONG WITH IT, INDICATING CONTINUED ENTANGLEMENT. THE WIRE WAS PULLED BACK TOO FAR, FULLY INTO THE DS, AND THEN THE WIRE WAS RAPIDLY RE-ADVANCED. ABOUT A MINUTE LATER, THE BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND THEN THE DECISION WAS MADE TO CONVERT TO OPEN-HEART SURGERY TO REPAIR THE SUSPECTED LACERATION FROM THE WIRE. THE SURGEON NOTED THE LACERATION WAS LOCATED IN THE RIGHT ATRIUM (RA) BUT DID NOT PROVIDE DETAILS REGARDING ITS SIZE. THE INJURY IS SUSPECTED TO BE NEAR THE INFERIOR VENA CAVA (IVC)- RA JUNCTION, THOUGH THIS HAS NOT BEEN CONFIRMED. THE PATIENT WAS PLACED ON RIGHT

  Patient problems: Cardiac Perforation

  MAUDE report 23426909 ↗
• DeathOct 29, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE A RIGHT VENTRICLE (RV) PERFORATION OCCURRED. THE DELIVERY SYSTEM REMAINED IN THE PATIENT WHEN CHEST COMPRESSIONS WERE STARTED. THE PATIENT WAS CONVERTED TO UNPLANNED CARDIAC SURGERY TO REPAIR RV. THE PATIENT PASSED ON THE TABLE. SMALL AMOUNTS OF TRABECULATION NOTED ON THE PATIENT. TRACE EFFUSION NOTED TO BE THE SAME AS IT WAS OBSERVED IN SCREENING AND THE PATIENT WAS ALSO NOTED TO HAVE PULMONARY HYPERTENSION. THE IMAGING QUALITY WAS GOOD WITH THE IMAGES BEING CLEAR AND THE TEAM HAVING BILATERAL ACCESS. DURING WIRE PLACEMENT, WIRE KEPT POPPING OUT ANTERIORLY. HOWEVER, IT WAS EASY TO ADJUST SO PROCEDURE WAS CONTINUED. WIRE CHECK CONFIRMED THERE WAS NO OTHER LOCATION FOR THE WIRE. NO ISSUES INSERTING DELIVERY SYSTEM (DS) THROUGH LEFT SIDE, HOWEVER, THE DS WAS STUCK AT CROSSING WITH MAX PRIMARY ON. PRIMARY WAS REDUCED AND THE WIRE POPPED OUT AGAIN AFTER DS CROSSED THE ANNULUS. AFTER THE WIRE WAS RESET AND NOTED TO BE GOOD. THE PATIENT WAS HYPOTENSIVE WHEN PLACING THE WIRE AND ANESTHESIA WAS HAVING DIFFICULTY MAINTAINING BLOOD PRESSURE. THE TEAM CHECKED IF AN E

  Patient problems: Cardiac Perforation

  MAUDE report 23420276 ↗
• InjuryOct 24, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE PHYSICIAN OPTED FOR LEFT JUGULAR APPROACH DUE TO THE PATIENT HAVING A HEAVILY TRABECULATED RIGHT VENTRICLE (RV), SMALL RA, AND PROMINENT ERIDGE. THE WIRE PATH WAS ESTABLISHED PER RECOMMENDATION (NO PIGTAIL) CURL OF WIRE ESTABLISHED IN RA AND PUSHED INTO RV FREELY. WHILE POSITIONING THE WIRE POSTERIORLY (AS IS TYPICAL FOR JUGULAR ACCESS), IT INITIALLY RESTED ATOP THE RV TRABECULATIONS CAUSING THE WIRE CURL TO PARTIALLY ENTER THE TV ANNULUS, TOO CLOSE TO THE ATRIUM. THE WIRE WAS ADVANCED AND SAT FURTHER INTO RV TOWARDS THE RV FREE WALL/ANTERIOR (RIGHT WHERE THE TRABECULATIONS BECAME LESS PROMINENT). THE DELIVERY SYSTEM (DS) WAS INSERTED AND ADVANCED/CROSSED INTO RV PER TYPICAL PROCEDURE, BUT PRESSURES DROPPED IMMEDIATELY AFTER CROSSING AND A SIGNIFICANT EFFUSION WAS NOTED. UNABLE TO IDENTIFY AREA OF LACERATION ON ECHO DUE TO SIGNIFICANT RV COLLAPSE (CARDIAC TAMPONADE). THE DELIVERY SYSTEM WAS LEFT IN WHILE EFFORTS TO DRAIN EFFUSION STARTED VIA PERICARDIOCENTESIS AND COMPRESSIONS WERE STARTED AT THE SAME TIME AS IT WAS NOTED ON ECHO THERE WAS LITTLE TO NO

