Trifecta™ TFGT-25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 05415067018236), received between Jun 29, 2018 and Jun 16, 2026 — classified as 5 deaths, 69 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (33 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 80 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2019. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON 29 DECEMBER 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 25526375 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25 MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2019. 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 25491323 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25 MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 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 25491077 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25 MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. 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 25488663 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2018. 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 25486366 ↗
• InjuryDec 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 25MM TRIFECTA VALVE WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT PROCEDURE. THE IMMEDIATE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND EARLY FOLLOW-UP DEMONSTRATED SIGNIFICANT IMPROVEMENT IN CARDIAC FUNCTION, WITH EJECTION FRACTION RISING TO 45¿50% AND THE PROSTHESIS FUNCTIONING NORMALLY. ON (B)(6) 2019, AN ECHOCARDIOGRAPHY (ECG) PERFORMED AND CONFIRMED STABLE PERFORMANCE, WITH NORMAL TRANSVALVULAR GRADIENTS AND NO EVIDENCE OF STRUCTURAL DETERIORATION. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED FOR THE ONSET OF PROGRESSIVELY WORSENING EXERTIONAL DYSPNEA OVER SEVERAL MONTHS, ALONG WITH ASTHENIA, EASY FATIGABILITY, AND LOSS OF APPETITE. THE PATIENT GOT ADMITTED IN TO THE HOSPITAL. THE ECG SHOWED ATRIAL FIBRILLATION WITH A VENTRICULAR RESPONSE OF 80 BPM. THE CHEST COMPUTED TOMOGRAPHY (CT) REVEALED SIGNS OF CHRONIC BRONCHOPULMONARY DISEASE AND NO MEDIASTINAL COLLECTIONS. ECHOCARDIOGRAPHY INITIALLY SUGGESTED A PERIPROSTHETIC LEAK DUE TO PARTIAL DETACHMENT OF THE PROSTHESIS (A FINDING LATER NOT CONFIRMED BY SUBSEQUENT, MORE ACCURATE EXAMINATIONS). THE PROSTHESIS WAS DESCRIBED AS ¿IN PLACE WITH NORMAL TRANSVALVULAR GRADIENTS, LEFT VENTRICLE MODERATELY HY

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Atrial Fibrillation; Dyspnea; Fatigue; Mitral Valve Insufficiency/ Regurgitation; Renal Failure

  MAUDE report 23882571 ↗
• InjuryJul 8, 2025Degraded; Material Split, Cut or Torn; Degraded; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 25MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE IT WAS NOTED THAT THERE WAS STRUCTURAL VALVE DETERIORATION. ON (B)(6) 2025, THE DECISION WAS MADE TO EXPLANT THE 25MM TRIFECTA GT VALVE AND REPLACE IT WITH A 25MM EPIC PLUS SUPRA VALVE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

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

  MAUDE report 22436934 ↗
• InjuryJan 23, 2025Degraded; Insufficient Device Problem Information; Device Stenosis; Degraded; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. THE PATIENT WAS HAVING ANOTHER SURGERY.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Insufficient Information

  MAUDE report 21218652 ↗
• InjuryOct 18, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2024, IT WAS FOUND THAT THE VALVE WAS SEVERELY SCARRED AND DIFFICULT TO REMOVE. THE VALVE WAS REMOVED AND A NEW 25MM EPIC VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20487269 ↗
• InjuryJul 3, 2024Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE IMPLANTATION. ON AN UNKNOWN DATE, A 31MM EPIC VALVE WAS IMPLANTED DURING A MITRAL VALVE IMPLANTATION. IN (B)(6) 2024, THE PATIENT WAS HOSPITALIZED DUE TO HEART FAILURE, AORTIC REGURGITATION, AND MITRAL REGURGITATION. ON (B)(6) 2024, THE TRIFECTA VALVE WAS EXPLANTED AS THERE WERE TWO TORN CUSPS. THE TRIFECTA VALVE WAS REPLACED WITH A 25MM NON-ABBOTT AORTIC VALVE. ON THE SAME DATE, THE EPIC VALVE WAS EXPLANTED AS THE LEAFLET HAD WRINKLES AND WAS NOT ABLE TO PROPERLY MAINTAIN COAPTATION. THE EPIC VALVE HAD REGURGITATION DUE TO WRINKLES ON THE LEAFLET. THE EPIC VALVE WAS REPLACED WITH A 31MM NON-ABBOTT MITRAL VALVE. THE PATIENT STATUS WAS REPORTED AS STABLE.

