THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM 29AP4045Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00690103210866), received between Apr 25, 2022 and Aug 5, 2026 — classified as 2 deaths, 30 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryAug 5, 2026Patient Device Interaction Problem

  As reported by the Field Clinical Specialist (FCS), approximately three months following implantation of a 29 mm Alterra Prestent and two months following implantation of a 29 mm SAPIEN 3 valve in the pulmonic position within a non-Edwards transannular patch, an incidental observation was made during an unrelated surgical procedure. While performing an aortic root replacement, the operator noted that the Alterra outflow apices appeared to be extending outside the anatomy. There was no effusion, and the operator stated that the finding had no clinical significance. The planned aortic root replacement procedure was completed, after which the surgeon patched the main pulmonary artery (MPA) in the area where the Alterra apices appeared exposed.The operator further reported that the patient experienced postoperative right ventricular (RV) failure requiring placement of a right ventricular assist device (RVAD). At a later date, life-sustaining support was withdrawn, and the patient expired. The cause of death was described as biventricular failure. The operator specifically stated that the Alterra Prestent and SAPIEN 3 valve were functioning well and that the patient failed to recover fo

  Patient problems: Insufficient Information

  MAUDE report 50141458 ↗
• MalfunctionApr 7, 2026Fracture

  AS REPORTED FROM A CLINICAL STUDY, APPROXIMATELY ONE (1) YEAR AND SEVEN (7) DAYS POST TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH AN ALTERRA PRESTENT AND 29 MM SAPIEN 3 VALVE, THERE WAS ONE (1) ALTERRA PRESTENT TYPE I FRACTURE. MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS, APPROXIMATELY ONE (1) YEAR AND SEVEN (7) DAYS POST TPVR PROCEDURE, AN ECHOCARDIOGRAM DEMONSTRATED NO PULMONARY VALVE STENOSIS AND TRIVIAL TO NO PULMONARY VALVE REGURGITATION. THE PATIENT ALSO UNDERWENT A CARDIAC CATHETERIZATION. ORTHOGONAL FLUOROSCOPIC BIPLANE VIEWS OF THE ALTERRA PRESTENT AND SAPIEN 3 VALVE DEMONSTRATED NO FRAME FRACTURE, NO DISTORTION, AND NO DISPLACEMENT WHEN COMPARED TO A PRIOR IMAGING STUDY. ROTATIONAL CINE IMAGING DEMONSTRATED STABLE POSITION OF BOTH DEVICES AND EVIDENCE OF ONE ALTERRA PRESTENT TYPE I FRACTURE WAS IDENTIFIED. THERE WAS NO EVIDENCE OF ALTERRA PRESTENT DEFORMATION, PARTIAL COLLAPSE, FRAGMENTATION, IN-FOLDING, OR MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809103 ↗
• MalfunctionMar 13, 2026Fracture

  AS REPORTED ALTERRA CLINICAL STUDY, DURING REVIEW OF THE 6-MONTH FLUOROSCOPY POST TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN AN ALTERRA PRESTENT, ONE TYPE 1 FRACTURE WAS FOUND AT THE ALTERRA PRESTENT OUTFLOW, RUNG 6. THIS FRACTURE IS NOT VISUALIZED AT THE PREVIOUS TIMEPOINT.

