Trifecta™ TFGT-19ARecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 05415067018205), received between Jul 17, 2018 and Jun 12, 2026 — classified as 3 deaths, 47 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (22 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 19MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON DD (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 25491639 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 19MM TRIFECTA GT VALVE WAS IMPLANTED ON (B)(6) 2016. 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 25491129 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 19MM TRIFECTA VALVE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT THE VALVE WAS EXPLANTED ON (B)(6) 2020. THE CAUSE OF THE EXPLANT IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BECOME AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25486656 ↗
• InjuryJun 11, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT DOUBLE VALVE REPLACEMENT (DVR) USING 19MM TRIFECTA AND 27MM EPIC VALVE. THE ANNULAR DIMENSIONS WERE APPROXIMATELY 21 MM FOR THE AORTIC VALVE AND 29 MM FOR THE MITRAL VALVE. ON (B)(6) 2025, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. ON (B)(6) 2025, THE PATIENT REQUIRED A REDO PROCEDURE DUE TO THE ONSET OF AORTIC STENOSIS. THE TRIFECTA VALVE WAS EXPLANTED AND A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS IMPLANTED. THE EXPLANTED TRIFECTA WAS CALCIFIED. THE 27MM EPIC VALVE WAS EXPLANTED AND A NEW 21MM SJM REGENT HEART VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED HOSPITALIZED.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 22190276 ↗
• InjuryFeb 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA GT VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. THE PATIENT WAS REPORTED TO BE STABLE AND RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21479644 ↗
• InjuryOct 18, 2024Calcified; Incomplete Coaptation; Calcified; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 19MM TRIFECTA GT VALVE WAS IMPLANTED FOR AORTIC STENOSIS. ON AN UNKNOWN DATE, A PACEMAKER WAS IMPLANTED FOR ATRIOVENTRICULAR (AV) CONDUCTION PROBLEMS. IN ADDITION, THE PATIENT EXPERIENCED SUPRAVENTRICULAR ARRHYTHMIAS AND ATRIAL FIBRILLATION (AF) AND THEY WERE ANTICOAGULATED FOR PAROXYSMAL AF. ON ANOTHER UNKNOWN DATE FOLLOWING, AN ECHOCARDIOGRAPHY WAS CONDUCTED AND INDICATED THE LEFT VENTRICULAR EJECTION FRACTION (EF) WAS BELOW NORMAL RANGE. DUE TO LOW EF, ON (B)(6) 2024, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM NON-ABBOTT VALVE. IT WAS NOTED THAT THE TRIFECTA VALVE WAS VERY STIFF WITH CALCIFIC PLAQUE ON THE VALVE LEAFLETS CAUSING RESTRICTED LEAFLET MOTION.

  Patient problems: Arrhythmia; Atrial Fibrillation; Heart Failure/Congestive Heart Failure

  MAUDE report 20487411 ↗
