SJM Regent™ AGFN-756 (REF 19AGFN-756)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05414734005852), received between Jun 27, 2018 and May 7, 2024 — classified as 5 deaths, 35 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON 25 MARCH 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION. DURING IMPLANTATION, WHILE PLACING THE VALVE ONE OF THE LEAFLETS DETACHED AND WENT INSIDE THE PATIENT ANATOMY. THE VALVE HAD BEEN ROTATED WITH THE VALVE ROTATOR WITHOUT RESISTANCE. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THE VALVE WAS IN A CLOSED POSITION WHEN IT WAS ROTATED AND THE LEAFLET DISLODGED. THE REGENT VALVE WAS REMOVED AND THE LEAFLET WAS RECOVERED FROM THE LEFT ATRIUM INTACT BY SURGICALLY OPENING THE LEFT ATRIUM WITH ECHOCARDIOGRAPHIC GUIDANCE. A SECOND 19MM REGENT AORTIC MECHANICAL HEART VALVE (SERIAL: (B)(6)) WAS THEN ATTEMPTED TO BE IMPLANTED. WHILE ATTEMPTING TO ROTATE THE VALVE IN CLOSED POSITION, BOTH LEAFLETS DISLODGED. THE LEAFLETS WERE REMOVED FROM THE PATIENT SUCCESSFULLY WITHOUT UNUSUAL INTERVENTION. A THIRD MASTERS HP VALVE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS REPORTEDLY A DELAY THAT RESULTED IN NO PATIENT EFFECTS AS BYPASS TIME WAS EXTENDED 40-50 MINUTES. THE PATIENT WAS REPORTED TO BE STAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259938 ↗
• DeathMay 6, 2024Incomplete Coaptation; Physical Resistance/Sticking; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE EXTRACORPOREAL CIRCULATION (EC) WAS CONNECTED IN A TYPICAL WAY AND MACROSCOPICALLY THE HEART WAS SMALL. AFTER PERFORMING THORACOTOMY, A COMPLETELY CALCIFIED AORTIC VALVE WAS LOCATED. THE AORTIC RING WAS CLEANED OF CALCIFICATIONS AND VALVE SUTURES WERE PLACED SUB-ANNULARLY ON SMALL PATCHES. THE DIAMETER OF THE AORTIC LUMEN WAS MEASURED AT THE ANNULUS LEVEL AND DECIDED TO USE A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE. THE LEAFLET FUNCTION WAS TESTED USING A MECHANICAL HEART VALVE LEAFLET TESTER. DURING PROCEDURE, UNTIL THE VALVE WAS BROUGHT ON THE SUTURES TOWARDS THE NATIVE ANNULUS, THE VALVE REMAINS IN THE HOLDER AND THE VALVE LEAFLETS ARE CLOSED. THE VALVE WAS PLACED SUPRA-ANNULARLY. AFTER TYING THE FIRST TWO VALVE SUTURES, IT WAS FOUND THAT THE VALVE WAS UNABLE TO ROTATE RELATIVE TO THE SUTURE RING AND THAT THE VALVE LEAFLETS WERE NOT FULLY OPENED. SEVERAL MORE SUTURES WERE TIED, RESULTING IN A SLIGHT IMPROVEMENT MOBILITY. THE PHYSICIAN DECIDED TO REPLACE THE VALVE. THE VALVE WAS REMOVED AND THE MECHANICAL DAMAGE VISIBLE ON THE UPPER EDGE OF THE VALVE RING WAS REL

  Patient problems: Heart Failure/Congestive Heart Failure; Ischemia; Shock

  MAUDE report 19250091 ↗
• MalfunctionApr 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON 07 MARCH 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE ( SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION. AFTER THE VALVE WAS SUTURED, A TEAR WAS OBSERVED ON THE VALVE RING. THERE WAS NO LEAFLET DAMAGE, AND NO DISLODGMENT OF ANY PIECES OF THE VALVE. THE VALVE WAS REMOVED AND A REPLACEMENT 19MM REGENT VALVE (SERIAL: (B)(6)) WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED ON BYPASS THROUGHOUT THE PROCEDURE AND THERE WAS NO UNUSUAL INTERVENTION DUE TO THE EXTENDED BYPASS TIME. THERE WAS NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026205 ↗