  Patient problems: Insufficient Information

  MAUDE report 24594232 ↗
• InjuryFeb 2, 2026Migration or Expulsion of Device

  AS REPORTED BY THE FIELD SPECIALIST, DURING A TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE USING AN ALTERRA AND A 29 MM SAPIEN 3 VALVE, THE ALTERRA PRESTENT "SLIPPED" TO THE RIGHT VENTRICLE (RV) DURING ADVANCEMENT OF THE NON-EDWARDS SHEATH. THE PATIENT HAD A LARGE RV PSEUDOANEURYSM, WHICH RESULTED IN A CHALLENGING CASE WITH TRACKING AND STABILITY. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REVEALED THAT THERE WERE CHALLENGES TRACKING THE ALTERRA THROUGH THE PATIENT'S ANATOMY. AN ATTEMPT WAS MADE TO DELIVER THE ALTERRA USING THE RIGHT PULMONARY ARTERY (RPA) BEFORE SWITCHING TO THE LEFT PULMONARY ARTERY (LPA). IT WAS INDICATED THAT THERE WAS INTERACTION BETWEEN THE ALTERRA PRESTENT AND NON-EDWARDS SHEATH THAT CAUSED OR CONTRIBUTED TO THE ALTERRA PRESTENT "SLIPPING". IT WAS NOTED THAT THERE WERE NOT ENOUGH ENGAGEMENT AND SUPPORT OF THE ALTERRA, AND THAT THE PROCEDURE SHOULD HAVE BEEN STAGED. THE PERCEIVED ROOT CAUSE OF THE ALTERRA PRESTENT "SLIPPING" WAS THE LARGE RV PSEUDOANEURYSM. THERE WAS NO TROUBLESHOOTING PERFORMED AS THE ALTERRA PRESTENT "SLIPPED" QUICKLY AND WAS LEFT PARTIALLY IN THE PSEUDOANEURYSM AND PARTLY IN THE MAIN PULMONARY ARTERY (MPA). THE

  Patient problems: Insufficient Information

  MAUDE report 24236998 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  AS REPORTED BY ALTERRA PAS CLINICAL STUDY, THE PATIENT PRESENTED FOR THE 1 YEAR FOLLOW UP POST TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN A 29MM ALTERRA PRESTENT, AND THERE WERE 2 TYPE 1 FRACTURES ALONG THE RIGHTWARD ASPECT OF THE INFLOW OF THE ALTERRA PRESTENT. THE PATIENT IS DOING WELL WITHOUT SYMPTOMS, AND THE VALVE IS FUNCTIONING WELL. PER MEDICAL RECORDS RECEIVED, AT THE 1 YEAR FOLLOW UP, THE PATIENT DENIED SYMPTOMS AND WAS OVERALL FEELING BETTER. A TTE WAS PERFORMED AS PART OF THE FOLLOW UP AND THERE WAS NO EVIDENCE OF STENOSIS OR REGURGITATION WITHIN THE SAPIEN VALVE AND NO EVIDENCE OF PARAVALVULAR LEAK. FLUOROSCOPIC EVALUATION OF THE STENT WAS PERFORMED. RESULTS NOTED THAT THERE ARE NO FRACTURES ALONG THE OUTFLOW OF THE ALTERRA, THE SAPIEN 3 VALVE IS STABLE WITH NO FRACTURE. THERE IS STABLE MOBILITY OF THE RIGHTWARD AND ANTERIOR ASPECT OF THE INFLOW, SIMILAR TO THE TIME OF IMPLANTATION. THERE ARE 2 TYPE 1 FRACTURES ALONG THE RIGHTWARD ASPECT OF THE INFLOW OF THE ALTERRA PRESTENT, WITHOUT DEFORMATION OF THE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439653 ↗
• InjuryAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) PROCEDURE INVOLVING A 29MM SAPIEN 3 VALVE, THE FIELD CLINICAL SPECIALIST (FCS) REPORTED THAT THE PATIENT, WHO PRESENTED WITH CONGENITAL PULMONARY STENOSIS AND A NATIVE MAIN PULMONARY ARTERY (MPA), UNDERWENT ALTERRA DEPLOYMENT WITH WIRE POSITIONING ACHIEVED VIA THE LEFT PULMONARY ARTERY (LPA). THE ALTERRA STENT WAS DEPLOYED WITH A SLIGHT ANGLE, THOUGH IT WAS NOT DEEMED PROBLEMATIC. THE PDS TRACKED SUCCESSFULLY, AND THE VALVE WAS DEPLOYED. HOWEVER, POST-DEPLOYMENT ANGIOGRAPHY REVEALED SIGNIFICANT TILTING OF THE DISTAL ANTERIOR AND LATERAL APICES AGAINST THE MPA. A PERICARDIAL EFFUSION BEGAN TO DEVELOP AND, ALTHOUGH INITIALLY DRAINED, IT RECURRED PERSISTENTLY. THE CARDIOVASCULAR OPERATING ROOM (CVOR) TEAM WAS CONSULTED, AND A MULTIDISCIPLINARY DECISION WAS MADE TO PROCEED WITH SURGICAL EXPLANTATION OF THE DEVICE. AT LAST REPORT, THE PATIENT WAS STABLE AND DOING WELL.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22907728 ↗
• MalfunctionJul 15, 2025Fracture; Fracture

