Trifecta™ TF-19ARecalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 05414734052016), received between Jun 15, 2018 and Jun 12, 2026 — classified as 5 deaths, 103 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (42 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 19MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2020. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25491322 ↗
• InjuryDec 4, 2025Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2016, A 19MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 23MM. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT HAD A OUTPATIENT VISIT AND AN EXACERBATION OF AORTIC REGURGITATION (AR) WAS OBSERVED, BUT HEART FAILURE WAS CONTROLLED WITH DIURETICS. DUE TO THE PATIENT¿S AGE OF 90 AND REFUSAL OF REOPERATION, THE CASE HAD BEEN UNDER OBSERVATION. HOWEVER, IN EARLY (B)(6), THE PATIENT PRESENTED WITH COMPLAINTS OF DYSPNEA AND ECHOCARDIOGRAPHY REVEALED AR, MITRAL REGURGITATION (MR), AND TRICUSPID REGURGITATION (TR), AND REOPERATION WAS DECIDED BASED ON THE PATIENT¿S OWN WILL. ON (B)(6) 2025, A SURGICAL PROCEDURES PERFORMED WERE REDO AORTIC VALVE REPLACEMENT (AVR) AND MITRAL VALVE PROLAPSE WITH TRICUSPID ANNULOPLASTY (MVP WITH TAP). A NEW 19MM EPIC SUPRA VALVE WAS IMPLANTED. A TEAR WAS OBSERVED AT THE JUNCTION BETWEEN RIGHT CORONARY CUSP (RCC) AND NON-CORONARY CUSP (NCC). THE PATIENT WAS REPORTED UNSTABLE.

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

  MAUDE report 23716273 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation; Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2015, A 19MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 24MM. ON AN UNKNOWN DATE IN AUG 2025, A HEART MURMUR WAS NOTED AND THE PATIENT WAS FOLLOWED UP IN THE OUTPATIENT CLINIC. ON AN UNKNOWN DATE IN OCTOBER, THE PATIENT REPORTED EXERTIONAL DYSPNEA INTERFERING WITH DAILY LIFE, PROMPTING ANOTHER OUTPATIENT VISIT AND AN AORTIC REGURGITATION WAS DIAGNOSED BY ECHOCARDIOGRAPHY. A SURGERY WAS PERFORMED, INCLUDING REDO AORTIC VALVE REPLACEMENT (REDO AVR) AND CORONARY ARTERY BYPASS GRAFTING (CABG) OF TWO VESSELS. A 21MM EPIC SUPRA VALVE WAS IMPLANTED IN THE PATIENT. A PANNUS FORMATION WAS OBSERVED ON THE INFLOW SIDE OF THE VALVE. APPROXIMATELY ONE-THIRD OF THE RIGHT CORONARY CUSP (RCC) IS TORN, AND AN ADDITIONAL TEAR IS PRESENT AT THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP (LCC) AND THE RCC. THE PATIENT WAS REPORTED STABLE.

