Trifecta™ TF-23ARecalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 05414734052030), received between Jun 27, 2018 and Sep 25, 2026 — classified as 22 deaths, 194 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (72 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that on (b)(6) 2017, a 23mm SJM Trifecta Valve was implanted for a aortic valve replacement procedure. On (b)(6) 2025, the patient required premature replacement. While attempting to close chest, the patient developed ventricular tachycardia and ventricular fibrillation and ultimately required placement of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The patient's chest remained open until (b)(6)2025. An automated implantable cardioverter-defibrillator was placed on (b)(6) 2025 prior to discharge the same day.

  Patient problems: Insufficient Information

  MAUDE report 50896836 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2024. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25491954 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2025. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25491642 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23760716 ↗
• InjuryNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD AN EXISTING 23MM TRIFECTA VALVE IMPLANTED. DURING THE PROCEDURE, THE VALVE WAS OBSERVED TO BE SLIPPING DOWN AND UNABLE TO ANCHOR PROPERLY, A SECOND 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED FLEXNAV DS, WHILE THE ISSUE REMAIN UNCHANGED. HENCE, A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 23653009 ↗
• InjuryNov 7, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2015, AN UNKNOWN SIZE TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH EXERTIONAL DYSPNEA, AN SEVERE AORTIC STENOSIS AND AORTIC INSUFFICIENCY SHOWED IN ECHOCARDIOGRAM (ECHO). ON (B)(6) 2025, THE VALVE GOT EXPLANTED DUE TO SEVERE AORTIC STENOSIS AND A 23MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23496896 ↗
• InjuryOct 23, 2025Material Split, Cut or Torn; Device Stenosis; Material Split, Cut or Torn; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014, A 23MM TRIFECTA VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, STENOSIS, LEAFLET TEAR, AND REGURGITATION WERE OBSERVED ON ECHOCARDIOGRAPHY; THE PATIENT HAD ASSOCIATED SYMPTOMS OF HEART FAILURE. ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS IMPLANTED VIA VALVE-IN-VALVE WITH GOOD RESULTS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 23372505 ↗
• InjuryApr 4, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2015, A 23MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH A HISTORY OF AORTIC STENOSIS. ON AN UNKNOWN DAY IN (B)(6) 2024, IT WAS NOTED VIA ECHOCARDIOGRAM THAT THE PATIENT SHOWED AN INCREASED AORTIC VALVE GRADIENT, AN AORTIC VALVE VELOCITY OF 4M/S, AND REDUCED EJECTION FRACTION OF 55%. THERE WAS NO NOTED AORTIC REGURGITATION PRESENT, BUT RATHER HARDENING OF THE VALVE LEAFLETS. THE DECISION WAS MADE TO EXPLANTED THE 23MM TRIFECTA VALVE AND REPLACE IT WITH A 23MM NON-ABBOTT DEVICE. THE VALVE WAS SUCCESSFULLY EXPLANTED A REPLACED WITHOUT HANDLING THE VALVE WITH ANY UNPROTECTED FORCEPS OR SHARP INSTRUMENTS. THE EXPLANTED 23MM TRIFECTA VALVE HAD NO TEAR OBSERVED IN THE LEAFLETS OR SUTURE CUFF. HOWEVER, THE CUSP WAS FOUND TO HAVE FIBROSIS. THE PATIENT HAVE CHRONIC RENAL INSUFFICIENCY. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 21773819 ↗
• InjuryMar 20, 2025Degraded; Degraded