  Patient problems: Cardiac Perforation

  MAUDE report 23384434 ↗
• InjuryOct 24, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE WIRE WAS SUCCESSFULLY PLACED AT THE APEX AND THE LEFT GROIN WAS DILATED TO 33FR WITH MINIMAL RESISTANCE. THE EVOQUE DELIVERY SYSTEM (DS) WAS INSERTED INTO THE GROIN, BUT UPON REACHING THE LEFT COMMON ILIAC, THE IC MOVED THE TABLE TO VISUALIZE THE DELIVERY SYSTEM ON FLUOROSCOPY AND COMMENTED THAT THE WIRE WAS NOT BEING ADEQUATELY PINNED WHICH ALLOWED FOR THE DS TO PUSH WIRE SLACK FORWARD DURING INSERTION. HE STATED THE WIRE HAD TOO MUCH SLACK, WHICH WAS PREVENTING THE DELIVERY SYSTEM FROM PROPERLY TRACKING ACROSS THE WIRE. FLOURO WAS ADJUSTED AND WIRE SLACK WAS VISIBLE. THE IC INSTRUCTED THE FELLOW HOW HE WANTED HIM TO MANAGE THE WIRE ENABLING THE DELIVERY SYSTEM TO SUCCESSFULLY TRACK TO THE IVC. THE DELIVERY SYSTEM WAS FLEXED ACROSS THE TRICUSPID VALVE AND CENTRALIZED. SHORTLY AFTER CROSSING THE TRICUSPID VALVE, THE ANESTHESIOLOGIST COMMENTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED BUT WAS STABLE SINCE HE WAS TREATING IT. THE IC OBSERVED THAT THE ILIAC POTENTIALLY COULD HAVE PERFORATED WHEN THE FELLOW DID NOT MANAGE THE WIRE PROPERLY, BUT THE DELIVER

  Patient problems: Perforation of Vessels

  MAUDE report 23381223 ↗
• InjuryOct 22, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM WHERE THE GUIDEWIRE WAS SITTING AT THE APEX OF THE RIGHT VENTRICLE (RV) WHEN THE PERFORATION OCCURRED. THE PERFORATION/PERICARDIAL EFFUSION WAS CAUSED BY THE WIRE. THE INITIAL GUIDEWIRE PLACEMENT WAS EASY, UNEVENTFUL AND ON POSTERIOR SEPTAL. FREE WIRE AT WIRE CHECK AND WIRE POSITION WAS APPROPRIATE. NO SIGNIFICANT WIRE PRESSURE OBSERVED DURING CROSSING, CROSSING WAS SLOW AND CONTROLLED DUE TO PROXIMITY OF PACING LEAD. THE DELIVERY SYSTEM (DS) CROSSING WAS SLOW AND CONTROLLED AND MANAGED WIRE WHILE CROSSING. THE WIRE ADVANCED MORE APICALLY AFTER CROSSING THE VALVE WITH MORE OF THE STIFF SECTION EXPOSED FROM THE DS AND THERE WAS POSSIBLE TENSION AT THE IVC LEVEL. THE WIRE WAS RETRACTED, AND ANESTHESIA NOTED A DROP IN THE PATIENT'S BLOOD PRESSURE. ECHO WAS DONE AND THERE WAS A LARGE PERICARDIAL EFFUSION OBSERVED. THE DS WAS ACROSS THE VALVE WHEN THE PERFORATION OCCURRED. THERE WAS NO OTHER INDICATION ON FLUORO OTHER THAN WIRE CURL APPEARING DEEPER AND DEFORMATION OF THE CURL. THERE WAS NO INTENTIONAL PUSH ON THE GUIDEWIRE TO OBTAIN HEIGHT AND/OR NAVIGATIONAL MANEUV

