Trifecta™ TF-21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 05414734052023), received between Jun 27, 2018 and Jun 17, 2026 — classified as 12 deaths, 175 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (56 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 191 reports, in the reporter's own words as published by the FDA.

• DeathJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 21A MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25537810 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 21MM TRIFECTA VALVE WAS IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2014. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2014. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25488343 ↗
• InjuryOct 24, 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) 2013, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. THE ANNULAR DIMENSION OF THE NATIVE VALVE WAS 26 MM. ON EARLY (B)(6) THE PATIENT SEEN WITH COMPLAINTS OF HEART FAILURE SYMPTOMS, INCLUDING SHORTNESS OF BREATH AND EXERTIONAL DYSPNEA. UPON ECHOCARDIOGRAPHIC EXAMINATION, AORTIC REGURGITATION (AR) WAS IDENTIFIED, AND THE PATIENT WAS TEMPORARILY HOSPITALIZED FOR MEDICAL CARE. AS THE HEART FAILURE SYMPTOMS HAVE NOT IMPROVED, REOPERATION HAS BEEN SCHEDULED. A NEW 25MM EPIC SUPRA VALVE WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED STABLE.

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

  MAUDE report 23378766 ↗
• InjuryOct 20, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2018, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE FOLLOW UP IMAGING SHOWED HIGH GRADIENT AND IT WAS NOTED THAT THE VALVE WAS STENOSED. A NEW 23MM NAVITOR VISION VALVE WAS CHOSEN AND A VALVE-IN-VALVE PROCEDURE WAS PERFORMED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23337197 ↗
• InjuryAug 19, 2025Calcified; Patient-Device Incompatibility; Device Stenosis; Calcified; Patient-Device Incompatibility; Device Stenosis

  N/A.

  Patient problems: Aortic Valve Stenosis; Arrhythmia; Dyspnea

  MAUDE report 22846477 ↗
• InjuryJul 14, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014, A 21MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH SEVERE AORTIC VALVE STENOSIS. THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND NUMERICAL DATA FROM THE ECHOCARDIOGRAM CONFIRMED THE CONDITION. ON (B)(6) 2025, THE DECISION WAS MADE TO EXPLANT THE 21MM TRIFECTA VALVE AND REPLACE IT WITH A 21MM EPIC PLUS SUPRA VALVE. THE CAUSE OF AORTIC STENOSIS IS ATTRIBUTED TO CALCIFICATION OF THE VALVE LEAFLETS. THE EXPLANTED CALCIFIED VALVE HAD A PART OF THE LEAFLET REMOVED DURING EXPLANT DUE TO BEING CALCIFIED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 22495113 ↗
• InjuryMay 2, 2025Patient-Device Incompatibility; Device Stenosis; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN IN (B)(6) 2024, THE PATIENT PRESENTED WITH HIGH GRADIENT, FATIGUE AND SHORTNESS OF BREATH AND A STRUCTURAL DETERIORATION WAS NOTED. ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND A 25MM NON-ABBOTT VALVE WAS IMPLANTED. A SEVERE CALCIFICATION AND LEAFLET THICKENING WITH STENOSIS WAS NOTED ON THE EXPLANTED VALVE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 21950141 ↗
• InjuryApr 4, 2025Calcified; Patient-Device Incompatibility; Device Stenosis; Calcified; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2016, A 21MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2025, IT WAS NOTED VIA ECHOCARDIOGRAM THAT THE PATIENT HAD INCREASED AORTIC VALVE GRADIENTS AND SYNCOPE. THE PATIENT ALSO HAD MITRAL VALVE STENOSIS OF A 27MM NON-ABBOTT DEVICE. THE PATIENT ALSO EXHIBITED SYMPTOMS OF SHORTNESS OF BREATH, AND DIZZINESS. THERE WAS NO AORTIC REGURGITATION PRESENT OR CHRONIC RENAL INSUFFICIENCY. ON (B)(6) 2025, THE DECISION WAS MADE TO EXPLANT THE 21MM TRIFECTA VALVE AND REPLACE IT WITH A 21MM EPIC PLUS SUPRA VALVE. THE VALVE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITHOUT HANDLING THE VALVE WITH ANY UNPROTECTED FORCEPS OR SHARP INSTRUMENTS. THE EXPLANTED 21MM TRIFECTA VALVE HAD NO TEAR OBSERVED IN THE LEAFLETS OR SUTURE CUFF. HOWEVER, THE VALVE WAS FOUND TO HAVE FIBROSIS, PANNUS, AND CALCIFICATION. THERE WAS NO NOTED INTERACTION BETWEEN ANY STENT POST AND PATIENT ANATOMY. THE PATIENT DOES NOT HAVE OTHER COMORBIDITIES THAT MAY IMPACT CALCIUM METABOLISM AND DOES NOT TAKE CALCIUM SUPPLEMENTS. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Movement Disorder; Syncope/Fainting