  IT WAS REPORTED THAT IN 2014, A 23MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT IN AN OFF-LABEL USE. THE NAVITOR WAS GOING TO BE IMPLANTED WITHIN THE 23MM TRIFECTA VALVE. A PRE-DILATION WAS PERFORMED WITH A 22MM BALLOON. THE NAVITOR WAS ABLE TO BE SUCCESSFULLY IMPLANTED AND THE SAME BALLOON USED FOR THE PRE-DILATION WAS USED TO POST-DILATE THE VALVE. THE RESULT WAS EXCELLENT. THERE WAS NO GRADIENT AND NO PVL. THE HEALTHCARE PROFESSIONAL DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 21652683 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, THE VALVE WAS EXPLANTED AND A NEW UNKNOWN VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21322975 ↗
• InjuryOct 25, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT IN 2011, A 23MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE AREA OF THE NATIVE VALVE WAS 286MM^2. ON A LATER DATE, THE PATIENT WAS DISCOVERED TO HAVE VALVE STENOSIS AND WAS SYMPTOMATIC. ON (B)(6) 2024, A 23MM NAVITOR VISION VALVE WAS IMPLANTED DURING A VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT STATUS WAS STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20534436 ↗
• InjurySep 20, 2024Perivalvular Leak; Material Separation; Device Stenosis; Intravalvular regurgitation; Perivalvular Leak; Material Separation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2015, A 23MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE IT WAS NOTED THAT THE VALVE WAS STENOSED. ON (B)(6) 2024, THE DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE PROCEDURE USING A 25MM PORTICO NG/NAVITOR VALVE. ON (B)(6) 2024, IT WAS NOTED THAT THERE WAS PARAVALVULAR LEAKAGE OF THE 23MM TRIFECTA VALVE. THE DECISION WAS MADE TO STOP THE PATIENT'S BISOPROLOL MEDICATION. ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN PERIVALVULAR LEAK (PVL) REPAIR PROCEDURE. IT'S NOTED THAT ONE DAY AFTER THE PVL REPAIR PROCEDURE, THE PATIENT DEVELOPED A 5 SECOND PAUSE WITH ATRIAL FIBRILLATION. THE PATIENT DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Atrial Fibrillation; Dyspnea

  MAUDE report 20271422 ↗
• InjuryApr 26, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2015, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT RETURNED AND HAD PURE AORTIC REGURGITATION (AR) WITH SEVERE AORTIC STENOSIS. ON (B)(6) 2024, A NEW 25MM NAVITOR VALVE WAS CHOSEN AND TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WAS PERFORMED SUCCESSFULLY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 19195892 ↗
• InjuryApr 8, 2024Perivalvular Leak; Device Stenosis; Intravalvular regurgitation; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON A (B)(6) 2015 A 23MM TRIFECTA AORTIC VALVE WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT RETURNED WITH STRUCTURAL VALVE DETERIORATION OF THE 23MM TRIFECTA VALVE. THE PATIENT HAD DYSPNEA AND FATIGUE ALONG WITH AORTIC STENOSIS, PERIVALVULAR LEAK, AND AORTIC REGURGITATION. ON (B)(6) 2024, IT WAS DECIDED TO IMPLANT A 25MM NAVITOR VALVE IN VALVE TO TREAT THE ISSUE. MEASUREMENTS NOT OBTAINED VIA COMPUTERIZED TOMOGRAPHY (CT) FOR THE PROCEDURE. THE 25MM NAVITOR WAS ADVANCED THROUGH THE TRIFECTA UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM (LOT: 9048461). AT 80% DEPLOYMENT, THE VALVE WAS AT AN ACCEPTABLE HEIGHT IN RELATED TO THE BASE OF THE TRIFECTA, BUT A SMALL PERIVALVULAR LEAK (PVL) WAS PRESENT. THE VALVE WAS FULLY DEPLOYED AT 5-6MM BELOW THE BASE OF THE TRIFECTA AND POST DILATATION WAS PERFORMED WITH A 22MM NON-ABBOTT BALLOON VALVULOPLASTY (BAV). FOLLOWING POST DILATATION, THE VALVE MIGRATED INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AT A DEPTH OF 10MM AND MODERATE PVL REMAINED. THE PATIENT HOWEVER REMAINED HEMODYNAMICALLY STABLE. NO REPOSITIONING OF THE MIGRATED VALVE WAS ATTEMPTED. A SECOND 25MM NAVITOR VALVE (SERIAL: (B)(6)) WAS IMPLANTED AT 5MM (BA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 19067935 ↗
• InjuryFeb 20, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2015, A 23MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2023, THE VALVE WAS NOTED TO HAVE STENOSIS AND REGURGITATION DUE TO VALVE LEAFLET STIFFNESS. THE VALVE WAS SUSPECTED TO HAVE STRUCTURAL VALVE DETERIORATION (SVD). THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM EPIC SUPRA VALVE. THE PATIENT WAS LATER DISCHARGED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 18744170 ↗
• InjuryJan 30, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  THE ARTICLE, "CARDIO-OBSTETRICS TEAM-BASED MANAGEMENT OF A PREGNANT PATIENT WITH SEVERE BIOPROSTHETIC AORTIC VALVE DISEASE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 38-YEAR-OLD PREGNANT FEMALE PATIENT WITH A BICUSPID AORTIC VALVE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM TRIFECTA VALVE WAS IMPLANTED. THE PATIENT PRESENTED 4 YEARS POST-PROCEDURE WITH SWELLING AND DYSPNEA DUE TO MILD AORTIC STENOSIS, MEAN GRADIENT = 22MMHG, NOTED BY TRANSTHORACIC ECHOCARDIOGRAPHY (TTE). A YEAR FOLLOWING, THE PATIENT WAS DIAGNOSED WITH FIRST-TRIMESTER PREGNANCY AND TTE NOTED THE MEAN AORTIC GRADIENT INCREASED TO 33MMHG AND THEN 46MMHG WHEN THE PATIENT WAS REFERRED TO A CARDIO-OBSTETRICS PROGRAM. DURING THE PATIENT'S SECOND TRIMESTER, THE PATIENT BEGAN EXPERIENCING MILD HEART FAILURE THAT WAS MANAGED VIA LOW-DOSE ORAL FUROSEMIDE. A FOLLOW UP TTE NOTED THE MEAN AORTIC GRADIENT WAS 67MMHG AND WAS DIAGNOSED WITH MODERATE-TO-SEVERE AORTIC REGURGITATION. EARLY IN THE THIRD TRIMESTER, THE PATIENT HAD WORSENING LOWER EXTREMITY EDEMA LEADING TO INCREASE IN FUROSEMIDE. AT 30 WEEKS' GESTATION, THE PATIENT WAS ADMITTED FOR WORSENING HEART FAILURE AND SHORTNESS OF BREATH. INITIALLY, THE PATIEN