  Patient problems: Cardiac Perforation

  MAUDE report 23359617 ↗
• DeathSep 12, 2025Malposition of Device; Malposition of Device

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE USING THE EVOQUE SYSTEM WHERE INITIAL GUIDEWIRE PLACEMENT WAS CHALLENGING DUE TO TRAJECTORY ISSUES NEAR THE RVOT. THE TEAM RECROSSED AND USED A PIGTAIL FOR THE SECOND ATTEMPT; THE WIRE CURL RETRACTED TO MID-VENTRICLE, INDICATING IT WAS FREE OF ANATOMY. AT TIME-OUT, THE PHYSICIAN HAD AN ANTERIOR TRAJECTORY THAT COULD NOT BE CORRECTED DUE TO SIGNIFICANT SECONDARY FLEX, AND THE TEAM AGREED TO PROCEED. ANCHOR DEPLOYMENT SHOWED AN EXCELLENT SEPTAL-LATERAL (S/L) WINDOW, BUT THE POSTERIOR-ANTERIOR (A/P) VIEW WORSENED AS THE OUTER CAPSULE RETRACTED. AT 90 DEGREES, ALL LEAFLETS WERE CONFIRMED OVER THE ANCHORS. S/L WAS COAXIAL AND CENTRAL, WHILE A/P HAD A POSTERIOR POSITION WITH ANTERIOR TRAJECTORY. ATTEMPTS TO CORRECT WITH SYSTEM ADVANCEMENT AND WIRE PUSH HAD LIMITED EFFECT. AFTER A HALF-ATRIAL FLIP, LEAFLETS REMAINED INSIDE ANCHORS, BUT S/L SHIFTED LATERALLY. SECONDARY FLEX WAS REDUCED TO REGAIN A/P CONTROL, BUT POSTERIOR ANCHORS DID NOT MOVE ATRIALLY, AND LATERAL ANCHORS DROPPED. ADDITIONAL WIRE PRESSURE IMPROVED ANCHOR HEIGHT, THOUGH NO EXCESSIVE PRESSURE WAS SEEN ON FLUOROSCOPY. THE WIRE CURL A

  Patient problems: Cardiac Perforation

  MAUDE report 23044289 ↗
• InjuryAug 5, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR) PROCEDURE INVOLVING THE EVOQUE SYSTEM IN WHICH DURING THE INTRODUCTION AND ADVANCEMENT OF THE EVOQUE DELIVERY SYSTEM (DS) RESISTANCE WAS NOTED. THE DS WAS LEFT IN PLACE AND WHILE ANGIOGRAM WAS PERFORMED IT WAS REVEALED THAT THE LEFT ILIAC VEIN HAD PERFORATED. ACCESS WAS OBTAINED USING A 12 FR SHORT SHEATH. A PIGTAIL CATHETER WAS THEN PLACED INTO THE RIGHT ATRIUM (RA), FOLLOWED BY ADVANCEMENT OF THE XS SAFARI WIRE INTO THE RA. AT THAT POINT, THE PIGTAIL WAS REPOSITIONED. THE AGILIS SHEATH WAS ADVANCED OVER THE SAFARI WIRE INTO THE RA, FLEX WAS ADDED, AND THE SAFARI WAS FURTHER ADVANCED. THE WIRE WAS THEN REPOSITIONED POSTERIOR TO A PAPILLARY MUSCLE, AND THE AGILIS WAS SUBSEQUENTLY REMOVED. GROIN DILATION WAS PERFORMED USING ALL DILATORS, INCLUDING THE 33 FR, WITHOUT RESISTANCE OR INCIDENT. IT WAS THEN NOTED THAT THE WIRE HAD MIGRATED FROM THE APEX INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). A 26 FR X 35 MM GORE DRYSEAL SHEATH WAS INSERTED INTO THE GROIN, THE AGILIS WAS REINTRODUCED, AND THE WIRE WAS REPOSITIONED INTO THE RV APEX. WIRE POSITION WAS MAINTAINED, AFTER WHICH BOTH THE AGILIS AND THE

  Patient problems: Perforation of Vessels

  MAUDE report 22723226 ↗

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