Trifecta™ TFGT-21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 05415067018212), received between Jun 21, 2018 and Sep 29, 2026 — classified as 12 deaths, 106 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (50 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 124 reports, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Material Split, Cut or Torn; Intravalvular regurgitation

  It was reported that on (b)(6) 2018, a 21mm Trifecta GT Valve was chosen for implant. It was then reported on (b)(6) 2024, a decision was made perform redo-surgical aortic valve replacement due to severe aortic regurgitation and other unspecified heart problems. During intraoperative investigation, it was observed one of the Trifecta Valve leaflets had completely torn away. The 21mm Trifecta GT Valve was explanted and replaced with a 23mm non-Abbott valve. It was later reported the patient passed away on (b)(6) 2024.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50940683 ↗
• DeathJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 21A MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. 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 25526756 ↗
• InjuryJun 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 21 MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2023. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25526447 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 21MM TRIFECTA VALVE WAS IMPLANTED ON 2/13/2017. 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 25488083 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018, A 21MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE VALVE GOT EXPLANTED

  Patient problems: Insufficient Information

  MAUDE report 24532039 ↗
• InjuryDec 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 21MM TRIFECTA GT VALVE WAS IMPLANTED FOR VALVE REPLACEMENT SURGERY. ON (B)(6) 2024, THE PATIENT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CONFIRMED THAT THE VALVE WAS LEAKING. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED THROUGH THE FEMORAL ARTERY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 23889337 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Insufficient Information

  MAUDE report 23660563 ↗
• InjuryOct 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23238564 ↗
• MalfunctionMar 14, 2025Perivalvular Leak; Material Split, Cut or Torn; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2019, A 21MM TRIFECTA GT VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, LEAKING VALVE WAS OBSERVED. THE VALVE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21610709 ↗
• InjuryDec 2, 2024Device Stenosis; Device Stenosis

  USER FACILITY MEDWATCH REPORT MW5160636 RECEIVED THAT STATES, "I HAD AN ABBOTT TRIFECTA VALVE PLACED ON (B)(6) 2019. I HAD IMPROVED HEALTH IMMEDIATELY AFTER. HOWEVER, IN OR AROUND 2021, I BEGAN HAVING INCREASED SHORTNESS OF BREATH AND OTHER SYMPTOMS. THESE CONTINUED TO ESCALATE OVER THE NEXT 3 YEARS. I WAS HOSPITALIZED NUMEROUS TIMES, SOMETIMES FOR A MONTH AT A TIME. I HAD NUMEROUS PAINFUL MEDICAL PROCEDURES DONE. I HAD DECREASED BLOOD FLOW WHICH CAUSED SEVERAL PROBLEMS INCLUDING DECREASED HEALING (I UNDERWENT A LOWER LEG AMPUTATION IN 2022), AN ISCHEMIC BOWEL/INTESTINES WHICH CAUSED A NEARLY FATAL CHRONS FLARE; I CODED TWICE REQUIRING CPR; I WAS AIRLIFTED FROM (B)(6) TO (B)(6) FOR TREATMENT; I HAD SEVERAL AMBULANCE TRANSPORTS; I REQUIRED BOTH IN-PATIENT AND OUTPATIENT TREATMENT AND AT-HOME CARE. TWICE, I WAS TOLD TO GET MY AFFAIRS IN ORDER BECAUSE I NEEDED CARDIAC PROCEDURES THAT WERE EXTREMELY HIGH RISK. THIS HAS BEEN A TERRIFYING AND COSTLY EXPERIENCE FOR BOTH ME AND MY FAMILY. MY DOCTOR TOLD ME THE HEART VALVE USED HAS BEEN RECALLED AND NEEDED TO BE REPLACED. AFTER THREE YEARS OF HELL, I UNDERWENT A VALVE-IN-VALUE PROCEDURE AND FEEL BETTER BUT I AM STILL RECOVERING FROM ALL THE

