Regent™ 19AGFN-756Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05415067042934), received between Jul 19, 2024 and Sep 18, 2026 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (14 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026, a 19mm SJM Regent Heart Valve w/Flex Cuff was chosen for a procedure. During the operation, it was noted that the valve leaflets were stuck. The valve got removed and an Unknown size Mechanical Heart Valve was implanted while patient on bypass. There was no delay in the procedure. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817176 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING IMPLANT, THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR; NO RESISTANCE WAS FELT WHEN ROTATING. THEN, A LEAFLET DISLODGED IN ONE PIECE AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO INSTRUMENT WAS IN CONTACT WITH THE VALVE AT TIME OF DISLODGEMENT. THE PHYSICIAN DID NOT ATTEMPT TO REINSERT THE DISLODGED LEAFLET. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE AND THE VALVE WAS IN A CLOSED POSITION WHEN IT WAS ROTATED. THE DEVICE WAS NOT IMPLANTED AND EXCHANGED FOR A NEW 19MM REGENT AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN NORMAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627035 ↗
• MalfunctionMay 15, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY. THE LEAFLET FUNCTION WAS TESTED USING A SILICONE PRODUCTS, DURING THE SURGERY, AFTER THE IMPLANTED MECHANICAL VALVE ENABLED THE HEART TO RESUME BEATING AGAIN ON ESOPHAGEAL ULTRASOUND EXAMINATION, IT WAS FOUND THAT THE TRANS-VALVE PRESSURE DIFFERENCE WAS TOO HIGH AND THE BLOOD FLOW RATE WAS TOO FAST. LATER, TESTS REVEALED THAT IT WAS DIFFICULT TO OPEN AND CLOSE THE VALVE LEAFLETS. DUE TO INSUFFICIENT STOCK AT THE HOSPITAL, A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS RE-IMPLANTED FOR THE ESOPHAGEAL ULTRASOUND WHILE PATIENT ON BYPASS. AT THIS TIME, THE TRANS-VALVE PRESSURE DIFFERENCE AND FLOW RATE WERE NORMAL. THERE WAS NO DELAY IN THE PROCEDURE AND PATIENT WAS REPORTED DISCHARGED FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184048 ↗
• MalfunctionMay 11, 2026Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. AFTER IMPLANTATION, NO ROTATION WAS OBSERVED BUT UPON REMOVAL OF THE MAIN BODY, A VALVE LEAFLET WAS FRACTURED INTO MULTIPLE PIECES AND DISLODGED. ALL PIECES WERE COMPLETELY REMOVED FROM THE PATIENT. WHILE ROTATING A RESISTANCE WAS ENCOUNTERED AND IT REPORTEDLY DID NOT MOVE AT ALL. A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143377 ↗
• MalfunctionApr 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT PROCEDURE. DURING PROCEDURE, THE ANNULUS WAS SIZED AS 19MM WITH THE SIZER. DURING THE IMPLANTATION OF VALVE, IT DIDN¿T SEAT PROPERLY, SO EXPLANTED IMMEDIATELY AND IMPLANTED A NON-ABBOTT VALVE WHILE PATIENT ON BYPASS. THERE WAS NO ADDITIONAL PRODUCT EXPERIENCE WAS NOTED. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959520 ↗
• MalfunctionApr 17, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING THE PROCEDURE, ONE OF THE LEAFLET CAME OUT & WENT TO LEFT VENTRICLE (LV).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912455 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) SURGERY. DURING PROCEDURE, AFTER SIZING WHEN THE VALVE WAS BEING PLACED (DURING CUFF LIGATION), AN ABNORMALITY OF THE LEAFLET WAS VISUALLY OBSERVED. UPON INSPECTION, THE LEAFLET WAS FOUND TO BE DAMAGED AND DETACHED FROM THE VALVE. PRIOR TO THE VISUAL CONFIRMATION OF THE ABNORMALITY, THE LEAFLET PORTION HAD NOT BEEN TOUCHED. THE VALVE WAS REMOVED AND A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS IMPLANTED WHILE PATIENT ON BYPASS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911077 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A AORTIC VALVE REPLACEMENT (AVR) PROCEDURE. THE SIZING WAS CONDUCTED USING THE REGENT-DEDICATED SIZER AND THE VALVE GOT IMPLANTED. A CORONARY ARTERY OBSTRUCTION WAS THEN CONFIRMED PRIOR TO WEANING FROM CARDIOPULMONARY BYPASS, AND THE VALVE WAS REPLACED WITH A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE. THE PROCEDURAL TIME WAS PROLONGED, THE PATIENT¿S RECOVERY WAS REPORTED TO HAVE BEEN UNEVENTFUL. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 24470897 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. POST IMPLANTATION, IT WAS OBSERVED THAT ONE OF LEAFLET THE VALVE WAS DISLODGED. THERE WAS SOME RESISTANCE FELT WHEN ROTATING. THE VALVE WAS IN THE CLOSED POSITION WHEN IT WAS ROTATED AND THE LEAFLET DISLODGED. THE VALVE WAS EXPLANTED AND THE NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS IMPLANTED INSTEAD WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247830 ↗