• DeathJul 26, 2024Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM RIGID SADDLE RING WAS CHOSEN FOR IMPLANT FOR MITRAL VALVE ANNULOPLASTY. IT WAS ALSO REPORTED THE PATIENT RECEIVED CONCOMITANT 19MM TRIFECTA GT VALVE FOR AORTIC VALVE REPLACEMENT. IT WAS REPORTED ON (B)(6) 2024, ECHOCARDIOGRAPHY REPORTED SEVERE MITRAL VALVE INSUFFICIENCY AND MODERATE TRICUSPID VALVE INSUFFICIENCY. IT WAS THEN REPORTED ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED DUE TO WORSENING HEART FAILURE. DURING ECHOCARDIOGRAPHY, IT WAS REPORTED THE TRIFECTA GT VALVE WAS SEVERELY INSUFFICIENT LIKELY ATTRIBUTED TO LEAFLET RUPTURE AND VALVE DETERIORATION. THE PATIENT PRESENTED WITH LUNG EDEMA. THE PATIENT WAS STABILIZED AND A DECISION WAS MADE TO PERFORM SURGICAL INTERVENTION ON (B)(6) 2024 FOR CONCOMITANT MITRAL AND AORTIC VALVE REPLACEMENT WITH TRICUSPID VALVE REPAIR. THE 28MM RIGID SADDLE RING WAS EXPLANTED AND REPLACED WITH A NON-ABBOTT PERICARDIAL VALVE FOR MITRAL REGURGITATION AND ANTERIOR LEAFLET CALCIFICATION. THE TRIFECTA GT VALVE WAS REPLACED WITH A 21MM NON-ABBOTT VALVE. THE PATIENT'S TRICUSPID VALVE WAS REPAIRED WITH AN UNKNOWN DEVICE. DURING THE INTERVENTION PROCEDURE, IT WAS REPORTED THE PATIENT SUFFERED MYOCARDIAL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Ischemia; Myocardial Infarction; Pulmonary Edema; Renal Failure; Shock

  MAUDE report 19838649 ↗
• InjuryJul 19, 2024Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2020, A 19MM TRIFECTA GT VALVE WAS IMPLANTED IN THE PATIENT DURING AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2024, A MILD AORTIC REGURGITATION (AR) WAS CONFIRMED AT THE OUTPATIENT CLINIC. IN (B)(6) 2024, THE PATIENT DEVELOPED SYMPTOMS OF DYSPNEA, LEG EDEMA, AND ANEMIA. IN EARLY (B)(6) 2024, SEVERE AORTIC INSUFFICIENCY (AR) AND MODERATE-SEVERE AORTIC STENOSIS (AS) WERE CONFIRMED. THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2024, THE TRIFECTA VALVE WAS EXPLANTED, AND A NEW 21MM NON-ABBOTT VALVE WAS IMPLANTED. THE AR AND AS WERE IMPROVED POSTOPERATIVELY. A LEAFLET TEAR WAS CONFIRMED ON THE EXPLANTED TRIFECTA VALVE. THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 19784625 ↗
• InjurySep 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, A 19MM TRIFECTA GT WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023 THE PATIENT HAD CARDIOGENIC SHOCK, HIGH BLOOD PRESSURE WHEN THE VALVE FAILURE WAS DISCOVERED. ON (B)(6) 2023, IT WAS REPORTED THAT THE DEVICE WAS SCHEDULED TO BE EXPLANTED AND REPLACED WITH A NON-ABBOTT DEVICE, DUE TO STRUCTURAL VALVE DETERIORATION AND TEAR OF COMMISSURAL. THE CAUSE OF THE EXPLANT IS UNKNOWN. PATIENT STATUS IS UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 17703028 ↗
• InjuryAug 1, 2023Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2017, A 19MM TRIFECTA GT VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IN (B)(6) 2023, PATIENT BEGAN EXPERIENCING SYMPTOMS OF HEART FAILURE AND WAS LATER ADMITTED TO THE HOSPITAL. SEVERE AORTIC REGURGITATION AND MILD MITRAL REGURGITATION WERE OBSERVED. THERE WAS ALSO A 50MM TUMOR SEEN ON THE ASCENDING AORTA. ON (B)(6) 2023, A MITRAL VALVE REPLACEMENT AND AORTIC VALVE REPLACEMENT WERE PERFORMED. THE TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH A 21MM NON-ABBOTT VALVE, AND A 30MM NON-ABBOTT VALVE WAS IMPLANTED IN THE MITRAL VALVE. A BYPASS OF SELECTIVE SAPHENOUS VEIN GRAFT TO RIGHT CORONARY ARTERY (SVG-RCA) WAS ALSO ADDED DUE TO RISK OF RIGHT CORONARY ARTERY OCCLUSION. ON THE EXPLANTED TRIFECTA VALVE, IT WAS NOTED THAT CIRCUMFERENTIALLY ON THE OUTFLOW SIDE, THERE WAS A CUSP TEAR CORRESPONDING TO THE RIGHT CORONARY CUSP. THE NATIVE AORTIC VALVE WAS REPORTED TO BE 23MM IN DIAMETER. THE PATIENT STATUS WAS STABLE.