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

  MAUDE report 23618847 ↗
• InjuryJun 9, 2025Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis; Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2015, A 19MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL DUE TO SUSPECTED HEART FAILURE. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 20MM. A CORONARY ANGIOGRAM (CAG) REVEALED STENOSIS IN LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA). BASED ON ULTRASOUND EXAMINATION, THE BLOOD FLOW VELOCITY WAS NOTED TO BE HIGH, THEREFORE, THE PATIENT WAS ALSO DIAGNOSED WITH AORTIC STENOSIS. ON (B)(6) 2025, A PROCEDURE WAS PERFORMED AS THE PATIENT REPORTED DYSPNEA ON EXERTION. THE VALVE WAS EXPLANTED AND A NEW 19MM EPIC PLUS SUPRA VALVE WAS IMPLANTED. A PANNUS WAS NOTED CIRCUMFERENTIALLY ON THE OUTFLOW SIDE OF THE EXPLANTED TRIFECTA VALVE. ADDITIONALLY, PANNUS WAS NOTED ON INFLOW SIDE, AND THE LEAFLET CORRESPONDING TO THE LEFT CORONARY CUSP (LCC) WAS COMPLETELY CALCIFIED AND IMMOBILE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 22167296 ↗
• InjuryJun 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2021 DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. ECHO IMAGING WAS PERFORMED AND REVEALED SEVERE AORTIC REGURGITATION. THE TRIFECTA WAS EXPLANTED AND A TEAR WAS OBSERVED ALONG THE STENT BETWEEN THE LEFT AND RIGHT CORONARY CUSPS. A 19MM NON-ABBOTT WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22122858 ↗
• InjuryNov 22, 2024Calcified; Material Puncture/Hole; Patient-Device Incompatibility; Intravalvular regurgitation; Calcified; Material Puncture/Hole; Patient-Device Incompatibility; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2014, A 19MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE NATIVE AORTIC VALVE ANNULUS WAS MEASURED AS 25MM. ON (B)(6) 2024, THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE, INCLUDING SHORTNESS OF BREATH AND PALPITATIONS. AN ECHOCARDIOGRAM REVEALED AORTIC REGURGITATION. ON (B)(6) 2024, THE VALVE WAS EXPLANTED, AND A HOLE WAS FOUND IN THE NON-CORONARY CUSP (NCC) OF THE VALVE. IT WAS OBSERVED THAT THERE WAS A SUTURE NEAR THE AREA, AND IT WAS BELIEVED THAT THIS SUTURE ADHERED TO THE NCC, CAUSING THE HOLE. PANNUS AND CALCIFICATION WAS ALSO NOTED ON THE VALVE. A 23MM EPIC PLUS VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 20759464 ↗
• InjuryOct 4, 2024Patient-Device Incompatibility; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation; Patient-Device Incompatibility; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2015, A 19MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2024, STRUCTURAL VALVE DETERIORATION (SVD) AND LEAFLET TEAR WERE CONFIRMED BY ECHOCARDIOGRAPHY. ON (B)(6) 2024, THE VALVE WAS EXPLANTED. THE VALVE HAD STENOSIS, REGURGITATION, PANNUS, AND SVD. THE VALVE WAS REPLACED WITH A 17MM SJM REGENT HEART VALVE WITH FLEX CUFF. THE PATIENT STATUS WAS REPORTED AS STABLE.

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

  MAUDE report 20368388 ↗
• InjuryOct 2, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  THE ARTICLE, "FIRST-IN-HUMAN: LEAFLET LACERATION WITH BALLOON MEDIATED ANNIHILATION TO PREVENT CORONARY OBSTRUCTION WITH RADIOFREQUENCY NEEDLE (LLAMACORN) FOR VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT" WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 84 YRS OLD PATIENT WITH NEW YORK HEART ASSOCIATION (NYHA) III DYSPNEA AND CHRONIC CORONARY SYNDROMES (CCS) III ANGINA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED. IT WAS THEN REPORTED THE PATIENT PRESENTED SEVERE AORTIC STENOSIS DUE TO DEGENERATED AORTIC VALVE BIOPROSTHESIS. AORTIC STENOSIS (AS), LEFT VENTRICULAR EJECTION FRACTION (LVEF) 58%, MAVG 36 MMHG, DIMENSIONLESS VELOCITY INDEX (DVI) 0.2, 2D, EOA0.5CM2; 3+ TRANSVALVULAR AR. CARDIAC COMPUTED TOMOGRAPHY REVEALED LEFT MAIN CORONARY ARTERY(LMCA) HEIGHT 8.8 MM, VENTRICULAR TACHYCARDIA (VTC) 38.8MM. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 23MM NAVITOR VALVE IN DEGENERATIVE 21 MM TRIFECTA (ABBOTT) AORTIC PROSTHESIS. THE PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA IN THE CARDIAC CATHETERIZATION LABORATORY WITH FLUOROSCOPIC AND TRANSOESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE. INTRAVENOUS UNFRA