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

  MAUDE report 19666499 ↗
• DeathJul 2, 2024Device Stenosis; Device Stenosis

  USER FACILITY MEDWATCH REPORT MW5155723 RECEIVED THAT STATES "MY DAUGHTER RECEIVED THE ST JUDE TRIFECTA VALVE (B)(6) 2017. SHE DID FINE UP UNTIL 8-10 MONTHS AGO. SHE DEVELOPED FATIGUE, SHORTNESS OF BREATH, AND EDEMA. IT TOOK HER 6 MONTHS GET IN TO BE SEEN BY A CARDIOLOGIST. WHEN SHE FINALLY DID, SHE WAS IN SEVERE HEART FAILURE. SHE HAD AN ECHO COMPLETED AND HER EJECTION FRACTION HAD REDUCED TO 20% AND HER IMPLANTED AORTIC VALVE WAS SEVERELY STENOTIC. SHE WAS TRANSFERRED TO A HIGHER LEVEL OF CARE. SHE UNDERWENT OPEN HEART SURGERY (B)(6) 2024. SHE REQUIRED ECHMO AND A PUMP. HER CHEST WAS NEVER ABLE TO BE CLOSED. SHE FOUGHT FOR 10 DAYS AND PASSED AWAY (B)(6) 2024. (B)(6) HOSPITAL IN (B)(6) SHOULD HAVE PICTURES OF THE VALVE. I DO NOT KNOW IF THEY KEPT OF VALVE OR SENT IT FOR PATHOLOGY." IT WAS REPORTED THAT ON 16 JANUARY 2017, A 25MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN 2023, THE PATIENT DEVELOPED FATIGUE, SHORTNESS OF BREATH, AND EDEMA. SIX MONTHS AFTER SYMPTOMS BEGAN, THE PATIENT WAS SEEN BY A CARDIOLOGIST, AND THE PATIENT WAS IN SEVERE HEART FAILURE. AN ECHOCARDIOGRAM WAS COMPLETED, AND EJECTION FRACTION WAS 20%. THE IMPLANTED VALVE WAS SEVERELY STE

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

  MAUDE report 19656243 ↗
• InjuryApr 2, 2024Degraded; Degraded

  IT WAS REPORTED THAT ON (B)(6) 2017, A 25MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2023, STENTS PLACED IN THE HEART DUE TO BLOCKAGES. ON (B)(6) 2023, THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT (ICU) SUFFERING FROM CONGESTIVE HEART FAILURE. THE PHYSICIAN MENTIONED ALL THE CARDIAC EVENTS WERE RELATED TO THE DETERIORATED TRIFECTA VALVE. ON AN UNKNOWN DATE IN (B)(6) 2023, THE PATIENT WAS TRANSPORTED BACK TO THE HOSPITAL WHERE THE IMPLANT PROCEDURE WAS DONE. THE PHYSICIANS PERFORMED A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND A UNKNOWN SIZE REPLACEMENT VALVE WAS IMPLANTED. THE TRIFECTA VALVE WAS DETERIORATED AND LOST FUNCTION AND THE PATIENTS' CARDIAC FUNCTION WAS SIGNIFICANTLY IMPAIRED DUE TO TRIFECTA VALVE. THE REPLACEMENT VALVE WAS FUNCTIONING BUT THE FUNCTION WAS THE VALVE WAS IMPAIRED DUE TO DETERIORATED TRIFECTA VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19020453 ↗
• InjuryMar 22, 2024Degraded; Degraded

  USER FACILITY MEDWATCH REPORT MW5151357 RECEIVED THAT STATES "I EXPERIENCED A SEVERE PAIN IN THE UPPER BACK THAT LASTED ALL DAY. OTHER SYMPTOMS WERE A CHRONIC DRY COUGH AND SHORTNESS OF BREATH I WENT TO THE EMERGENCY CARE UNIT WHERE I RECEIVED AN ECHOCARDIOGRAM AND WAS ADMITTED TO THE HOSPITAL. I WAS TOLD THAT MY AORTIC REPLACEMENT VALVE HAD BADLY DETERIORATED AND THAT I NEEDED IT TO BE ADDRESSED PROMPTLY. THE DETERIORATED VALVE WAS A ST. JUDE TRIFECTA GT INSTALLED ON (B)(6) 2017. AS A RESULT I HAD A MEDTRONIC VALVE INSERTED BYTAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT)." IT WAS REPORTED THAT ON (B)(6) 2017, A 25MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON A LATER DATE, THE PATIENT EXPERIENCED SEVERE UPPER BACK PAIN, CHRONIC DRY COUGH, AND SHORTNESS OF BREATH. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND RECEIVED AN ECHOCARDIOGRAM, WHICH REVEALED VALVE DETERIORATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6)2023, THE PATIENT RECEIVED A TRANSCATHETER AORTIC VALVE IMPLANTATION, OR VALVE-IN-VALVE SURGERY. THE PATIENT STATUS WAS STABLE.

