Trifecta™ TF-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734052061), received between Oct 11, 2019 and Sep 19, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Backflow” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY MEDWATCH REPORT MW5158559 RECEIVED THAT STATES ¿MY FATHER RECEIVED AN ABBOTT TRIFECTA TISSUE HEART VALVE (MODEL TF-29A) IN (B)(6) 2016. HE DISCOVERED THAT THE DEVICE WAS RECALLED ON 06/21/2024 AFTER WORSENING HEALTH CONDITION THAT LEAD TO EVENTUAL HOSPITALIZATION ON (B)(6) 2024 AND DEATH ON (B)(6) 2024 PRIOR TO A SURGERY TO REPLACE THE DEFECTIVE HEART VALVE." IT WAS REPORTED THAT ON AN UNKNOWN DATE AND YEAR, A 29MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE AND YEAR, THE PATIENT HAD WORSENING HEART FAILURE AND HOSPITALIZED. THE PATIENT WAS HOSPITALIZED AND PASSED AWAY PRIOR TO SURGICAL INTERVENTION. THE CAUSE OF DEATH IS UNKNOWN, NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS RECALLED ON (B)(6) 2024.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20257203 ↗
• InjuryDec 22, 2023Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  USER FACILITY MEDWATCH REPORT # MW5148065 RECEIVED THAT STATES " A PATIENT PRESENTED WITH AN ABBOTT 29MM TRIFECTA VALVE WITH MODERATE AORTIC INSUFFICIENCY AND A MEAN GRADIENT OF 31MMHG. A 29MM SAPIEN 3 VALVE WAS IMPLANTED WITH NO ISSUES, A RESIDUAL MEAN GRADIENT OF 4MMHG AND TRACE AORTIC INSUFFICIENCY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 29MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH A MODERATE AORTIC INSUFFICIENCY AND A MEAN GRADIENT OF 31MMHG. ON AN UNKNOWN DATE, A NEW 29MM NON-ABBOTT VALVE WAS IMPLANTED WITH NO ISSUES WITH A MEAN GRADIENT OF 4MMHG AND TRACE OF AORTIC INSUFFICIENCY.

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

  MAUDE report 18383121 ↗
• MalfunctionJun 30, 2020Backflow; Material Split, Cut or Torn; Backflow; Material Split, Cut or Torn

  ON (B)(6) 2020 DR. (B)(6) INFORMATION SJM THAT HE WAS EXPLANTING A TRIFECT VALVE THAT WAS IMPLANTED APPROXIMATELY 6 YEARS AGO. THE PATIENT WAS EXPERIENCE DISTRESS. AN ECHO WAS PERFORMED THAT REVEALED THE PATIENT WAS SUFFERING FROM WIDE OPEN AORTIC INSUFFICIENCY DUE TO A POSSIBLE LEAFLET TEAR. IT WAS CONFIRMED UPON EXPLANT THE LEAFLET WAS TORN. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Aortic Insufficiency

  MAUDE report 10211294 ↗
• InjuryOct 11, 2019Obstruction of Flow; Obstruction of Flow

  9 OCTOBER 2019: ADDITIONAL INFORMATION RECEIVED ON 7 OCTOBER 2019 REPORTED THAT THE PATIENT WAS DISCHARGED ON THE 3RD POST-OPERATIVE DAY. ON (B)(6) 2014, A 29MM TRIFECTA VALVE WAS IMPLANTED. IN EARLY SUMMER OF 2019, THE PATIENT PRESENTED WITH EXERTIONAL DYSPNEA AND MG OF 44. TEE SHOWED TWO CUSPS OF THE VALVE WERE IMMOBILE AND ALL LEAFLETS SEEMED THICKENED. ON (B)(6) 2019, A VALVE IN VALVE WAS PERFORMED AND A COMPETITORS 34MM EVOLUT R WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Dyspnea

  MAUDE report 9182655 ↗