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

  MAUDE report 20352426 ↗
• InjuryAug 14, 2024Patient-Device Incompatibility; Material Split, Cut or Torn; Patient-Device Incompatibility; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2017, A 19MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2024, IT WAS REPORTED THAT A 19MM TRIFECTA WAS EXPLANTED SINCE THE DEVICE HAS BEEN TORN, AND WAS CAUSING AR (AORTIC VALVE REGURGITATION), DYSPNEA, CONFIRMED BY ECHOCARDIOGRAMS. UPON EXPLANT, A TEAR WAS NOTED FROM THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP (LCC),AND THE RIGHT CORONARY CUSP (RCC). THERE WAS ALSO PANNUS NOTED ON THE VALVE. A 23MM EPIC PLUS SUPRAWAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. PATIENT CONDITION IS STABLE,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 19983825 ↗
• InjuryJan 11, 2024Incomplete Coaptation; No Apparent Adverse Event; Device Stenosis; Intravalvular regurgitation; Incomplete Coaptation; No Apparent Adverse Event; Device Stenosis; Intravalvular regurgitation

  USER FACILITY MEDWATCH REPORT MW5148474 RECEIVED THAT STATES "THE PATIENT UNDERWENT A 19MM TRIFECTA PULMONARY VALVE REPLACEMENT ON (B)(6) 2015 FOR TETRALOGY OF FALLOT. IN (B)(6) 2019 THE PATIENT DEVELOPED SEVERE PULMONARY STENOSIS AND INSUFFICIENCY REQUIRING A BALLOON VALVULOPLASTY. THEN IN (B)(6) 2021 THE PATIENT RE-DEVELOPED PULMONARY STENOSIS REQUIRING ANOTHER BALLOON VALVULOPLASTY. IN (B)(6) 2023 THE PATIENT HAD TO UNDERGO A THIRD BALLOON VALVULOPLASTY FOR REDEVELOPMENT OF PULMONARY STENOSIS. DURING THE VALVULOPLASTY IT WAS NOTED THAT THE HEART VALVE WAS AT 17MM. THE PATIENT DOES HAVE SEVERE INSUFFICIENCY WITH FIXED LEAFLETS OF HER BIOPROSTHETIC VALVE, HER VALVE TRUE ID IS 17MM AND CANNOT BE EXPANDED OR FRACTURED. THE PATIENT NOW HAS SEVERE PULMONARY INSUFFICIENCY, DILATED RIGHT VENTRICLE AND EXERCISE INTOLERANCE. THE TEAM HAS DISCUSSED HER CASE AND THE NEXT INTERVENTION WILL NEED TO BE SURGICAL VALVE REPLACEMENT DUE TO THE SIZE CONSTRAINTS OF THE VALVE." IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2015, A 19MM TRIFECTA PULMONARY VALVE WAS IMPLANTED TO TREAT A CASE OF TETRALOGY OF FALLOT. IN 2019, THE PATIENT DEVELOPED SEVERE PULMONARY STENOSIS AND PULMONARY VALVE INSUFFICIENCY.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 18499661 ↗
• InjuryDec 13, 2023Calcified; Patient-Device Incompatibility; Patient Device Interaction Problem; Device Stenosis; Calcified; Patient-Device Incompatibility; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014, A 19MM TRIFECTA VALVE WAS IMPLANTED IN AN AORTIC VALVE REPLACEMENT. THE NATIVE VALVE DIMENSION WAS 22MM. IN (B)(6) 2022, PROGRESSION OF AORTIC STENOSIS BECAME APPARENT WITH A VALVE PRESSURE GRADIENT OF 40MMHG. IN (B)(6) 2023, THE PATIENT HAD A VALVE PRESSURE GRADIENT OF 40MMHG AND WORSENING DYSPNEA, AND THE PATIENT WAS URGENTLY HOSPITALIZED DUE TO SIGNS OF HEART FAILURE. ON (B)(6) 2023, THE 19MM TRIFECTA VALVE WAS EXPLANTED. VISUALIZATION OF THE EXPLANTED VALVE EXHIBITED PANNUS, CALCIFICATION, AND THROMBUS. THROMBUS COULD NOT BE CONFIRMED VIA ECHOCARDIOGRAM PREVIOUSLY. A REPLACEMENT 21MM EPIC SUPRA VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 18322141 ↗
• InjuryDec 12, 2023Off-Label Use; Device Stenosis; Intravalvular regurgitation; Off-Label Use; Device Stenosis; Intravalvular regurgitation