  Patient problems: Aortic Valve Stenosis; Dyspnea; Ischemia; Pain

  MAUDE report 20820482 ↗
• DeathJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2024, THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 19610172 ↗
• InjuryJun 20, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024 , A 21MM TRIFECTA GT VALVE WAS CHOSEN FOR IMPLANT. THE VALVE WAS IMPLANTED. AFTER CARDIOPULMONARY BYPASS OPERATION, ECHO IMAGING FOUND THAT ONE OF THE LEAFLETS WAS NOT OPENING COMPLETELY. CARDIOPULMONARY BYPASS WAS USED AGAIN TO REMOVE THE TRIFECTA GT. THE VALVE WAS REPLACED WITH A NEW 19MM EPIC SUPRA VALVE WAS VALVE AND COMPLETED THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575272 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 21MM TRIFECTA GT FINAL PACKAGE - WR WAS IMPLANTED IN A PATIENT. THE IMPLANTATION WAS SUCCESSFUL AND THE DEVICE FUNCTIONED UNTIL IT SUDDENLY STOPPED FUNCTIONING IN (B)(6) 2023. AT THAT TIME, THE PATIENT BEGAN EXPERIENCING EXTREME FATIGUE, HEART PALPITATIONS, AND SHORTNESS OF BREATH. A CARDIAC ANGIOGRAM WAS PERFORMED WHICH DEMONSTRATED SIGNIFICANT AORTIC REGURGITATION DUE TO MALFUNCTIONING FLAPS ON THE VALVE. A REMOVAL AND REPLACEMENT OF THE DEVICE WAS SCHEDULED IMMEDIATELY THEREAFTER. THE REMOVAL AND REPLACEMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. THE VALVE WAS REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT IS STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 19558887 ↗
• InjuryJun 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019 , A 21MM TRIFECTA GT FINAL PACKAGE WAS IMPLANTED IN A PATIENT ALONG WITH ARTIFICIAL BLOOD VESSEL (NON-ABBOTT PRODUCT: J GRAFT) PLACEMENT. IN (B)(6)2023, ECHOGRAPHY CONFIRMED AORTIC INSUFFICIENCY AND AND SHORTNESS OF BREATH. IN (B)(6) 2024, HEART FAILURE SYMPTOMS WERE CONFIRMED, AND THE PATIENT WAS AWARE OF THE HEART FAILURE. AORTIC INSUFFICIENCY WAS SEVERE. ON (B)(6) 2024, ANOTHER AORTIC VALVE REPLACEMENT PROCEDURE USING A 19MM EPIC SUPRA AORTIC VALVE WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT EFFECTS. UPON EXPLANT, THE WAS TORN CUSP (FROM THE TIP OF THE STENT TO NADIR) OF THE VALVE. THE PATIENT IS STABLE, AND UNDER OBSERVATIONS. NO MEDICATION WAS NOTED IN THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19529754 ↗
• InjuryMar 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2021, A 21MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, THE PATIENT RETURNED WITH SHORTNESS OF BREATH. ON (B)(6) 2023, THE TRIFECTA VALVE WAS EXPLANTED AND A REPLACEMENT NON-ABBOTT VALVE WAS IMPLANTED. THE EXPLANTED VALVE WAS OBSERVED TO HAVE A LONGITUDINAL TEAR. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Dyspnea

  MAUDE report 18906470 ↗
• InjuryFeb 15, 2024Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 21MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED. IN (B)(6)2023, THE PATIENT VISITED A NEARBY FACILITY DUE TO DIFFICULTY BREATHING. ON (B)(6) 2023, TEAR WAS OBSERVED IN THE STENT AREA BETWEEN THE RIGHT CORONARY CUSP AND THE NON-CORONARY CUSP. SEVERE AORTIC REGURGITATION WAS OBSERVED. ON (B)(6) 2024, ANOTHER PROCEDURE WAS PERFORMED. THE TRIFECTA WAS EXPLANTED AND A 19MM VALVE WAS IMPLANTED. THE PATIENT IS REPORTED TO BE UNDER REHABILITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 18711817 ↗
• InjuryJan 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2022, A 21MM TRIFECTA GT VALVE WAS IMPLANTED IN A PATIENT. IT WAS NOTED VIA ECHOCARDIOGRAM, IN (B)(6) 2023, THAT THE VALVE HAD STRUCTURAL VALVE DETERIORATION WITH A TORN CUSP, RESULTING IN AORTIC REGURGITATION, SYMPTOMS OF HEART FAILURE, AND LEG SWELLING. THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND A NON-ABBOT DEVICE WAS IMPLANTED AS A REPLACEMENT. IT WAS NOTED DURING EXPLANT THAT THE 21MM TRIFECTA GT VALVE ALSO HAD TORN LEAFLETS. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