  AS REPORTED FROM A CLINICAL STUDY AND THROUGH REVIEW OF THE MEDICAL RECORDS, APPROXIMATELY 1 YEAR POST TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH A 29 MM SAPIEN 3 VALVE INSIDE THE ALTERRA PRESTENT, A FLUOROSCOPY WAS PERFORMED REVEALING THERE WERE TWO (2) MINOR WIRE FRAME FRACTURES OF THE ALTERRA PRESTENT WITHOUT A LOSS OF STRUCTURAL INTEGRITY.

  Patient problems: Insufficient Information

  MAUDE report 22511036 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A STAGED ALTERRA CASE WAS PLANNED AND PERFORMED. THE PROCEDURE WAS SUCCESSFUL WITHOUT COMPLICATION AND YIELDED AN EXCELLENT PLACEMENT OF THE ALTERRA PRE-STENT ON THIS 20-YEAR-OLD FEMALE WITH AN ORIGINAL DIAGNOSIS OF PULMONARY STENOSIS, STATUS POST BALLOON VALVULOPLASTY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS RETURNED TO PACU. COMPLETION OF SAPIEN 3 VALVE PLACEMENT WAS SCHEDULED IN THREE MONTHS. THE PATIENT CAME IN FOR FOLLOW UP APPROXIMATELY ONE MONTH LATER AND HAD A LARGE PERICARDIAL EFFUSION. A CT WAS PERFORMED SHOWING THE STRUTS WERE EXTRAVASCULAR IN BOTH THE MAIN PULMONARY ARTERY AND RIGHT VENTRICULAR OUTFLOW TRACT. SHE WAS STABLE SO THE PHYSICIAN WAS THINKING OF WATCHING HER AND THEN DECIDING TO DRAIN. THE PHYSICIAN BROUGHT THE PATIENT TO THE CATH LAB THE NEXT DAY AND PERFORMED PERICARDIOCENTESIS, YIELDING 650CC OF SEROSANGUINEOUS FLUID. THE DRAIN WAS LEFT IN PLACE TO SEE IF THERE WOULD BE FURTHER ACCUMULATION, AND AS OF THE NEXT MORNING, THERE WAS AN ADDITIONAL 58CC OF DRAINAGE. THE PATIENT REMAINED IN THE HOSPITAL AND WAS STABLE. 5 DAYS AFTER THE PERICARDIOCENTESIS, THERE WAS NO MORE EFFUSION, THE DRAIN WAS TAKE

  Patient problems: Pericardial Effusion

  MAUDE report 22463976 ↗
• DeathJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, THE PATIENT PRESENTED FOR AN ALTERRA CASE. THE PATIENT WITH A HISTORY OF PULMONARY HYPERTENSION WITH PRIOR EVALUATION FOR MITRAL STENOSIS, WAS NOTED TO HAVE SEVERE PULMONARY REGURGITATION AT WORKUP. BASELINE PRESSURES (AT START OF PROCEDURE) OF RIGHT VENTRICLE (RV) 78/11, PULMONARY ARTERY (PA) 77/27, PULMONARY CAPILLARY WEDGE PRESSURE (PCWP) 15, SYSTEMIC ARTERIAL PRESSURE 99/69. FOLLOWING HEMODYNAMICS, A NON-EDWARDS WIRE WAS PLACED TO THE DISTAL RIGHT PULMONARY ARTERY (DRPA) AND THE ALTERRA PRE-STENT WAS ADVANCED THROUGH THE NON-EDWARDS SHEATH, SLIGHTLY DISTAL TO THE ORIGIN OF THE RIGHT PULMONARY ARTERY (RPA) WITHOUT DIFFICULTY. THE PRE-STENT WAS EXPOSED TO APPROXIMATELY 30% AND MAIN PULMONARY ARTERY (MPA) ANGIOGRAPHY WAS PERFORMED. THE ALTERRA WAS THEN WITHDRAWN TO A LEVEL AT/NEAR THE NATIVE PULMONARY ANNULUS. THE ALTERRA WAS FURTHER EXPOSED TO 50% AT WHICH TIME IT WAS NOTED THAT FORWARD PRESSURE WAS APPLIED TO THE ALTERRA DELIVERY SYSTEM (DS); THE IMPLANTER WAS INSTRUCTED TO RELEASE THE OUTER SHAFT OF THE DS, AS THIS WAS CREATING DISTAL MEDIAL/INFERIOR "CANTING" OF THE PRE-STENT, AS WELL AS EXCESSIVE LEFT/LATER DEVICE BIAS. THE ALTERRA

