SJM Regent™ 23AGFN-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05414734006095), received between Jun 29, 2018 and Mar 21, 2024 — classified as 3 deaths, 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 44 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE LEAFLET FUNCTION WAS TESTED USING A LEAFLET TESTER AND NO PROBLEM WAS NOTED. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT BE ROTATED. THE VALVE WAS REMOVED AND A NEW 20MM NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950519 ↗
• InjuryMar 5, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON 01 FEBRUARY 2024, A 23MM SJM REGENT MECHANICAL HEART VALVE WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE ANNULUS WAS 21MM. THE VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, IT WAS NOTED THAT THE VALVE WAS NOT CLOSING PROPERLY AND SEVERE AORTIC REGURGITATION (AR) AS A RESULT. ON 09 FEBRUARY 2024, 8 DAYS AFTER THE IMPLANT PROCEDURE THE VALVE WAS EXPLANTED AND A REDO AVR WAS PERFORMED WITH A NEW 23MM VALVE BY ANOTHER SURGEON. THE PHYSICIAN MENTIONED THERE WAS NO PROBLEM WITH THE VALVE AND THERE HAD BEEN INADEQUATE DEBRIDEMENT OF THE ANNULUS BELOW ONE OF THE HINGES AND NO THROMBUS WAS NOTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18837220 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. ON (B)(6) 2022, THE PATIENT UNDERWENT A HEAD AND NECK COMPUTED TOMOGRAPHY ANGIOGRAM DUE TO POOR MUSCLE STRENGTH IN THE LEFT LOWER LIMB. RESULTS INDICATED A STROKE IN THE RIGHT FRONTAL AREA. ON (B)(6) 2022, ANOTHER COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED AN EMBOLUS. THE PATIENT'S ANTICOAGULANT LIPID REGULATION WAS CONTINUED AND A PLAQUE WAS STABILIZED. THE PATIENT WAS ADMINISTERED MEDICATION. THE PATIENT ENTERED REHABILITATION AND WAS ADMINISTERED WARFARIN ON (B)(6) 2022. THE PATIENT HAD A NEEDLING/ACUPUNCTURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, A CRANIOCEREBRAL COMPUTED TOMOGRAPHY SCAN REVEALED THAT THE INFARCT HAD SLIGHTLY DECREASED IN SIZE. IT WAS ALSO NOTED THAT THE PATIENT'S LEFT LOWER LIMB MUSCLE STRENGTH IMPROVED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. TWO WEEKS POST-DISCHARGED, IT WAS NOTED THAT THE PATIENT'S LEFT LOWER LIMB MUSCLE STRENGTH HAD NORMALIZE