• MalfunctionMar 15, 2024Fracture; Incomplete Coaptation; Physical Resistance/Sticking; Fracture; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANTATION. BEFORE IMPLANTATION, A RESECTION WAS PERFORMED WHICH COMPLETELY DECALCIFIED THE LEAFLET. USING THE SIZING RING, THE ANNULUS WAS MEASURED TO BE 19MM. WHEN THE SUTURE WAS PASSED THROUGH THE SEWING CUFF AND KNOTTED, IT WAS NOTICED THAT THE RING WAS FRACTURED AND A DISC WAS STUCK. THE VALVE WAS REMOVED. THERE HAD BEEN RESISTANCE WHILE ROTATING. HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. ALL PIECES OF THE FRACTURED RING WERE REMOVED FROM THE ANATOMY. THE PHYSICIAN DECIDED TO ENLARGE THE AORTIC RING VIA THE YANG TECHNIQUE AND IMPLANT A REPLACEMENT 23MM REGENT AORTIC VALVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT REMAINED ON CARDIOPULMONARY BYPASS THROUGHOUT THE PROCEDURE WITHOUT INTERVENTION. THERE WAS A REPORTED DELAY THAT RESULTED IN NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915823 ↗
• MalfunctionJan 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON 04 JANUARY 2024, A 19MM REGENT AORTIC MECHANICAL HEART VALVE (MHV) WAS CHOSEN FOR IMPLANT. THE PATIENT WAS PRESENTED WITH RHEUMATIC HEART DISEASE (RHD). DURING IMPLANTATION, ONE LEAFLET GOT DISLODGED FROM PIVOT AND FELL INTO THE LEFT VENTRICLE CAVITY. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE, AND THIS EVENT WAS NOT DURING ROTATION OF THE VALVE. THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. THE DEVICE WAS REMOVED AND DISCARDED. A REPLACEMENT 17MM REGENT AORTIC MECHANICAL HEART VALVE (MHV) WAS SUCCESSFULLY IMPLANTED. 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 TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592070 ↗
• MalfunctionJan 3, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR). DURING PROCEDURE, THE VALVE WAS SIZED AND IMPLANTED. THE VALVE WAS ENGAGED IN THE ANNULUS BUT, THE PIVOT GUARD WAS HITTING THE HYPERTROPHIED LEFT VENTRICLE (LV) MUSCLE DUE TO DEFORMATION AND THAT AFFECT THE VALVE DISC MOVEMENT. THE VALVE WAS REMOVED AND REPLACED INTRA-PROCEDURALLY WITH A NEW NON-ABBOTT VALVE, 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 18437022 ↗
• DeathDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 17 OCTOBER 2023, A 21MM REGENT VALVE WAS CHOSEN FOR IMPLANTATION. ONCE IMPLANTED, THE VALVE LEAFLETS WOULD NOT OPEN OR CLOSE WHEN TESTING THE VALVE. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE VALVE WAS OVERSIZED. THE 21MM REGENT WAS REMOVED, AND A REPLACEMENT 19MM REGENT VALVE WAS IMPLANTED SUCCESSFULLY. AT THE END OF THE PROCEDURE, THE PATIENT HAD DIFFICULTY BEING REMOVED FROM CARDIOPULMONARY BYPASS (CPB). THE PATIENT WAS PLACED ON AN IMPELLA DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE. THE PHYSICIAN THOUGHT IT WAS UNRELATED TO THE VALVE AND THAT IT WAS POSSIBLY DUE TO UNDIAGNOSED PULMONARY HYPERTENSION.