  Patient problems: Great Vessel Perforation

  MAUDE report 22346291 ↗
• InjuryJun 19, 2025Migration; Migration

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A CASE IN PULMONIC POSITION, AN ALTERRA DEVICE WAS PLACED IN THE PULMONARY ANNULUS WITHOUT DIFFICULTY. AS THE PHYSICIAN WAS TRACKING THE PULMONIC DELIVERY SYSTEM (PDS), THE PDS BUMPED INTO THE FIRST ALTERRA AS THE PHYSICIAN WAS ADVANCING IT THROUGH AND CAUSED IT TO DISLODGE. THE ALTERRA MIGRATED DISTAL INTO THE MAIN PULMONARY ARTERY. THE PDS WAS REMOVED AND A SECOND ALTERRA WAS PLACED TO SECURE A LANDING ZONE. THE DISTAL PORTION OF THE SECOND ALTERRA WAS PLACED IN THE PROXIMAL PORTION OF THE FIRST ALTERRA TO SECURE THE FIRST ALTERRA. THE TEAM THEN USED A COMMANDER DELIVERY SYSTEM TO PLACE A NEW 29 MM SAPIEN 3 VALVE IN THE ALTERRA WAIST. THE SYSTEMS WERE REMOVED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 22294391 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  FROM ALTERRA CLINICAL STUDY, APPROXIMATELY 2 MONTHS AND 9 DAYS POST-IMPLANTATION OF THE ALTERRA PRESTENT IN THE PULMONIC POSITION, ALTERRA PRESTENT FRACTURES NOTED DURING INTRA-PROCEDURAL FLUORO IMAGING AT THE TIME OF THE SAPIEN 3 VALVE IMPLANT PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22107644 ↗
• InjuryMay 19, 2025Perivalvular Leak; Perivalvular Leak

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, SEVERE PARA-ALTERRA REGURGITATION WAS EVIDENT FOLLOWING DELIVERY OF THE ALTERRA PRE-STENT IN PULMONIC POSITION. AS REVIEWED DURING PRE-CASE PLANNING, THE DIMENSIONS OF THE PROXIMAL RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ANATOMY, AS WELL AS THE DISTAL MAIN PULMONARY ARTERY (MPA) WERE OUTSIDE OF THE TOLERANCE OF ALTERRA. FOLLOWING A DISCUSSION WITH THE PATIENT'S FAMILY, THE DECISION WAS MADE TO ATTEMPT A TRANSCATHETER APPROACH WITH THE UNDERSTANDING THAT A SURGICAL INTERVENTION MAY BE REQUIRED. FOLLOWING DELIVERY OF THE ALTERRA PRE-STENT, ANGIOGRAPHY WAS PERFORMED AND SEVERE PARA-ALTERRA REGURGITATION WAS EVIDENT. THE PROCEDURE WAS ABORTED AND THE IMPLANTING PHYSICIAN STATED THAT THE PATIENT WILL BE REFERRED FOR SURGICAL PULMONARY VALVE REPLACEMENT TO BE PERFORMED ELECTIVELY WITHIN 30 DAYS TO 6 WEEKS.