  USER FACILITY MEDWATCH REPORT WAS RECEIVED THAT STATES "THE PATIENT UNDERWENT A 19MM TRIFECTA PULMONARY VALVE REPLACEMENT ON (B)(6) 2015 FOR TETRALOGY OF FALLAT. IN (B)(6) 2019 THE PATIENT DEVELOPED SEVERE PULMONARY STENOSIS AND INSUFFICIENCY REQUIRING A BALLOON VALVULOPLASTY. THEN IN (B)(6) 2021 THE PATIENT RE-DEVELOPED PULMONARY STENOSIS REQUIRING ANOTHER BALLOON VALVULOPLASTY. IN (B)(6) 2023 THE PATIENT HAD TO UNDERGO A THIRD BALLOON VALVULOPLASTY FOR REDEVELOPMENT OF PULMONARY STENOSIS. DURING THE VALVULOPLASTY IT WAS NOTED THAT THE HEART VALVE WAS AT 17MM. THE PATIENT DOES HAVE SEVERE INSUFFICIENCY WITH FIXED LEAFLETS OF HER BIOPROSTHETIC VALVE. HER VALVE TRUE ID IS 17MM AND CANNOT BE EXPANDED OR FRACTURED. THE PATIENT NOW HAS SEVERE PULMONARY INSUFFICIENCY DILATED RIGHT VENTRICLE AND EXERCISE INTOLERANCE. THE TEAM HAS DISCUSSED HER CASE AND THE NEXT INTERVENTION WILL NEED TO BE SURGICAL VALVE REPLACEMENT DUE TO THE SIZE CONSTRAINTS OF THE VALVE." IT WAS REPORTED THAT ON (B)(6) 2015 A 19MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT DUE TO PULMONARY VALVE TETRALOGY OF FOLLAT. IN (B)(6) 2019 THE PATIENT DEVELOPED SEVERE PULMONARY STENOSIS AND INSUFFICIENCY REQUIRING A BALLOON VAL

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

  MAUDE report 18314885 ↗
• InjuryNov 20, 2023Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  THE ARTICLE, "CHIMNEY STENTING FOR RIGHT CORONARY ARTERY AT HIGH-RISK OF OBSTRUCTION WITH FLAIL LEAFLET IN TAV-IN-SAV", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 92-YEAR-OLD FEMALE WITH SEVERE AORTIC STENOSIS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS CHOSEN FOR IMPLANT. IT WAS THEN REPORTED SEVEN YEARS POST-PROCEDURE, THE PATIENT WAS HOSPITALIZED WITH ACUTE HEART FAILURE AND REQUIRED CATECHOLAMINE AND NON-INVASIVE POSITIVE PRESSURE VENTILATION. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED AORTIC REGURGITATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED PROLAPSE OF THE VALVE LEAFLET CORRESPONDING TO THE RIGHT CORONARY CUSP AND SEVERE TRANSVALVULAR REGURGITATION. A DECISION WAS MADE TO PROTECT THE RIGHT CORONARY ARTERY (RCA) VIA CHIMNEY STENT PROCEDURE FROM THE OSTIUM OF THE RCA ABOVE THE TRIFECTA VALVE. A 23MM EVOLUT PRO+ VALVE WAS THEN CHOSEN FOR IMPLANT FOR TRANSCATHETER VALVE-IN-VALVE PROCEDURE. [THE PRIMARY AUTHOR WAS JIRO SAKAMOTO, TENRI HOSPITAL, 200 MISHIMACHO, TENRI, NARA 632-0015, JAPAN].

