SJM Regent™ 19AGN-751Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05414734005869), received between Sep 24, 2018 and Apr 7, 2026 — classified as 3 deaths, 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE LEAFLET CAME OUT AND WENT LEFT VENTRICLE. THEY CONFIRMED THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. THE VALVE GOT REMOVED AND REPLACED WITH ANOTHER VALVE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808722 ↗
• MalfunctionFeb 9, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, 19MM SJM REGENT HEART VALVE WAS CHOSEN TO REPLACE A DEGENERATED NATIVE AORTIC VALVE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE OF THE LEAFLETS OF THE MECHANICAL REGENT VALVE PROLAPSED. THIS OCCURRED IMMEDIATELY AFTER THE VALVE IMPLANTATION BEGAN, WITHOUT PRIOR ATTEMPTS TO ROTATE THE VALVE OR MECHANICALLY POSITION IT. A NEW 19MM VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE AND PATIENT WAS REPORTED DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298416 ↗
• MalfunctionSep 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073881 ↗
• MalfunctionJul 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT HEART VALVE WAS SELECTED FOR IMPLANT IN A PATIENT. IT WAS NOTED DURING PROCEDURE THAT THE SUTURE CUFF OF THE VALVE WAS TORN WHEN THE NEEDLE AND THREAD WERE APPLIED AND WAS THEREFORE NOT IMPLANTED. THE VALVE WAS REMOVED AND NOT HANDLED WITH ANY UNPROTECTED FORCEPS OR SHARP INSTRUMENTS. THE VALVE HOLDER WAS NOT REMOVED AND WAS USED TO PARACHUTE THE VALVE INTO THE ANNULUS. A COR-KNOT DEVICE WAS NOT USED DURING THE PROCEDURE. THE DECISION WAS MADE TO REPLACE 19MM REGENT HEART VALVE WITH A 17MM REGENT HEART VALVE TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO CLINICAL SIGNS OR SYMPTOMS ASSOCIATED WITH THIS EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONALLY, THE PATIENT WAS NOT TAKEN OFF BYPASS AND PLACED BACK ON BYPASS AT ANY POINT DUE TO THIS EVENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639361 ↗
• MalfunctionJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. THE NATIVE AORTIC VALVE WAS SIZED WITH A 19MM REGENT AGN SIZER. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED AND MOVING NORMALLY WHEN TESTED WITH A LEAFLET TESTER. THE REGENT AORTIC VALVE WAS THEN IMPLANTED. HOWEVER, POST-IMPLANT, IT WAS OBSERVED THAT THE LEAFLET DID NOT OPEN. SUBSEQUENTLY, THE VALVE WAS REMOVED. OUTSIDE OF THE PATIENT, THE LEAFLETS WERE TESTED AGAIN AND OPENED WITH NO ISSUE. A NEW 17MM REGENT AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. OF NOTE, PRIOR TO THE REGENT PROCEDURE, A 25MM MASTERS MITRAL MECHANICAL HEART VALVE WAS IMPLANTED TO TREAT SEVERE MITRAL REGURGITATION; NO IMPLANT COMPLICATIONS WERE REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387119 ↗
• DeathJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS PARACHUTED DOWN, THE HANDLE WAS REMOVED AND THE SUTURES WERE TIED. THE VALVE WAS NOT ATTEMPTED TO BE ROTATED. PRIOR TO PATIENT CLOSURE, THE VALVE LEAFLETS WERE INTENDED TO BE TESTED FOR MOBILITY. HOWEVER, IT WAS DISCOVERED THAT ONE OF THE LEAFLETS WAS MISSING. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREES. THE LEAFLET HAD DISLODGED IN ONE PIECE AND WAS RECOVERED FROM THE PATIENT. THE VALVE WAS EXPLANTED AND A NEW 21MM REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED AS THE SAME SIZE WAS NOT AVAILABLE. POST-OPERATIVELY, THE PATIENT REMAINED ON VENTILATOR SUPPORT. ON (B)(6) 2024, THE PATIENT STOPPED MAKING URINE AND WAS NOT HOLDING BLOOD PRESSURE. THEREFORE, INTRA-AORTIC BALLOON WAS INSERTED TO AUGMENT THE BLOOD PRESSURE. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO HAVE PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS UNKNOWN. THE 21MM REGENT VALVE REMAINS IMPLANTED IN THE PATIENT. HOWEVER, THE PATIENT ALLEGED THAT THE 19MM VALVE CONTRIBUTED TO THE PATIENT PASSING AND THAT THE 21MM REGENT VALVE DID NOT CONTRIBUTE TO THE PATIENT PASSING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21093909 ↗