• MalfunctionJan 30, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A MALFUNCTION OF VALVE LEAFLET OPENING AND CLOSING WAS NOTED. A NEW 17MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT ON BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED RECOVERED AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223764 ↗
• MalfunctionDec 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE MECHANICAL LOBE HAS DIFFICULTY WITH OPEN AND CLOSE. A NEW UNKNOWN SIZE REGENT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889622 ↗
• MalfunctionDec 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, A MALFUNCTION OF VALVE LEAFLET OPENING AND CLOSING WAS NOTED. THE VALVE WAS REPLACED WITH THE SAME MODEL. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888174 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790213 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE LEAFLETS WERE SHED. A NEW NON-ABBOTT VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617853 ↗
• MalfunctionAug 7, 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. DURING IMPLANT, THE VALVE LEAFLETS WERE TESTED WITH A VALVULAR SIZER AND FAILED TO CLOSE PROPERLY, RESULTING IN SIGNIFICANT REGURGITATION; THE VALVE DID NOT HAVE DIFFICULTY OPENING. THE VALVE WAS REMOVED AND TESTED OUTSIDE OF THE PATIENT IN WHICH THE LEAFLETS MOVED NORMALLY. A NEW 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745034 ↗
• MalfunctionJun 6, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE WHEN ATTEMPTING TO ROTATE THE VALVE, THAT A LEAFLET DISLODGEMENT OCCURRED AND AN ORIFICE FRACTURE OCCURRED. THERE WAS NO RESISTANCE FELT WHEN ROTATING THE VALVE AND NO INSTRUMENTS ENCOUNTER THE VALVE AT THE TIME OF DISLODGMENT/FRACTURE. NOTHING ELSE OTHER THAN THE HOLDER HANDLE USED TO POSITION OR ROTATE THE VALVE. THE HOLDER HANDLE 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/FRACTURED. THE LEAFLET WAS ABLE TO BE RETRIEVED, BUT IT'S NOTED THAT THERE ARE REMAINS OF THE VALVE THAT REMAIN IN THE HEART. THE PHYSICIAN DID NOT TRY TO REINSERT THE DISLODGED LEAFLET. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 19MM REGENT HEART VALVE WITH FLEX CUFF WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. HOWEVER, IT WAS NOTED THAT HALFWAY THROUGH IMPLANTATION, THE DISC OF THE REPLACEMENT VALVE RUPTURED. THE DISC COMPLETELY DETACHED WHEN THE SUTURES WERE TIED. THE PATIENT WAS STABLE AND FULLY RECOVERED AT THE TIME OF REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159807 ↗
• MalfunctionJun 4, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, AFTER PLACEMENT, ATTEMPTED ROTATION WAS DIFFICULT, AND WHEN A BIT OF FORCE WAS APPLIED TO ROTATE, THE PIVOT GUARD WAS FRACTURED. THE VALVE WAS EXPLANTED AND A NEW 19MM NON-ABBOTT VALVE WAS USED INSTEAD. THERE WAS AN EXTENSION OF THE PROCEDURE TIME, BUT IT DID NOT AFFECT THE PATIENT'S PROGNOSIS. THE PATIENT¿S CURRENT STATUS WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145134 ↗
• InjuryMay 15, 2025Incomplete Coaptation; Patient Device Interaction Problem; Incomplete Coaptation; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 19MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS S IMPLANTED 13 YEARS AGO. A FOLLOW UP WAS CONDUCTED ON (B)(6) 2025, A HEART FAILURE WAS DETECTED WITH SYMPTOMS SHORTNESS OF BREATH AND PALPITATIONS. UPON FURTHER EXAMINATION, IT WAS FOUND THAT ONE SIDE OF THE ARTIFICIAL VALVE WAS NOT FUNCTIONING DUE TO THROMBUS OR PANNUS-LIKE TISSUE STICKS NEAR THE PIVOT, CAUSING THE VALVE MALFUNCTION. THE HE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) CLOSEST TO THE TIME OF THE EVENT WAS 2.0. ON 21 APR 2025, THE VALVE WAS EXPLANTED AND A NEW 19MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE WAS IMPLANTED. UPON EXAMINING THE EXCISED VALVE, A THROMBUS-LIKE SUBSTANCE WAS FOUND ATTACHED NEAR THE PIVOT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Arrhythmia; Dyspnea; Thrombosis/Thrombus

