Trifecta™ TF-25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 05414734052047), received between Jul 4, 2018 and Jun 12, 2026 — classified as 9 deaths, 83 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (30 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 96 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2026. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25492055 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA VALVE WAS IMPLANTED ON AN UNKNOWN DATE IN NOVEMBER OF 20123. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON AN UNKNOWN DATE IN (B)(6) OF 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 25491958 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2012. 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 25491795 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2016. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON DD (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 25488117 ↗
• InjuryOct 18, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2014, A 25MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, PATIENT PRESENTED WITH DYSPNEA AND SYNCOPE. THE PHYSICIAN CONFIRMED THE AORTIC VALVE PROSTHESIS HAD EXUBERANT CALCIFICATION AND THERE WAS BOTH STENOSIS AND REGURGITATION. THE VALVE WAS EXPLANTED AND A NEW 21MM NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

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

  MAUDE report 20487244 ↗
• InjuryJun 19, 2024Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2017, A 25MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. SEVEN YEARS AFTER, PATIENT PRESENTED WITH SHORTNESS OF BREATH AND THE IMAGING SHOWED VALVE FAILURE. ON (B)(6) 2024, THE VALVE WAS EXPLANTED AND A NEW 27MM NON-ABBOTT VALVE WAS IMPLANTED AFTER DOING A ROOT ENLARGEMENT. THE EXPLANTED VALVE WAS CALCIFIED. THE PATIENT WAS REPORTED STABLE AND RECOVERING.

  Patient problems: Dyspnea

  MAUDE report 19570829 ↗
• MalfunctionDec 1, 2023Degraded; Degraded

  IT WAS REPORTED THAT ON 08 OCTOBER 2015, A 25MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. ABOUT 6 YEARS POST-PROCEDURE, THE PATIENT EXPERIENCED HEALTH ISSUE. IT WAS NOTED THAT THE DEVICE FAILED

  Patient problems: Insufficient Information

  MAUDE report 18247488 ↗
• InjuryNov 6, 2023Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT IN 2016, A 25MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. LATER ON AN UNKNOWN DATE, THE PATIENT HAD HIGH GRADIENT AND FOLLOW UP IMAGING WITH ECHOCARDIOGRAPHY WAS PERFORMED. STENOSIS AND CALCIFICATION WERE NOTED. ON (B)(6) 2023, A 25MM NAVITOR VALVE WAS IMPLANTED INTO THE TRIFECTA VALVE, IN AN OFF-LABEL VALVE-IN-VALVE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18075018 ↗
• DeathSep 25, 2023Device Stenosis; Device Stenosis

  USER FACILITY MEDWATCH REPORT #MW5144860 RECEIVED THAT STATES "MY HUSBAND, "(B)(6)," BORN ON (B)(6) 1942 RECEIVED A VALVE REPLACEMENT ON (B)(6) 2018. IT FAILED AND DETERIORATED AND HE DIED ON (B)(6) 2023. ABBOTT TRIFECTA TISSUE HEART VALVE; "ST JUDE MEDICAL CENTER". SERIAL NO: (B)(6), MODEL T5-25A; 1-800-344-5833. IT DON'T HAVE ACCESS TO MEDICAL RECORDS. MY HUSBAND WAS ADMITTED TO (B)(6) MEDICAL CENTER ON (B)(6) 2023 AND DIED ON (B)(6) 2023. HOSPITAL ADDRESS AND PHONE: (B)(6), PHONE (B)(6). THERE WERE MULTIPLE TESTS." IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IT WAS LATER REPORTED ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH DYSPNEA AND CONGESTIVE HEART FAILURE DUE TO PROSTHETIC VALVE STENOSIS. PROSTHETIC VALVE STENOSIS WAS CONFIRMED IN ECHOCARDIOGRAPHY WITH HIGH GRADIENT, MEAN GRADIENT OF 56 MMHG, AND A VELOCITY OF GREATER THAN 4.6 M/SEC. IT WAS REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2023 DUE TO ACUTE ON CHRONIC CONGESTIVE HEART FAILURE.