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

  MAUDE report 18438145 ↗
• InjuryOct 26, 2023Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2018, A 21 MM TRIFECTA GT (TFGT-21A, SERIAL#(B)(6)) VALVE WAS IMPLANTED SUCCESSFULLY. DUE TO AN ENLARGED ANNULUS, THE DEVICE WAS IMPLANTED MORE DIAGONALLY. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED DUE TO AORTIC STENOSIS AND REGURGITATION (ASR). DUE TO SEVERE CALCIFICATION THAT AFFECTED VALSALVA, THE VALVE WAS UNABLE TO FUNCTION SO IT WAS EXPLANTED. A 21MM NON-ABBOTT VALVE WAS IMPLANTED IN IT'S PLACE. THE PATIENT EXPERIENCED MYOCARDIAL ISCHEMIA SO THEY WERE PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND AN INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT IS REPORTED TO BE UNSTABLE. THE PHYSICIAN THOUGHT THE DIAGONAL NATURE OF THE IMPLANT MAY HAVE PLACED UNUSUAL STRESS ON THE DEVICE.

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

  MAUDE report 18012538 ↗
• InjuryOct 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 21MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE PATIENT'S NATIVE VALVE MEASUREMENTS WERE APPROXIMATELY 21MM IN DIAMETER. IT WAS ALSO REPORTED THAT DURING A FOLLOW-UP ECHOCARDIOGRAPHY ON (B)(6) 2022, THERE WERE NO ISSUES REPORTED. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH ACUTE HEART FAILURE, PULMONARY HYPERTENSION, SEVERE AORTIC REGURGITATION, MODERATE MITRAL REGURGITATION, AND MODERATE TRICUSPID REGURGITATION. ON (B)(6) 2023, STRUCTURAL VALVE DETERIORATION (SVD) WAS CONFIRMED VIA ECHOCARDIOGRAPHY SHOWING A TEAR ON THE LEFT CORONARY CUSP AND THREE COMMISSURES (STENT POSTS) WERE ATTACHED TO THE AORTIC WALL. A DECISION WAS MADE TO PERFORM AN EMERGENCY SURGICAL PROCEDURE TO EXPLANT THE VALVE AND REPLACE WITH A 21MM NON-ABBOTT VALVE. THE PATIENT STATUS WAS STABLE.

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

  MAUDE report 17941174 ↗
• InjuryOct 11, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2017, A 21MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED AND PERIVALVULAR LEAKAGE/REGURGITATION OF THE 21MM TRIFECTA GT VALVE WAS DISCOVERED. IT WAS NOTED THAT THERE WAS NO CALCIFICATION OF THE VALVE. THE DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE PROCEDURE USING AN UNKNOWN DEVICE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17912333 ↗
• InjurySep 21, 2023Intravalvular regurgitation; Intravalvular regurgitation

  A MEDWATCH EMAIL WAS RECEIVED ON 30 AUGUST 2023, REPORTING THE INCIDENT WITH E100-25M-00 AND TFGT-21A . IT WAS REPORTED THAT A 25MM STENTED PORCINE,MIT,EPIC 25MM-00 AND 21MM TRIFECTA GT FINAL PACKAGE - WR WAS IMPLANTED IN A PATIENT ON (B)(6) 2018. ON AN UNKNOWN DATE AND YEAR, THE PATIENT WAS HOSPITALIZED REQUIRING INCREASE IN MEDICATION DUE TO HEART FAILURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) RESULTS SHOWED AORTIC VALVE: BIOPROSTHETIC AORTIC VALVE PRESENT. LEAFLETS ARE MOBILE, THERE WAS MODERATE TRANSVALVE AORTIC REGURGITATION . THE DI IS 0.41. AT IS 92MS. THE MG IS 28MMH MITRAL VALVE WELL SEATED, NO STENOSIS OR REGURGITATION. TEE REVEALS NORMAL RIGHT VENTRICULAR/LEFT VENTRICULAR FUNCTION AND NORMAL WASH OUT JET. NO PARAVALVULAR LEAK (PVL). THE BIOPROSTHETIC TRIFECTA AORTIC VALVE HAS MILD DEGENERATION CHANGES WITH NO STENOSIS, HOWEVER HAS MODERATE AORTIC REGURGITATION AND ALSO PATIENT PROSTHESIS PRESENT. NEED TO SWITCH TO COUMADIN DUE TO VALVULAR ATRIAL FIBRILLATION (AF), WITH LOCAL CARDIOLOGIST. POTENTIAL MISMATCH OF THE DEVICE. PATIENT STATUS IS UNKNOWN REFERENCE REPORT: MW5120624.