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 18608988 ↗
• InjuryDec 27, 2023Calcified; Patient-Device Incompatibility; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation; Calcified; Patient-Device Incompatibility; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation

  THE ARTICLE, "EARLY STRUCTURAL VALVE DETERIORATION OF TRIFECTA AORTIC BIOPROSTHESIS : REPORT OF A CASE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 60-YEAR-OLD MALE PATIENT WHO UNDERWENT AORTIC VALVE REPLACEMENT. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM TRIFECTA VALVE WAS IMPLANTED. SEVEN YEARS POST-PROCEDURE ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA, SEVERE AORTIC REGURGITATION, AND AORTIC STENOSIS. IT WAS NOTED INTRAOPERATIVELY THERE WAS A LARGE LACERATION IN THE LEFT CORONARY CUSP ADJACENT TO THE NON-CORONARY AND LEFT CORONARY COMMISSURE AND LEAFLET CALCIFICATION. FURTHER INVESTIGATION NOTED CIRCUMFERENTIAL FIBROUS PANNUS INGROWTH AT THE INFLOW PORTION. A DECISION WAS MADE TO EXPLANT THE TRIFECTA VALVE AND REPLACED WITH AN INSPIRIS VALVE OF UNKNOWN SIZE. THE PATIENT ADDITIONALLY UNDERWENT CONCOMITANT MITRAL VALVE PLASTY AND LEFT ATRIAL APPENDAGE CLIPPING. THE PATIENT WAS REPORTED STABLE AND TRANSFERRED TO A REHABILITATION FACILITY ON THE 36TH POSTOPERATIVE DAY. [THE PRIMARY AUTHOR WAS KEITA TANAKA, JAPANESE RED CROSS MEDICAL CENTER, TOKYO, JAPAN.]

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea

  MAUDE report 18405967 ↗
• InjuryNov 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(4) 2015, A 23MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. BEGINNING IN LATE FEBRUARY OR EARLY MARCH OF 2021, THE PATIENT BEGAN EXPERIENCING SHORTNESS OF BREATH WHEN GOING ON WALKS. THE PATIENT ALSO DEVELOPED A COUGH AND PROFUSE SWEATING. THE COUGHING FITS WERE SO SEVERE AT TIMES THAT THE PATIENT TORE A MUSCLE IN HIS SIDE. INITIALLY, PHYSICIAN THOUGHT THAT THE PATIENT HAD PNEUMONIA WHICH THEY TREATED WITH CODEINE COUGH SYRUP MEDICATION THAT INCREASES THE RISK OF CARDIAC EVENTS, INCLUDING DEATH. FORTUNATELY, A PULMONOLOGIST DETERMINED THAT THE PATIENT SYMPTOMS WERE DUE TO HEART FAILURE. MORE SPECIFICALLY, ON MAY 13, 2021, THE PATIENT PULMONOLOGIST IDENTIFIED "MODERATE TO SEVERE AORTIC REGURGITATION." ON MAY 26,2021, THE DEFECTIVE TRIFECTA HEART VALVE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE THE PATIENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 18239941 ↗
• InjuryOct 9, 2023Intravalvular regurgitation; Intravalvular regurgitation