  Patient problems: Embolism/Embolus; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 18493894 ↗
• InjuryJan 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM REGENT MECHANICAL AORTIC VALVE WAS CHOSEN FOR IMPLANTATION. THE VALVE WAS PLACED, BUT THERE WAS DIFFICULTY GETTING SUTURE STRUTS ABOVE VALVE WHICH CAUSED POTENTIAL PERI VALVULAR LEAK. THE VALVE WAS EXPLANTED AND A REPLACEMENT 23MM REGENT MECHANICAL VALVE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18447121 ↗
• MalfunctionNov 30, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6)2023, A 23MM REGENT AORTIC MECHANICAL HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, THE VALVE LEAFLETS COULD NOT OPEN OR CLOSE. DURING THE ATTEMPT TO ADJUST THE OPENING AND CLOSING DIRECTION OF THE VALVE, USING SURGICAL FORCEPS, A SMALL PIECE OF THE VALVE ORIFICE WAS NOTED TO CRACK. THE VALVE WAS REMOVED AND A REPLACEMENT 23MM REGENT AORTIC MECHANICAL HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240923 ↗
• MalfunctionOct 25, 2023Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT. THE VALVE WAS IMPLANTED AND WAS CONFIRMED TO BE WELL SEATED. BEFORE THE PATIENT WAS TAKEN OFF PUMP, IT WAS NOTICED THE LEAFLETS WERE STICKING AND NOT OPENING PROPERLY. IT WAS DECIDED TO REMOVE THE DEVICE. A REPLACEMENT 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE AND RECOVERING. THERE WAS NO ADVERSE PATIENT EFFECT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007852 ↗
• MalfunctionOct 12, 2023Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR PROCEDURE. IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE FIRST 23MM SJM REGENT HEART VALVE WITH FLEX CUFF, THAT THE LEAFLET TESTING WAS ABNORMAL BUT THE VALVE WAS STILL USED. AFTER VALVE SUTURING, DURING VALVE LEAFLET TESTING, IT WAS NOTED THAT THE LEAFLETS OF THE VALVE WERE STICKING AND HAD DIFFICULTY OPENING AND CLOSING FREELY. THE DECISION WAS MADE REMOVE AND REPLACE THE 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WITH ANOTHER 23MM REGENT HEART VALVE TO COMPLETE THE PROCEDURE. THIS ISSUE REPORTEDLY CAUSED A CLINICALLY SIGNIFICANT DELAY, BUT THE DELAY DID NOT RESULT IN ADVERSE PATIENT EFFECT. THE PATIENT WAS NOT TAKEN OFF BYPASS AND PLACED BACK ON BYPASS DUE TO THIS EVENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927495 ↗
• MalfunctionSep 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, 23MM SJM REGENT MECHANICAL HEART VALVE, WAS SELECTED FOR AN IMPLANT. A RUBBER HOSE WAS USED TO TEST LEAFLET FUNCTION. AFTER IMPLANTATION, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE WELL. DEVICE WAS EXPLANTED AND REPLACED WITH A NEW 23MM SJM REGENT MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. POST EXPLANT, WHEN THE VALVE WAS TESTED, IT WAS MOVING NORMALLY. THE PATIENT IS STABLE AND WAS GIVEN WARFARIN SODIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725740 ↗
• MalfunctionSep 7, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023 A 23MM REGEN AORTIC VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE VALVE LEAFLET FAIL TO OPEN AND CLOSE SMOOTHLY. A 23MM REGENT HEART VALVE DEVICE WAS IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702013 ↗
• MalfunctionAug 7, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT (B)(6) 2023, A 23MM SJM REGENT MECHANICAL HEART VALVE WITH FLEX CUFF WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE HOLDER HANDLE FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. IT WAS NOTED AFTER IMPLANTING THE VALVE, THAT ONE OF THE LEAFLETS WAS UNABLE TO CLOSE/COAPT PROPERLY. DEVICE WAS REPLACED WITH ANOTHER 23MM SJM REGENT MECHANICAL HEART VALVE WITH FLEX CUFF. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICAL SIGNIFICANT DELAY AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475007 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1036 - REGENT CHINA PMCF CN5812 - 342 ((B)(4)). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT MECHANICAL HEART VALVE WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD INFECTION OF INCISIONAL WOUND AND WAS HOSPITALIZED ON THE SAME DAY. THERE WAS AN OPEN INCISION ABOUT 3CM ON THE STERNAL SURGERY AREA WITH NIFF. THE PUS BURST OUT AFTER A HARD SQUEEZE ON THE PREVIOUS SURGICAL DRAINAGE AREA. ELECTIVE DEBRIDEMENT TREATMENT IS PLANNED ON AN UNKNOWN DATE. BETWEEN JULY 05-09 2023, THE WOUND DRESSING WAS CHANGED DAILY. THE INCISION HEALED WELL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THE PATIENT IS STABLE, THE DEVICE IS WORKING AS INTENDED.

  Patient problems: Unspecified Infection

  MAUDE report 17414100 ↗
• MalfunctionJul 26, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR IMPLANT. AFTER IMPLANTING THE VALVE, IT WAS NOTED THE VALVE LEAFLETS WERE JAMMED AND COULD NOT MOVE. A DECISION WAS MADE TO EXPLANT THE VALVE. THE EXPLANTED VALVE WAS TESTED AGAIN FOR LEAFLET FUNCTION AND NOTED TO NOT OPEN AND CLOSE SMOOTHLY. A REPLACEMENT 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED IN THE PATIENT. IT WAS REPORTED THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT BUT 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 17398390 ↗
• MalfunctionJul 19, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023 A 23MM SJM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. AFTER IMPLANTATION, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET OPENED AND CLOSED ABNORMALLY. DEVICE WAS REPLACED WITH A NEW 21MM SJM REGENT MECHANICAL HEART VALVE THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356564 ↗
• MalfunctionJul 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM REGENT MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT FOR A PATIENT UNDERGOING AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. IT WAS REPORTED AFTER THE VALVE WAS IMPLANTED, IT WAS NOTICED THE LEAFLETS HAD "IMPERFECT MOVEMENT" AND HAD DIFFICULTY MOVING FREELY. IT WAS REPORTED ONLY THE LEAFLET TESTER WAS USED TO TEST LEAFLET MOBILITY AND NO OTHER INSTRUMENT OR TOOL CAME IN CONTACT WITH THE LEAFLETS. A DECISION WAS MADE TO EXPLANT AND REPLACE THE 23MM VALVE WITH A 21MM REGENT MECHANICAL HEART VALVE. THE REPLACEMENT 21MM VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE 23MM VALVE WAS NOT TESTED FOR LEAFLET MOBILITY AFTER EXPLANT. IT WAS REPORTED THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. 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 17346653 ↗
• InjuryJun 26, 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 09 MAY 2023, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THERE WAS NO DIFFICULTY IMPLANTING THE VALVE NOTED. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS NOTED FOLLOWING THE IMPLANT PROCEDURE THAT THE PATIENT HAD A LOW CARDIAC OUTPUT. THE DECISION WAS MADE TO PLACE THE PATIENT ON AN INTRA-AORTIC BALLOON PUMP. ON (B)(6) 2023, THE PATIENT WAS ADMINISTERED AND DIGOXIN. ON (B)(6) 2023, THE PATIENT ADMINISTERED LEVOSIMENDAN AND LANDIOLOL . ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT BEGAN TO SUFFER FROM A NOSOCOMIAL PNEUMONIA INFECTION. THE DECISION WAS MADE TO INTUBATE THE PATIENT FOR MECHANICAL VENTILATION THERAPY. THE PATIENT WAS ALSO STARTED ON IMIPENEM AND CILSTATIN. ON (B)(6) 2023, THE DECISION WAS MADE TO PERFORM A CARDIOVERSION DUE TO THE PATIENT'S ATRIAL FIBRILLATION. ON (B)(6) 2023, THE PATIENT WAS ADMINISTERED TIGECYCLINE. ON (B)(6) 2023, THE PATIENT WAS WEANED OFF THE INTRA-AORTIC BALLOON PUMP, AS THEIR SYSTOLIC FUNCTION WAS NORMAL AND