  MAUDE report 21774056 ↗
• InjuryFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2016, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21448893 ↗
• DeathNov 22, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2014, A 21MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED, WHICH SHOWED WORSENING AORTIC STENOSIS. DURING THE PRE-SURGICAL WORKUP, IT WAS DETERMINED THAT THE PATIENT HAD A LOW LEFT MAIN CORONARY OSTIUM AND A 6X4X5CM TISSUE MASS IN THE RIGHT CARDIOPHRENIC ANGLE CONTINUOUS WITH THE PERICARDIUM. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION OF TRANSCATHETER AORTIC VALVE REPLACEMENT VS. SURGICAL AORTIC VALVE REPLACEMENT. ON (B)(6) 2019, THE PATIENT HAD A HEART CATHETERIZATION PERFORMED, WHICH DEMONSTRATED MILD BILATERAL ENLARGEMENT, SEVERE AORTIC STENOSIS, MODERATE AORTIC REGURGITATION, MODERATE MITRAL REGURGITATION, DILATED MILDLY HYPOKINETIC LEFT VENTRICLE, AND A MAL-POSITIONED PROSTHETIC AORTIC VALVE. THE PATIENT WAS VOLUME OVERLOADED WITH A WEDGE PRESSURE OF 35MMHG. THE PATIENT WAS ADMITTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) WITH CONGESTIVE HEART FAILURE. ON (B)(6) 2019, THE SURGERY SERVICE NOTED THAT THE PATIENT NEEDED A REDO SURGICAL PROSTHETIC VALVE. ON (B)(6) 2019, A REPEAT ECH

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

  MAUDE report 20759472 ↗
• InjuryOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2016, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, THE TRIFECTA VALVE WAS EXPLANTED AND A UNKNOWN SIZE VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20567420 ↗
• InjuryOct 2, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  THE ARTICLE, "AORTIC DISSECTION EXTENDING INTO THE INTERVENTRICULAR SEPTUM FOLLOWING RE-DO AORTIC VALVE REPLACEMENT SURGERY IN A PATIENT WITH TAKAYASU¿S ARTERITIS: A RARE CASE REPORT" WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 39-YEAR-OLD FEMALE WITH A HISTORY OF MILD AORTIC REGURGITATION (AR) EXPERIENCED A WORSENING OF DYSPNEA FOR SEVERAL MONTHS, DESPITE RECEIVING TREATMENT WITH DIURETICS AND ARB. THE PATIENT HAD NO HYPERTENSION NOR FAMILY HISTORY OF CARDIOVASCULAR DISEASE. EXAMINATION REVEALED GRADE III/VI TO-AND-FRO MURMUR AT THE LEFT LOWER STERNAL BORDER. ECHOCARDIOGRAPHY REVEALED LEFT VENTRICLE (LV) DILATION, PRESERVED LV EJECTION FRACTION, AND PROGRESSION TO SEVERE AR WITHOUT AN APPARENT CAUSE. THE PATIENT SUBSEQUENTLY UNDERWENT AORTIC VALVE REPLACEMENT WITH A MECHANICAL VALVE DUE TO SYMPTOMATIC SEVERE AR. THE PATIENT EXPERIENCED INTERMITTENT FEVER FOR ONE MONTH AT APPROXIMATELY THREE YEARS AFTER THE OPERATION, AT WHICH TIME ECHOCARDIOGRAPHY SHOWED MODERATE PARAVALVULAR AR AND PARTIAL DIS-ADHESION OF THE MECHANICAL AORTIC VALVE WITH A FLUTTERING MASS. THE PATIENT SUBSEQUENTLY RECEIVED RE-DO AORTIC VALVE REPLACEMENT WITH A BIOPROSTHETIC VALVE 21MM TRIFECTA VALVE DUE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Dyspnea; Fever; Heart Block; Pseudoaneurysm