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

  MAUDE report 17438866 ↗
• InjuryMay 4, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED INTO THE PATIENT. ON (B)(6) 2023, IT WAS NOTED BY ECHOCARDIOGRAM THAT THE PATIENT HAD MODERATE TO SEVERE AORTIC REGURGITATION. THE PATIENT REPORTED DYSPNEA. THE PHYSICIAN SUSPECTS A TEAR. DIURETICS WERE ADMINISTERED. THE PATIENT IS REPORTED TO BE HOSPITALIZED AND RECOVERING.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 16868279 ↗
• MalfunctionApr 20, 2023Degraded; Perivalvular Leak; Degraded; Perivalvular Leak

  CLINICAL INFORMATION: (B)(6) - TRIFECTA GT PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED DUE TO AORTIC STENOSIS OF THE NATIVE VALVE. ON (B)(6) 2018, A POST PROCEDURE ECHOCARDIOGRAM WAS PERFORMED AND SHOWED MILD PARAVALVULAR AORTIC REGURGITATION. THE MAX VELOCITY WAS RECORDED AT 4.55M/S, THE MAX GRADIENT WAS 55 MMHG, AND MID-GRADIENT WAS 55MMHG. DURING THE SIX-MONTH FOLLOW-UP APPOINTMENT, NO REGURGITATION WAS OBSERVED. ON (B)(6) 2023 DURING A SCHEDULED TEST, IT WAS CONFIRMED THAT STRUCTURAL VALVE DETERIORATION HAD OCCURRED ON THE TRIFECTA VALVE DUE TO DECREASED LEAFLET MOBILITY. THE PATIENT'S DYSPNEA PROGRESSED TO NEW YORK HEART ASSOCIATION (NYHA) II. NO INTERVENTION WAS PROVIDED. THE PATIENT CONTINUES TO BE FOLLOWED IN THE CLINICAL STUDY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 16781869 ↗
• InjuryFeb 22, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT (B)(6) 2018, A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. GRADIENTS BEGAN TO INCREASE FROM 12 MONTHS POST PROCEDURE AND SEVERE AORTIC VALVE STENOSIS WAS OBSERVED WITH A MEAN 60MMHG WITH MODERATE AORTIC REGURGITATION. A VALVE-IN-VALVE PROCEDURE WAS SCHEDULED FOR (B)(6) 2023. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16421667 ↗
• DeathJan 5, 2023Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2019 A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED. ON AN UNKNOWN DATE, AORTIC REGURGITATION WAS OBSERVED VIA ECHOAORTOGRAPHY. THE PATIENT ALSO EXPERIENCED HEART FAILURE AND DYSPNEA ON EXERTION. ON (B)(6) 2022, A NON-EMERGENCY PROCEDURE WAS PERFORMED, AND THE TRIFECTA GT VALVE WAS EXPLANTED. IT WAS OBSERVED THAT THE EXPLANTED TRIFECTA GT VALVE HAD RUPTURED VALVE CUSPS. AN UNKNOWN SIZE NON-ABBOTT VALVE WAS IMPLANTED AS A REPLACEMENT. MEDICATIONS WERE ADMINISTERED AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE FOLLOWING DAY ON (B)(6) 2022, WHILE THE PATIENT WAS ON PERCUTANEOUS CARDIOPULMONARY SUPPORT, THE PATIENT SUDDENLY DETERIORATED AND PASSED AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16109885 ↗
• InjuryJan 5, 2023Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA GT VALVE WAS IMPLANTED. ON (B)(6) 2022, AORTIC REGURGITATION WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS EXPLANTED. THE CUFF WAS INJURED DURING EXPLANT; THE UPPER PART OF THE LR COMMISSURE REMAINED CONNECTED, THE RIGHT SIDE WAS LARGE AND THE LEFT SIDE WAS SLIGHTLY DEPRESSED. A NEW 19MM SJM REGENT MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16108270 ↗