  Patient problems: Heart Failure/Congestive Heart Failure; Pneumonia

  MAUDE report 17204648 ↗
• InjuryJun 9, 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 (B)(6) 2023, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. IT WAS NOTED DURING PROCEDURE THAT THE PATIENT HAD PERICARDIAL SYMPHYSIS. OTHER CONCOMITANT PROCEDURES PERFORMED WERE MITRAL VALVE REPLACEMENT, TRIPLE CARDIOPULMONARY BYPASS, AND PERICARDIAL DENUDATION. ON (B)(6) 2023, PATIENT HAD VENTRICULAR FIBRILLATION AND LOSS OF CONSCIOUSNESS, REQUIRING CARDIOPULMONARY RESUSCITATION, TRACHEAL INTUBATION, AND INTRAVENOUS INJECTION OF ADRENALINE. MULTIPLE ROUNDS OF DEFIBRILLATION AND ADRENALINE INJECTIONS WERE PERFORMED TO RESTORE AN AUTONOMOUS HEARTBEAT. BLOOD PRESSURE REMAINED LOW AT 63/43MMHG. ADRENALINE INJECTIONS WERE CONTINUED, AND THE AMOUNT OF NOREPINEPHRINE WAS INCREASED. THE PATIENT HAD BEEN PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP) AFTER PROCEDURE ON (B)(6) 2023. ICE WAS APPLIED TO THE HEAD TO COOL DOWN AND PROTECT THE BRAIN. THE PATIENT'S BLOOD PRESSURE WAS MONITORED BY THE RADIAL ARTERY, WHICH WAS CLOSE TO THAT MONITORED BY THE IABP. METHYLENE BLUE WAS PROVIDED DUE TO THE LOW PERIPHERAL VASCULAR RESISTANCE. THE PATIENT STAT