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18171927 ↗
• InjuryNov 16, 2023Device Damaged by Another Device; Material Deformation; Intravalvular regurgitation; Device Damaged by Another Device; Material Deformation; Intravalvular regurgitation

  THE ARTICLE, "TRANSCATHETER HEART VALVE STUCK IN A SURGICAL BIOPROSTHESIS DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 77-YEAR-OLD MAN. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED. IT WAS LATER REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH SEVERE TRANSVALVULAR AORTIC REGURGITATION (AR) DUE TO STRUCTURAL VALVE DEGENERATION OF THE 19MM TRIFECTA VALVE. A DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE (VIV) PROCEDURE WITH A 23MM EVOLUT PRO+ (MEDTRONIC). PRE-PROCEDURAL MULTIDETECTOR COMPUTED TOMOGRAPHY (MDCT) NOTED THE TRIFECTA VALVE HAD BEEN OBLIQUELY IMPLANTED. DURING PROCEDURE, THE STENT POST OF THE TRIFECTA VALVE HAD PROTRUDED INTO THE EVOLUT PRO+ STRUT AND BECAME DEFORMED WHEN ATTEMPTING TO RESHEATH THE EVOLUT PRO+. THE EVOLUT PRO+ SYSTEM WAS FORCEFULLY WITHDRAWN FROM THE TRIFECTA WHICH RESULTED IN SERIOUS LEAFLET DAMAGE TO THE TRIFECTA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR TORRENTIAL AR. THE EVOLUT PRO+ VALVE WAS SUCCESSFULLY IMPLANTED DURING THE SECOND ATTEMPT AND HEMODYNAMICS WERE STABILIZED. THE ARTICLE CONCLUDED ATTENTION SHOULD BE PAID TO THE RISK OF

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18148976 ↗
• InjuryOct 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2023, A RE-DO PROCEDURE WAS PERFORMED WITH THE 19MM TRIFECTA BEING EXPLANTED DUE TO SEPARATED LEAFLET. A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Insufficient Information

  MAUDE report 17987592 ↗
• InjuryAug 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON 17 MAY 2014, A 19MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN THE AORTIC VALVE POSITION. THE NATIVE VALVE ANNULUS WAS MEASURED TO BE 21MM. IN MARCH OF 2023, AORTIC REGURGITATION WAS CONFIRMED AT THE OUTPATIENT CLINIC. THERE WERE NO SUBJECTIVE SYMPTOMS ASSOCIATED THE REGURGITATION. ON (B)(6) 2023, THE TRIFECTA VALVE WAS EXPLANTED AND A 19MM NON-ABBOTT VALVE WAS IMPLANTED. A TEAR WAS OBSERVED ON THE EXPLANTED TRIFECTA VALVE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17445747 ↗
• InjuryJul 28, 2023Patient-Device Incompatibility; Device Stenosis; Intravalvular regurgitation; Patient-Device Incompatibility; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2016, A 19MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2016, A TRANSVALVULAR LEAK WAS FOUND AT CENTER POSITION. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE FACILITY AND WAS DIAGNOSED WITH AORTIC STENOSIS. A LIGHT TO MODERATE TRANSVALVULAR LEAK WAS NOTED AT THE CENTER POSITION. ON (B)(6) 2022, A MODERATE TRANSVALVULAR LEAK WAS NOTED AT THE CENTER POSITION, AND AORTIC STENOSIS WAS OBSERVED. ON (B)(6) 2023, A TRANSVALVULAR LEAK WAS RECOGNIZED AT THE CENTER POSITION, AND AORTIC STENOSIS WAS OBSERVED. MODERATE AORTIC REGURGITATION AND VALVULAR INSUFFICIENCY WERE NOTED. STRUCTURAL VALVE DETERIORIATION (SVD) WAS SUSPECTED. FROM (B)(6) 2023 TO (B)(6) 2023, THE PATIENT WAS ADMITTED FOR HEART FAILURE. ON (B)(6) 2023, THE 19MM TRIFECTA VALVE WAS EXPLANTED. THE N SIDE OF THE LEFT CORONARY CUSP (LCC) AND THE RIGHT SIDE OF THE NON-CORONARY CUSP (NCC) WERE COMPLETELY DISCONNECTED. A RING-SHAPED PANNUS HAD FORMED UNDER THE VALVE. A 19MM NON-ABBOTT VALVE WAS IMPLANTED AS A REPLACEMENT. THE PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 17414449 ↗
• InjuryJul 26, 2023Calcified; Device Stenosis; Calcified; Device Stenosis

  N/A.