• InjurySep 16, 2024Incomplete Coaptation; Incomplete Coaptation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224212 ↗
• MalfunctionApr 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM SJM REGENT HEART VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. DURING PREPARATION, THERE WAS NOTHING WRONG WITH THE VALVE. THE VALVE WAS IMPLANTED IN THE PATIENT. AFTER THE PROCEDURE, ONCE THE VALVE WAS IMPLANTED IT WAS FOUND THAT THE VALVE LEAFLET COULDN'T MOVE. THE PHYSICIAN REMOVED THE VALVE AND A NEW 19MM NON-ABBOTT VALVE WAS IMPLANTED INTRA-PROCEDURALLY, WHILE THE PATIENT WAS STILL ON BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146344 ↗
• DeathJun 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT INTO THE AORTIC POSITION. DURING THE PROCEDURE THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. FRAGMENTATION OF THE OBTURATOR ELEMENT WAS NOTED DURING FIXATION OF THE VALVE. THE LEAFLET TO THE VALVE RING BROKE OFF. THE DISLODGED LEAFLET DISLODGED AS ONE PIECE AND WAS REMOVED FROM THE PATIENT. THERE WAS NO RESISTANCE FELT WHEN ROTATING THE VALVE. THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR. NO INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF DISLODGEMENT. THE PATIENT COLLAPSED INTRAOPERATIVELY AND WAS PUT ON CARDIOPULMONARY BYPASS. IT WAS NOTED THAT THE SEVERITY OF THE EVENT WAS LIFE THREATENING. A 19MM REGENT HEART VALVE WAS IMPLANTED AS A REPLACEMENT. ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. THE CAUSE OF THE DEATH IS MULTI-ORGAN FAILURE. THE IMPLANTER CLASSIFIED THE DEATH AS DUE TO THE DESTRUCTION OF THE DEVICE RESULTED IN A 150% INCREASE IN AORTIC CLAMPING TIME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 17200087 ↗
• MalfunctionFeb 6, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANTED. DURING THE PROCEDURE AFTER THE IMPLANTATION, IT WAS NOTICED THAT VALVE COULD NOT BE ROTATED AND ONE OF THE LEAFLET OF THE VALVE WAS NOT CLOSING PROPERLY, RESULTING IN ACUTE AORTIC INCOMPETENCY. THE VALVE WAS EXPLANTED AND A NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304049 ↗
• DeathDec 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2022, A 19MM SJM REGENT HEART VALVE WAS SELECTED FOR IMPLANTATION. DURING THE PROCEDURE, WHEN THE DEVICE WAS ROTATED TO POSITION THE VALVE. THERE WAS NOTABLE RESISTANCE FELT WHILE ROTATING. IT WAS THEN NOTED THAT THE DEVICE WAS FRACTURED NEAR THE ANNULUS OF THE PATIENT. THE VALVE WAS THEN REPLACED WITH ANOTHER 19MM SJM REGENT HEART VALVE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE REPLACEMENT OF THE VALVE CAUSED A DELAY OF APPROXIMATELY 40 MINUTES. 12 HOURS FOLLOWING THE PROCEDURE, LOW CARDIAC OUTPUT WAS NOTED AND THE PATIENT WAS PLACED ON ECMO. THE PATIENTS HEMODYNAMICS AND EJECTION FRACTION (EF) VALUES IMPROVED. ON (B)(6) 2022, THE PATIENT PASSED AWAY DUE TO HEMOPTYSIS. IT IS BELIEVED THAT PROLONGED BYPASS AND CROSS-CLAMP TIME DURING THE PROCEDURE CONTRIBUTED TOWARDS PATIENT DEATH.