  Patient problems: Insufficient Information

  MAUDE report 22048179 ↗
• DeathMay 19, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29MM SAPIEN 3 ULTRA RESILIA (S3UR) AND ALTERRA IN THE AORTIC POSITION IN AN OFF-LABEL CASE VIA TRANSEPTAL (THROUGH THE FONTAN), THE ALTERRA SUCCESSFULLY LANDED IN THE AORTIC POSITION. THE TEAM SUCCESSFULLY DELIVERED THE S3UR INTO THE ALTERRA, HOWEVER THE WHOLE SYSTEM SEEMED TO MIGRATE LV AND THERE WAS SEVERE AORTIC INSUFFICIENCY (AI). A SECOND 29MM S3UR VALVE WAS PREPPED AND DELIVERED INTO THE FIRST S3UR AND ALTERRA. THE PATIENT WENT INTO PEA AND WAS NEVER ABLE TO RECOVER. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE SEVERE AI WAS A PARASTENT LEAK. IT SEEMED PRESENT ON THE ANGIO POST VALVE DEPLOYMENT. THERE WAS NO VALVE DYSFUNCTION OF THE FIRST S3UR. THE SECOND S3UR WAS ONLY PLACED TO FIX THE AI THROUGH THE OPEN STRUTS OF THE ALTERRA AND THE FIRST S3UR.

  Patient problems: Insufficient Information

  MAUDE report 22047078 ↗
• InjuryMar 24, 2025Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  ADDITIONAL INFORMATION PROVIDED PER MEDICAL RECORDS: FOLLOWING INITIAL ALTERRA DEVICE PLACEMENT, IT WAS OBSERVED THAT THE ALTERRA PRESTENT HAD MOVED SLIGHTLY MORE DISTAL INTO THE PULMONARY ARTERY BIFURCATION. SEVERAL OF THE INFLOW APICES OF THE ALTERRA DEVICE WERE IN-FOLDED AND CAUSED OBSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). ON THE CRANIAL VIEW, THE MEDIAL SIDE OF THE INFLOW PORTION OF THE ALTERRA PRESTENT WAS NOTED TO BE VERY MOBILE AND BULGED INTO THE RVOT WITH SYSTOLE. A FRACTURE WAS ALSO NOTED ON THE MEDIAL ASPECT OF THE INFLOW APICES OF THE ALTERRA, WHICH WERE HINGING AT THE CENTER OF THE ALTERRA AND FORMING A TRAP-DOOR TYPE OF OBSTRUCTION. THE RIGHT VENTRICLE PRESSURE WAS ELEVATED ALMOST 2/3 SYSTEMIC, WHICH INDICATED THAT THE PROXIMAL FLAILING PART OF THE STENT WAS CAUSING AN OBSTRUCTION. A SECOND ALTERRA DEVICE WAS PLACED TO OVERLAP WITH THE FIRST PRESTENT, HOWEVER THERE WAS STILL AN OBSTRUCTION. THE ALTERRA WAS THEN DILATED, WHICH ALSO DID NOT RESOLVE THE ELEVATED SYSTOLIC PRESSURE. A 29MM SAPIEN (S3) VALVE WAS THEREFORE PLACED, WHICH RESULTED IN SIGNIFICANT IMPROVEMENT IN THE OBSTRUCTION AND NO PULMONARY INSUFFICIENCY. AT THE END OF THE CASE, THE S3 VALVE

  Patient problems: Insufficient Information

  MAUDE report 21684166 ↗
• InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE FIELD CLINICAL SPECIALIST (FCS), A 42-YEAR-OLD FEMALE PRESENTED FOR ALTERRA PLACEMENT. THE PATIENT HAS A HISTORY OF PULMONIC STENOSIS AND UNDERWENT PULMONARY VALVULOPLASTY APPROXIMATELY 10 YEARS AGO. SCREENING REPORTS SHOWED AN INTACT NATIVE ANNULUS WITH A MARKEDLY DILATED DISTAL MPA. THE PLAN WAS TO IMPLANT THE ALTERRA WITH THE INFLOW APICES JUST PROXIMAL TO THE ANNULUS. AFTER EXPERIENCING DIFFICULTY POSITIONING THE WIRE IN THE RIGHT PULMONARY ARTERY (RPA), A LUNDERQUIST WIRE WAS PLACED IN THE DISTAL LEFT PULMONARY ARTERY (LPA). THE ALTERRA WAS TRACKED TO THE INTENDED LANDING ZONE, AND DEPLOYMENT WAS INITIATED IN THE LPA, WITH THE ALTERRA RETRACTED TO THE MPA. THE DISTAL APICES FLOWERED AS EXPECTED, AND DEPLOYMENT CONTINUED TO APPROXIMATELY 50%. CLOSE INSPECTION OF THE OUTFLOW APICES REVEALED SOME CONCERN WITH THE ANTERIOR ASPECT. IT WAS DETERMINED THAT ADDITIONAL RETRACTION OF THE ALTERRA WAS NEEDED TO LAND THE INFLOW APICES PROXIMAL TO THE NATIVE ANNULUS, WITH THE EXPECTATION THAT THE ANTERIOR APICES WOULD CORRECT THEIR ORIENTATION. DEPLOYMENT CONTINUED TO APPROXIMATELY 65%, AND ADDITIONAL ANGIOGRAPHY WAS PERFORMED TO ASSESS THE OUTFLOW APICES AND INFLOW POSITION. THE CO