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

  MAUDE report 17399257 ↗
• InjuryJul 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  . THE ARTICLE, ¿PERCUTANEOUS RETRIEVAL OF AN AORTIC VALVE VEGETATION CAUSING SEVERE REGURGITATION AND CARDIOGENIC SHOCK¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 82-YEAR-OLD WOMAN WITH A HISTORY OF ATRIAL FIBRILLATION, INTERSTITIAL LUNG DISEASE, AND A BICUSPID AORTIC VALVE COMPLICATED BY SEVERE AORTIC STENOSIS AFTER TWO PRIOR SURGICAL VALVE REPLACEMENTS. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2017, A 19MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. IT WAS LATER REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH DYSPNEA AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED A MOBILE VEGETATION (ENDOCARDITIS LESION) ON THE VALVE CAUSING SEVERE AORTIC REGURGITATION. IT WAS REPORTED THE PATIENT COMPLETED ANTIBIOTIC TREATMENT WHEN THEY EXPERIENCED CARDIOGENIC SHOCK WITH END ORGAN HYPOPERFUSION. A DECISION WAS MADE TO PERFORM A TRANSCATHETER DEBULKING OF THE VEGETATION. AFTER SNARING THE VEGETATION, IT WAS REMOVED VIA ELECTROCAUTERY AND PROMPTLY ASPIRATED. A 23MM EVOLUT VALVE WAS THEN IMPLANTED IN THE PATIENT. THE PATIENT WAS DISCHARGED AFTER THE 4TH DAY AND WAS ASYMPTOMATIC AFTER 3 MONTHS. THE ARTICLE CONCLUDED SEVERE BIOPROSTHETIC VALVE REGURGITATION IS A LIFE-THREATENING CO

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

  MAUDE report 17356112 ↗
• InjuryJul 6, 2023Degraded; Device Stenosis; Intravalvular regurgitation; Degraded; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 19MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. PRIOR TO IMPLANT, THE ANNULUS SIZE WAS MEASURED TO BE 19MM. ON (B)(6) 2020, THE PATIENT STATED THAT THEY BEGAN TO EXPERIENCE CHEST PAIN. A TRANSTHORACIC ECHOCARDIOGRAM AND ANGIOGRAM WERE PERFORMED, AND THE PATIENT WAS ADVISED FOR AORTIC VALVE REPLACEMENT DUE TO AORTIC STENOSIS, STRUCTURAL VALVE DETERIORATION, ATRIAL REGURGITATION (AR). THE PATIENT WAS REPORTED AS STABLE AND WAS PLANNING FOR VALVE REPLACEMENT IN THE FUTURE. THE VALVE WAS NOT SURGICALLY REPLACED AT THE TIME OF LAST REPORT.

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

  MAUDE report 17270782 ↗
• InjuryJun 23, 2023Calcified; Device Stenosis; Calcified; Device Stenosis