  Patient problems: Hemoptysis

  MAUDE report 16039925 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTICLE FROM THE HEART'S ORIGINAL "AORTIC VALVE REPLACEMENT COMPLICATED POSTOPERATIVELY BY ACUTE ANGLE CLOSURE GLAUCOMA", REPORTED A CASE 65-YEAR-OLD MALE WITH A HISTORY OF CARDIAC MURMUR WHO UNDERWENT CARDIAC CATHETERIZATION. NO ANOMALY FOR CORONARY ARTERIES WAS POINTED OUT. ALTHOUGH AORTIC STENOSIS WAS CONFIRMED, PRESSURE GRADIENT BETWEEN LEFT VENTRICLE AND AORTA WAS 23MMHG. THE PATIENT WAS SCHEDULED TO FOLLOWED IN OUTPATIENT CLINIC 2 YEARS AGO ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT WAS ADMITTED TO HOSPITAL FOR CHEST DISCOMFORT NOTED WHILE HE WAS PLAYING BASEBALL. THE ECHOCARDIOGRAPHY CONFIRMED 4M/S AORTIC VALVE BLOOD VELOCITY AND AORTIC STENOSIS. ST ELEVATION ON V1-3 AND LEFT VENTRICLE HYPERTROPHY WAS DETECTED BY ELECTROCARDIOGRAM. IN ADDITION, CARDIAC ENZYME ELEVATION WAS OBSERVED. THE PATIENT WAS TREATED INTERNALLY AND ONCE THE SYMPTOM WAS STABLE, CARDIAC CATHETERIZATION WAS PERFORMED AGAIN. PG (PRESSURE-GRADIENT) INCREASED UP TO 56MMHG AND AORTIC STENOSIS PROGRESS WAS CONFIRMED. ONE MONTH LATER, AVR (AORTIC VALVE REPLACEMENT) WAS CONDUCTED. A 19MM SJM REGENT VALVE WAS IMPLANTED IN AORTIC POSITION. THE PATIENT COMPLAINED NUMBNESS LEFT LOWER EXTREMITY AND DIFFIC

  Patient problems: Blurred Vision; Transient Ischemic Attack

  MAUDE report 15651941 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS BEING CONSERVATIVELY REPORTED DUE THE PATIENT'S DEATH AND ITS PROXIMITY TO THE IMPLANT PROCEDURE. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTED VALVE. IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF SEVERE AORTIC REGURGITATION (SVR), DILATED LEFT VENTRICLE DUE TO CARDIOMYOPATHY AND POOR LEFT VENTRICLE EJECTION FRACTION (LVEF OF LESS THAN 30%) UNDERWENT AN IMPLANT OF A 19 MM AORTIC SJM REGENT HEART VALVE ON (B)(6) 2022. IT WAS REPORTED THAT AS THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS, THE PATIENT REMAINED HEMODYNAMICALLY STABLED AND THE PATIENT DID NOT REMAIN INTUBATED POST PROCEDURE. POST PROCEDURE THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA FOR FURTHER MANAGEMENT, WHERE THE PATIENTS LVEF REMAINED POOR. IN ADDITION, THE PATIENT DEVELOPED A MYOCARDIAL INFARCTION (MI) ALONG WITH TACHYCARDIA. THE PATIENT DID NOT RESPOND TO TREATMENT AND PASSED AWAY ON (B)(6) 2022. IT WAS NOTED THAT DURING THE PROCEDURE THERE WERE NO ADVERSE EVENT AND THE PATIENT REMAINED STABLE. THE 19MM REGENT VALVE PERFORMED AS INTENDED. IT WAS NOTED THAT THE PATIENT PASSED AWAY DUE TO THE THEIR COMORBIDITIES AND THE MI EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiomyopathy; Myocardial Infarction