  USER FACILITY MEDWATCH REPORT MW5145211 RECEIVED THAT STATES "PATIENT ADMITTED TO THE HOSPITAL WITH SECOND EPISODE OF HEART FAILURE. HE HAD A 23 MM TRIFECTA VALVE PLACED IN 2017 AT (B)(6) HOSPITAL. AFTER ECHOCARDIOGRAPHIC EVALUATION IT APPEARS THAT HE HAS SEVERE PROSTHETIC AORTIC REGURGITATION. SINCE THE VALVE HAS BEEN IN PLACE ONLY 7 YEARS THIS APPEARS TO BE EARLY FAILURE AND DUE TO PREVIOUS PROBLEMS REPORTED WITH THIS TYPE OF VALVE THIS REPORT IS BEING SUBMITTED." IT WAS REPORTED THAT IN 2017, A 23MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A SECOND EPISODE OF HEART FAILURE. AFTER ECHOCARDIOGRAM EVALUATION, IT APPEARED THAT THE PATIENT HAD SEVERE AORTIC REGURGITATION. IT WAS UNKNOWN IF THE VALVE WAS REPLACED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 17895274 ↗
• InjuryOct 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  USER FACILITY MEDWATCH REPORT MW5144960 RECEIVED THAT STATES "(B)(6), 2017 HAD AORTIC VALVE SURGERY WITH TRIFECTA 23 AORTIC VALVE. TWO WEEKS LATER, ADDITIONAL SURGERY REQUIRED, HAD INFECTION AND DOCTOR. REMOVED STERNUM. HAD TO HAVE TAVR(TRANSCATHETER AORTIC VALVE REPLACEMENT) TO REPLACE THE TRIFECTA 23 ON (B)(6) 2023 DUE TO ISSUES WITH TRIFECTA VALVE. THIS IS JUST A GLIMPSE OF WHAT I HAVE BEEN THROUGH SINCE MY 1ST SAVR IN 2017. PLEASE FEEL FREE TO CONTACT US IF YOU HAVE ANY QUESTIONS." IT WAS REPORTED THAT IN 2017, A 23MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. TWO WEEKS LATER, AN ADDITIONAL SURGERY WAS REQUIRED DUE TO INFECTION, AND THE STERNUM WAS REMOVED. ON (B)(6) 2023, A TRANSCATHETER AORTIC VALVE IMPLANTATION WAS CONDUCTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17877195 ↗
• InjurySep 5, 2023Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation; Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation

  THE ARTICLE, "CASE SERIES OF EARLY STRUCTURAL VALVE DETERIORATION OF TRIFECTA BIOPROSTHESIS - NEW ZEALAND EXPERIENCE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 62-YEAR-OLD FEMALE WITH CONGENITAL BICUSPID AORTIC VALVE AND HISTORY OF HYPERTENSION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. THE PATIENT PRESENTED 31 MONTHS LATER WITH ACUTE SEVERE AORTIC REGURGITATION AND HEART FAILURE. A DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACE WITH A 22MM NON-ABBOTT VALVE. IT WAS FOUND INTRAOPERATIVELY THERE WAS A TORN NON-CORONARY CUSP OF THE TRIFECTA VALVE. THE EXPLANTED VALVE WAS EXAMINED AND FOUND TO HAVE PANNUS INGROWTH ON ONE LEAFLET. THE ARTICLE CONCLUDED THE TRIFECTA VALVE HAS AN ACCEPTABLE SAFETY PROFILE AND OFFERS GOOD HEMODYNAMICS DUE TO THE EXTERNALLY MOUNTED LEAFLETS. HOWEVER, THEIR EXPERIENCE OF EARLY SVD AND FAILURE IS CONCERNING FOR VALVE DURABILITY. FURTHER COMPARISON TO OTHER BIOPROSTHETIC VALVES AND LONGER TERM FOLLOW-UP ARE REQUIRED TO CHARACTERIZE THE MECHANISM OF FAILURES. [(B)(6)]. POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, HEART FAILURE, SURGICAL INTERVENTION, HOSPITALIZATION, PANNUS, T