  MAUDE report 20352630 ↗
• InjuryOct 2, 2024Degraded; Degraded

  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 . IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 21MM TRIFECTA VALVE WAS IMPLANTED. IT WAS THEN REPORTED THE PATIENT PRESENTED WITH DEGENERATED AORTIC VALVE BIOPROSTHESIS. LEFT VENTRICULAR EJECTION FRACTION (LVEF) 60%, DIMENSIONLESS VELOCITY INDEX (DVI) 0.40, 2D, 4+ TRANSVALVULAR AR. CARDIAC COMPUTED TOMOGRAPHY REVEALED LEFT MAIN CORONARY ARTERY(LMCA) HEIGHT 8.5 MM, VENTRICULAR TACHYCARDIA (VTC) 3.0. MM. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 23MM NAVITOR VALVE. 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 UNFRACTIONATED HEPARIN WAS ADMINISTERED TO AN ACTIVATED CLOTTING TIME OF >300. TO PREVENT CORONARY OBSTRUCTION DURING TRANSC

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 20352586 ↗
• InjuryOct 2, 2024Device Stenosis; Device Stenosis

  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 83 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 21MM 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) 65%, MAVG 48 MMHG, DIMENSIONLESS VELOCITY INDEX (DVI) 0.20, 2D, PLANIMETRY OF BIOPROSTHETIC AORTIC VALVE ORIFICE 0.41CM2. CARDIAC COMPUTED TOMOGRAPHY REVEALED LEFT MAIN CORONARY ARTERY(LMCA) HEIGHT 6.4 MM, VENTRICULAR TACHYCARDIA (VTC) 31.1MM. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 23MM NAVITOR VALVE. 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) GU

  Patient problems: Angina; Aortic Valve Stenosis; Dyspnea

  MAUDE report 20352583 ↗
• InjuryAug 29, 2024Patient-Device Incompatibility; Device Stenosis; Patient-Device Incompatibility; Device Stenosis

  N/A.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 20102868 ↗
• InjuryJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2015, A 21MM TRIFECTA AORTIC VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT "SURGERY TO REPLACE IT." THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459230 ↗
• InjuryMar 6, 2024Device Stenosis; Device Stenosis

  THE ARTICLE, "COR-KNOT USE IN SAVR FACILITATES COPLANAR ANGLE ADJUSTMENT DURING TAVR", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 84-YEAR-OLD FEMALE PATIENT WITH CHRONIC RENAL FAILURE, WITH ESTIMATED GLOMERULAR FILTRATION RATE OF 31 ML/MIN/M2. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2016, A 21MM TRIFECTA VALVE WAS IMPLANTED. IT WAS THEN REPORTED ON AN UNKNOWN DATE POST-PROCEDURE, THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS WITH A MEAN PRESSURE GRADIENT OF 96MMHG. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WITH A 23MM EVOLUT PRO PLUS VALVE. IT WAS ALSO REPORTED PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED COR-KNOTS IN HER AORTIC ANNULUS. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY WITHOUT RENAL INJURY. [THE PRIMARY AND CORRESPONDING AUTHOR WAS (B)(6).]