  Patient problems: Dyspnea; Pain

  MAUDE report 18961324 ↗
• InjuryMar 11, 2024Degraded; Device Stenosis; Degraded; Device Stenosis

  MEDWATCH REPORT #: MW5150926 RECEIVED REGARDING A 25MM TRIFECTA BIOPROSTHETIC AORTIC VALVE EXPERIENCED EPISODES OF DIZZINESS, CHEST PAIN, ARM PAIN, SHORTNESS OF BREATH, LETHARGIC, UNABLE TO LIE DOWN. IT PASSED. THEN, HAPPENED AGAIN A FEW DAYS LATER AND WAS TAKEN TO ER. SENT HOME THE SAME DAY. WORSENING EPISODES TO INCLUDE BELCHING, AND NOT HUNGRY. RETURNED TO HOSPITAL (B)(6) 2024. DIAGNOSED (B) (6) 2024 WITH SEVERE PROSTHESIS STENOSIS OF A ST. JUDE TRIFECTA BIOPROSTHETIC AORTIC VALVE. PATIENT WAS TRANSFERRED TO (B)(6) AND IS AWAITING POSSIBLE TAVR PROCEDURE CURRENTLY. IT WAS REPORTED THAT ON 26 AUGUST 2016, A 25MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED EPISODES OF DIZZINESS, ANGINA, ARM PAIN, DYSPNEA, LETHARGY, UNABLE TO LIE DOWN. THE SYMPTOMS EVENTUALLY PASSED BUT THEN CAME BACK A FEW DAYS LATER SO THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT RETURNED HOME THE SAME DAY. SYMPTOMS BEGAN TO THEN INCLUDE BELCHING AND REDUCED APPETITE. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH SEVERE AORTIC STENOSIS. PATIENT WAS TRANSFERRED AND IS AWAITING POSSIBLE INTERVENTION.

  Patient problems: Angina; Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 18874523 ↗
• InjuryDec 15, 2023Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2020, A 25MM TRIFECTA GT VALVE IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THE NATIVE VALVE DIMENSION WAS 25MM. ON (B)(6) 2023, IT WAS REPORTED THAT PATIENT PRESENTED WITH EXPERIENCING DYSPNEA ON EXERTION FOR THREE MONTHS. FURTHER TESTING REVEALED TRANS-PROSTHETIC MODERATE-SEVERE AORTIC INSUFFICIENCY (AI) DUE TO EARLY VALVE DEGENERATION. ON (B)(6) 2023, A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED, AND A 23MM NON-ABBOTT VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 18337006 ↗
• InjurySep 26, 2023Incomplete Coaptation; Patient-Device Incompatibility; Material Split, Cut or Torn; Incomplete Coaptation; Patient-Device Incompatibility; Material Split, Cut or Torn

  N/A

  Patient problems: Insufficient Information

  MAUDE report 17818803 ↗
• 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 70-YEAR-OLD FEMALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2013, A 25MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH AORTIC REGURGITATION AND AORTIC STENOSIS. A DECISION WAS MADE TO EXPLANT THE VALVE ON AN UNKNOWN DATE IN 2019, 67 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 TREVOR TNAY, WELLINGTON REGIONAL HOSPITAL, WELLINGTON, AOTEAROA NEW ZEALAND WITH CORRESPONDING EMAIL: [email protected]] POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, AORTIC STENOSIS, SURGICAL INTERVENTION, HOSPITALIZATION *PATIENT 9*

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

  MAUDE report 17686450 ↗
• 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 82-YEAR-OLD MALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2013, A 25MM 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 2019, 66 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 TREVOR TNAY, WELLINGTON HOSPITAL, WELLINGTON, AOTEAROA NEW ZEALAND WITH CORRESPONDING EMAIL: [email protected]]. POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION. *PATIENT 10*.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17684843 ↗
• 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 80-YEAR-OLD MALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2017, A 25MM 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 2020, 20 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 TREVOR TNAY, (B)(6) HOSPITAL, (B)(6), AOTEAROA NEW ZEALAND WITH CORRESPONDING EMAIL: [email protected]]. POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION. *PATIENT 7*.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17684766 ↗
• InjuryAug 31, 2023Material Split, Cut or Torn; Device Stenosis; Material Split, Cut or Torn; Device Stenosis