  Patient problems: Insufficient Information

  MAUDE report 18301293 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023 A 19MM SJM REGENT HEART VALVE WAS IMPLANTED IN A PATIENT. DURING THE PROCEDURE THE VALVE LOBE FELL OFF WHEN THE VALVE WAS ROTATED. THE TWO LEAFLETS DISLODGED AS ONE PIECE AND WAS RECOVERED FROM THE PATIENT. THEREFORE, THE SURGEON REMOVED THE SUTURES AND REPLACED ANOTHER 19MM SJM REGENT HEART VALVE THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121752 ↗
• MalfunctionNov 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT. AFTER IMPLANTATION OF THE VALVE, IT WAS FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE WELL, AND AFTER REMOVAL. DEVICE WAS REPLACED A NEW 19MM SJM REGENT HEART VALVE THAT COMPLETED THE PROCEDURE. THE PATIENT WAS GIVEN WARFARIN WITH AN IRN GOAL OF 1.8-2. 0. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120132 ↗
• MalfunctionNov 7, 2023Fracture; Incomplete Coaptation; Fracture; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT AORTIC MHV,FLEX C UFF, WAS SELECTED FOR AN IMPLANT. DURING IMPLANTATION THE VALVE WAS COR-KNOTTED IN AND THEN ROTATED. WHEN THE HOLDER WAS REMOVED THE LEAFLETS WERE STUCK CLOSED. THEY DID EVERYTHING POSSIBLE TO OPEN THE LEAFLETS. WHEN THEY GOT ONE LEAFLET TO OPEN THE OTHER LEAFLET BROKE INTO THREE PIECES IN THE LEFT VENTRICLE AND WAS RECOVERED FROM THE PATIENT. THE LEAFLETS AND VALVE WERE REMOVED AND A NON ABBOTT VALVE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088126 ↗
• InjuryOct 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038697 ↗
• MalfunctionOct 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN TRIED IMPLANTED THE VALVE IN TOUGH ANATOMY, BUT THE FRAME OF THE VALVE FRACTURE OCCURRED WHEN THE VALVE WAS GRASPED WITH A CLAMP WHILE ATTEMPTING TO INSERT IT INTO THE ANULUS. A NON-ABBOTT DEVICE WAS IMPLANTED A REPLACEMENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007829 ↗
• MalfunctionOct 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. AFTER THE VALVE WAS SUTURED ONTO THE ANNULUS, SPONTANEOUS CIRCULATION WAS ATTEMPTED TO BE RETURNED AS THE PUMP WAS OFF. REGURGITATION WAS CONFIRMED BY TEE AT THE SAME TIME AND IT WAS ALSO CONFIRMED ASYNCHRONIZED LEAFLET MOTION. THE PUMP WAS ATTACHED TO THE PATIENT AND OBTAINED CARDIAC ARREST AGAIN, THEN THE AORTA WAS INCISED. AFTER THAT, THE PHYSICIAN ROTATED THE LEAFLET AND CONFIRMED THOSE NORMAL MOVEMENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17940912 ↗
• InjuryOct 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE WAS IMPLANT IN A PATIENT. PERIOPERATIVELY, ANTICOAGULANT DRUG LOVENOX WAS GIVEN TO THE 49-YEAR-OLD PATIENT. TREATMENT WAS INTERRUPTED FOR 48 HOURS FOLLOWING HEPATIC CYTOLYSIS. ULTRASOUND CHECKS WERE CARRIED OUT FOR 7 DAYS POSTOPERATIVELY AND SHOWED NOTHING AND PATIENT PATIENT CONTINUE TO HAVE ANTICOAGULANT. THE PATIENT HAVE ANY HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY. ON (B)(6) 2023, IT WAS REPORTED THAT THROMBOSIS WAS DETECTED ON THE VALVE FOLLOWING AN ULTRASOUND CHECK. EVIDENCE OF DYSFUNCTION OF THE MECHANICAL VALVE WITH AN AVERAGE GRADIENT OF 67 MMHG AND IAO 2/4 WHEREAS THE PREVIOUS ULTRASOUNDS WERE UNREMARKABLE ON THE VALVULAR LEVEL. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND CINE-ANGIOGRAPHY SHOWED ONE WING TO BE IMMOBILE AND ANOTHER BLOCKED IN AN INTERMEDIATE POSITION. THE DEVICE WAS EXPLANTED AND A NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 17927521 ↗
• MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT AORTIC VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, AFTER IMPLANTATION, IT WAS FOUND THAT THE VALVE BLADE WAS LOOSE AND COULD NOT BE USED ANYMORE. DEVICE WAS REPLACED WITH A NEW 19MM REGENT AORTIC VALVE THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775399 ↗