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18849822 ↗
• InjuryFeb 6, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014 A 21MM TRIFECTA VALVE (TF-21A, 180110465) WAS SUCCESSFULLY IMPLANTED DURING AORTIC VALVE REPLACEMENT SURGERY. ON 10 MAY 2023, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF INCREASING DYSPNEA AND BILATERAL LOWER EXTREMITY SWELLING. THE PATIENT WAS DIAGNOSED WITH CARDIOMYOPATHY, CONGESTIVE HEART FAILURE, SEVERE STENOSIS AND AORTIC VALVE DISORDER. THE LEAFLETS WERE OBSERVED TO BE OPENING MINIMALLY. THE PATIENT WAS ADMITTED FOR TREATMENT AND WAS STABILIZED. ON (B)(6) 2023, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT SURGERY TO REPLACE THE TRIFECTA VALVE DUE TO DETERIORATION. A 23MM NON-ABBOTT DEVICE WAS IMPLANTED. THE EXPLANTED TRIFECTA VALVE WAS OBSERVED TO HAVE SMALL ADHERENT OF TAN/GREY CALCIFIED TISSUE. THE PATIENT IS REPORTED TO BE ALIVE AND WELL.

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

  MAUDE report 18654900 ↗
• InjuryJan 10, 2024Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation; Patient-Device Incompatibility; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 20 MAY 2016, A 21MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. SOMETIME IN (B)(6) 2023, THE PATIENT RETURNED SYMPTOMATIC WITH AORTIC REGURGITATION GRADE 2. ON (B)(6) 2023, THE TRIFECTA VALVE WAS EXPLANTED AND A REPLACEMENT 23MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED. IN THE EXTRACTED TRIFECTA, THERE WAS A TEAR IN THE COMMISSURAL PART OF LEFT-CORONARY CUSP (LCC) AND RIGHT-CORONARY CUSP (RCC), AND PANNUS WAS TENSED IN INFLOW SIDE IN THE WHOLE CIRCUMFERENCE. THE EXPLANTED VALVE WAS MARKED WITH A BLUE POLYETHYLENE SUTURE ON THE LEAFLET AT LCC. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18485761 ↗
• InjuryDec 28, 2023Degraded; Patient-Device Incompatibility; Intravalvular regurgitation; Degraded; Patient-Device Incompatibility; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 21MM TRIFECTA VALVE WAS IMPLANTED FOR AORTIC VALVE REPAIR (AVR) PROCEDURE WITH A CONCOMITANT CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR CHEST PAIN, BREATHLESSNESS, LOSS OF APPETITE, AND COUGH WITH SPUTUM DUE TO EARLY STRUCTURAL VALVE DETERIORATION. IT WAS REPORTED ON AN UNKNOWN DATE IN (B)(6) 2023, THE PATIENT UNDERWENT REDO SURGICAL AORTIC VALVE REPLACEMENT PROCEDURE.

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

  MAUDE report 18413487 ↗
• InjuryDec 7, 2023Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 21MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2022, THE PATIENT PRESENTED WITH RECURRENT EPISODES OF ARRHYTHMIA AND EXERTIONAL DYSPNEA. ON ULTRASOUND IMAGING, THERE WAS AORTIC VALVE STENOSIS, LEAKAGE, AND CALCIFICATION. ON (B)(6) 2023, THE VALVE WAS EXPLANTED AND REPLACED WITH AN ABBOTT BIOPROSTHETIC VALVE. ON THE EXPLANTED DEVICE, THERE WAS SEVERE AORTIC STENOSIS, VALVE RESECTION, AND ANNULUS CALCIFICATION. THERE WERE NO LEAFLET TEARS. THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 18288681 ↗
• InjuryNov 21, 2023Intravalvular regurgitation; Intravalvular regurgitation