  MAUDE report 13860236 ↗
• InjuryDec 2, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED A 19MM SJM REGENT HEART VALVE WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED WHILE PARACHUTING THE VALVE, IT WAS DIFFICULT TO SEAT THE VALVE ON THE ANNULUS. THE DEVICE WAS EXPLANTED AND EXCHANGED WITH A SMALLER, 17MM SJM REGENT HEART VALVE. THE EVENT DID LEAD TO PROLONGED PROCEDURE, AND PROLONGED TIME ON THE CARDIOPULMONARY BYPASS. THE PATIENT IS STABLE AND IS RECOVERING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(6) 2021. (B)(6). OED: HCP WAS DOING AVR IN THE PATIENT AND DURING THE PROCEDURE HCP IMPLANTING 19MM AGN VALVE AND WHILE PARACHUTING THE VALVE HCP FACED SOME DIFFICULTY TO SIT THE VALVE ON THE ANNULUS SO HE EXPLANTED THE VALVE AND IMPLANT 17MM AGN VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920484 ↗
• InjuryMay 26, 2021Material Separation; Material Separation

  RELATED MANUFACTURER REPORT NUMBER: 2648612-2021-00054. ON (B)(6) 2021, A 19MM SJM REGENT HEART VALVE WAS SELECTED FOR IMPLANT. WHILE THE DEVICE WAS FITTED INTO THE AORTA AND SUTURES WERE PLACED, THE DEVICE LEAFLETS BECAME FRACTURED. THE DEVICE WAS REMOVED WITH ALL FRACTURED LEAFLET PIECES AND A NEW 19MM SJM REGENT HEART VALVE WAS SELECTED. WHILE THE REPLACEMENT DEVICE WAS BEING ROTATED, THE VALVES LEAFLET BECAME DISLODGED. THE DEVICE AND LEAFLET WERE REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER 19MM SJM REGENT HEART VALVE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE HOWEVER, THE PROCEDURE EXTENDED LONGER THAN WHAT IS CLINICALLY ACCEPTABLE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891213 ↗
• InjuryMay 26, 2021Fracture; Fracture

  RELATED MANUFACTURER REPORT NUMBER: 2648612-2021-00055. ON (B)(6) 2021, A 19MM SJM REGENT HEART VALVE WAS SELECTED FOR IMPLANT. WHILE THE DEVICE WAS FITTED INTO THE AORTA AND SUTURES WERE PLACED, THE DEVICE LEAFLETS BECAME FRACTURED. THE DEVICE WAS REMOVED WITH ALL FRACTURED LEAFLET PIECES AND A NEW 19MM SJM REGENT HEART VALVE WAS SELECTED. WHILE THE REPLACEMENT DEVICE WAS BEING ROTATED, THE VALVES LEAFLET BECAME DISLODGED. THE DEVICE AND LEAFLET WERE REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER 19MM SJM REGENT HEART VALVE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE HOWEVER, THE PROCEDURE EXTENDED LONGER THAN WHAT IS CLINICALLY ACCEPTABLE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891205 ↗
• MalfunctionFeb 24, 2021Fracture; Fracture

  ON (B)(6) 2021, A FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEVERE MITRAL STENOSIS(MS), SEVERE RHEUMATIC HEART DISEASE(RHD) AND SEVERE AORTIC STENOSIS(AS). THE PATIENT WAS POSTED FOR A DOUBLE VALVE REPLACEMENT(DVR) AND TVA. A 19MM REGENT HEART VALVE (SN: (B)(4)) WAS SELECTED FOR IMPLANT IN THE PATIENT'S NATIVE AORTIC VALVE. DURING THE PROCEDURE THE LEAFLET OF THE VALVE BROKE DURING PLACEMENT OF THE SUTURES ALL PIECES OF THE FRACTURED LEAFLET WERE RECOVERED AND THE VALVE WAS REPLACED WITH A COMPETITOR'S VALVE. THE PATIENT DID NOT EXPERIENCE ANY SERIOUS INJURIES AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE INCLUDED BYPASS TIME. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376270 ↗
• InjuryNov 4, 2019Fracture; Fracture