  Patient problems: Great Vessel Perforation

  MAUDE report 21537857 ↗
• InjuryFeb 11, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29MM SAPIEN 3 VALVE AND 29MM ALTERRA PRESENT IN THE PULMONIC POSITION, THE PATIENT'S DEEP SEPTUM AT THE BIFURCATION LED TO AN IDEAL DISTAL ALTERRA PLACEMENT, SEVERAL DIFFERENT APPROACHES WERE MADE TO ACHIEVE THIS. THE TEAM SWITCHED FROM RIGHT PULMONARY ARTERY (RPA) TO THE LEFT PULMONARY ARTERY (LAP) WITH BOTH LUNDERQUIST AND SUPER STIFF WIRES IN BOTH POSITIONS WHILE TRYING TO DEPLOY THE ALTERRA BECAUSE IT ENDED UP TOO PROXIMAL AND WANTED TO OPEN POSTERIORLY, INVERTING THE STRUTS. A SECOND SYSTEM WAS OPENED AFTER 3 ATTEMPTS AND THEY SWITCHED TO A SOFTER WIRE SUCCESSFULLY DEPLOYING THE ALTERRA IN THE MOST IDEAL POSITION. (SHORTER MPA, REVIEWED AND DEEMED FAVORABLE) AFTER VALVE DEPLOYMENT, THE ENTIRE SYSTEM MIGRATED INTO THE RIGHT VENTRICLE (RV) DUE TO POOR ENGAGEMENT AT THE PROXIMAL PORTION AND THE PATIENT HAD TO GO TO SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21356929 ↗
• InjuryJan 6, 2025Fluid/Blood Leak; Migration or Expulsion of Device; Fluid/Blood Leak; Migration or Expulsion of Device

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, IN A PATIENT WITH A COMPLEX CONGENITAL HEART, AN ALTERRA WAS MODIFIED BY REMOVING THE PTFE COVERING OF THE INFLOW APICES, BY THE SURGEON. THE ALTERRA WAS RE-MOUNTED ON THE DELIVERY SYSTEM AND WAS ADVANCED TO THE LEVEL OF THE DKS (FUNCTIONAL SYSTEMIC, NATIVE VALVE), VIA LEFT CAROTID SURGICAL CUTDOWN, UTILIZING A 24FR X 33CM GORE DSF. THE ALTERRA PRE-STENT WAS PLACED WITH THE WAIST EFFECTIVELY AT THE ANNULUS. A 29MM SAPIEN 3 WAS MOUNTED ON A CERTITUDE DELIVERY SYSTEM AND WAS ADVANCED TO THE WAIST OF ALTERRA AND WAS DELIVERED FOLLOWING A REDUCTION IN FLOW TO THE LEFT VENTRICULAR ASSIST DEVICE (LVAD). ALTHOUGH SUCCESSFULLY DEPLOYED TO THE ALTERRA WAIST, THE DEVICE MIGRATED INFERIORLY TO A LOWER POSITION (VENTRICULAR). SUBSEQUENT ASCENDING AORTA (ASAO) ANGIOGRAPHY REVEALED SEVERE PARA-ALTERRA REGURGITATION. THE IMPLANTING TEAM REQUESTED A SECOND 29MM SAPIEN 3 TO BE PREPARED ON COMMANDER DELIVERY SYSTEM AND THIS WAS ADVANCED VIA THE GORE DSF/CAROTID, PLACED SLIGHTLY SUPERIOR TO THE INITIAL THV IMPLANT. THE DEGREE OF PARAVALVULAR LEAK (PVL) WAS ASSESSED PER ASAO ANGIOGRAPHY