  N/A

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18185292 ↗
• InjuryNov 16, 2023Intravalvular regurgitation; Intravalvular regurgitation

  THE ARTICLE, "TREATMENT OF HEART FAILURE CAUSED BY ACUTE AR CAUSED BY SVD A CASE OF PERFORATION OF THE PULMONARY ARTERY BY A RIGHT HEART CATHETER COMPLICATED BY OVERUSE OF COIL-EMBOLIZATION AND ECMO DRIVEN INFERIOR TAVIN SAV", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 83-YEAR-OLD WOMAN WITH ATRIAL FLUTTER, DYSLIPIDEMIA, AND AORTIC STENOSIS. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 21MM TRIFECTA VALVE WAS IMPLANTED. IT WAS THEN REPORTED NINE YEARS POST-PROCEDURE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH ON EXERTION, AND WAS ADMITTED TO THE HOSPITAL FOR ACUTE CARDIAC INSUFFICIENCY. NONINVASIVE POSITIVE PRESSURE VENTILATION AND DRUG TREATMENT WERE STARTED, BUT THE RESPONSE WAS POOR. TRANSTHORACIC CARDIAC ULTRASONOGRAPHY REVEALED AORTIC REGURGITATION AS CAUSE OF HEART FAILURE WITH SUSPECTED STRUCTURAL VALVE DETERIORATION (SVD) OF THE TRIFECTA VALVE. A SWAN-GANGLIA CATHETER (SGC) WAS PLACED BUT THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST WITH SUSPECTED PULMONARY ARTERY PERFORATION CAUSED BY SGC. AFTER SUCCESSFUL TREATMENT OF PERFORATION VIA PULMONARY ARTERY COIL EMBOLIZATION WITH TARGET XL 8MM/30CM X 1 AND 10MM/40CM X 3, VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGE

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

  MAUDE report 18149134 ↗
• InjuryOct 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE THE AORTIC VALVE. ON (B)(6) 2023, A 25MM NAVITOR VALVE WAS IMPLANTED INTO THE TRIFECTA VALVE IN A VALVE IN VALVE PROCEDURE. THE REASON FOR THE VALVE IN VALVE PROCEDURE IS UNKNOWN. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Insufficient Information

  MAUDE report 18041138 ↗
• InjurySep 18, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2019, A 21MM SJM TRIFECTA VALVE WAS IMPLANTED IN THE AORTIC POSITION, AND THE POST-OPERATIVE MEAN PRESSURE GRADIENT (MPG) WAS 10MMHG. ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED FOR EXERTIONAL DYSPNEA AND TREATED CONSERVATIVELY FOR ACUTE CORONARY SYNDROME (ACS) AND ACUTE DECOMPENSATED HEART FAILURE (ADHF). ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL FOR FURTHER MANAGEMENT. WHEN A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, THE PEAK PRESSURE GRADIENT WAS 60MMHG AND THE MEAN PRESSURE GRADIENT WAS 43MMHG. ON ECHO, THE PEAK PRESSURE GRADIENT WAS 62MMHG AND THE MEAN PRESSURE GRADIENT WAS 39MMHG. THE PATIENT WAS NOT WILLING TO UNDERGO REDO SURGERY. THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT ONCE THE PATIENT COMES BACK, THEY WOULD PLAN FOR REPLACEMENT. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT CLOSEST TO THE EXPLANT PROCEDURE, THE PATIENT HAD A PEAK PRESSURE GRADIENT OF 73MMHG AND MEAN PRESSURE GRADIENT OF 46MMHG, SO THE DECISION WAS MADE TO REPLACE THE DEVICE. THE PATIENT WAS ALSO EXPERIENCING AORTIC REGURGITATION. ON (B)(6) 2023, THE 21MM TRIFECTA VALVE WAS EMERGENTLY EXPLANTED AND

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

  MAUDE report 17769836 ↗