  USER FACILITY MEDWATCH REPORT # MW5119778 RECEIVED THAT STATES ¿I HAD AORTIC VALVE REPLACED IN (B)(6) 2016 WITH A ABBOTT TRIFECTA GT. I WAS INFORMED VALVE WOULD LAST 10 TO 20 YEARS ON AVERAGE. I WAS HOSPITALIZED IN (B)(6) 2023 AS I COULD NOT BREATHE AND WAS DIAGNOSED WITH CONGESTED HEART FAILURE DUE TO SUDDEN AORTIC VALVE FAILURE. I HAD OPEN HEART SURGERY TO REMOVE THE TRIFECTA GT VALVE AND ALL ASSOCIATED PARTS IT WAS REPLACED BY A DIFFERENT MANUFACTURERS VALVE. UPON REMOVAL THE TRIFECTA VALVE WAS FOUND TO HAVE SEVERE STENOSIS AND TWO OF THE THREE LEAFLETS WERE TORN PER SURGEON. I AM TRULY BLESSED TO BE ALIVE. HEART CATHETERIZATION, MRI, EKG, HEART ULTRA SOUND, X RAY, BLOOD WORK." IT WAS REPORTED THAT ON (B)(6) 2016, A 25MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN 2023, THE PATIENT WAS HOSPITALIZED WITH SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE DUE TO AORTIC VALVE FAILURE. ON (B)(6), 2023, THE PATIENT UNDERWENT SURGERY TO EXPLANT THE DEVICE AND REPLACE WITH A NON-ABBOTT VALVE. UPON REMOVAL OF THE VALVE, IT WAS FOUND TO HAVE SEVERE STENOSIS AND TWO OF THE THREE LEAFLETS WERE TORN. THE PATIENT STATUS WAS RE

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

  MAUDE report 17661869 ↗
• InjuryJul 6, 2023Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT'S NATIVE AORTA. ON AN UNKNOWN DATE IN 2020, AORTIC REGURGITATION (AR) WAS OBSERVED VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE). THE PATIENT DID NOT PRESENT WITH SYMPTOMS OF HEART FAILURE. A FOLLOW-UP WAS PERFORMED, AND THE PATIENT'S LEFT VENTRICULAR DIASTOLIC DYSFUNCTION (LVDD) EXCEEDED 65MM. ON (B)(6) 2023, A TEAR WAS OBSERVED ON THE TRIFECTA VALVE, IT WAS EXPLANTED, AND A 21MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED AS A REPLACEMENT. A PORTION OF THE STENT POST WAS CUT DURING EXTRACTION. THE EXPLANTED TRIFECTA VALVE WAS ANALYZED, AND THE LEFT CORONARY CUSP AND NON-CORONARY CUSP STENT POSTS WERE TORN. NO PANNUS OR CALCIFICATION WAS OBSERVED ON THE EXPLANTED VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17269047 ↗
• InjuryMay 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 25MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2023, THE VALVE WAS EXPLANTED DUE TO A TEAR ON THE VALVE. ASSOCIATED PATIENT SYMPTOMS WITH THIS EVENT WERE UNKNOWN, AND THE VALVE FAILURE WAS DETECTED ON ECHOCARDIOGRAPHY. THE DEVICE WAS REPLACED WITH A 25MM NON-ABBOTT VALVE. RUPTURED VALVE CUSPS WERE OBSERVED ON THE EXPLANTED DEVICE. THE PATIENT STATUS WAS UNKNOWN. THE SIZING FOR THE NATIVE VALVE ANNULAR DIMENSIONS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16940091 ↗
• InjuryMay 11, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM TRIFECTA GT WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, ON THE THIRD POSTOPERATIVE DAY, A CENTRAL JET TRANSVALVULAR LEAK WAS FOUND. THE VALVE WAS REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916370 ↗
• InjuryApr 24, 2023Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2019, A 25MM TRIFECTA VALVE WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS DETERMINED THAT THE PATIENT NEEDED A NEW VALVE DUE TO AORTIC INSUFFICIENCY. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 25MM EPIC PLUS. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 16799516 ↗
• InjuryFeb 22, 2023Calcified; Incomplete Coaptation; Material Split, Cut or Torn; Intravalvular regurgitation; Calcified; Incomplete Coaptation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED. ABOUT 4 YEARS LATER, THE PATIENT REPORTED SHORTNESS OF BREATH. IN A SCHEDULED APPOINTMENT, IT WAS DETERMINED THAT THE PATIENT HAD AORTIC INSUFFICIENCY. ON (B)(6) 2022, THE DEVICE WAS EXPLANTED, AND AN UNKNOWN SIZE EPIC PLUS VALVE WAS IMPLANTED AS A REPLACEMENT. THERE WERE LEAFLET TEARS AND CALCIFICATION ON THE EXPLANTED VALVE. THE TRIFECTA VALVE ALSO SHOWED INCOMPLETE COAPTATION AFTER EXPLANT. THE PATIENT WAS REPORTED AS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 16417742 ↗