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

  MAUDE report 17809994 ↗
• InjurySep 8, 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 AN 79-YEAR-OLD MALE WITH HYPERTENSION, STAGE 4 CHRONIC KIDNEY DISEASE, HISTORY OF SMOKING, DIABETES, AND DYSLIPIDEMIA. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN FEBRUARY 2017, A 25MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT WITH A CONCOMITANT CORONARY AORTIC BYPASS GRAFT PROCEDURE. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH ASYMPTOMATIC MURMUR DUE TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWING TWO REGURGITANT JETS, ONE FROM THE NON-CORONARY AND LEFT CORONARY CUSP AND ANOTHER FROM THE NON-CORONARY AND RIGHT CORONARY CUSP BASE. IT WAS LATER REPORTED ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH HEART FAILURE. A DECISION WAS MADE TO PERFORM A TRANSCATHETER VALVE-IN-VALVE PROCEDURE AND IMPLANT A 26MM NON-ABBOTT VALVE ON AN UNKNOWN DATE 20 MONTHS POST INITIAL 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

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

  MAUDE report 17712249 ↗
• 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 AUGUST 2015 A 25MM A TRIFECTA VALVE WAS IMPLANTED IN A 78.1-YEAR-OLD PATIENT WITH CALCIFIED AORTIC STENOSIS. ON 02 FEBRUARY 2021, THE PATIENT HAD STENOSIS OF THE BIOPROSTHESIS AND LOOS

  Patient problems: Endocarditis

  MAUDE report 16819288 ↗
• DeathApr 25, 2023Device Stenosis; Device Stenosis

  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 ON 30 JUNE 2014, A 25MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN MAY 2018, AN ULTRASOUND WAS PERFORMED WHICH SHOWED MODERATE VALVE STENOSIS WITH NO LEAK. THE AO

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16810368 ↗
• InjuryApr 20, 2023Degraded; Degraded

  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 (B)(6) 2013, A 25MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT WITH A PAST MEDICAL HISTORY OF AORTIC INSUFFICIENCY. IT WAS REPORTED THAT IN (B)(6) 2018, THE PATIENT HAD MITRO-AORTIC END

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

  MAUDE report 16781617 ↗
• DeathApr 20, 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 ON AN UNKNOWN DATE IN MAY OF 2013 A 27MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT A PAST MEDICAL HISTORY OF CALCIFIED AORTIC STENOSIS. ON 25 JULY 2014, THE PATIENT HAD AORTIC ENDOCARDITI

  Patient problems: Endocarditis

  MAUDE report 16781595 ↗
• InjuryApr 20, 2023Device Stenosis; Device Stenosis

  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 ON (B)(6) 2012, A 25MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH CALCIFIED AORTIC STENOSIS. ON (B)(6) 2021, ECHOCARDIOGRAM SHOWED NORMAL LEFT VENTRICULAR EJECTION FRACTI

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16780590 ↗
• InjuryApr 20, 2023Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  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 ON 30 MAY 2013, A 25MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED DUE TO CALCIFIED AORTIC STENOSIS IN A PATIENT. ON 4 FEBRUARY 2019, IT WAS OBSERVED THAT THE PATIENT HAD PREDOMINANTLY LEFT

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

  MAUDE report 16778389 ↗
• InjuryApr 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  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 OF 2013 ON AN UNKNOWN DATE, A 25MM TRIFECTA VALVE WAS IMPLANTED IN A 63.3-YEAR-OLD PATIENT WITH AORTIC INSUFFICIENCY. IT WAS REPORTED THAT IN NOVEMBER 29, 2018, THE PATIENT HAD

  Patient problems: Endocarditis

  MAUDE report 16770699 ↗
• InjuryApr 11, 2023Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  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, (B)(6) HOSPITAL, (B)(6). IT WAS REPORT THAT IN (B)(6) 2016, A 25MM TRIFECTA VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2021, ECHOCARDIOGRAPHY SHOWED AORTIC REGURGITATION WITHOUT STENOSIS. THE AVERAGE LV-AORTIC GRADIENT WAS 8 MMHG. THE MAXIMUM LV-AORTIC GRADIENT WAS 16 MMHG. THE DIAMETER OF THE FLUSH CHAMBER WAS 25 MM. THE SUB-AORTIC VELOCITY

