Trifecta™ TFGT-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067018250), received between Nov 13, 2018 and Jun 12, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 29MM 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 25491126 ↗
• InjuryMay 24, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2020, A 29MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED. IN (B)(6) 2022, THE PATIENT BEGAN HAVING SHORTNESS OF BREATH. THE PATIENT'S BNP WAS ELEVATED, SUGGESTING HEART FAILURE. ON (B)(6) 2023, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED SEVERE BIOPROSTHETIC VALVULAR REGURGITATION WITH HOLODIASTOLIC FLOW REVERSAL IN THE DESCENDING AORTA. THE MEAN GRADIENT WAS 18MMHG. ON (B)(6) 2023, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THAT THE RIGHT CORONARY CUSP OF THE TRIFECTA VALVE WAS FLAILED AND PROLAPSING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THERE WAS SEVERE, ECCENTRIC, POSTERIORLY DIRECTED AORTIC REGURGITATION. ON (B)(6) 2023, THE VALVE WAS EXPLANTED AND REPLACED WITH A 29MM EPIC SUPRA VALVE. THE PHYSICIAN NOTED THAT ONE OF THE LEAFLETS WAS TORN AWAY FROM THE STRUTS. A PATHOLOGY REPORT OF THE TRIFECTA VALVE SHOWED TWO VALVE LEAFLETS WERE RAGGED AND DISRUPTED.

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

  MAUDE report 19394448 ↗
• InjuryMay 17, 2022Degraded; Incomplete Coaptation; Degraded; Incomplete Coaptation

  IT WAS REPORTED THAT IN (B)(6) 2019, A 29MM TRIFECTA GT VALVE WAS IMPLANTED. THE PATIENT LATER PRESENTED WITH SYMPTOMS OF SEVERE AORTIC REGURGITATION. THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION ON (B)(6) 2022, AND A 29MM NON-ABBOTT VALVE WAS IMPLANTED WITHIN THE TRIFECTA VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14426950 ↗
• InjuryFeb 3, 2022Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2019, A 29MM TRIFECTA¿ GT VALVE WAS IMPLANTED. IN (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY ROOM VIA AMBULANCE DUE TO SUDDEN CHEST PAIN AND WAS ADMITTED TO THE HOSPITAL. AN ECHOCARDIOGRAPHY WAS PERFORMED AND AORTIC REGURGITATION (AR) WAS NOTED. A TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TOE) WAS PERFORMED FOR FURTHER IMAGING AND A POSSIBLE TEAR WAS NOTED ON THE NON-CORONARY CUSP (NCC). ON (B)(6) 2022, THE VALVE WAS EXPLANTED AND UPON EXPLANT A 5MM PARALLEL TEAR WAS NOTED ON ONE OF THE LEAFLET STENTS. A NEW 27MM TRIFECTA¿ GT VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. OPERATIVE NOTES AND ECHO REPORT WAS REQUESTED BUT CANNOT BE OBTAINED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Chest Pain

  MAUDE report 13440179 ↗
• InjuryApr 27, 2021Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  ON (B)(6) 2021, A 29MM TRIFECTA¿ GT VALVE WAS IMPLANTED. POST IMPLANT, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A SIGNIFICANT LEAK WAS NOTED AND ONE OF THE LEAFLETS HAD WEAK MOVEMENT. DUE TO THE SIZE OF THE LEAK THE IT WAS DECIDED TO EXPLANT THE VALVE IMMEDIATELY AND IMPLANT A NON ABBOTT VALVE. THE PATIENT WAS ON THE PUMP FOR A EXTRA 75 MINUTES BUT WAS REPORTED TO BE STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734936 ↗
• InjuryJan 7, 2021Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2017, A 29MM TRIFECTA¿ GT VALVE WAS IMPLANTED. AN VALVE IN VALVE IS ANTICIPATED TO HAPPEN IN (B)(6) 2021 DUE TO A POSSIBLE PROLAPSED CUSP. THE PATIENT WAS REPORTED TO IN UNSTABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUEST BUT CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11135750 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, A 29MM TRIFECTA GT VALVE WAS SELECTED FOR IMPLANT. AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE AORTIC INSUFFICIENCY, AND THE VALVE WAS EXPLANTED. AN EDWARDS INSPIRIS RESILIA TISSUE VALVE (SIZE UNKNOWN) WAS IMPLANTED. THE EXPLANT RESULTED IN EXTENDED CROSS-CLAMP TIME. THE PATIENT IS REPORTED TO BE RECOVERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT UNAVAILABLE.

  Patient problems: Aortic Regurgitation

  MAUDE report 8593455 ↗
• InjuryNov 13, 2018Perivalvular Leak; Microbial Contamination of Device; Perivalvular Leak; Microbial Contamination of Device

  ON (B)(6) 2018, A 29MM TRIFECTA GT VALVE WAS IMPLANTED. THE PATIENT WAS DISCHARGED FIVE DAYS LATER. THREE WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED FEVER, MALAISE AND A PERICARDIAL RUB WAS DETECTED. THE PATIENT WAS GIVEN NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. ON (B)(6), THE PATIENT REPORTED CONFUSION AND RECENT MEMORY LOSS. A NEUROLOGY CHECKUP DETECTED EMBOLIC CEREBROVASCULAR DISEASE. ON (B)(6), ECHOCARDIOGRAM REVEALED PARAVALVULAR LEAKAGE OF THE 29MM TRIFECTA GT. VEGETATION WAS NOT OBSERVED. ON (B)(6), TRANSESOPHAGEAL ECHO REVEALED SEVERE PARAVALVULAR LEAKAGE AND THE BEGINNING OF LEFT VENTRICULAR DILATION. A CT SCAN COMPLETED ON THE SAME DAY REVEALED BIOCCIPITAL AND BIPARIETAL ISCHEMIA AND EDEMA. THE 29MM TRIFECTA GT VALVE WAS EXPLANTED THE SAME DAY UNDER EXTRACORPOREAL CIRCULATION (HEART-LUNG MACHINE). AT THE TIME OF REOPERATION, VEGETATION WAS FOUND ON THE VALVE AND BELOW THE VALVE RING WHERE A COMPACT AND CONSIDERABLY SIZED MASS HAD FORMED, PARTIALLY OBSTRUCTING THE EXIT OF THE LEFT VENTRICLE. DETACHMENT OF THE VALVE ON THE LEFT CORONARY BORDER AND THE START OF ABSCESS ON THE FREE WALL OF THE LEFT VENTRICLE WERE ALSO OBSERVED. SURGICAL REMOVAL OF THE VEGETATION AND INFECTE

  Patient problems: Death; Endocarditis; Hemorrhage, Cerebral

  MAUDE report 8067351 ↗