  Patient problems: Insufficient Information

  MAUDE report 21082520 ↗
• InjuryDec 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 2 MONTHS POST-IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE PULMONIC POSITION WITH AN ALTERRA PRESTENT, THE PATIENT WAS ADMITTED WITH AN EFFUSION. THE PATIENT HAD IT DRAINED WITHOUT REACCUMULATING, THEY HAD SUSPECTED IT WAS AN EROSION OR PERFORATION. WE ARE CURRENTLY WAITING ON CT ANALYSIS TO CONFIRM OR DENY THIS. THE EFFUSION DID NOT REACCUMULATE, HOWEVER THE PATIENT WAS HYPOTENSIVE WITH A HIGH WHITE COUNT AND FOUND TO HAVE ENTEROCOCCUS BACTEREMIA. THE TEAM DOES NOT KNOW WHEN THIS STARTED AND IF THIS HAS ANYTHING TO DO WITH THE EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 20898267 ↗
• MalfunctionJun 13, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  DURING A TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE, THE ALTERRA STENT WAS PLACED IN THIS PATIENT'S RIGHT VENTRICLE (RV) OUTFLOW TRACT, AND IT WAS NOTED THAT THE PROXIMAL ALTERRA WAS COMPRESSED/FRACTURED. THE PHYSICIANS OPENED A NON-EDWARDS BALLOON AND DILATED THE PROXIMAL STENT. AFTER THE DILATION, IT WAS NOTED THERE WAS ABNORMAL STENT FRAME MOVEMENT AT THE PROXIMAL SHOULDER. IT WAS DETERMINED THAT THE CASE NEEDED TO BE STAGED. THE DECISION WAS MADE TO LET THE PATIENT TAKE A FEW WEEKS TO HEAL, AND THE SAPIEN VALVE WOULD BE PLACED AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 19534236 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A STAND ALONE 29MM ALTERRA STENT, PATIENT PRESENTED WITH CHEST PAIN. A REPEAT CT WAS PERFORMED FOR THE CHEST PAIN. THE SITE REPORTED IT MAY HAVE BEEN DO TO VOLUME OVERLOAD AND WIDE OPEN PI. SHE WAS IN THE ED BUT SEEMED TO BE ABLE TO MANAGE WITH DIURETICS. THE PATIENT WAS SCHEDULED FOR COMPLETION OF THE PROCEDURE WITH A 29MM SAPIEN 3 VALVE. THE PROCEDURE WAS PERFORMED AS A SITE LAUNCH, PROCTOR SUPPORTED WITHOUT COMPLICATION AND WITH THE INTENTION OF STAGING THE PROCEDURE D/T DIMENSIONS OF THE DISTAL MPA. THE PATIENT IS DOING WELL CLINICALLY. PER REVIEW OF THE PROVIDED IMAGERY: AN IMAGE REVIEW WAS PERFORMED AND DETERMINED: 1C PENETRATION AT 12 OCLOCK WITH CORRESPONDING PE, PROBABLE 4 1A (1 UNEQUIVOCAL) AND 3 AREAS OF INTIMAL CONTACT IN THE OUTFLOW AREA WITH NO APPARENT FULL PENETRATION (PROBABLE 1 AREA WITH PARTIAL INTIMAL PENETRATION UNCERTAIN IF THIS WILL BE LABELLED 1A).

  Patient problems: Chest Pain

  MAUDE report 19532342 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  AS REPORTED BY THE ENCIRCLE CLINICAL TRIAL, UPON RETROSPECTIVE REVIEW OF THE 30-DAY CHEST X-RAY, ONE FRACTURE WAS FOUND AT THE ALTERRA INFLOW. THIS WAS FOUND RETROSPECTIVELY WITH KNOWLEDGE OF THE 1-YEAR FLR.