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 17101067 ↗
• MalfunctionMay 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON 26 APRIL 2023, A 23MM SJM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE VALVE WAS INSTALLED, AND THE SURGEON NEEDED TO TURN THE VALVE TO OBTAIN OPTIMAL ORIENTATION. HOWEVER, BOTH LEAFLETS POPPED OUT WHEN TURNING THE VALVE. IT IS UNKNOWN IF THE DEVICE WAS REPLACED, PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975780 ↗
• InjuryMay 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS SELECTED FOR AN IMPLANT. THE LEAFLETS WERE MOVING NORMALLY WHEN TESTED AT THE TIME OF DEVICE PREPARATION. PLASTIC SURGICAL INSTRUMENTS AND PHYSIOLOGICAL SALINE WERE USED TO TEST LEAFLET FUNCTION. THE DEVICE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. POST PROCEDURE, IT WAS FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE PROPERLY AND WAS EXPLANTED. THE LEAFLET WAS TESTED AFTER EXPLANT BUT DID NOT MOVED NORMALLY. ON THE SAME DAY, A NEW 23MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED AS A REPLACEMENT. THE PATIENT TOOK WARFARIN AFTER PROCEDURE AND LATEST INR IS 2.5. THE PATIENT IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890484 ↗
• MalfunctionApr 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM SJM REGENT HEART VALVE W/FLEX CUFF WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, THE VALVE WAS ATTEMPTED TO TWIST BUT THE VALVE WOULD NOT ROTATE. IT WAS NOTED THAT THE PATIENT HAD A SMALL LEFT VENTRICULAR OUTFLOW TRACT (LVOT). IT APPEARED THAT ONE OF THE VALVE LEAFLETS WOULD NOT OPEN PROPERLY. THE VALVE WAS EXPLANTED AND A 21MM NON-ABBOTT VALVE WAS IMPLANTED INTRAOPERATIVELY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709778 ↗
• MalfunctionNov 20, 2022Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE W/FLEX CUFF WAS IMPLANTED INTO A PATIENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS PERFORMING POORLY WITH SIGNIFICANT REGURGITATION. THE DEVICE WAS REMOVED FROM PATIENT ANATOMY, AND A NEW 23MM SJM REGENT HEART VALVE W/FLEX CUFF WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS REPORTED TO BE RECOVERING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE HEALTHCARE PROFESSIONAL HAS NOT STATED THAT THEY BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831820 ↗
• InjuryOct 18, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM REGENT VALVE WAS IMPLANTED IN THE AORTIC. THE LEAFLET WAS OPENING AND CLOSING PROPERLY WHEN THE DEVICE WAS IMPLANTED. ON AN UNKNOWN DATE IN 2022, TWO WEEKS AFTER SURGERY, ONE LEAFLET BECAME IMMOBILE. THE PATIENT WAS CONTROLLED AT INR 1.96 OR ABOVE. THROMBOSIS WAS NOT CONFIRMED BY IMAGING, BUT THROMBOLYTIC THERAPY WAS PROVIDED WITH NO IMPROVEMENT OBSERVED. THEREFORE, ON (B)(6) 2022, THE DEVICE WAS EXPLANTED FROM THE PATIENT AND A NON-ABBOTT DEVICE WAS IMPLANTED AS A REPLACEMENT. THE DEVICE WAS DAMAGED DURING EXTRACTION. THE LEAFLET MAY BE DAMAGED WHEN THE DEVICE WAS WASHED. THE PATIENT'S CONDITION IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625603 ↗
• MalfunctionOct 4, 2022Incomplete Coaptation; Physical Resistance/Sticking; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT. AFTER THE DEVICE WAS IMPLANTED, A WATER INJECTION TEST WAS PERFORMED AND SHOWED LIMITED FLAP MOVEMENT. IT WAS REPORTED THAT THE VALVE DID NOT CLOSE COMPLETELY. THE DEVICE WAS THEN EXPLANTED AND REPLACED WITH A NON-ABBOTT DEVICE. THE PATIENT WAS REPORTED AS STABLE AND NORMAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540063 ↗
• MalfunctionOct 3, 2022Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, AN SJM REGENT HEART VALVE W/FLEX CUFF WAS IMPLANTED. HOWEVER THE LEAFLET WAS UNABLE TO OPEN AND CLOSE NORMALLY DUE TO AN OBSTRUCTION. THE VALVE WAS EXPLANTED AND THE MECHANICAL FLAP WAS REPLACED WITH ANOTHER OF THE SAME BRAND AND MODEL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533500 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022 AN 23MM REGENT HEART VALVE WAS IMPLANTED WITH NO REPORTED COMPLICATIONS. THE FOLLOWING DAY ON (B)(6) 2022, THE PATIENT HAD STILL NOT WOKEN UP SINCE THE PROCEDURE. THE PATIENT WAS NOTED TO HAVE BEEN IN CARDIOGENIC SHOCK WITH RENAL FAILURE. THE PHYSICIAN ALLEGED THAT THE CAUSE OF THE CARDIOGENIC SHOCK WAS DUE TO THE LARGE INNER DIAMETER OF VENTRICLE AND HEART FAILURE PRIOR TO PROCEDURE, AND LONG CARDIOPULMONARY BYPASS TIME. THE PATIENT RECEIVED INTRAVENOUS DOPAMINE, NOREPINEPHRINE, AND ADRENALIN. CREATININE LEVEL WAS NOTED AS 299 MCMOL/L. THE PATIENT UNDERWENT BEDSIDE RIGHT FEMORAL VEIN PUNCTURE CATHETERIZATION AND BEDSIDE DIALYSIS. IN ADDITION, A BLOOD ROUTE WAS ESTABLISHED AT THE FEMORAL VEIN CATHETERIZATION SITE FOR SODIUM BICARBONATE HEMODIALYSIS PLUS PERFUSION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Renal Failure

  MAUDE report 15488799 ↗
• InjuryAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT AS REPORTED THAT ON (B)(6) 2022, A 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE A LEAFLET OF THE REGENT VALVE BECOME DISLODGED. THE DECISION WAS MADE TO REPLACE THE 23MM SJM REGENT HEART VALVE WITH FLEX CUFF WITH ANOTHER ONE OF THE SAME SIZE. HOWEVER, IT WAS NOTED THAT THERE WAS A 60 MINUTE DELAY IN PROCEDURE BECAUSE THE REPLACEMENT VALVE HAD TO BE DELIVERED FROM A DIFFERENT HOSPITAL. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15298682 ↗