• MalfunctionSep 15, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT MECHANICAL HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR PROCEDURE. AFTER THE VALVE WAS IMPLANTED, THE PHYSICIAN ATTEMPTED TO ROTATE THE VALVE WITH THE VALVE HOLDER. THE VALVE HOLDER WAS INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. IT WAS REPORTED THE VALVE WAS IN THE CLOSED POSITION, AND THE PHYSICIAN NOTED THE VALVE WAS HARD TO ROTATE WHEN ONE LEAFLET HAD FRACTURED INTO TWO PIECES. NO OTHER INSTRUMENTS WERE IN CONTACT WITH THE VALVE AT THE TIME OF ROTATION. A DECISION WAS MADE TO EXPLANT THE VALVE AND DISLODGED/FRACTURED LEAFLETS WERE COMPLETELY REMOVED. A REPLACEMENT 19MM REGENT MECHANICAL HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THERE WAS A DELAY OF 40 MINUTES TO THE PROCEDURE BUT IT WAS CONSIDERED NOT A CLINICALLY SIGNIFICANT DELAY, AND IT WAS ACCEPTABLE BY THE PHYSICIAN. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756661 ↗
• MalfunctionSep 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT MECHANICAL HEART VALVE, WAS SELECTED FOR AN IMPLANT. THE LEAFLETS AT THE TIME OF PREPARATION WAS NOT TESTED. DURING THE PROCEDURE, AFTER THE IMPLANTATION, THE PHYSICIAN FOUND OUT THE MECHANICAL LOBE DID NOT WORK WELL AND MAY GET STUCK. THE VALVE HAD DIFFICULTY OPENING AND CLOSING COMPLETELY. DEVICE WAS EXPLANTED FROM THE PATIENT AND A NEW 19MM SJM REGENT MECHANICAL HEART VALVE WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS GIVING WARFARIN AFTER SURGERY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724198 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1036 - REGENT CHINA PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 13 JULY 2023, AN 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT DRANK 600-700ML OF WATER AT ONCE AND SUDDENLY EXPERIENCED RESPIRATORY CHANGES, CARDIAC ARREST, AND UNRESPONSIVE EXHALATION. BOTH PUPILS WERE DILATED AND SLOW TO REACT TO LIGHT. CARDIAC COMPRESSIONS WERE PERFORMED IMMEDIATELY. ELECTROCARDIOGRAM (ECG) SHOWED VENTRICULAR FIBRILLATION. ENDOTRACHEAL INTUBATION WAS GIVEN IMMEDIATELY. ELECTRICAL DEFIBRILLATION WAS CONDUCTED, MEDICATION WAS ADMINISTERED, AND VENTRICULAR FIBRILLATION WAS RESOLVED. SEDATION AND ANALGESIA WERE GIVEN TO THE PATIENT. EJECTION FRACTION WAS 36%. THE PATIENT HAD A HISTORY OF POOR VENTRICULAR FUNCTION AND CHRONIC HEART FAILURE, WHICH WAS BELIEVED TO HAVE CAUSED THIS EVENT. AN ECHOCARDIOGRAM ON (B)(6) 2023 SHOWED THAT THE VALVE WAS WORKING WELL. THE PATIENT WAS REPORTED TO BE USING VENTILATOR ASSISTED BREATHING AND WAS PLACED ON TRACHEAL INTUBATION.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 17463692 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT MECHANICAL HEART VALVE, WAS SELECTED FOR AN IMPLANTED. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WAS MOVING NORMALLY WHEN TESTED WITH RUBBER HOSE. DURING THE PROCEDURE, AFTER IMPLANTATION, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE WELL. DEVICE WAS EXPLANTED FROM THE PATIENT AND A NEW 19MM SJM REGENT MECHANICAL HEART VALVE DEVICE WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. POST EXPLANT, THE DEVICE WAS MOVING NORMALLY WHEN TESTED. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426293 ↗
• MalfunctionJul 26, 2023Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT FOR AN AORTIC VALVE REPLACEMENT. DURING PROCEDURE, A SIZER WAS USED TO CHOOSE A 19MM VALVE. THE VALVE WAS IMPLANTED, BUT REGURGITATION WAS DETECTED PRIOR TO CHEST CLOSURE. THE REGURGITATION WAS NOTED AT THE NON-CORONARY CUSP AND RIGHT CORONARY CUSP COMMISSURES. THE VALVE WAS REMOVED AND REPLACED WITH A 21MM SJM REGENT HEART VALVE WITH FLEX CUFF. THE PATIENT REMAINED ON BYPASS DURING THIS EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED TO BE DISCHARGED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17399275 ↗