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

  MAUDE report 17789640 ↗
• 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 AN 89-YEAR-OLD FEMALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2017, A 21MM TRIFECTA GT 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 2019, 17 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. [THE PRIMARY AUTHOR WAS (B)(6) HOSPITAL, WELLINGTON, AOTEAROA NEW ZEALAND WITH CORRESPONDING EMAIL: (B)(6). POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION. *PATIENT 6*.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17685254 ↗
• InjurySep 5, 2023Material Split, Cut or Torn; Intravalvular regurgitation; 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 87-YEAR-OLD FEMALE WITH SIGNIFICANT HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION ON WARFARIN AND MILD RENAL IMPAIRMENT. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 21MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT WITH A CONCOMITANT CORONARY AORTIC BYPASS GRAFT PROCEDURE. THE PATIENT PRESENTED 17 MONTHS LATER WITH MODERATE TO SEVERE VALVULAR REGURGITATION DUE TO A CUSP TEAR CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). A DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACE WITH A 23MM NON-ABBOTT VALVE. 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: VALVULAR REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION, TORN CUSP *PATIENT 2*.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 17684934 ↗
• InjuryAug 2, 2023Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  A MEDWATCH EMAIL WAS RECEIVED ON 10 JULY 2023, REPORTING THE INCIDENT WITH A TRIFECTA GT VALVE. USER FACILITY MEDWATCH REPORT #MW5118853 RECEIVED THAT STATES "HEART FAILURE SYMPTOMS EARLY IN 2023 - FOUND TO HAVE STRUCTURAL VALVE DETERIORATION TRIFECTA AVR. SUMMARY OF TTE 03/2022. NORMAL LEFT VENTRICULAR SIZE, MASS AND FUNCTION WITH NO SIGNIFICANT REGIONAL WALL MOTION ABNORMALITIES. THE ESTIMATED LVEF IS 70%. NORMAL RIGHT HEART SIZE AND FUNCTION. NORMALLY FUNCTIONING BIOPROSTHETIC AORTIC VALVE WITH NO SIGNIFICANT STENOSIS OR REGURGITATION. BORDERLINE MILD MITRAL VALVE STENOSIS WITH TRACE TO MILD REGURGITATION. MILD TRICUSPID VALVE REGURGITATION WITH ESTIMATED MILDLY ELEVATED PULMONARY ARTERY SYSTOLIC PRESSURE. COMPARED TO THE PRIOR STUDY ON (B)(6) 2020, BORDERLINE MITRAL VALVE STENOSIS NOTED TODAY WITH OTHER FINDINGS APPEARING SIMILAR. SUMMARY OF TTE 6/2023, NORMAL LEFT VENTRICULAR SIZE AND SYSTOLIC FUNCTION WITH NO REGIONAL ABNORMALITIES, ESTIMATED LVEF IS 75%. NORMAL RIGHT VENTRICULAR SIZE AND FUNCTION. PROSTHETIC AORTIC VALVE WITH SEVERE STENOSIS AND MODERATE REGURGITATION. MITRAL ANNULAR CALCIFICATION WITH MILD MITRAL STENOSIS AND MILD TO MODERATE REGURGITATION. MODERATE TRICUSP

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

  MAUDE report 17446624 ↗
• InjuryAug 1, 2023Degraded; Degraded

  IT WAS REPORTED THAT ON (B)(6) 2018, A 21MM TRIFECTA GT FINAL PACKAGE - WR WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO EARLY STRUCTURAL VALVE DETERIORATION(SVD) AND LEFT HEART FAILURE NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGES. THE PATIENT IS AWAITING A VALVE IN VALVE PROCEDURE BUT A DATE OF THE SURGERY HAS NOT BEEN SCHEDULED. PATIENT STATUS IS STABLE.

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

  MAUDE report 17436151 ↗