  28 OCTOBER 2019: ADDITIONAL INFORMATION RECEIVED ON THIS DATE REPORTED THAT ALL PIECES OF THE DEVICE ARE CONFIRMED TO BE REMOVED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE USER DOES ALLEGE A CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME. 8 OCTOBER 2019: ADDITIONAL INFORMATION RECEIVED ON 7 OCTOBER 2019 REPORTED THAT THE PHYSICIAN HAD ALREADY LOWERED AND CUT THE STITCHES. THE PHYSICIAN WAS GOING TO TRY TO OPEN AND CLOSE THE VALVE WITH THE SILICONE PENCIL. HOWEVER, WHEN MOVING THE DEVICE, IT BROKE INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH A NEW 21MM MASTERS VALVE. ON (B)(6) 2019, A 19MM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. HOWEVER, THE DEVICE FAILED DURING IMPLANT AND WAS REMOVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272629 ↗
• InjuryOct 14, 2019Biocompatibility; Biocompatibility

  ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR ANALYSIS WITH SYMPTOMS OF DYSPNEA AND SYNCOPE. ON (B)(6) 2019, A REGENT MECHANICAL HEART VALVE WAS IMPLANTED IN THE AORTIC POSITION. WHILE THE PATIENT WAS HOSPITALIZED POSTOPERATIVELY THE PATIENT WAS ON ANTICOAGULATION THERAPY (CLEXANE). A WEEK LATER ON (B)(6) 2019, THE DEVICE WAS EXPLANTED DUE TO THROMBOSIS AND REPLACED WITH A 19MM INTUITY VALVE. THE INR LEVEL WAS 2. ON (B)(6) 2019, THE PATIENT DIED DUE TO RIGHT VENTRICLE FAILURE. THE PATIENT'S COMORBIDITIES INCLUDED: HYPERTENSION, ANXIOUS SYNDROME, AND GASTROINTESTINAL REFLUX.

  Patient problems: Death; Thrombus

  MAUDE report 9186206 ↗
• InjuryApr 9, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, AN AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED AND A 19MM REGENT VALVE WAS IMPLANTED IN A FEMALE PATIENT. DURING A FOLLOW-UP VISIT ON (B)(6) 2019, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS TREATED WITH A THROMBOLYSIS COURSE; HOWEVER, SYMPTOMS PROGRESSED. THE PATIENT UNDERWENT A RE-DO AVR PROCEDURE AND A TRIFECTA GT VALVE (SERIAL NUMBER: UNKNOWN) WAS IMPLANTED. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Dyspnea

  MAUDE report 8497612 ↗
• InjuryJan 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, A 19MM REGENT VALVE WAS SELECTED FOR IMPLANT. UPON IMPLANTATION AND ROTATION WITH THE HOLDER, ONE OF THE LEAFLETS DISLODGED AND MIGRATED TO THE INSIDE OF THE LEFT VENTRICLE. THE LEAFLET WAS RETRIEVED AND ANOTHER 19MM REGENT VALVE WAS IMPLANTED (SERIAL NUMBER: UNKNOWN). THE PATIENT IS REPORTED STABLE; HOWEVER, THE EVENT IMPACTED THE SURGERY DUE TO DELAY, RESULTING IN HEMODYNAMIC COMPROMISE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243923 ↗
• InjurySep 24, 2018Fracture; Fracture

  DURING IMPLANT OF A 19 MM REGENT VALVE, A LEAFLET FRACTURED INTO TWO PIECES DURING ROTATION. THE VALVE AND FRACTURED LEAFLET PIECES WERE SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A SECOND 19 MM REGENT VALVE (SN UNKNOWN). THE CPB/XC TIME WAS SIGNIFICANTLY EXTENDED (40-45 MINUTES) DUE TO THE REPORTED EVENT BUT THERE WAS NO HEMODYNAMIC COMPROMISE FOR THE PATIENT AND THE PATIENT REMAINED STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904442 ↗