• InjuryDec 16, 2022Incomplete Coaptation; Patient-Device Incompatibility; Material Deformation; Intravalvular regurgitation; Incomplete Coaptation; Patient-Device Incompatibility; Material Deformation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2018, A 19MM TRIFECTA GT WAS IMPLANTED. ON AN UNKNOWN DATE IN (B)(6) 2022, THE PATIENT REPORTED THAT THEY HAD SHORTNESS OF BREATH. ON AN UNKNOWN DATE OF (B)(6) 2022, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE DONE AND SEVERE AORTIC REGURGITATION WAS DISCOVERED. ON (B)(6) 2022, THE DEVICE WAS THEN EXPLANTED AND REPLACED WITH A 17MM NON-ABBOTT DEVICE. UPON EXPLANATION, IT WAS NOTED THAT THERE WAS PANNUS, INCOMPLETE COAPTATION, INFLEXIBLE LEAFLETS, AND THE LEFT CORONARY CUSP LEAFLET WAS STRETCHED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 15997609 ↗
• InjuryNov 21, 2022Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2016 A 19MM TRIFECTA VALVE WAS IMPLANTED INTO A PATIENT. POST-OPERATIVELY, THERE WAS AN INCREASE IN PRESSURE DIFFERENCE NOTED, BUT NO SYMPTOMS. ON AN UNKNOWN DAY IN (B)(6) 2022, ECHOCARDIOGRAM WAS PERFORMED AND REVEALED SEVERE AORTIC STENOSIS. ON (B)(6) 2022, THE TRIFECTA VALVE WAS EXPLANTED AND REPLACED WITH A 19MM NON-ABBOTT DEVICE. VISUAL INSPECTION OF THE EXPLANTED VALVE REVEALED ADHESIONS ON 2 OR 3 STENT POSTS AND LEAFLET SCLEROSIS. THE DEVICE CUSP AND STENT ON THE POST-NON-CORONARY CUSP (NCC) SIDE WERE DAMAGED DURING EXPLANT. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15835177 ↗
• InjuryNov 14, 2022Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT IN (B)(6) 2019, A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. THERE WAS MILD AORTIC REGURGITATION OBSERVED ON THE DEVICE, WHICH WAS CONFIRMED BY ECHO AORTOGRAPHY. NO THROMBUS WAS OBSERVED ON THE DEVICE. A TRANSCATHETER AORTIC VALVE IMPLANTATION, OR VALVE-IN-VALVE PROCEDURE, WAS SCHEDULED FOR (B)(6) 2022. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15794041 ↗
• InjuryOct 29, 2022Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2019, A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED DURING AN AORTIC VALVE REPLACEMENT PROCEDURE. IN (B)(6) 2022, THE VALVE FAILURE WAS DISCOVERED WHEN THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND AORTIC REGURGITATION. ON 3 OCTOBER 2022, THE TRIFECTA GT VALVE WAS EXPLANTED IN A NON-EMERGENT PROCEDURE, AND A 19MM NON-ABBOTT DEVICE WAS IMPLANTED IN THE AORTIC VALVE. A TEAR ON THE EXPLANTED VALVE WAS NOTED. THE EXPLANTING PHYSICIAN DID NOT NOTICE ANY INTERACTION BETWEEN ANY STENT POST ON THE ORIGINAL VALVE AND PATIENT ANATOMY. THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 15695909 ↗
• InjurySep 9, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM TRIFECTA GT VALVE WAS CHOSEN FOR IMPLANT FOR AN AORTIC VALVE REPLACEMENT. DURING IMPLANT, A DENSELY CALCIFIED NATIVE VALVE WITH A POINTED ORIFICE WAS FOUND; THE VALVE WAS SUCCESSFULLY IMPLANTED. THE SURGERY HAD NO COMPLICATIONS OR DEVIATION FROM THE USUAL SURGICAL TECHNIQUE. ON (B)(6) 2022, A GRADE III VALVULAR INSUFFICIENCY WAS FOUND. ECHOCARDIOGRAPHIC IMAGES WERE PERFORMED AND EVALUATED, AND THE INSUFFICIENCY OF THE PROSTHESIS WAS DETERMINED TO BE VALVULAR AND NOT PARAVALVULAR. ON (B)(6) 2022, THE VALVE WAS EXPLANTED AND A NEW 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15393573 ↗