• MalfunctionJul 24, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR IMPLANT. AFTER IMPLANTING THE VALVE, IT WAS NOTICED ONE OF THE LEAFLETS REMAINED IMMOBILE. A DECISION WAS MADE TO EXPLANT THE DEVICE AND REPLACE WITH A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF. IT WAS REPORTED THE EXPLANTED VALVE WAS CHECKED FOR NORMAL LEAFLET FUNCTION AND FOUND TO BE ABNORMAL AND IMMOBILE STILL. IT WAS REPORTED THE ONLY DEVICE THAT CAME IN CONTACT WITH THE LEAFLETS WAS THE ST VALVE TESTER. IT WAS ALSO REPORTED THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17384211 ↗
• MalfunctionJul 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT AORTIC MHV,FLEX CUFF, WAS SELECTED FOR AN IMPLANT. IN THE PREPARATION STAGE, IT WAS NOT CONVENIENT TO OBSERVE WHETHER THE VALVE LEAFLETS WERE NORMAL BECAUSE OF THE VALVE FRAME. LEAFLET FUNCTION WAS TESTED BY A RUBBER HOSE. AFTER IMPLANTATION, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET OPENED AND CLOSED ABNORMALLY. THE DEVICE WAS REPLACED WITH A NEW 19MM REGENT AORTIC MHV,FLEX CUFF, THAT COMPLETED THE PROCEDURE. THE PHYSICIAN INSTRUCT THE PATIENT TO TAKE ANTICOAGULANT DRUGS ROUTINELY ACCORDING TO THE ANTICOAGULATION REGIMEN AFTER ROUTINE REPLACEMENT OF THE MECHANICAL VALVE WITH A CURRENT INTERNATIONAL NORMALIZED RATIO (INR) IS 1.8 TO 2.5. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288884 ↗
• InjuryMay 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT¿ MECHANICAL HEART VALVE (FLEXCUFF¿), WAS IMPLANTED. PRIOR TO IMPLANT, THE LEAFLETS WERE MOVING NORMALLY WHEN TESTED AT THE TIME OF DEVICE PREPARATION WITH PLASTIC SURGICAL INSTRUMENTS AND PHYSIOLOGICAL SALINE WERE USED TO TEST LEAFLET FUNCTION. AFTER SURGERY, IT WAS FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE PROPERLY WHEN TESTED WITH PLASTIC SURGICAL INSTRUMENTS AND PHYSIOLOGICAL SALINE. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 19MM SJM REGENT¿ MECHANICAL HEART VALVE (FLEXCUFF¿), WHICH WAS SUCCESSFULLY IMPLANTED. POST-EXPLANT OF THE FIRST DEVICE, THE VALVE WAS TESTED, BUT THE LEAFLET DID NOT MOVE NORMALLY. THE PATIENT TOOK WARFARIN AFTER PROCEDURE AND LATEST INR IS 2.5.THE PATIENT REMAIN STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954204 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - REGENT CHINA PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT. A 905 MECHANICAL HEART VALVE SIZER SET HAD BEEN USED TO SIZE THE 19MM SJM REGENT HEART VALVE WITH FLEX CUFF. THE PATIENT HAD NOT BEEN ADMINISTERED HEPARIN FOR PROCEDURE, BUT HAD A NOTED ACTIVATED CLOTTING TIME (ACT) LEVEL OF 136 SECONDS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. POST-IMPLANT PROCEDURE, THE PATIENT PRESENTED AN INCREASE IN DRAINAGE FROM THEIR DRAINAGE TUBE WITH BLEEDING FROM THE MEDIASTINUM. THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) OF 1.22. HEMOSTATIC MEDICATION WAS ADMINISTERED, BUT THE PATIENT'S CONDITION DID NOT IMPROVE. POST-OPERATIVE BLEEDING WAS SUSPECTED AND AN EMERGENCY THORACOSCOPIC ASSISTED THORACOTOMY WAS PERFORMED. THE PATIENT ALSO REQUIRED A TRANSFUSION. POST-INTERVENTION THE PATIENT'S BLEEDING DECREASED AND THE PATIENT HAD LITTLE DRAINAGE FLOW. THE PATIENT WAS RECOVERING AT THE TIME OF REPORT, WITH A MOST RECENT INR OF 1.67. THERE WAS NO PROLONGED HOSP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16916593 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 19MM REGENT AORTIC MHV,FLEX C UFF, WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE PATIENT VENTILATOR PARAMETERS WERE GRADUALLY LOWERED AND EXTUBATION WAS PERFORMED OFF-LINE. AFTER EXTUBATION, THE PATIENT HAD SLIGHT SHORTNESS OF BREATH, FREQUENCY WAS 24-30 BREATH /MIN, AND AN INTERMITTENT NON-INVASIVE VENTILATOR ASSISTED RESPIRATION WAS PERFORMED, BUT NO SIGNIFICANT IMPROVEMENT WAS FOUND AND THE ABILITY TO COUGH AND EXPECTORATE SPONTANEOUSLY WAS POOR. TO FACILITATE AIRWAY MANAGEMENT, THE PATIENT HAD TRACHEOTOMY. AFTER FULL SPUTUM ASPIRATION, THE VENTILATOR WAS CONNECTED TO ASSIST VENTILATION. THE WHOLE PROCEDURE WAS SMOOTH AND THE PATIENT'S VITAL SIGNS WERE STABLE. THE DEVICE CONTINUE TO WORK AS INTENDED. THE PATIENT IS STABLE.

  Patient problems: Dyspnea; Respiratory Insufficiency

  MAUDE report 16558738 ↗