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16716102 ↗
• InjuryNov 16, 2022Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 25MM TRIFECTA VALVE WAS IMPLANTED INTO A PATIENT. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THERE WAS WORSENED VALVULAR INSUFFICIENCY. THE PATIENT WAS HOSPITALIZED AND IT WAS FOUND THAT THE VALVE HAD A TEAR NEAR THE STENT POST WHICH WAS FOUND USING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). ON (B)(6) 2022, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER 25MM TRIFECTA HEART VALVE TO RESOLVE THE EVENT. THE PATIENT IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15810283 ↗
• InjuryOct 21, 2022Calcified; Degraded; Intravalvular regurgitation; Calcified; Degraded; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2013, A 25MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. ON AN UNKNOWN DATE IN (B)(6) 2021, THE PATIENT EXPERIENCED A STROKE AND WAS PLACED ON ELIQUIS. IN (B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY VALVE REPLACEMENT DUE TO SEVERE AORTIC VALVE REGURGITATION AND VALVE DETERIORATION. UPON EXPLANT, THERE WAS CALCIFICATION NOTED ON THE DEVICE. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES A 25MM TRIFECTA VALVE WAS IMPLANTED IN (B)(6) 2013. SOMETIME IN (B)(6) 2022, SEVERE AORTIC VALVE REGURGITATION WAS DIAGNOSED AND REQUIRED EMERGENCY VALVE REPLACEMENT. THE SURGEON INDICATED VALVE DETERIORATED WITH MUCH CALCIFICATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Stroke/CVA

  MAUDE report 15651197 ↗
• InjuryJul 8, 2022Degraded; Incomplete Coaptation; Degraded; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2013, A PATIENT HAD A 25 MM TRIFECTA VALVE REPLACED. IN 2021, IT WAS REPORTED THAT THE PATIENT HAD A STROKE. IN 2022, AN EMERGENCY VALVE REPLACEMENT WAS CONDUCTED DUE TO SEVERE AORTIC REGURGITATION. IT WAS NOTED THAT THE VALVE HAD DETERIORATED SEVERELY. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14962547 ↗
• InjuryMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2015, A 25MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2022, THE VALVE WAS EXPLANTED FOR AN UNKNOWN REASON AND REPLACED WITH A SJM MECHANICAL VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14334165 ↗
• MalfunctionMar 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE IN 2015 A 25MM TRIFECTA VALVE WAS IMPLANTED. THE PATIENT NOW HAS AORTIC STENOSIS AND IS REQUIRING EXPLANT. THE EXPLANT PROCEDURE HAS NOT BEEN SCHEDULED YET. THE PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

  Patient problems: Valvular Stenosis

  MAUDE report 13830921 ↗
• InjuryJan 13, 2022Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  IT WAS REPORTED A 25MM SJM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2013. DURING A FOLLOW-UP VISIT IN THE CLINIC, AORTIC REGURGITATION (AR) WAS OBSERVED COMING FROM THE RIGHT CORONARY CUSP (RCC). THE AR JET FLOW REACHED THE CARDIAC APEX. ON (B)(6) 2021 THE PATIENT UNDERWENT EXPLANT OF THE 25MM SJM TRIFECTA VALVE, UPON EXPLANT, A LEAFLET TEAR WAS OBSERVED. A NON-ABBOTT DEVICE WAS PLACED AND THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13254520 ↗
• InjuryDec 20, 2021Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED ON AN UNKNOWN DATE A TRIFECTA STENTED TISSUE VALVE WAS IMPLANTED. THE PATIENT PRESENTED WITH FATIGUE AND ON (B)(6) 2021, THE VALVE WAS EXPLANTED DUE TO STENOSIS AND UPON EXPLANT THE CUFF AND A LEAFLET WAS TORN. A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN UNSTABLE CONDITION. OPERATIVE NOTES AND ECHO IMAGES WERE REQUESTED BUT CANNOT BE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: Fatigue

  MAUDE report 13043040 ↗