• InjuryAug 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM TRIFECTA GT VALVE HAD BEEN SUCCESSFULLY IMPLANTED. IT WAS NOTED HOWEVER, THAT WHEN WITHDRAWING FROM THE PUMP THE PATIENT HAD AORTIC REGURGITATION. THE DECISION WAS MADE TO EXPLANT THE 19MM TRIFECTA GT VALVE AND REPLACE IT WITH A 19MM NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15320708 ↗
• InjuryJul 28, 2022Incomplete Coaptation; Material Deformation; Material Split, Cut or Torn; Incomplete Coaptation; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON AN UNKNOWN DAY IN 2018, A 19MM TRIFECTA GT VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT AFTER HAVING BEEN SIZED USING AN ABBOTT SIZER SET. ON (B)(6) 2022, THE PATIENT RETURNED DUE TO AN UNKNOWN REASON. THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE WITH A NON-ABBOTT DEVICE BEING PLACED INSIDE THE 19MM TRIFECTA GT VALVE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15126169 ↗
• InjuryJul 19, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2018, A 19MM TRIFECTA GT VALVE WAS IMPLANTED. IN (B)(6) 2021, THE PATIENT HAD FOLLOW UP WITH NO PROBLEMS REPORTED. IN (B)(6) 2021, THE PATIENT WAS ADMITTED FOR HEART FAILURE. IN (B)(6) 2022, THE PATIENT WAS ADMITTED AGAIN AND ECHOCARDIOGRAPHY SHOWED SEVERE AORTIC REGURGITATION (AR). MEDICATION WAS ADMINISTERED, HOWEVER "HEART FAILURE DID NOT IMPROVE." IN (B)(6) 2022, THE PATIENT WAS ADMITTED FOR ADDITIONAL TREATMENT (OXYGEN INHALATION, MEDICATION). PATIENT SYMPTOMS INCLUDE DYSPNEA AND DIZZINESS. OPEN-HEART SURGERY WAS SUGGESTED, HOWEVER THE "PATIENT WAS RELUCTANT." TAVR WAS ALSO CONSIDERED, HOWEVER NO TREATMENT IS SCHEDULED. CONSERVATIVE THERAPIES WAS REPORTED AFTER DISCUSSION WITH THE PATIENT. THE VALVE REMAINS IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Dyspnea; Valvular Insufficiency/ Regurgitation

  MAUDE report 15053342 ↗
• MalfunctionJul 19, 2022Calcified; Calcified

  IT WAS REPORTED THAT A 19MM TRIFECTA VALVE WAS IMPLANTED IN 2018. ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH HIGH GRADIENT. IT WAS NOTED THAT THE PATIENT REQUIRES A REPLACEMENT SURGERY DUE TO THE CALCIFICATION OF THE LEAFLETS ON THE TRIFECTA VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15052903 ↗
• InjuryJun 10, 2022Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED A PATIENT UNDERWENT IMPLANT OF A 19MM TRIFECTA GT AORTIC VALVE ON 13 (B)(6) 2017. DURING A FOLLOW UP VISIT (DATE UNKNOWN) THE PATIENT PRESENTED WITH DYSPNEA AND AORTIC REGURGITATION WAS IDENTIFIED. ON (B)(6) 2022 THE PATIENT UNDERWENT EXPLANT OF THE TRIFECTA VALVE. UPON REMOVAL, THE STENT POST ADHESION TO THE AORTA IS BELIEVED TO HAVE CAUSED A CRACK FROM THE R-N STENT POST. A TEAR WAS ALSO OBSERVED ON THE VALVE LEAFLET. A NON-ABBOTT VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 14655798 ↗