  MAUDE report 22027827 ↗
• MalfunctionApr 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT MECHANICAL AORTIC VALVE WAS CHOSEN FOR IMPLANTATION. HEPARIN WAS ADMINISTERED. AFTER PLACEMENT OF THE VALVE, THE HOLDER WAS REMOVED FROM THE VALVE AND A SILICONE TESTER WAS USED TO TEST THE LEAFLETS. ONE LEAFLET COULD NOT MOVE FLEXIBLY. THE REGENT VALVE WAS EXPLANTED AND A REPLACEMENT 18MM NON-ABBOTT VALVE WAS IMPLANTED SUCCESSFULLY. AFTER EXPLANT THE LEAFLETS WERE TESTED AND THEY WERE FUNCTIONING NORMALLY. PATIENT'S INTERNATIONAL NORMALIZED RATIO WAS 1.8-2.0 POST PROCEDURE. THERE WAS REPORTEDLY A DELAY THAT DID NOT RESULT IN PATIENT CONSEQUENCES. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910819 ↗
• MalfunctionApr 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21833556 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE VALVE WAS ROTATED WITH A VALVE ROTATOR; SOME RESISTANCE WAS FELT DURING ROTATING. THE HOLDER HANDLE WAS FULLY INSERTED AT A 90 DEGREE ANGLE. THEN, THE "VALVE FRACTURED AND DISLODGED." THE LEAFLET DISLODGED AS ONE PIECE AND WAS CONFIRMED TO HAVE BEEN RECOVERED FROM THE PATIENT. NO INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF DISLODGEMENT. THE DISLODGED LEAFLET WAS NOT ATTEMPTED TO BE RE-INSERTED. THE VALVE WAS REMOVED AND EXCHANGED FOR A NEW 21MM NON-ABBOTT VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. AN EXTENDED SURGERY TIME WAS REPORTED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610490 ↗
• MalfunctionMar 11, 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. DURING DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY WHEN TESTED. SILICONE PRODUCTS WERE USED TO TEST LEAFLET FUNCTION. AFTER IMPLANT, ESOPHAGEAL ULTRASOUND SHOWED THAT THE VALVE COULD NOT OPEN AND CLOSE NORMALLY. THE VALVE WAS EXPLANTED AND UPON EXPLANT, LEAFLET FUNCTION WAS TESTED AGAIN AND THEY WERE MOVING NORMALLY, "BUT IT'S A LITTLE DIFFICULT." THE VALVE WAS EXCHANGED FOR A NEW 17MM REGENT AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. ESOPHAGEAL ULTRASOUND WAS REPEATED AND THE VALVE WAS OPENING AND CLOSING NORMALLY. THE PATIENT WAS REPORTED TO IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577155 ↗
• MalfunctionFeb 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2025, A 19MM REGENT VALVE WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHEN THE VALVE WAS IMPLANTED, IT WAS NOTICED THAT THE LEAFLETS DID NOT OPEN AND CLOSE EASILY. THE VALVE WAS REMOVED FROM THE PATIENT AND TESTED AGAIN. IT WAS FOUND THAT THE LEAFLETS STILL DID NOT OPEN AND CLOSE EASILY. A 17MM REGENT VALVE WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323639 ↗
• MalfunctionJan 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19 MM REGENT AORTIC MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION, IT WAS NOTED THAT THE LEAFLETS WERE NOT MOVING NORMALLY WHEN TESTED WITH "SIMPLE TESTING." DURING PROCEDURE, ONE OF THE LEAFLETS HAD DIFFICULTIES OPENING AND CLOSING. THE VALVE WAS EXPLANTED AND UPON EXPLANT, THE LEAFLETS WERE TESTED AGAIN AND THE ISSUE PERSISTED. THE PATIENT WAS NOT TAKING ANTITHROMBOTIC MEDICATION. THE VALVE WAS EXCHANGED FOR A NEW 19MM REGENT AORTIC MECHANICAL HEART VALVE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191415 ↗
• MalfunctionDec 10, 2024Physical Resistance/Sticking; 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. DURING PROCEDURE, ON BUBBLE STUDY IT WAS NOTED THAT THE VALVE WOULD NOT OPEN AND CLOSE SMOOTHLY. THE VALVE WAS REMOVED AND A NEW NON-ABBOTT VALVE WAS CHOSEN. THE VALVE WAS REPLACED AND COMPLETED THE PROCEDURE SUCCESSFULLY WHILE PATIENT 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 RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889052 ↗