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 17684345 ↗
• InjurySep 5, 2023Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  THE ARTICLE, "CASE SERIES OF EARLY STRUCTURAL VALVE DETERIORATION OF TRIFECTA BIOPROSTHESIS - NEW ZEALAND EXPERIENCE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 75-YEAR-OLD MALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2014, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH AORTIC REGURGITATION. A DECISION WAS MADE TO EXPLANT THE VALVE ON AN UNKNOWN DATE IN 2018, 39 MONTHS FOLLOWING THE FIRST IMPLANT PROCEDURE. THE ARTICLE CONCLUDED THE TRIFECTA VALVE HAS AN ACCEPTABLE SAFETY PROFILE AND OFFERS GOOD HEMODYNAMICS DUE TO THE EXTERNALLY MOUNTED LEAFLETS. HOWEVER, THEIR EXPERIENCE OF EARLY SVD AND FAILURE IS CONCERNING FOR VALVE DURABILITY. FURTHER COMPARISON TO OTHER BIOPROSTHETIC VALVES AND LONGER TERM FOLLOW-UP ARE REQUIRED TO CHARACTERIZE THE MECHANISM OF FAILURES. [(B)(6).] POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION. *PATIENT 4*.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17684108 ↗
• InjuryAug 31, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2016, A 23MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE AT THE BEGINNING OF 2023, THE PATIENT STARTED EXPERIENCING SEVERE SHORTNESS OF BREATH. TESTING REVEALED SIGNIFICANT CHANGES ON ECHOCARDIOGRAMS. ON (B)(6) 2023,THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH AN UNKNOWN DEVICE. POST PROCEDURE, THE PATIENT CONTINUED TO HAVE SEVERE SHORTNESS OF BREATH AND MANY LIMITATIONS.

  Patient problems: Dyspnea

  MAUDE report 17662802 ↗
• InjuryJul 7, 2023Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED ON (B)(6) 2013, A 23MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. IT WAS LATER REPORTED ON (B)(6) 2023, THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION. AN ECHOCARDIOGRAPHY CONFIRMED INCREASED PRESSURE GRADIENT DUE TO AORTIC STENOSIS. A DECISION WAS MADE TO EXPLANT THE 23MM TRIFECTA VALVE. THE VALVE WAS REPLACED WITH A 23MM NON-ABBOTT VALVE THAT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. IT WAS OBSERVED THERE WAS CALCIFICATION ON THE EXPLANTED VALVE.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 17282809 ↗
• InjuryJun 25, 2023Calcified; Incomplete Coaptation; Device Stenosis; Calcified; Incomplete Coaptation; Device Stenosis

  THE ARTICLE, "TRANSSEPTAL SNARING TECHNIQUE AS A BAILOUT FROM VALVULOPLASTY BALLOON ENTRAPMENT WITHIN A SELF-EXPANDING VALVE: A CASE REPORT", WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF A 71-YEAR-OLD MAN WITH SEVERE AORTIC STENOSIS DUE TO SURGICAL AORTIC VALVE FAILURE. IT WAS REPORTED THAT ON AN UNKNOWN DATE SIX YEARS PRIOR, THE PATIENT UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT (SAVR) PROCEDURE WITH AN UNKNOWN BIOPROSTHETIC VALVE. ONE YEAR LATER, THE PATIENT PRESENTED TO THE HOSPITAL DUE TO ENDOCARDITIS AND A DECISION WAS MADE TO PERFORM A SECOND SAVR AND EXPLANT THE UNKNOWN VALVE. A 23MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED AND IT WAS CONFIRMED ALL LEAFLETS DEMONSTRATED GOOD MOBILITY. IT WAS REPORTED THE PATIENT HAD MINOR RESIDUAL AORTIC PRESSURE GRADIENT NINE DAYS POST PROCEDURE. IT WAS REPORTED THAT 54 MONTHS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH STENOSIS OF THE TRIFECTA VALVE AND PRESENTED WITH SYSTOLIC HEART MURMUR AND MODERATE AORTIC GRADIENT OF 40MMHG. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 26MM NON-ABBOTT TRANSCATHETER HEART VALVE (THV) THAT WAS IMPLANTED SUCCESSFULLY. IT WAS REPORTED POST-PROCEDURE THE NEXT DAY

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure; Pulmonary Edema

  MAUDE report 17196276 ↗