  Patient problems: Insufficient Information

  MAUDE report 19300532 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION FROM A PHYSICIAN. AS REPORTED, A PATIENT UNDERWENT IMPLANT OF AN ALTERRA PRESTENT WITH SAPIEN 3 VALVE. MOST RECENT CT SCAN PERFORMED SHOWED ''EVIDENCE OF WORRISOME PENETRATION OF THE STRUTS, WHICH ARE IN CONTACT WITH THE TRANSVERSE ARCH AND THE STERNUM. THE STRUT AGAINST THE STERNUM SEEMS TO HAVE CREATED A SORT OF REACTION OF THE PERIOSTEUM TOO.'' NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Inflammation

  MAUDE report 19293278 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL (FCS), APPROXIMATELY 4 HOURS POST TRANSFEMORAL TPVR PROCEDURE WITH AN ALTERRA PRESTENT, THE FCS RECEIVED A TEXT MESSAGE FROM THE PHYSICIAN STATING THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AFTER CODING DUE TO A PERICARDIAL EFFUSION. THERE WAS DISTAL STENT EROSION. THE PATIENT WAS STABLE. PER REPORT, IT APPEARED AS THOUGH THE LEFTWARD, LATER ASPECT OF MPA. THERE WERE 3 TINES SEEN POKING THROUGH. THE 29MM SAPIEN VALVE WAS NOT IMPLANTED.

  Patient problems: Great Vessel Perforation

  MAUDE report 19240301 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY CLINICAL SAFETY IN REGARD TO A POST, APPROXIMATELY 1 MONTH POST TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN VALVE IN AN ALTERRA PRESENT, THE PATIENT PRESENTED WITH CHEST PAIN AND PERICARDIAL EFFUSION, WHICH WAS DRAINED. THE TEAM ELECTED TO TREAT THE PATIENT WITH HIGH DOSE ASPIRIN FOR 4 WEEKS WITH IMPROVEMENT IN SYMPTOMS AND THE EFFUSION. A FEW WEEKS LATER, THERE WAS RECURRENCE OF CHEST PAIN AND EFFUSION WITH ELEVATED CRP AGAIN, THE TEAM TREATED WITH HIGH DOSE STEROIDS WITH TIME TAPERING OVER 6 WEEKS. THE PATIENT IMPROVED AND DID WELL. HOWEVER, 2 MONTHS LATER, THE PATIENT PRESENTED AGAIN WITH SEVERE CHEST PAIN, FEVER, AND PERICARDIAL EFFUSION WITH ELEVATED CRP. IT WAS DECIDED TO REMOVE THE SAPIEN 3 VALVE AND ALTERRA RESTENTS AND PLACE A 23MM HOMOGRAFT. INTRAOPERATIVELY, THE SURGEON FOUND THAT THE ALTERRA PRESTENT WAS ERODING THROUGH THE WALL OF THE MAIN PULMONARY ARTERY IN MULTIPLE LOCATIONS. THE PATIENT IS DOING WELL WITH NO CHEST PAIN OR RECURRENCE OF THE EFFUSION.

  Patient problems: Great Vessel Perforation

  MAUDE report 19188110 ↗
• InjuryFeb 23, 2024Fracture; Device Damaged by Another Device; Material Deformation; Migration; Fracture; Device Damaged by Another Device; Material Deformation; Migration

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING THE IMPLANT OF A SECOND ALTERRA, THE EXISTING ALTERRA EMBOLIZED DISTALLY IN THE MAIN PULMONARY ARTERY (MPA) AND BECAME DISTORTED WHEN THE DELIVERY SYSTEM WAS ADVANCED OVER THE WIRE. THE SECOND DELIVERY SYSTEM DID NOT HAVE TRACKING DIFFICULTIES INSIDE THE PA. THE ALTERRA WAS STABLE AND NOTHING FURTHER WAS DONE. A SAPIEN VALVE WAS NEVER IMPLANTED. SEVEN DAYS AFTER THE PROCEDURE, THE PATIENT WAS ADMITTED FOR ACUTE CONGESTIVE HEART FAILURE SECONDARY TO RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION REQUIRING EMERGENT SURGICAL INTERVENTION. THE PATIENT WAS FOUND VOMITING, DIAPHORETIC, ALTERED MENTAL STATUS (AMS), AND REQUIRED NON-REBREATHER. THE PERCEIVED ROOT CAUSE OF THE RVOT OBSTRUCTION WAS THAT THE SECOND ALTERRA THAT WAS IMPLANTED CAUSED A SECOND TRAPPED DOOR.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 18770445 ↗