  THE ARTICLE, "IN-STENT RESTENOSIS PERCUTANEOUS CORONARY INTERVENTION AFTER CHIMNEY STENTING DURING TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 82-YEAR-OLD WOMAN WITH PRIOR AORTIC VALVE REPLACEMENT IN 2012. IT WAS REPORTED ON AN UNKNOWN DATE IN 2012, A 19MM TRIFECTA VALVE WAS IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL IN MARCH 2021 DUE TO HEART FAILURE AND UNSTABLE ANGINA. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED A DEGENERATED BIOLOGICAL AORTIC PROSTHESIS WITH SEVERE STENOSIS, AND CORONARY ANGIOGRAPHY (CA) SHOWED A SEVERELY CALCIFIED, CRITICAL STENOSIS IN THE RIGHT CORONARY ARTERY (RCA) OSTIUM. MULTISLICE COMPUTED TOMOGRAPHY (MSCT) CONFIRMED SEVERE RCA OSTIUM CALCIFICATION AND SHOWED A CONSIDERABLE RISK OF RCA OBSTRUCTION WITH TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION (VIV-TAVI). A DECISION WAS MADE TO PERFORM SIMULTANEOUS VIV-TAVI AND PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RCA USING A CHIMNEY STENTING TECHNIQUE WITH A 4X30MM DRUG-ELUTING STENT AND A 23MM NON-ABBOTT TRANSCATHETER HEART VALVE. THE PATIENT WAS DISCHARGED UNEVENTFULLY WITH NO REPORT OF ADVERSE PATIENT EFFECTS. THE ARTICLE CON

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

  MAUDE report 17195159 ↗
• InjuryJun 1, 2023Patient-Device Incompatibility; Device Stenosis; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED ON (B)(6) 2016, A 19MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON A LATER DATE, LATER IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AORTIC STENOSIS, AND ADHESION BETWEEN PANNUS AND THE AORTIC WALL WAS OBSERVED. ON (B)(6) 2023, TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT VALVE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17042808 ↗
• InjuryMay 24, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2011, A 19MM TRIFECTA VALVE WAS IMPLANTED. THE VALVE LATER FAILED DUE TO AORTIC STENOSIS. ON (B)(6) 2021, A 23MM PORTICO VALVE WAS IMPLANTED VIA A VALVE-IN-VALVE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16998537 ↗
• InjuryMay 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE EIGHT YEARS AGO, A 19MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. ON AN UNKNOWN DATE, ACUTE CARDIAC INSUFFICIENCY WAS CONFIRMED, CAUSED BY A TEAR IN A VALVE LEAFLET. ON (B)(6) 2023, THE VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN SIZE NON-ABBOTT TISSUE VALVE. THE PATIENT WAS REPORTED AS RECOVERING UNEVENTFULLY AFTER THE SURGERY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16847727 ↗
• DeathApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ABSTRACT ARTICLE, "TRIFECTA BIOPROSTHESES: EVALUATION OF THE SAFETY BASED ON THE STUDY OF DEGENERATIONS ACCORDING TO THE VARC-3 CLASSIFICATION", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE INTRINSIC IMPUTABILITY OF TRIFECTA FOR DYSFUNCTION ACCORDING TO THE VARC-3 CLASSIFICATION IN PATIENTS IMPLANTED AND TO REASSESS THEIR REFERENCING IN OUR CENTER. TRIFECTA VALVE WAS THE DEVICE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED, THE CLASSIFICATION OF FAILURES ACCORDING TO VARC-3 INDICATED THE INTRINSIC IMPUTABILITY OF THE TRIFECTA¿ BIOPROSTHESES REGARDING TO THE NUMBER OF SVD-TYPE DYSFUNCTIONS. ALTHOUGH THIS STUDY HAS LIMITATIONS, IT SHOWS THE UNDERSTATEMENT OF MEDICAL-DEVICES-VIGILANCE CASES BY THE MEDICAL STAFF. [THE PRIMARY AUTHOR OF THIS ARTICLE IS RICHEZ, OPHELIE, AMIENS-PICARDIE UNIVERSITY HOSPITAL, 1 ROND-POINT DU PROFESSEUR CHRISTIAN CABROL, 80054 AMIENS, FRANCE, WITH EMAIL ADDRESS OF : [email protected]]. IT WAS REPORTED THAT IN OCTOBER 2011, A 19MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT WITH AORTIC NARROWING. IN JANUARY 2013, THE PATIENT PRESENTED WITH INFECTIVE ENDOCARDITIS EXTENDED IN THE SUB-AORTIC TRIG

  Patient problems: Endocarditis

  MAUDE report 16816204 ↗